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3.533zm.697-5.133c.116 0 .29.066.29.266 0 .267-.232.467-.406.467-.116 0-.233-.067-.233-.267-.058-.333.117-.466.349-.466zM133.19 42.8c-.696 0-1.335-.467-1.335-1.467 0-1.466 1.103-2.2 2.032-2.2.696 0 1.335.534 1.335 1.467 0 1.467-.987 2.2-2.032 2.2zm.058-.467c.697 0 1.451-.466 1.451-1.666.058-.667-.406-1.067-.928-1.067-.639 0-1.451.6-1.451 1.667 0 .733.464 1.066.928 1.066zM136.15 39.2c.523-.133.813.067.755.6.29-.467.755-.667 1.22-.667.812 0 1.102.667.986 1.534L138.879 42c-.058.333-.058.467.29.4l-.058.4c-.58.133-.87 0-.755-.8l.233-1.333c.116-.667-.175-1.067-.697-1.067s-.987.4-1.103 1.067l-.406 2.066h-.523l.465-2.533c.116-.533.174-.733-.29-.667l.116-.333zM140.272 41.733c-.058.534.348.6.812.6.407 0 .93-.2.987-.6.058-.4-.232-.533-.754-.6-.523-.066-1.161-.266-1.161-.866 0-.8.754-1.2 1.509-1.2.638 0 1.219.333 1.103 1h-.465c.058-.4-.29-.534-.696-.534-.406 0-.929.2-.929.667 0 .267.29.4.755.467.638.066 1.277.266 1.103 1.133-.116.733-.813 1-1.568 1.067-.696 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class="sf_colsIn col-md-8 pl-0" data-sf-element="Column 1" data-placeholder-label="Column 1"> <div > <div class="sfContentBlock sf-Long-text" ><h1>Posters</h1></div> </div> </div> <div id="Main_C010_Col01" class="sf_colsIn col-md-4 pr-0 text-right" data-sf-element="Column 2" data-placeholder-label="Column 2"> <div > <div class="sfContentBlock sf-Long-text" ></div> </div> </div> </div> <div class="row" data-sf-element="Row"> <div id="Main_C006_Col00" class="sf_colsIn col-md-12" data-sf-element="Column 1" data-placeholder-label="Column 1"> <script> window.mgConfexProgramConfig = window.mgConfexProgramConfig || {}; window.mgConfexProgramConfig.dateLinks = [{"url":"https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/posters/poster-detail/intl2023-3665","activeClass":"active","title":"Poster Session 1","date":"Mon, May 8"},{"url":"https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/posters/poster-detail/intl2023-3666","activeClass":"","title":"Poster Session 2","date":"Mon, May 8"},{"url":"https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/posters/poster-detail/intl2023-3667","activeClass":"","title":"Poster Session 3","date":"Tue, May 9"},{"url":"https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/posters/poster-detail/intl2023-3668","activeClass":"","title":"Poster Session 4","date":"Tue, May 9"},{"url":"https://www.ispor.org/conferences-education/conferences/past-conferences/ispor-2023/program/posters/poster-detail/intl2023-3669","activeClass":"","title":"Poster Session 5","date":"Wed, May 10"}]; </script> <script> window.confexData = [{"title":"Use of Patient-Reported Outcomes As Key Drivers in Cost-Effectiveness Models: A Review of UK National Institute for Health and Care Excellence Health Technology Assessments","id":"aa188f58-ca74-4666-8d12-00269a2c5596","sessionCode":"EE101","topDisplay":"Dong O1, Manga N2, Zhong Y3, Zhang Y3, Krause T4, Griffin J1, Herring W1, Wolowacz S2 1RTI Health Solutions, Research Triangle Park, NC, USA, 2RTI Health Solutions, Manchester, UK, 3Bristol Myers Squibb, Lawrenceville, NJ, USA, 4Bristol Myers Squibb, London, UK","locationCode":"402","description":"\r\n\t<div>OBJECTIVES: The use of patient-reported outcomes (PROs) in cost-effectiveness models (CEMs) is not well understood. Our objective is to review the use of PROs as key drivers in the CEMs submitted to the United Kingdom National Institute for Health and Care Excellence (NICE). METHODS: We searched NICE health technology assessments (HTAs) from January 2016 through August 2022; three reviewers independently screened HTAs. HTAs were included if CEMs submitted by manufacturers contained a PRO as a key driver via the model structure (e.g., health state definition), treatment-effect parameters, treatment-stopping rules, or condition-specific utility measures from key trials. HTAs were excluded if they were terminated or were reviews. Oncology indications routinely rely on non-patient-reported endpoints and were excluded. RESULTS: Of 428 HTAs reviewed, 26 (6.1%) met the eligibility criteria. Indications included diseases of the musculoskeletal system and connective tissue (n=10, 38%), nervous system (n=6, 23%), respiratory system (n=3, 12%), skin and subcutaneous tissue (n=3, 12%), and others (n=4, 15%). All indications but one (heart failure) have been recognized as PRO-dependent diseases, which mainly use PRO endpoints for regulatory review of treatment benefit. PROs were included in the CEMs submitted to NICE via treatment-effect parameters (n=25, 96%), the model structure (n=24, 92%), treatment-stopping rules (n=21, 81%), and condition-specific utility measures from key trials (n=15, 58%). For 16 HTAs (62%), key PRO drivers in the CEMs were primary trial endpoints. CONCLUSIONS: Several recent NICE HTAs have used PROs as key drivers in CEMs. Most of these HTAs were for PRO-dependent diseases. When used, PROs were more likely to be incorporated in CEMs via treatment-effect parameters, the model structure, and treatment-stopping rules. Key PRO drivers in the CEMs were primary trial endpoints in most of the HTAs. Including PROs as key CEM drivers may be important in more fully reflecting the patient voice in HTA.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23dongposteree101v4123414-pdf.pdf?sfvrsn=5dd89216_0","title":"ISPOR23_Dong_POSTER_EE101_v4123414.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123414","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Utility of “Single Exposure” Versus Causal Architecture Approaches in Real-World Research","id":"353c6b4d-8275-4b85-864b-00394e199e17","sessionCode":"SA6","topDisplay":"Osterland A1, Dye J1, Annavarapu S1, O'Sullivan A2, Amirian ES1 1Ontada, Irving, TX, USA, 2Ontada, Las Colinas, TX, USA","locationCode":"906","description":"\r\n\t<div>Over recent decades, epidemiologic methodology has evolved substantially to encompass a gamut of techniques for focalizing on the most unbiased effect estimate of a single exposure (e.g., a treatment effect). By contrast, less attention has been paid to the refinement of study designs and analytic techniques intended to encompass the underlying milieu of co-occurring clinical, environmental, and social determinants that interactively influence disease risk or outcomes. Single exposure approaches (i.e., the “potential outcomes framework”) have been criticized as being reductionist and have long been debated in the broader epidemiologic community, despite the utility of this approach in optimizing internal validity. Further, the gap between clinical trial efficacy and real-world (RW) effectiveness remains a concern for both regulatory entities and payers, though this gap may be partly attributable to varying prevalences of important effect modifiers between trial and RW patient populations. This conceptual paper will expand upon the existing conceptual paradigms by applying them to RW research and delineating key considerations related to assessing whether a single exposure or causal architecture approach would be fit-for-purpose based on the overarching research question. Drawing upon examples from RW research types, such as use of external control groups, comparative effectiveness, and prediction of likely responders to treatment, the strengths and weaknesses of each approach will be demonstrated using case studies related to regulatory and/or payer decision-making. Methodologic recommendations will be provided. Ultimately, both single exposure and causal architecture approaches to study design and analysis have a place in pharmacoepidemiology and real-world research. A careful examination of when each approach is fit-for-purpose can lead to the application of innovative strategies to the design and conduct of RW studies.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23osterlandposter126337-pdf.pdf?sfvrsn=504d5551_0","title":"ISPOR23_Osterland_POSTER126337.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126337","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Variation in Health Technology Assessments for Nivolumab Plus Chemotherapy Vs Chemotherapy in First-Line Gastric Cancer","id":"c6fc8bf8-f48a-4fab-9d54-007968020e6e","sessionCode":"HTA5","topDisplay":"Bertwistle D1, Casabianca P2, Donvovan L3, Huetson P†4, Okorogheye G5, Theodorou E6, Vezina E7, Villeneuve J7, Yoon MR8 1Bristol Myers Squibb, Uxbridge, LON, UK, 2Bristol-Myers Squibb, Paris, 75, France, 3Bristol Myers Squibb, Mulgrave, VIC, Australia, 4Bristol Myers Squibb AB, Solna, Sweden, 5Bristol-Myers Squibb Pharmaceutical Ltd, Uxbridge, UK, 6Bristol Myers Squibb, London, UK, 7Bristol Myers Squibb, St. Laurent, QC, Canada, 8Bristol Myers Squibb, Virum, Denmark","locationCode":"610","description":"\r\n\t<div>OBJECTIVES: Health technology assessments (HTAs) inform reimbursement decisions. International differences in HTA processes lead to international differences in patient access to new treatments. Using HTAs for nivolumab plus chemotherapy in first-line gastric cancer as an example, we quantified the variation in time to patient access and in the evaluation of benefits between different HTA agencies. METHODS: We compared time to patient access using three measures, time from regulatory approval to reimbursement, time from regulatory approval to HTA submission and time from HTA submission to reimbursement. We compared HTA evaluation of benefits using the incremental QALY (ΔQALY) for the CM-649 trial direct comparison, nivolumab plus fluoropyrimidine and platinum chemotherapy vs fluoropyrimidine and platinum chemotherapy. Comparisons were also made between ΔQALYs submitted vs those accepted for each HTA agency. RESULTS: Time from regulatory approval to reimbursement varied from 0 to 13 months (n=11). Several countries have yet to reimburse, so the maximum time will be longer. Time from regulatory approval to HTA submission varied from -11 months to +12 months (n=16). Time from HTA submission to reimbursement varied from -9 to +22 months (n=8), with several countries yet to achieve reimbursement. For the HTA agencies for which details of the accepted ΔQALY were available (n=5), submitted ΔQALYs varied from 0.395 to 1.039, while the difference between the submitted and accepted ΔQALYs varied from – 47% to + 8%. CONCLUSIONS: Considerable variation was observed in time to patient access and evaluation of benefits. Variation in time to patient access was driven by differences in HTA and reimbursement processes. Submitted ΔQALYs varied partly due to differences in patient populations and database locks between submissions, but also due to differences in HTA agencies’ methodological preferences. Variation in submitted vs accepted ΔQALYs were mainly due to differences in the changes HTA agencies made to overall survival extrapolations.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bertwistleposter126282-pdf.pdf?sfvrsn=6c501319_0","title":"ISPOR23_Bertwistle_POSTER126282.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126282","diseases":[{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Diagnosing Irritable Bowel Syndrome (IBS): A Real-World Study to Assess Resource Utilization","id":"9b470e4e-56c5-40b9-95e4-01fc512cd895","sessionCode":"EE12","topDisplay":"Cherry L1, Salt II WB2, Magar R3 1AHRM Inc., Buffalo, NY, USA, 2IBS and Gut Microbiome Solutions, Dublin, OH, USA, 3AHRM Inc., Raleigh, NC, USA","locationCode":"214","description":"\r\n\t<div>OBJECTIVES: IBS is a common gastrointestinal disorder affecting over 10% of the US population. Accurately diagnosing IBS with current available invasive tests may be difficult since the focus is to rule out alarm features. Patients are subjected to invasive diagnostic tests that are costly and may not provide additional information. A real-world study has been initiated to evaluate the impact of a non-invasive 2nd generation blood test and breath test in terms of reducing the need for further testing and directing treatment vs control. The present analysis reports on 39 control subjects being seen by a gastroenterologist. METHODS: A medical records review of subjects presenting with GI symptoms for IBS-D/M or C were considered for inclusion into the study. Patient-level data for contacts, diagnostic tests, and medications are being captured between 2017 to present. Sample size of approximately 200 subjects from 2 gastroenterologists are currently being enrolled. Groups include control, subjects who have utilized a 2nd generation blood, ibs-smart®, trio-smart® breath test or both tests together are also being enrolled. RESULTS: Thirty-nine control group subjects are included in this analysis. The mean age was 59.5 years old, 77% female. Patients had an average of 2.8 tests with over 60% of patients having a diagnostic test more than one year after their first office visit. Over 60% of patients had a Colonoscopy, Upper Endoscopy, or Lactulose Breath Test. Less frequent tests include Capsule Endoscopy, C-Reactive Protein, Celiac Panel , first generation blood test for IBS and CT Scan. CONCLUSIONS: Colonoscopy and other invasive tests continue to be utilized adding to costs and discomfort of patients. Novel non-invasive blood and breath tests are currently being evaluated (sample too small to report) show promise in terms of reduction of downstream invasive testing and targeted treatment which may lead to lower system costs and accurate diagnosis.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ibs-smart-ispor-2023-production-copy127726-pdf.pdf?sfvrsn=af72dd83_0","title":"IBS Smart ISPOR 2023 Production Copy127726.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127726","diseases":[{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Prognostic Factors and Effect Modifiers in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma Who Failed at Least 2 Prior Lines of Therapy: A Systematic Literature Review","id":"45cda89b-a0a6-43d6-be5c-0229f608c02b","sessionCode":"SA4","topDisplay":"Kuang Y1, Cantos K2, Rashidi E3, Uyei J1, Archambault A4, Xu Y5, Hampp C4, Ma Q6, Jalbert J5, Ambati S4, Mohamed H4 1IQVIA, Inc., San Mateo, CA, USA, 2IQVIA, Inc., Boston, MA, USA, 3IQVIA, Inc., Los Angeles, CA, USA, 4Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA, 5Regeneron Pharmaceuticals, Inc, Sleepy Hollow, NY, USA, 6Regeneron Pharmaceuticals, Inc, Oak Park, CA, USA","locationCode":"908","description":"\r\n\t<div>OBJECTIVES: The treatment landscape is rapidly evolving for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL); however, prognostic factors and effect modifiers in later line settings in DLBCL have not been assessed systematically. This systematic literature review (SLR) was conducted to identify prognostic factors and effect modifiers in adult patients with r/r DLBCL who failed at least 2 prior lines of therapy (3L+). METHODS: An SLR was performed following Cochrane and PRISMA guidelines. MEDLINE, Embase, and CENTRAL were searched for articles published from 2016 through 2021, supplemented by conference abstract review, forward-citation searches, and bibliography review of key publications. Clinical trials and observational studies evaluating prognostic factors or effect modifiers for clinical outcomes were included. RESULTS: Among 2,269 records identified from the literature search, a total of 46 studies were included (9 trials and 37 observational studies). Thirty-six prognostic factors had statistically significant associations (p <0.05) with 7 outcomes. Overall survival (OS) was the most frequently evaluated outcome (38 studies), followed by progression-free survival (PFS; 22 studies), and objective response rate (8 studies). Among identified prognostic factors, higher Eastern Cooperative Oncology Group score, older age, having (primary) refractory disease, not achieving response to current or prior therapy, higher international prognostic index composite score, and elevated lactate dehydrogenase levels were associated with worse outcomes in ≥ 5 studies (OS: 29; PFS: 13; others: 8). None of the studies identified statistically significant effect modifiers for the population of interest. CONCLUSIONS: To the best of our knowledge, this SLR is the first to provide a comprehensive assessment of prognostic factors for 3L+ r/r DLBCL. No statistically significant effect modifiers were identified. Knowledge about important prognostic factors is critical for selecting and prespecifying variables for confounding adjustment and can support robust comparative analyses between real-world studies and clinical trials.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/regeneron-iqviaslr-on-dlbclispor-poster2023-04-21final125897-pdf.pdf?sfvrsn=a2cc4565_0","title":"Regeneron-IQVIA_SLR on DLBCL_ISPOR Poster_2023-04-21_final125897.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125897","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Impact of Health Literacy on Health-Related Quality of Life: A Cross-Sectional Study in Hong Kong","id":"dde97c0c-9147-4abd-a6bc-028a1518e244","sessionCode":"PCR44","topDisplay":"Tian Y1, Wong E1, Mo PKH1, Dong D2, Zhong C3, Cheung AWL1 1The Chinese University of Hong Kong, Hong Kong, Hong Kong, 2The Chinese University of Hong Kong, Shatin, China, 3The Chinese University of Hong Kong, Hong Kong, China","locationCode":"805","description":"\r\n\t<div>OBJECTIVES: Health literacy (HL) is increasingly recognized as an important determinant of health outcomes, as it links a person’s ability to process and use health-related information and make informed decisions. However, evidence on the association between HL and health-related quality of life (HRQoL) remains inconsistent. This study aimed to investigate the association between HL and its three domains (i.e., functional, interactive, and critical) and HRQoL among Chinese Hong Kong adults. METHODS: A cross-sectional study using quota sampling was conducted between August and September 2022. Standardized online questionnaires were administrated to a web panel. A validated Hong Kong version of HL scale was used to measure HL. HRQoL was assessed using the EQ-5D-5L. Descriptive statistics, Chi-square tests, and Tobit regression were performed. RESULTS: Of 401 participants 47.1% were males, 36.4% were aged 55 or above, and over half (52%) had inadequate HL skills. Gender and monthly household income were significantly associated with HL. 47.9% of the respondents reported having some problems with Anxiety/depression, followed by Pain/discomfort (26.9%) and mobility (10.7%). The mean EQ-5D index value was 0.91. Overall, inadequate HL was associated with poor HRQoL (coef. = 0.095, p < 0.001) after adjusting for age, gender, education, income, and chronic disease condition. In the analysis of individual domains of HL, people with adequate functional (coef. = 0.049, p = 0.029) and interactive HL (coef. = 0.119, p < 0.001) were more likely to have good HRQoL; such associations were not found for critical HL. CONCLUSIONS: This is the first study describing the association between HL and HRQoL in Hong Kong. The results indicate that inadequate HL was associated with worse HRQoL and different domains of HL vary in their association with HRQoL. Initiatives for improving people’s HRQoL may be improved by paying attention to people’s HL, specifically functional and interactive HL.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/pcr44125369-pdf.pdf?sfvrsn=22fab6b_0","title":"PCR44125369.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125369","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Burden of HPV-Associated Cancers Among Men in Ecuador, 2015-2019","id":"d6df1823-c103-4c49-89fd-0311ec54252a","sessionCode":"EPH30","topDisplay":"Sanchez X1, Jimbo R1, Parellada C2, Hernández F3, Diaz Puentes M3, Beltran C4, Puertas L3, Orengo J5 1Pontificia Universidad Católica del Ecuador, Quito, Ecuador, 2MSD Brazil, São Paulo, SP, Brazil, 3IQVIA, Bogota, Colombia, 4MSD Colombia, Bogota, Colombia, 5MSD (IA) LLC, Guaynabo, Puerto Rico, Coamo, PR, USA","locationCode":"430","description":"\r\n\t<div>OBJECTIVES: In Latin America, the human papillomavirus (HPV) attributable fraction (AF) in cancers of the penis, anus, and head and neck (H&N) are estimated in 50%, 88%, and 25%, respectively. The HPV-AF of these cancers could be eliminated if HPV infection is prevented (e.g.vaccination). In Ecuador, the HPV vaccination program targets only 9-10-year girls. Since data on HPV-associated cancer burden in men are not available in Ecuador, we assessed real-world evidence using local databases. METHODS: This was a retrospective observational study using the national hospital discharge and mortality databases of Ecuador. All hospitalizations for cancers most likely to be HPV-associated (penis, anus, and selected sites of head and neck [oropharynx/oral cavity/larynx]) in men ≥ 18years were identified using the International Classification of Diseases (ICD-10) from 2015 to 2019. The main variables were hospitalization rate, length of stay (LOS), age at discharge, and mortality rate. The mortality rate was calculated using the male population at risk. RESULTS: From 2015-2019, 4,880 hospitalizations occurred among men with anal/penile/selected H&N cancers (on average 976 hospitalizations/year). The average hospitalization rate combined for all these cancers were 18.4/100,000. The average LOS was 5.8, 6.8, 6.1, 6.6, 5.6 and 5.9 days for anal, penile, H&N, larynx, oral cavity and oropharynx respectively. The mean age (±SD) at hospitalization was 59.3(±15.6), 58.2(±17.3), 61.7(±14.0), 64.5(±12.7), 61.2(±15.0) and 58.3(±13.8) for anal, penile, H&N, Larynx, oral cavity and oropharynx respectively. Overall cancer mortality for all cancers studied was 2.5 deaths/ 100,000 men, totalizing 1,162 deaths. The mortality rate for anal, penile, H&N, larynx, oral cavity and oropharynx was 0.1/100,000, 0.5/100,000, 1.9/100,000, 1.0/100,000, 0.4/100,000 and 0.5/100,000 respectively. CONCLUSIONS: Local databases provided valuable real-world evidence on the use of hospital resources and the burden of HPV-associated cancer in men. Considering local/regional HPV-AF, estimates can be obtained to inform health public policies in men.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/20230424isporeposterecuadorfinalversion125110-pdf.pdf?sfvrsn=ef231e6_0","title":"2023_04_24_ISPOR_ePoster_Ecuador_final_version125110.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125110","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Defining Colorectal Cancer Recurrence with Structured-Health Data Algorithms: A Targeted Literature Review","id":"0ceeb3cb-d2d1-4b57-b61b-03841f0a90cb","sessionCode":"SA5","topDisplay":"Cheng S1, Veenstra D2, Bansal A2 1University of Washington, Kirkland, WA, USA, 2University of Washington, Seattle, WA, USA","locationCode":"909","description":"\r\n\t<div>OBJECTIVES: Roughly 50% of patients with colorectal cancer (CRC) experience recurrence within 2 years of surgical resection. Population-level real-world data often lacks recurrence status, making it difficult to adequately classify patients. Several algorithms have been developed to detect progression, metastasis, and recurrence in structured-health data, but methods and validation vary, thus potentially misclassifying patients and leading to inconsistent results dependent on the algorithm used for outcomes research. This review aimed to identify current approaches to developing and validating structured-health data algorithms used to define disease recurrence in patients with CRC. METHODS: A targeted literature review was performed in PubMed (MEDLINE) database. Observational or validation studies that utilized administrative claims, EMR/EHR, or cancer registries to define or estimate recurrence status and published within the past 10 years were included if they were the original source of the algorithm. Model type, algorithm components, and performance (specificity, sensitivity, positive predictive value, negative predictive value) were reported. Algorithms were classified by recurrence components, (secondary malignancy codes, treatment/procedure codes, or combination of both) and compared. RESULTS: A total of 128 papers were identified in PubMed and manual searches and six studies were included in the final review. Two studies did not validate the algorithm against a gold standard (chart review). The specificity was generally high across all validated algorithms (79-100%). Sensitivities were highly variable between and within model type and components (13-83%). The algorithm with the highest sensitivity was a rule-based model with secondary malignancy and treatment/procedure codes. CONCLUSIONS: Recent algorithms used to estimate CRC recurrence using population-level health data are limited in number and heterogenous. All validated algorithms had high specificities, but sensitivities were variable. The reported low sensitives could result in an underestimation of CRC recurrence. There is a need for standardization of detection algorithms with improved performance to accurately identify this patient population in real-world data.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23chengposter123698-pdf.pdf?sfvrsn=f5a2ec1e_0","title":"ISPOR23_Cheng_POSTER123698.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123698","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Epidemiology Description, Treatment Patterns, Resource Utilization and Biomarker Testing of Metastatic Triple Negative Breast Cancer (TNBC) Patients in Costa Rica","id":"85e65e00-0123-4f99-9893-03bd9a981dec","sessionCode":"RWD15","topDisplay":"Beltran C1, Rosado A1, Garcia MDL2, Urrego-Reyes J3, Chacin N4, Rendon AM5 1Merck Sharp & Dhome, Bogota, CUN, Colombia, 2Links & Links, Ciudad de Mexico, DF, Mexico, 3MSD Colombia, Bogota DC, CUN, Colombia, 4MSD Colombia, Bogota, Colombia, 5MSD Central America, Panama city, Panama","locationCode":"822","description":"\r\n\t<div>OBJECTIVES: This research aims to explore metastatic (stage IV) TNBC epidemiology, clinical data, biomarker use, anticancer therapy, Healthcare Resource Utilization (HCRU), cost of healthcare, and Local Burden of Disease (LBD) in adult female population within Costa Rican public health sector. METHODS: Study population were patients with metastatic stage TNBC treated during 2019 full year. Data from Costa Rican public health system official and available sources (ICD 10 C 50 encoded records from National Registry of Tumors and National Social Security Fund), as well as local review of the medical literature, were used to estimate metastatic (stage IV) TNBC epidemiology, clinical profile, HCRU, costs of treatments and healthcare tariff. A Delphi Panel of physicians was developed to build the processes of diagnosis, healthcare, and specific treatments of metastatic TNBC. Finally, cost analysis and estimation of the LBD in the Costa Rican National Social Security Fund was performed. RESULTS: In 2019 there were 284 incident cases of TNBC (18.38% from total breast cancer), where 27.5% were in. women <50 years. Stage IV represented 8.94% of total incident TNBC (25 cases). Stage IV deaths were 30.9% of all TNBC mortality. Determination of HR and HER2 was carried out in >90% of cases. Other biomarkers were used <10% (BRCA, PD-L1/PD-1, NTRK, MSI-H/dMMR, CK, EGFR). Metastatic stage treatment was anthracyclines as mono drug (25%), anthracyclines+taxanes (25%) and taxanes only (40%). Other drugs were used in ≤10%. Disability Adjusted Life Years (DALYs) per capita estimated for stage IV were 31.70. CONCLUSIONS: TNBC is a growing disease over time. Its lethality is notorious with an incremental mortality of approximately 15% (stage IV mortality rate of 0.84 x 100 thousand). HR and determination of HER2 are fully available, however other biomarkers are not routinely used.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23beltranposter127052-pdf.pdf?sfvrsn=44297fcc_0","title":"ISPOR23_BELTRAN_POSTER127052.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127052","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Implementing Prefilled Sterile Syringes in the Peads Emergency Department of Tertiary Care Hospital, Pakistan: A Novel Approach to Enhance Medication Safety","id":"0cbef327-aaa0-4259-9f56-04034893c8cd","sessionCode":"CO31","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"131","description":"\r\n\t<div>OBJECTIVES: The aim of this study was to evaluate the efficacy of selected ready-to-administer prefilled sterile syringes (PFSs) in reducing time of medication administration in critically ill pediatric patients in the emergency department (ED) of tertiary care hospital, Karachi, Pakistan. METHODS: This was a quasi-experimental study done on the quality project from July 2017 to Sept 2017 in the Emergency Department of a tertiary care hospital of Karachi, Pakistan. This project was implemented by adopting PDSA methodology. In this study, mean reduction in IV medication administration time was studied. Three most frequently used peads emergency medications were selected in particular strengths for the pilot as ready-to-administer prefilled sterile syringes i-e magnesium sulphate syringe 5mg/2ml, 3% hypertonic saline 150 ml piggyback, and paracetamol syring 200mg/20ml. Pre and post intervention data was collected and analyzed inferentially in SPSS by using paired sample t-test. RESULTS: The mean reduction in dose administration time from 156 seconds to 34.5 seconds (95% CI, 112.9 to 129.4) for magnesium sulphate syringe 5meq/2ml and mean reduction in dose administration time from 304 seconds to 45 seconds (95% CI, 236.4 to 281.4) for paracetamol syring 200mg/20ml was observed. Inferentially the mean reduction in time was significant i.e.p&lt;0.05 after implementing both prefilled syringes. CONCLUSIONS: Implementing ready-to-administer sterile prefilled syringes in peads emergency patients not only significantly reduces the medication administration time but it is also a good strategy to enhance patient safety in pediatric population. It has a potential to improve throughput in Emergency department. Therefore, prefilled sterile syringes use should be routinely employed.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127668","diseases":[{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluating the Impact of Antibiotic Duration on Superinfection after Controlling for Cumulative Spectrum Scores","id":"983e89d9-6d31-496e-88ca-05e1db031ef8","sessionCode":"CO13","topDisplay":"Park T St. John's University, Queens, NY, USA","locationCode":"116","description":"\r\n\t<div>OBJECTIVES: To examine the impact of antibiotic duration on the risk of superinfection (SI) development after adjusting for a cumulative antibiotic spectrum score (CASS). METHODS: This was a retrospective cohort study using data (2010-2017) from a tertiary care hospital in the US. Adult patients with severe sepsis or septic shock who received at least one antibiotic were included. Based on the calculated spectrum scores for every antibiotic, a CASS was estimated for each day of antibiotic exposure. Duration of antibiotic exposures was classified into four groups (group 1: 1-3 days, group 2: 4-7 days, group 3: 8-10 days, group 4: 11-14 days). The outcome was the development of a superinfection (multi-drug resistant bacteria, Clostridioides difficile, or Candida species) > 3 days after cohort entry. Cox proportional hazard regressions were conducted to calculate the adjusted hazard ratio (HR) of SIs while controlling for numerous covariates including a CASS. RESULTS: Of 10221 patients included in the analysis, 2107 (20.6%) developed a superinfection. The incidence rate of a superinfection was 0.495 per 100 person-days. Compared to those with no SI, the SI cohort was in more serious conditions (APACHE score: 17.0±5.8 vs. 16.2±5.7, p < 0.001) and had higher comorbidities (Charlson score: 6.2±3.1 vs. 6.0±3.3, p = 0.047). After cohort entry, patients with SI were found to have increased days of exposure to mechanical ventilation (mean difference [MD] 0.90 days, 95% CI: 0.35-1.44), urinary catheters (MD 0.72 days, 95% CI: 0.18-1.27), and vasopressors (MD 0.59 days, 95% CI: 0.17-1.01) than those with no SI. The adjusted HRs of SIs were 2.520 (95% CI: 1.533-4.141), 2.458 (95% CI: 1.191-5.074), and 1.792 (95% CI: 0.486-6.601) for group 2, 3, and 4, respectively, compared to group 1. CONCLUSIONS: The risk of SIs increased as the duration of antibiotic exposures increased, which supports the utility of antibiotic de-escalation strategy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23parkposter125564-pdf.pdf?sfvrsn=4d47793c_0","title":"ISPOR23_Park_POSTER125564.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125564","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Optimal Gonorrhea Control through Vaccination and Screening: A Mathematical Modeling and Cost-Effectiveness Study","id":"3026427b-f0f9-49f6-be2d-05fcf0f804c7","sessionCode":"EE97","topDisplay":"Williams A1, Gromov D2, Spicknall IH1, Romero-Severson EO3 1Centers for Disease Control and Prevention, Atlanta, GA, USA, 2University of Latvia, Riga, Latvia, 3Los Alamos National Laboratory, Los Alamos, NM, USA","locationCode":"340","description":"\r\n\t<div>OBJECTIVES: Gonorrhea rates have increased 111% in the U.S. since 2009, and gonorrhea’s ability to rapidly develop antimicrobial resistance has left clinicians with few options for treatment. Recent observational studies have suggested that a serogroup B meningococcal vaccine may also be partially effective against gonococcal infection. In this paper, we calculate the dynamic optimal mixture of vaccination and screening interventions for population-level gonorrhea control. METHODS: We modeled the transmission of gonorrhea in a heterosexual population of 100,000 individuals over 10 years. Each year, patients could be vaccinated or enrolled in a quarterly screening program until an annual budget constraint was reached. Baseline transmission dynamics were determined by behavioral and biological factors parameterized from existing literature. We estimated costs of enrollment and participation in the gonorrhea vaccination and/or screening programs. A recently developed numerical method was used to compute the optimal combination of vaccination and screening by sex and enrollment modality (i.e., background screening versus symptomatic STI clinic visits) over the 10-year study period that minimized gonorrhea incidence. RESULTS: Under the baseline scenario, the optimal solution allocated the entire budget towards vaccinating males. Over the 10-year study period, >8,100 cases of gonorrhea were averted ($370 per case averted). This was consistent across sensitivity analyses, except for two scenarios (decreasing screening cost; decreasing vaccine protection duration) that resulted in a combination of vaccination and screening, with female screening predominantly replacing male vaccination after year 6. Under a scenario without vaccination (only screening was available), ~3,500 fewer infections were averted and ~1,500 more courses of antibiotics were administered. CONCLUSIONS: A currently available vaccine, though modestly effective, may be preferable to frequent testing for the control of gonorrhea. This project illustrates the substantial value of the option to vaccinate for gonorrhea prevention. Dynamic optimal control models can yield practical insights for infectious disease prevention.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ngdocpispor126020-pdf.pdf?sfvrsn=e1d39bc1_0","title":"NG_DOCP_ISPOR126020.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126020","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"},{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Preliminary Assessment of Sample Size As a Search Strategy Filter on Embase.Com in Targeted Literature Searches","id":"5f3b8300-ddc2-47fe-a8ca-06a8e6c385c9","sessionCode":"MSR10","topDisplay":"Mangat G, Saipriya J, Sharma S Parexel International, Mohali, India","locationCode":"647","description":"\r\n\t<div>OBJECTIVES: Studies with small sample sizes are generally unreliable and should be interpreted considering the disease context and available evidence. It is accepted practice to remove such studies during synthesis in reviews with substantial evidence. We analyzed the use of a sample size filter to allow removing these studies during the search strategy phase. METHODS: The sample size is generally reported in the published abstract. A filter consisting of truncated numbers in proximity with keywords like patients, controls, adults, pediatrics, males, females, men, etc., and phrases like 'n:,' 'n=*' was developed. These filters were combined with disease terms of five oncology indications to establish reproducibility. The search was focused on epidemiology, as the sample size is an essential criterion for such reviews. Lastly, the filter was validated against published literature reviews on the same five indications that used sample size as a restriction but did not limit their search to study size. RESULTS: The search resulted in 1489, 1612, 2108, 2431, and 1903 numbers needed to screen (NNS) for mesothelioma, melanoma, follicular lymphoma, gastric, and endometrial cancer, respectively. After applying the filter, the NNS was reduced by 33-48%. Despite the reduction of NNS, the search retrieved some non-relevant studies, such as studies mentioning years, percentages, specific numbered biomarkers, or the performance status of patients. We observed that it was challenging to retrieve older studies as previous reporting standards didn't recommend mentioning the sample size in abstracts. However, this gap can be covered through manual searching or restricting this filter's use in reviews to retrieve the latest evidence. The filter's sensitivity was 78-91% (mesothelioma: 87%, melanoma: 91%, follicular lymphoma: 84%, gastric cancer: 78%, and endometrial cancer: 82%). CONCLUSIONS: The search filter would need further refinement and testing. However, it significantly reduces the NNS and can be considered in targeted reviews with sample size restriction.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gsinghmsr10poster126761-pdf.pdf?sfvrsn=ceafc50a_0","title":"ISPOR23_GSingh_MSR10_POSTER126761.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126761","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"International Comparisons of Health Technology Assessment and Reimbursement Outcomes for Oncology Drugs with Regulatory Review through Project Orbis","id":"28a2c8a9-04c8-4913-8f78-071f1bf176c7","sessionCode":"HPR161","topDisplay":"Beca J, Scott K, Gosselin S, Ajrawat P, Thon J, Lee SM MORSE Consulting Inc., Toronto, ON, Canada","locationCode":"508","description":"\r\n\t<div>OBJECTIVES: Project Orbis is an international regulatory collaboration led by the US Food and Drug Administration (FDA) Oncology Center of Excellence. It represents a framework for concurrent submission and review of oncology products, with the aim to give patients faster access to promising cancer treatments. However, products with limited clinical evidence can pose challenges for health technology assessment (HTA) and public-payer decisions. We examined HTA and reimbursement outcomes for Project Orbis drugs reviewed in Canada and other jurisdictions globally from program inception in 2019 to end of 2022. METHODS: We identified all Project Orbis drugs approved by Project Orbis partner jurisdictions: Canada, Australia, and UK. We collected all related HTA recommendations and reimbursement outcomes for all three countries plus two other EU jurisdictions: France and Germany until Mar/2023. Using publicly available information, we collected clinical details that might affect decision-making, including level of evidence assessed and disease context to identify trends. We determined concordance in regulatory approvals, HTA recommendations and funding across jurisdictions and compared timelines where possible. RESULTS: Most drug-indications approved through Project Orbis by the US were approved by Canada (49, 72%), or Australia (42, 62%). International consistency was more limited, with 37 (55%) approved by both Canada and Australia, and 11 (16%) by Canada, Australia and UK. Only 30% of approved drug-indications had completed HTA in Canada within 6 months of regulatory approval despite availability of parallel regulatory-HTA review. Of drug-indications with Canadian and Australian approvals and 6+ months follow-up, 68% had initial HTA outcomes across both jurisdictions. CONCLUSIONS: We present evidence assessing whether Project Orbis is delivering on its intent to facilitate access to oncology therapies in jurisdictions around the world. We provide insights into health-system context, HTA recommendations and reimbursement decision-making internationally for therapies that have been granted expedited regulatory approval with potentially high uncertainty.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23becaposterv2127056-pdf.pdf?sfvrsn=e5093974_0","title":"ISPOR23_Beca_POSTERV2127056.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127056","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Coding Trends of Single Gene and Next Generation Sequencing Tests for Patients with Advanced Non-Small Cell Lung Cancer Using a EHR-Linked Claims Database","id":"0787942f-6b42-4c6b-b338-076c82ebfa66","sessionCode":"RWD35","topDisplay":"Abbass I1, To TM2, Sheinson D3, Wong W2, Ross R4, Ogale S5 1Genentech Inc., South San Francisco, CA, USA, 2Genentech, South San Francisco, CA, USA, 3Genentech, La Jolla, CA, USA, 4Genesis Research, New York, NY, USA, 5Genentech, Inc., South San Francisco, CA, USA","locationCode":"843","description":"\r\n\t<div>OBJECTIVES: Coding, billing and reimbursement complexities limit use of claims data in assessing real-world biomarker testing, both single gene test (SGT) and next-generation sequencing (NGS). Using an electronic health record (EHR) database linked to claims, and EHR as the gold standard, we assessed the impact of different reimbursement coding algorithms on identifying biomarker tests in claims over time. METHODS: Biomarker tests for patients with aNSCLC were identified from the nationwide Flatiron Health EHR –derived de-identified database (results date between 2013-2021) linked to Komodo Health’s Healthcare Map of de-identified patient-level claims data. For every documented NGS and SGT test in Flatiron Health, a ∓ 30 day period from the results date was employed to identify any biomarker testing claim (matching claim). Tests were identified using a combination of Proprietary Laboratory Analyses (PLA) and Current Procedural Terminology (CPT) codes. A hierarchical algorithm to identify tests was developed in which highly specific codes superseded less specific codes. RESULTS: There were 16,770 SGT and 2,873 NGS tests identified in EHR among 5,390 patients. The matching rates of tests in EHR to claims were 71% and 77% for NGS and SGT, respectively, using the broadest algorithm. NGS declined to 46% when using a highly specific algorithm. Stacked coding using a combination of at least two CPT codes for molecular tests was the most commonly used method to bill for NGS (31.6%), followed by PLA (17.3%) and NGS specific codes (15.3%). The matching rates increased overtime with more PLA and NGS specific codes being used to bill for NGS. CONCLUSIONS: Identifying NGS tests in claims remains challenging due to variations in coding and reimbursement, despite the increased use of NGS specific codes. This work could shed light on future efforts that aim to develop an algorithm to identify NGS tests in claims data.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023coding-trends-nsclc-postergog-04-28-23v1-1ia126147-pdf.pdf?sfvrsn=d13575bd_0","title":"ISPOR 2023_Coding Trends NSCLC Poster_GOG-04-28-23v1.1_IA126147.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126147","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Improving the Interpretability of Ordinal Endpoints in NMAs","id":"5ac58afc-90a5-40b0-81d4-07e83abe6526","sessionCode":"MSR23","topDisplay":"Disher T EVERSANA, West Porters Lake, NS, Canada","locationCode":"641","description":"\r\n\t<div>OBJECTIVES: Ordinal endpoints are common in NMAs for health technology assessment submissions. PASI is a continuous endpoint used in psoriasis trials that is typically reported as number of patients reaching 50/75/90/100% improvement. In NMAs, PASI is usually analyzed as an ordinal outcome leveraging the parallel lines or proportional odds assumption. While clinicians are familiar with % improvement thresholds, they may be more interested in summaries that not typically reported in trials: The full distribution of PASI % change, mean PASI % change, or median PASI % change. We provide proof-of-concept for a unified framework that allows estimation of clinically relevant estimates using any PASI NMA. METHODS: We use simulated data to create a realistic distribution of PASI % change that is modeled with a flexible semi-parametric proportional odds model. We combine this baseline model with odds ratios output from a proportional odds NMA of PASI 50/75/90/100 to allow for the generation of the full PASI % change distribution in the population described by the individual participant data. Potential deviation from the proportional odds assumption is explored with linear and spline terms, which can be incorporated in subsequent NMA. RESULTS: The proposed method can be used to calculate differences in any quantity of interest with uncertainty, including visualizations of the difference in entire distributions of PASI % change. The extension to partial proportional odds models creates the possibility to explore how different therapies may have greater effects on some areas of the distribution than others. CONCLUSIONS: Proportional odds models can allow for the use of any ordinal NMA output to generate clinically relevant contextualization of results for summaries not commonly reported in trials. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/msr23-improving-the-interpretability-of-ordinal-endpoints-in-nma---ispor-2023124511-pdf.pdf?sfvrsn=a047671d_0","title":"MSR23 Improving the interpretability of ordinal endpoints in NMA - ISPOR 2023124511.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124511","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identifying and Quantifying Elements of Value for Nivolumab and Ipilimumab in First-Line Non-Small Cell Lung Cancer","id":"fe0777c2-78bd-4185-97b9-080300622d34","sessionCode":"EE40","topDisplay":"Orsini I1, Venkatachalam M1, Yuan Y2, Lee A3, Penrod JR2 1Precision HEOR, London, UK, 2Bristol Myers Squibb, Princeton, NJ, USA, 3Bristol Myers Squibb, Uxbridge, LON, UK","locationCode":"238","description":"\r\n\t<div>OBJECTIVES: Cost-effectiveness analyses are often used by health technology appraisal agencies to inform reimbursement decisions for new therapies. These evaluations, however, are often performed adopting a payer’s perspective that does not include important elements of value that treatments may generate (e.g., increased productivity, reduced caregiving costs, patients’ hope, option value, or insurance value). There is currently limited evidence quantifying condition-specific novel value elements. METHODS: To assess the impact of novel value elements on traditional cost-effectiveness analysis, this study estimated the net monetary benefit (NMB) associated with nivolumab plus ipilimumab (N+I) as first-line strategy for patients with metastatic non-small cell lung cancer (mNSCLC) compared with platinum doublet chemotherapy (PDC) in the United Kingdom (UK). Three perspectives were explored: traditional payer, traditional societal, and broad societal. The CheckMate 227 Part 1 pivotal trial informed N+I and PDC clinical efficacy, safety, treatment duration, and utilities. Quantitative measures of patients’ and caregivers’ indirect costs, value of hope, option value, and insurance value were informed by mNSCLC-specific studies identified through a targeted literature review. RESULTS: Under a traditional payer perspective, N+I was associated with higher costs and provided more quality-adjusted life-years (QALYs) compared with PDC (£71,154 incremental costs, 1.09 incremental QALYs). At a willingness-to-pay threshold of £50,000/QALY gained, the estimated NMB was -£16,437, indicating that costs exceed benefits. Expanding the traditional payer perspective to a traditional societal perspective led to a slight increase in the incremental costs, whilst further expanding the analysis to a broad societal perspective increased the QALY gain of N+I by 118% (1.09 versus 2.38 QALYs). The NMB estimated adopting a broad societal perspective was +£48,042, indicating that the benefits associated with N+I outweighed its costs. CONCLUSIONS: Including novel value elements in the cost-effectiveness analysis for N+I as first-line mNSCLC strategy was able to capture additional value beyond the traditional payer perspective.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23orsiniposter125956-pdf.pdf?sfvrsn=2dc0f344_0","title":"ISPOR23_Orsini_POSTER125956.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125956","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Telehealth: Interconnected Future of Healthcare in Emirate of Dubai, a Claims Data Analysis","id":"b5bff69e-304e-4f3f-9726-0862d0e24307","sessionCode":"HSD21","topDisplay":"Farghaly M1, Alrustamani LA1, Aladawy AIA1, Mukherjee B2 1Dubai Health Care Authority, Dubai, United Arab Emirates, 2IQVIA, Dubai, United Arab Emirates","locationCode":"605","description":"\r\n\t<div>OBJECTIVES: Dubai Health Authority (DHA) supports establishment of telehealth infrastructure with the aim of improvement of technological and innovative advances in medicine to enable low-cost accessible healthcare solutions in the Emirate of Dubai. The objective of the analysis was to characterize telehealth utilization and identify gaps in care. METHODS: A retrospective analysis was conducted using insurance e-claims (Dubai Private Insurance) database between January 2019 to October 2022. All telehealth services claims were identified to describe the trends in telehealth services and relative distribution by clinical condition as indicated by ICD-10 codes and specialty. Pulse survey among patients was also conducted. RESULTS: There was a rise in telehealth utilization in 2020 across the emirate peaking in May, it started to taper downward in July 2020 and stabilized in 2021 before showing an upward trend again in 2022. Nonelderly adults were most likely to utilize telehealth services, while only 6.7% elderly utilized telehealth during the study timeframe. Circulatory system, infectious diseases, endocrine nutritional and metabolic disorders were among the most common diagnostic categories for telehealth services accounting for 43.8% of patients utilizing telehealth. Family medicine, internal medicine and pediatrics were among the commonest specialty accounting for 63.7% of overall claims. Pulse survey indicated acceptance of telehealth services as an alternative health care delivery service. CONCLUSIONS: The claims analysis during the study period shows an increase in telehealth use. This dynamic reporting enables us to identify trends in uptake of digital technology particularly beneficial in high-needs group of patients and monitor services as per the standards for provision of telehealth services in the emirate.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23farghalyposter2126772-pdf.pdf?sfvrsn=935f1735_0","title":"ISPOR23_Farghaly_POSTER2126772.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126772","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Representation of Sex at Birth in Real-World Evidence, Randomized Clinical Trial, and Surveillance, Epidemiology, and End Results (SEER) Cancer Patient Registry Data By Cancer Type","id":"f85206a7-6b50-4c47-b26d-089264d6a734","sessionCode":"RWD13","topDisplay":"Gentile D1, Balanean A1, Brown M1, Asgarisabet P2, Savill K2, Chopra D1, Klink A1, Swain R2, Feinberg B3 1Cardinal Health Specialty Solutions, Dublin, OH, USA, 2Cardinal Health Real-World Evidence and Insights, Dublin, OH, USA, 3Cardinal Health Specialty Solutions, ATLANTA, GA, USA","locationCode":"826","description":"\r\n\t<div>OBJECTIVES: <span class=\"NormalTextRun SCXW247350410 BCX8\" data-ccp-charstyle=\"cf01\" data-ccp-charstyle-defn=\"{"ObjectId":"a9bc1e36-b0f8-462d-80c8-9df1a72217c3|38","ClassId":1073872969,"Properties":[469775450,"cf01",201340122,"1",134233614,"true",469778129,"cf01",335572020,"1",201342448,"1",469777841,"Segoe UI",469777842,"Segoe UI",469777843,"Calibri",469777844,"Segoe UI",469769226,"Segoe UI,Calibri",268442635,"18",469778324,"Default Paragraph Font"]}\">In randomized clinical trials (RCTs) for oncology, individuals assigned female at birth have historically been underrepresented. However, the significance of this variance and extent to which it impacts the representativeness of cancer research data sets have not been established. We evaluated 5 recently completed real-world (RWE) studies, corresponding RCTs, and SEER data from a parallel time period to assess female sex representation. METHODS: <span class=\"NormalTextRun SCXW34903424 BCX8\" data-ccp-charstyle=\"cf01\" data-ccp-charstyle-defn=\"{"ObjectId":"a9bc1e36-b0f8-462d-80c8-9df1a72217c3|38","ClassId":1073872969,"Properties":[469775450,"cf01",201340122,"1",134233614,"true",469778129,"cf01",335572020,"1",201342448,"1",469777841,"Segoe UI",469777842,"Segoe UI",469777843,"Calibri",469777844,"Segoe UI",469769226,"Segoe UI,Calibri",268442635,"18",469778324,"Default Paragraph Font"]}\">Sex at birth for patients with advanced lung, liver, melanoma, or kidney cancers (2) was compared across 5 RWE chart review studies (completed between 2020-2022), 5 corresponding RCTs (reported between 2014-2021), and the most recently available SEER data for the diagnoses (2017-2019) using 2-sided chi-square tests. RESULTS: Sex at birth was collected for 26,325 patients (RWE: n=2,120, 8.1%; RCT: n=3,962, 15.1%; SEER: n=20,243, 76.9%). Aggregated across the populations studied, female representation was 37.6% in RWE, 26.4% in RCTs, and 29.6% in SEER. Female representation was significantly higher in RWE than RCT (P<.001) and in RWE than SEER (P<.001). Within advanced renal cell carcinoma, female representation was significantly higher in RWE (36.4%) compared with RCT (26.6%, P<.001) and SEER (29.2%, P=.006). Female representation was also significantly higher in advanced non-small cell lung cancer RWE studies (40.5%) than in RCTs (18.6%, P<.001) and in advanced melanoma RWE studies (44.9%) than in RCTs (35.4%, P=.001). CONCLUSIONS: <span class=\"NormalTextRun CommentStart SCXW258476395 BCX8\" data-ccp-charstyle=\"cf01\" data-ccp-charstyle-defn=\"{"ObjectId":"a9bc1e36-b0f8-462d-80c8-9df1a72217c3|38","ClassId":1073872969,"Properties":[469775450,"cf01",201340122,"1",134233614,"true",469778129,"cf01",335572020,"1",201342448,"1",469777841,"Segoe UI",469777842,"Segoe UI",469777843,"Calibri",469777844,"Segoe UI",469769226,"Segoe UI,Calibri",268442635,"18",469778324,"Default Paragraph Font"]}\">Participants assigned female at birth remain underrepresented in RCTs, which drive inferences about the safety and efficacy of interventions, clinical decision-making, and payer reimbursement. Despite limitations including different study periods and unique sex distributions associated with some cancer types, female representation was highest in RWE studies and lowest in RCTs. Well-conducted <span class=\"NormalTextRun SCXW258476395 BCX8\" data-ccp-parastyle=\"pf0\" data-ccp-parastyle-defn=\"{"ObjectId":"a9bc1e36-b0f8-462d-80c8-9df1a72217c3|37","ClassId":1073872969,"Properties":[469775450,"pf0",201340122,"2",134233614,"true",469778129,"pf0",335572020,"1",469777841,"Times New Roman",469777842,"Times New Roman",469777843,"Times New Roman",469777844,"Times New Roman",469769226,"Times New Roman",268442635,"24",335559740,"240",201341983,"0",134233118,"true",134233117,"true",469778324,"Normal"]}\">RWE studies may fill gaps left by RCTs for improving representation and generalizability to female patients with cancer. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporrepresentationrwd13final124013-pdf.pdf?sfvrsn=2e966203_0","title":"ISPOR_Representation_RWD13_FINAL124013.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124013","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Why the Increase? Drilling Down on Increases in Prescribed Medication Expenditures in the United States between 2011 and 2020: Findings from the Medical Expenditures Panel Survey","id":"0cae71f4-caee-4272-9d99-08a254cb0eea","sessionCode":"HPR3","topDisplay":"Chi W1, Song J2, Yazdanfard S1, Daggolu J1, Varisco T3 1University of Houston, College of Pharmacy, Houston, TX, USA, 2University of Houston, Hobby School of Public Affairs, Houston, TX, USA, 3University of Houston, Houston, TX, USA","locationCode":"505","description":"\r\n\t<div>OBJECTIVES: The objective of this study was to identify determinants of increasing medication expenditures in the US between 2011 and 2020. METHODS: This was a cross-sectional analysis of prescription medication expenditures extracted from the 2011-2020 Medical Expenditures Panel Survey (MEPS). Total annual antidiabetic expenditures were calculated for each of the following payer categories: Out-of-pocket, Medicare, Medicaid, TRICARE/Veterans Administration/CHAMPVA (TVAC), Other Government Sources, Private Insurance, and Other Sources. Totals were weighted to account for MEPS design elements and ordinary linear regression, stratified by payer type, was used to estimate trends in annual total antidiabetic expenditures between 2011 and 2020. Inflation was adjusted to US dollar (USD) in 2020. RESULTS: Increasing trends in total prescribed medication expenditures were observed between 2011-2020 ($341.49-$473.12 billion. P <0.0001). Within the prescribed medicines, metabolic agents comprised the largest expenditure above other drug categories for the duration. Within the metabolic agents, the antidiabetic agents comprised the largest expenditure for the duration. An increasing trend in antidiabetic agent expenditure was observed for the duration 2011-2020 ($27.15 - $89.17 billion, P<.0001). In observing the source of payment categories in antidiabetic agent expenditures, an increasing trend was observed for Medicare ($7. - $38.23 billion, P <.0001), Medicaid ($2.65 - $8.86 billion, P =. 001), Private Insurance ($9.91 - $33.80 billion, P<.0001), TVAC ($0.75 - $1.51 billion, P =.03), and Other sources ($0.12 - $0.37 billion, P =.009). No trend was observed for Out-of-pocket (P=.93) and Other Government Sources (P =.08). Insulin comprised the largest expenditure above other antidiabetic agents for the duration in Out-of-pocket, Medicare, Medicaid, Private Insurance and Other Government Resources. CONCLUSIONS: The total antidiabetic agent expenditure as well as the respective amounts for Medicare, Medicaid, Private Insurance, TVAC and other sources increased between 2011 and 2020. Further studies are warranted to explore specific factors contributing to the increasing trend.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23chiposter-2123635-pdf.pdf?sfvrsn=c44a4f16_0","title":"ISPOR23_Chi_POSTER 2123635.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123635","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Application of Real-World Data in Health Economic Evaluations in China: A Systematic Review","id":"08a33500-04f7-45d8-bd08-09b1585b9446","sessionCode":"EE100","topDisplay":"Xie S1, Yang H2, Liu J2 1IQVIA, Shanghai, 31, China, 2IQVIA, Beijing, China","locationCode":"403","description":"\r\n\t<div>OBJECTIVES: In the recent decade, there has been increasing application of real-world data (RWD) in the health economic evaluations, but there lacking studies to synthesize current evidence on the application of RWD in China. This study aims to evaluate the landscape of RWD, to identify the data sources, and to assess the quality of the economic studies involved with RWD in China. METHODS: We conducted a systematic review on local economic modeling that used RWD and published from January 2019 to December 2021 in English and Chinese databases, such as PubMed and CNKI. Followed by the analysis on the supportive areas and data sources of the applied RWD. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 checklist was applied to assess the quality of the included studies. RESULTS: A total of 2504 studies on economic modeling were initially identified, 61 mentioned the use of RWD, and studies with RWD comprised of 1.7%-3.0% of all studies annually. RWD was majorly used to support studies in oncology (41.0%) and cardiovascular diseases (16.4%). Cost-utility analysis accounted for 89% of the studies, with quality-adjusted life year measured as clinical outcomes. More studies (40%) were carried out from payer’s perspective, while others were from healthcare system (n=16) and societal (n=15) perspective. Diverse data sources were identified including hospital information system (49.2%), survey (n=14), and open websites and public data (n=9). The application of RWD was most frequent to support the effectiveness and cost inputs. Only 15% of the studies (n=9) met at least 80% of CHEERS criteria. CONCLUSIONS: Although the adoption of RWD was observed in more economic studies, the supportive areas are limited to the cost inputs and the quality of data sources are varied. Further researches are encouraged to develop the framework of the generation of RWD and used in the economic modeling.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23quposterv3124943-pdf.pdf?sfvrsn=3d3fd8b5_0","title":"ISPOR23_Qu_PosterV3124943.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124943","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Quality of Electronic Health Records: Managing Aggregated Patient Demographic Information","id":"1cf4c717-dae2-4fc3-8510-0a76f7771b41","sessionCode":"RWD38","topDisplay":"Jaffe D1, Ruo P2, Way N3 1Cerner Enviza, an Oracle Company, Jerusalem, Israel, 2Cerner Enviza, an Oracle Company, Kansas City, MO, USA, 3Cerner Enviza, an Oracle Company, Santa Barbara, CA, USA","locationCode":"900","description":"\r\n\t<div>OBJECTIVES: Electronic health records (EHRs) are a real-time aggregate of patient health and related data for improved care and outcomes. Inconsistencies in patient data within and between healthcare systems may result from variability in collection methods, documentation, and coding practices, in addition to longitudinal changes in a patient’s profile. This study examines the impact of multiple entries for patient demographic information on data quality in the US Cerner Real-World Data (CRWD). METHODS: Data were examined for all patients in the US CRWD, a cloud-based, de-identified, and Health Insurance Portability and Accountability Act-compliant dataset (extract 7/2022). Demographic data for age, gender, race, ethnicity, state of residence, marital status, and spoken language were examined. Patient data were considered informative if they satisfied acceptable values or coding standards. Uninformative data included null values, responses of refused/declined to answer, or uninterpretable data. Descriptive statistics were used to examine all CRWD patients (100+ million) and those with encounters in the past five years (50+ million) with multiple responses. This study received IRB exemption status. RESULTS: Approximately one in five patients had ≥1 multiple response demographic variables (all=18%; past five years=23%). Of those with multiple responses, more patients had ≥2 demographic variable multiples in the past 5 years (46%) than overall (39%), however, fewer uninformative responses were observed for those with encounters in the past five years than overall (relative decrease range=10-70%). Multiple responses for year of birth, gender, ethnicity, and state predominantly comprised a single informative value (>93%) compared to race (74%), marital status (37%), or language (36%) (all data). Following removal of uninformative data, multiple discrepant responses represented <2% (all) or <3% (past five years) of a patient’s demographic data. CONCLUSIONS: Alongside improvements in data collection and quality over time, attention to data cleaning and purposeful data management are necessary for creating fit-for-purpose EHR data.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126086","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Scoping Review and Meta-Analysis on the Effectiveness and Safety of Powered Stapler and Manual Stapler","id":"c1268937-a87d-4758-8374-0ac5ddab3896","sessionCode":"CO44","topDisplay":"Xu Q1, Liu B2 1School of Public Health, Fudan University, shanghai, China, 2School of Public Health, Fudan University, Shanghai, China","locationCode":"142","description":"\r\n\t<div>OBJECTIVES: To evaluate effectiveness and safety of the powered staplers versus manual staplers performing in surgery. METHODS: A systematic literature search (CNKI, Wang Fan, Medline, EMBASE and Web of science) was performed to identify clinical studies comparing powered staplers and manual staplers. The primary outcomes including operation time, length of hospital stay, blood loss, anastomotic leakage/air leakage incidence, bleeding/blood transfusion rate, 30-day readmission rate, physician satisfaction and instrument performance index. Meta-analysis was conducted to calculate odds ratio (OR) and mean difference (MD) with corresponding 95% confidence intervals. Further subgroup analysis was conducted to compare powered with manual in linear/vascular staplers and powered with manual in circular staplers. RESULTS: A total of 19 studies were included in final analysis, with 6 single-arm studies on powered staplers and 13 studies comparing the use of powered and manual staplers in surgery. Thirteen of the included studies were retrospective studies and 6 were prospective studies. Statistically significant differences were observed in terms of operation time [MD=-13.65, 95CI% (-17.23, -10.06)], length of hospital stay [MD=-1.37, 95CI% (-2.03, -0.71)], anastomotic leakage/air leakage incidence [OR=0.43, 95CI% (0.26, 0.70)], and 30-day readmission rate [OR=0.80, 95%CI (0.71, 0.89)] in favor of powered staplers. No statistically significant differences were observed for blood loss, bleeding/blood transfusion rate. Subgroup analysis showed compared with manual linear/vascular staplers, powered linear/vascular staplers significantly reduced the operation time and 30-day readmission rate, while showed no significant superiority in anastomotic leakage/air leakage incidence and bleeding/blood transfusion rate. Compared with manual circular staplers, powered circular staplers significantly reduced the incidence of anastomotic leakage. Also, existing studies showed powered stapler was more user-friendly, better instrument performance. CONCLUSIONS: Our study showed superiority of powered staplers compared to manual staplers in operation time, length of hospital stay, anastomotic leakage/air leakage incidence and 30-day readmission rate. However, further high-quality studies are needed to obtain definitive conclusions.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23xuposterv2125289-pdf.pdf?sfvrsn=dde78ae1_0","title":"ISPOR23_XU_POSTERV2125289.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125289","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Relative Efficacy of Pharmacological Treatments of Agitation and Aggression in Patients with Dementia: A Systematic Review and Network Meta-Analysis","id":"3bdeec65-99b6-403b-b5e6-0b135d327916","sessionCode":"CO19","topDisplay":"Rane A1, Prabhune K2, Chen N3, Kaliki S2, Yunusa I3 1Agios Pharmaceuticals, Cambridge, MA, USA, 2MCPHS University, Boston, MA, USA, 3University of South Carolina, Columbia, SC, USA","locationCode":"119","description":"\r\n\t<div>OBJECTIVES: In agitated older adults with dementia who are threatening to harm themselves or others, pharmacological treatments are recommended when first-line non-pharmacological strategies are ineffective. However, with newer clinical trials available, there is a need to provide current evidence of these pharmacological agents' relative efficacy. To determine the most efficacious pharmacological treatment for agitation and aggression in patients with dementia. METHODS: A systematic search was performed on MEDLINE®/PubMed, Ovid EMBASE®, and Cochrane Library (CENTRAL, Cochrane DSR) to identify relevant articles published from the inception of each database to August 2022. We included randomized controlled trials (RCTs) of patients with dementia who are agitated and/or aggressive and require pharmacological treatment. Two independent reviewers screened titles, abstracts, and full texts of all identified articles to determine eligibility for inclusion in the systematic review and network meta-analysis (NMA). We conducted a random-effects NMA to estimate pooled relative standardized mean differences in agitation and/or aggression measures (based on Cohen-Mansfield Agitation Inventory [CMAI] and Neuropsychiatric Inventory [NPI]-agitation and aggression sub scores) and their 95% confidence intervals (CI). RESULTS: Thirty-two RCTs consisting of 13264 patients (66% female; mean age, 79.75 (8.74) were included in the NMA. Aripiprazole (SMD: -0.707; 95% CI: -1.314 to -0.100) and risperidone (SMD: -0.487 95% CI: -0.924 to -0.049) were found to be significantly more efficacious than placebo. In addition, although not significant, point estimates suggest that there could be an improvement in agitation and/or aggression across all drugs compared to the placebo except for quetiapine, memantine, donepezil, and haloperidol. CONCLUSIONS: Aripiprazole and risperidone demonstrated significant improvement in agitation in patients with dementia. The decision to prescribe should be based on comprehensive consideration of the benefits and risks, including those not evaluated in this NMA. <quillbot-extension-portal></quillbot-extension-portal></div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127737","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessing and Comparing Psychometric Properties of Both 3L/5L of EQ-5D-Y and Adult EQ-5D Versions in Adolescents with Prevalent Disease Conditions in Ethiopia","id":"21aeb2a2-dab3-457b-8ca4-0b33765bb4ce","sessionCode":"PCR19","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"727","description":"\r\n\t<div>OBJECTIVES: To assess and compare the psychometric properties of the 3L and 5L versions of EQ-5D-Y and the adult EQ-5D in healthy adolescents with a range of health conditions. METHODS: Adolescents with and without health conditions were recruited from the neurologic and infectious clinics at Tikur Anbessa Specialized Hospital, as well as from different governmental schools in Addis Ababa, Ethiopia. The feasibility, reliability, and known group validity of both 3L/5L of EQ-5D-Y and adult EQ-5D versions was tested and compared in a cross-sectional study among adolescent with HIV AIDS and epilepsy health conditions and in a control group of ‘healthy’ adolescents (n≈ 425). The questionnaires were administered by randomness and separated by a cognitive task. Test-retest reliability and responsiveness was also examined after one month of the first visit (n= 56, n= 40 respectively). RESULTS: A sample of 425 (186 school sample (healthy), 106 Epilepsy and 133 HIV AIDS) were included in the sample for analysis. The number of missing data in all dimensions of the EQ-5D (both adult and youth versions) were negligible, so the feasibility was acceptable. There was a range of 7- 18% and 10-32% inconsistent responses moving from EQ-5D-3L to EQ-5D-Y-3L and from EQ-5D-5L to EQ-5D-Y-5L. The Y-5L showed moderate to high association for test-retest reliability across dimensions of level sum score (LSS) ICC score of 0.959 (95% CI, 0.931,0.975) and VAS ICC score of 0.793 (95% CI, 0.671, 0.873) in individual with unchanged chronic health conditions and for the general population. The findings revealed that the Amharic EQ-5D-5L(-Y-5L) and EQ-5D-3L(-Y-3L) has significant known group validity as shown by the difference in scores among disease groups (HIV vs Epilepsy, HIV vs Healthy, and Epilepsy vs Healthy). CONCLUSIONS: The results shows that the Amharic EQ-5D-5L(-Y-5L) and EQ-5D-3L(-Y-3L) are valid, reliable and feasible instruments for children/adolescents across disease conditions and healthy children/adolescent populations in Ethiopia.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125174","diseases":[{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Contextualizing Health-State Utilities in Patients with Transfusion-Dependent Βeta-Thalassemia (TDT)","id":"b277b1c3-2e30-44f1-8287-0b3520b13f15","sessionCode":"PCR38","topDisplay":"Gruppioni K1, Howell TA2, Jordan J2, Matza L2, Boudreaux J3, Fritch Lilla S4, Glaros AK5, Sheth S6, Paramore C7 1bluebird bio, Inc., Middletown, RI, USA, 2Patient-Centered Research, Evidera, Bethesda, MD, USA, 3Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Atlanta, GA, USA, 4Children's Minnesota, Minneapolis, MN, USA, 5Central Michigan University, Mount Pleasant, MI, USA, 6Weill Cornell Medicine, Cornell University, New York, NY, USA, 7bluebird bio, Inc., Somerville, MA, USA","locationCode":"747","description":"\r\n\t<div>OBJECTIVES: TDT is a rare genetic disease with impaired production of healthy red blood cells due to insufficient adult hemoglobin (HbA) production. The resulting ineffective erythropoiesis, and iron overload from chronic transfusions, makes this a complex disease. Cost-utility analyses in TDT to-date use health-state utility values that have not been compared to disease-specific quality of life (QoL) measures. This study aimed to contextualize TDT utility-value estimates with disease-relevant data. METHODS: Eligible participants were US patients >12 years old (yo) with TDT. Participants completed TranQoL, a TDT-specific measure of QoL, and reported the timing of most recent blood transfusion. Participants 12–15 yo completed the EQ-5D-Y and participants >16 yo completed the EQ-5D-3L. As a US value set for EQ-5D does not exist, scores were derived using the value set for Spain. RESULTS: 23 participants >16 yo (mean age: 36.9 yo) and 9 participants 12–15 yo (mean age: 13.0 yo) completed interviews. Mean (SD) TranQoL score was 67.12 (17.53) among participants >16 yo, and 77.58 (9.07) among participants 12–15 yo. Mean (SD) EQ-5D-3L score was 0.86 (0.15), with 42.9% of participants at the ceiling (i.e., 1.0). Mean (SD) EQ-5D-Y score was 0.93 (0.09), with 55.6% at the ceiling. The EQ-5D-3L was correlated with the TranQoL (r=0.71; p<0.001), but with notable variation (e.g., TranQoL scores ranged from 60.3–95.8 for those with EQ-5D=1). Neither EQ-5D version correlated significantly with days since last RBC transfusion (-3L: r=-0.097 (p=0.676); -Y: r=-0.345 (p=0.362)), a TDT burden indicator. CONCLUSIONS: TranQoL scores were consistent with the literature. The substantial ceiling effect suggests EQ-5D may not be sensitive to QoL impact in TDT. Low correlation of EQ-5D with days since transfusion raises questions about sensitivity to clinical burden. Additional research on EQ-5D and TranQoL correlation is warranted. Sponsorship: This study was funded by bluebird bio.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gruppioniposter123416-pdf.pdf?sfvrsn=c319d128_0","title":"ISPOR23_Gruppioni_POSTER123416.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123416","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Feasibility of Mapping between EQ-5D-5L and ASCOT: An Exploratory Analysis","id":"31b76173-b9b2-44c6-9ee9-0c7845f52e3f","sessionCode":"PCR48","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"803","description":"\r\n\t<div>OBJECTIVES: The aim of this analysis is to test the feasibility of mapping between the health-related quality of life (HRQoL) instrument EQ-5D-5L, and the social care related quality of life (SCRQoL) instrument ASCOT. This is a first step towards looking at a combined holistic instrument that incorporates both instruments and measures QoL more broadly. METHODS: Analysis was conducted using a pre-existing data set of the Australian general population. Descriptive assessment of the sample and the outcome measures of interest was conducted to observe any link between the item response pattern and demographic characteristics. Spearman’s rank correlation, one-way ANOVA, and Cohen’s D were estimated. Direct mapping between the two instruments was done using ordinary least squares (OLS) and multinomial logistic regression method was used for indirect/response mapping. RESULTS: There were 794 respondents with 52.1 % females and 78.7% born in Australia.The mean EQ-5D-5L utility score (0.75) was slightly lower than the mean ASCOT utility score (0.81). Correlation between the EQ-5D-5L and ASCOT utility values was found to be moderate (0.55) where ASCOT dimension- social contact had the highest correlation (0.46) with anxiety-depression dimension of EQ-5D-5L in comparison to any other dimension. Known group validity results show that all indicators are sensitive to differences at the 0.01 significance level, with effect size generally in the moderate range. The direct mapping OLS model had a RMSE value of around 0.16 and adjusted R-squared value of 0.34 which at best provides weak evidence of the model’s predictive capacity. Response mapping indicates that EQ-5D-5L anxiety-depression questions are related to cleanliness and social contact questions from ASCOT (p-value < 0.05). CONCLUSIONS: There is divergence between the EQ-5D-5L and ASCOT descriptive systems although there are some areas of overlap in the psychosocial sphere of QoL. It provides valuable insight about interactions between responses to items from the two instruments.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124448","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Reviewing the Use of Commercial Options during NICE Review for Medicines Prescribed in the Primary Care Setting in England","id":"411b419d-0843-44f4-ad78-0d851fa9054b","sessionCode":"HPR26","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"527","description":"\r\n\t<div>OBJECTIVES: Commercial options such as Patient Access Schemes (PAS) and Commercial Access Agreements (CAA) have been introduced in the UK to allow patient access to innovative medicines while ensuring value for money for the NHS and a fair return on investment to industry. PAS and CAA enable companies to improve the cost-effectiveness of their medicine in a way that is not reflected in the public UK list price, therefore not impacting international reference pricing. However, the use of these commercial options is typically restricted to medicines prescribed in secondary care due to funding flow challenges in the UK. The aim of this study was to review the use of commercial options for medicines prescribed in primary versus secondary care settings. METHODS: A review of all NICE pharmaceutical technology appraisals in existence to December 2022 was conducted to assess how many utilized a PAS or CAA to gain positive or optimized recommendation. These medicines were cross-referenced with the Red/Amber/Green (RAG) system from two representative medicine management groups to identify the setting in which the medicine is prescribed (primary or secondary). Where the medicine was not listed, further judgement was used to determine the prescribing setting. RESULTS: In total, 814 medicines were appraised and recommended. Of these, 210 were recommended with a PAS and 79 with a CAA, and within this subset only two medicines were recommended with a CAA for primary care prescribing based on the RAG system. No primary care medicines were recommended with a PAS. CONCLUSIONS: Given the importance of the UK as an international reference market for pharmaceutical pricing, commercial options that enable confidential flexibility to meet NICE cost-effective thresholds should be accessible to all medicines suitable for prescribing in the primary care setting to avoid limiting access to innovative medicines in primary care</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126992","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Driving Positive Patient Outcomes with Prior Authorization Analytics","id":"1b198f81-c287-4af6-a8c8-0da27446ab46","sessionCode":"CO233","topDisplay":"Jayapalan H1, Shah N1, Patel A2, Chaudhari P2 1Indegene, Bangalore, KA, India, 2Indegene Inc., Princeton, NJ, USA","locationCode":"121","description":"\r\n\t<div>OBJECTIVES: The stringent process of prior authorization (PA) has negative impacts on timeliness of treatments acting as an administrative burden for the payers, providers, and care delays for patients. This study focuses on deployment of PA analytics for a specialty product using advanced clinical, predictive, and prescriptive analytics and generating payer/provider insights for solving the challenge of drug abandonment and driving outcomes for patients. METHODS: Deep clinical knowledge base along with natural language processing (NLP) and machine learning (ML)-driven analytics tools were used in processing huge volumes of unstructured patient PA data from the patient hub. Case-by-case retrospective analysis of 5000 patients’ PA submissions in severe and critical autoimmune conditions in Neurology, Rheumatology, Nephrology, Pulmonology, and Ophthalmology across various payers and providers was performed to generate insights through patient clinical profiling and mapping payer and provider behaviour modelling. The unstructured medical records or case forms were converted to comprehensible structured data using NLP-based clinical algorithms to determine cause and effect of prior rejection instances. The structured data analytics helped ensure generation and interpretation of patient clinical profiling insights, cost-benefit analysis and payer behaviour mapping insights to derive recommendations that the pharma client leveraged to have focused negotiations with payers on better drug coverage decisions and PA approvals. RESULTS: The medical necessity and payer modelling insights, and case-by-case actionable recommendations helped a leading US-based pharma enterprise in recording a 32% improvement in PA approvals through reduction in unwarranted rejections of clinically valid PA submissions. The provider modelling insights helped the pharmaceutical enterprise in provider education to close the gaps in the submission of clinical evidence for better PA submissions, achieving about 10% reduction in PA rejections. CONCLUSIONS: This NLP driven analytics solution enabled the pharma enterprise to drive outcomes by ensuring faster patient access to drugs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124064","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"},{"id":"e1e9019e-ac29-46cb-aa8b-f773e1917103","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Analysis of Canadian and International Health Technology Assessment Uncertainty for Spinal Muscular Atrophy Therapies","id":"3e882117-756f-44a5-8994-0dca0687951d","sessionCode":"HTA3","topDisplay":"Arena P1, Jaksa A2, Brière A3, Lambert L4 1Aetion, Inc, El Segundo, CA, USA, 2Aetion, Inc, Boston, MA, USA, 3Canadian Agency for Drugs and Technologies in Health, Ottawa, ON, Canada, 4Canadian Agency for Drugs and Technologies in Health, Newington, ON, Canada","locationCode":"609","description":"\r\n\t<div>OBJECTIVES: To compare uncertainties about the optimal use of three therapies for spinal muscular atrophy (SMA) across Canada and other countries and to determine if ongoing research or future real-world evidence (RWE) studies can address these uncertainties. METHODS: We reviewed the websites of international health technology assessment (HTA) agencies - CADTH, NICE, SMC, HAS, G-BA, IQWiG, and PBAC - for reimbursement decisions on SMA therapies nusinersen, onasemnogene abeparvovec, and risdiplam. We also evaluated input from additional Canadian stakeholders: patients, payers, and providers. We then identified and categorized uncertainties cited in assessments and compared them across HTA bodies/stakeholders. Additionally, we evaluated ongoing studies in SMA and relevant market access agreements to identify information that could potentially address the stated uncertainties. RESULTS: Across 59 total documents, 17 uncertainties were identified that encompassed two themes: gaps regarding a therapy’s clinical/economic evidence and SMA health system gaps. Canadian stakeholders expressed concern about the lack of data for key subgroups and the therapies’ long-term safety/efficacy. Among HTA bodies, the most frequently noted uncertainties were unrepresentative clinical trial populations, missing/incomplete data for over 40 key subgroups, lack of comparative effectiveness data, lack of long-term efficacy/safety data, and uncertainties about costing inputs/health economics analyses. SMA health systems gaps regarding access to therapies and patient financial burden were commonly reported across Canadian stakeholders and HTA bodies. Of 97 studies identified that could potentially address uncertainties, 64 were ultimately deemed relevant. CONCLUSIONS: There was substantial overlap in SMA uncertainties cited across types of stakeholders. RWE was also identified as an appropriate tool to address certain remaining uncertainties, such as missing/incomplete data for key subgroups and variability in the clinical environment. These findings ultimately highlight the need for additional research in SMA and the opportunities for and value of collaboration. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127226","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Systematic Literature Review and Meta-Analysis of Work Productivity in Patients with Axial Spondyloarthritis Treated with Biologic or Targeted Synthetic Disease-Modifying Antirheumatic Drugs","id":"700fd3d5-bdea-4398-9107-0e191926e6aa","sessionCode":"SA2","topDisplay":"Rudwaleit M1, Mørup M2, Humphries B3, Zannat NE3, Willems D4, Taieb V5, Boonen A6 1University of Bielefeld, Bielefeld, Germany, 2UCB Pharma, Copenhagen, Denmark, 3Cytel Inc., Waltham, MA, USA, 4UCB Pharma, Brussels, Belgium, 5UCB Pharma, Colombes, France, 6Maastricht University Medical Centre and Maastricht University, Maastricht, Netherlands","locationCode":"905","description":"\r\n\t<div>OBJECTIVES: To quantify work productivity among patients with axial spondyloarthritis (axSpA) treated with biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). METHODS: A systematic literature review (SLR) was conducted according to PRISMA guidelines. MEDLINE, Embase, EconLit, Cochrane, and relevant conference proceedings were searched for randomized and non-randomized studies with a b/tsDMARD in axSpA reporting on health-related quality of life and productivity outcomes. Studies published between 2010 and October 21, 2021 that included results from any version of the Work Productivity and Activity Impairment (WPAI) questionnaire were analyzed. These scores represent the percentage of time that individuals were unproductive due to absenteeism, presenteeism, overall work impairment, and impairment during daily activities due to axSpA. A random-effects meta-analysis was performed for each WPAI domain (absenteeism, presenteeism, work impairment, and activity impairment) using mean change in WPAI score from baseline. Outcomes reported between 12 and 16 weeks were pooled. RESULTS: A total of 5580 records were identified and 412 were selected for full-text review. Among 180 included records representing 62 unique studies, 19 reported WPAI outcomes. The majority of analyzed studies were randomized trials (n=11), followed by prospective observational studies (n=7), and one single-arm trial. Seventeen studies evaluated patients with ankylosing spondylitis (AS) and four studies evaluated those with non-radiographic axSpA. The proportion of patients employed varied widely (33%–100%). In all studies, presenteeism was a greater contributor to overall work impairment than absenteeism. Among patients taking b/tsDMARDs and placebo, mean change in WPAI score from baseline at 12–16 weeks was –5.7 vs –0.5 for absenteeism, –20.6 vs –11.2 for presenteeism, –20.8 vs –11.1 for work impairment, and –21.2 vs –11 for activity impairment. CONCLUSIONS: In axSpA, presenteeism is the predominant contributor to work impairment. Treatment with b/tsDMARDs is associated with improvements in productivity across all WPAI domains at 12–16 weeks.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-us-2023axspa-slr-humanistic-economic-burdensubmission-version125885-pdf.pdf?sfvrsn=84415570_0","title":"ISPOR-US 2023_axSpA SLR Humanistic Economic Burden_Submission Version125885.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125885","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Incidence of Malignancies in Sickle Cell Disease: A Systematic Review","id":"7fcd507d-c18b-4cf0-84f5-0e5ae6ac8eb1","sessionCode":"EPH31","topDisplay":"Baldwin Z, Devine B University of Washington, Seattle, WA, USA","locationCode":"431","description":"\r\n\t<div>OBJECTIVES: Curative regimens, such as stem cell transplant, employ cytotoxic agents to facilitate acceptance of novel progenitor cells, though the risk associated with malignancy post-treatment remains a concern. In anticipation of the widespread introduction of gene therapies, our aim was to conduct a systematic review to characterize the baseline risk of cancer in SCD patients regardless of types of therapy. METHODS: We searched PubMed and EMBASE from database inception through end of 2022 for studies that reported cancer incidence rates. Inclusion and exclusion criteria were applied via the Population, Intervention, Comparator, Outcomes, Time Horizon, Study Design (PICOTS) format. Data extracted from the included studies were study design, authors, year published, populations, interventions where applicable, addressed cancers, occurrence outcomes, observation windows, and data source. We report descriptive statistics for characteristics of studies and ranges of reported outcomes across all studies. RESULTS: There were 1,349 references drawn from the search queries, with 1,270 titles screened after duplicate removal. Abstract screening was conducted on 64 studies, 27 were full text reviewed with an additional 6 studies added after hand searching the reference sections, for a total of 33. After applying the inclusion and exclusion criteria, 17 studies were included for data extraction. Crude incidence rates ranged from 0.32 to 8.3 per 1,000 person-years for solid cancers, and 0.218 to 6 per 1,000 person-years for hematologic cancers. Incidence rates after stem cell transplant were 9.4 to 18 and 33 per 1,000 person-years for hematologic and solid cancers, respectively. CONCLUSIONS: The literature suggests that the incidence of hematologic cancers and solid tumors in individuals with SCD was greater after undergoing stem cell transplant. The wide ranges suggest much uncertainty and speak to the variability in demographic and clinical characteristics, as well study design.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23baldwinposter125712-pdf.pdf?sfvrsn=9b976d1b_0","title":"ISPOR23_Baldwin_POSTER125712.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125712","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Burden of Familial Chylomicronemia Syndrome (FCS) in Brazilian Patients – A Pilot Qualitative Study","id":"a438160d-983a-4e1e-b3d2-0e757cdb055b","sessionCode":"PCR30","topDisplay":"Vicente F1, Paula E2, D’Silva DA3, Tomazos I3, Primo CD4, Bretas IDL4 1PTC Farmacêutica do Brasil Ltda., São Paulo , Brazil, 2PTC Farmacêutica do Brasil Ltda., São Paulo, SP, Brazil, 3PTC Therapeutics Inc., NJ, NJ, USA, 4PTC Farmacêutica do Brasil Ltda., São Paulo, Brazil","locationCode":"738","description":"\r\n\t<div>OBJECTIVES: FCS in Brazil is characterized by low clinical awareness that negatively affects the patient journey and experience, often resulting in inadequate care. Research addressing the FCS patient burden in Brazil could provide insights to refine healthcare services and improve outcomes. This is the first qualitative study in Brazil aimed to understand the burden of FCS in patients. METHODS: In-depth face-to-face semi-structured interviews were conducted with eight patients (1 male/7 females, age range 40-55 years old) in June 2022. The interviews aimed to capture patients' journeys, and identify their needs, motivation and perspective about FCS in Brazil. Transcripts were analyzed thematically in an iterative process. RESULTS: Eight patients commonly reported the following three life impact themes: psychological burden, medical problems, and interpersonal problems. Patients perceived that the greatest impact of FCS was on their emotional/mental well-being, with all 8 patients reporting depression. Medical/physical problems were described by patients and caregivers. All 8 patients experienced acute pancreatitis and reported severe abdominal pain. Diet was reported as a frequent source of anxiety by patients, preventing them from participating in social activities and interpersonal problems, including constraints in professional, personal, and financial life, stigmatization and a lack of understanding by others. Furthermore, two patients reported that living with FCS impacted their decision to have children, perhaps this is linked to the risk of complications from FCS during pregnancy. Socioeconomic factors were considered crucial to their psychological and interpersonal problems and adherence to a low-fat diet. CONCLUSIONS: This first study in Brazil provides an understanding of the burden of FCS. Patients with FCS are affected by psychological, medical, and interpersonal problems, while the disease significantly impacts their socioeconomic life. These findings support the need for greater disease awareness for FCS and more economic impact studies on the disease in Brazil.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23vicenteposter126827-pdf.pdf?sfvrsn=2d23bf61_0","title":"ISPOR23_Vicente_POSTER126827.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126827","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Distribution of the Annual Costs of a Cohort of Patients with Diabetes in a Large Colombian Health Insurer","id":"b807f63e-2187-4e9e-af7e-0e97ac4301b5","sessionCode":"MSR5","topDisplay":"Echeverri E1, Ruiz AJ1, Rondon M2, Rosselli D3 1Pontificia Universidad Javeriana, Cali, VAC, Colombia, 2Pontificia Universidad Javeriana, Bogota, Colombia, 3Pontificia Universidad Javeriana, Bogota, CUN, Colombia","locationCode":"644","description":"\r\n\t<div>OBJECTIVES: To analyze the distribution of overall annual costs of a cohort of adult patients with Type 2 diabetes, from the third-party perspective of a private health insurer in Colombia. METHODS: Direct medical costs were extracted from administrative claims provided by a large private health insurer, derived from the year prior to the introduction of a new disease management program for adults with type 2 diabetes which was gradually introduced nationwide during 2019. Costs in Colombian pesos (COP) were converted into US dollars (USD) at the average official exchange rate for 2019 (1 USD = 3,281 COP). Descriptive statistics of overall costs are presented. RESULTS: Costs were obtained from 18,328 subjects. The average annual cost for this cohort was USD $1,736, with a huge standard deviation (USD $3,414). On the other hand, the median cost was well below the mean (USD $863), and the interquartile range went from USD $476 to $1644. While 4% of patients had an annual cost below USD $150 and another 23.5% would cost between USD $300 and $600, a relatively small proportion (2.7%) had a cost above USD $9,000. The gamma distribution was the best fit for the data (parameters 0.09;2). CONCLUSIONS: Overall costs of complex medical conditions like diabetes are far from having “normal” or uniform distributions. Median costs are normally well below the mean which tends to be skewed to the right due to a relatively small proportion of patients, those with several comorbidities or with high cost complications, which incur in disproportionally high costs for the healthcare system.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23rosselli02poster127020-pdf.pdf?sfvrsn=f962c1a4_0","title":"ISPOR23_Rosselli02_POSTER127020.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127020","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"An Assessment of the Evolving Methods and Role of Health Equity Factors in ICER’s Final Evidence Reports","id":"1ca2b118-8265-4151-a34c-0eb2e8808849","sessionCode":"HTA18","topDisplay":"Penley B, Ng J, Haileselassie H, Westrich K Xcenda/AmerisourceBergen, Carrollton, TX, USA","locationCode":"621","description":"\r\n\t<div>OBJECTIVES: ICER reports rely on a value assessment framework (VAF) methodology, which is periodically updated. With ICER’s 2023 update and forthcoming white paper on assessment methodologies to support health equity goals, there is an opportunity to evaluate the role of health equity in past ICER reports, informing the appropriate role and methodologic changes to support health equity in future reports. This research aims to determine how the role of health equity factors in ICER’s Final Evidence Reports has evolved over the past 5 years. METHODS: All Final Evidence Reports published before 08/01/22 under ICER’s 2017-2019 (n=22) and 2020-2023 (n=19) VAFs were exploratorily reviewed. We extracted equity-related text throughout reports, with a particular focus on the “Contextual Considerations and Potential Other Benefits” section. We identified the methods ICER used to consider the equity impacts of an intervention, through which we identified ICER-noted barriers to the provision of equity. RESULTS: Equity barriers were more frequently identified in 2020-2023 reports (socioeconomic: 58% vs 41%; race: 42% vs 27%; geographic: 42% vs 23%; disease-related: 21% vs 14%; gender: 11% vs 5%). ICER appraisal panels voted on the impact of an intervention on reducing health inequities more frequently under the 2020-2023 VAF (75% vs 61%). ICER’s policy roundtable discussions under the 2020-2023 VAF increasingly called upon all stakeholders to address health equity (53% vs 0%). Quantitatively, equity-related analyses, including Health Improvement Distribution Index calculations, were more common in 2020‑2023 (16% vs 5%). Only 1 equity-related scenario analysis that determined an intervention’s cost-effectiveness was conducted. CONCLUSIONS: The role of health equity remains predominately qualitative in ICER reports. Although its overall consideration has increased, there is still room for improvement, particularly in increasing equity-related quantitative analyses. In its upcoming VAF update, ICER has the opportunity to advance the methods by which they support society’s goal of reducing health inequities.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23penleyposterv2123940-pdf.pdf?sfvrsn=e4220013_0","title":"ISPOR23_Penley_POSTERv2123940.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123940","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Variation in Medicaid and Commercial Coverage of Cell and Gene Therapies","id":"f2617a87-7f04-4eb8-b875-0ede6d819b7a","sessionCode":"HPR19","topDisplay":"Beinfeld M1, Rucker J1, Jenkins N1, de Breed LA2, Chambers J1 1Tufts Medical Center, Boston, MA, USA, 2August LLC, New York, NY, USA","locationCode":"522","description":"\r\n\t<div>OBJECTIVES: Cell and gene therapies (CGTs) are potentially curative treatments for a growing array of diseases. CGTs pose a particular challenge to health care payers due to their one-time administration, high costs and uncertain long-term benefits. Most patients who are eligible for CGTs are covered by Medicaid or Commercial health plans. In this study we assessed variation in Medicaid and Commercial coverage for 11 CGTs. METHODS: We used the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database to identify coverage policies for 11 FDA-approved CGTs issued by 17 large US commercial payers as of April 2021. We also searched individual state websites to identify Medicaid policies. We categorized policies according to type of restriction: subgroup (i.e., age, gene status, diagnostic criteria), step therapy protocol (patients are required to first try an alternative therapy), and prescriber requirements (a particular type of specialist must prescribe the drug) and compared these to the FDA label. RESULTS: Our sample included 167 Medicaid and 198 Commercial CGT coverage policies. Medicaid policies were more likely to include restrictions beyond the FDA label than commercial policies (68% versus 54%, respectively). Restrictiveness varied across CGTs, with plans imposing few restrictions for access to Imlygic for melanoma, while restrictions were common for Luxturna for genetic retinal dystrophy and Zolgensma for spinal muscular atrophy. Both Medicaid and Commercial plans varied in clinical requirements such as frailty or functional score, life expectancy, genetic factors, disease severity, or age. Step therapy protocols were uncommon. CONCLUSIONS: Medicaid and Commercial plans frequently use coverage restrictions beyond the FDA label for access to CGTs, however the use of restrictions varies depending on type of plan and CGT. We identified significant variation in coverage restrictions for CGTs both within and across Medicaid and Commercial plans, suggesting inconsistent patient access to these important therapies.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23beinfeldposter125256-pdf.pdf?sfvrsn=9b619895_0","title":"ISPOR23_Beinfeld_POSTER125256.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125256","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Sustained Humanistic Burden and Work Impact in Adults with Transfusion-Dependent Beta-Thalassemia (TDT): Results from a Global Longitudinal Survey","id":"ed5c15d4-f864-42d2-9336-105303b30099","sessionCode":"PCR29","topDisplay":"Drahos J1, Boateng-Kuffour A1, Calvert M2, Levine L3, Dongha N4, Li N1, Pakbaz Z5, Shah F6, Ainsworth N7, Martin A7 1Vertex Pharmaceuticals Incorporated, Boston, MA, USA, 2University of Birmingham, Birmingham, UK, 3Independent Consultant, Petaluma, CA, USA, 4Independent Consultant, London, UK, 5University of California Irvine School of Medicine, Orange, CA, USA, 6NHS Blood and Transplant, London, UK, 7QC Medica, Liverpool, UK","locationCode":"739","description":"\r\n\t<div>OBJECTIVES: Transfusion-dependent β-thalassemia (TDT) is a severe form of β-thalassemia requiring frequent, lifelong red blood cell transfusions and iron chelation therapy. This longitudinal study examined the impact of TDT on participants’ health-related quality of life and work productivity. METHODS: A longitudinal survey was administered at three timepoints (month 0 [M0], month 3 [M3], month 6 [M6]) in the US, the UK, France, Germany, and Italy and included multiple patient-reported outcome (PRO) measures: FACT-G, EQ-5D-5L, FACIT-Fatigue (only M1), and WPAI. Key eligibility criteria included receiving ≥8 blood transfusions in each of the last 2 years. Descriptive analyses were conducted at M3. These data were compared with M0 data (previously reported), where available. RESULTS: The survey was completed by 121 adult participants with TDT living in the US (n=60) and the UK, Germany, Italy, and France (n=61) at M3. Overall, 70.0% were female, their mean age was 38.5 years (standard deviation [SD]=10.5), and 33.9% had full-time employment (≥32 hours/week). Participants received a mean of 18.2 (SD=7.9) transfusions annually, equivalent to a mean of 1 transfusion every 2.9 weeks. Participants spent a median of 19.0 hours (interquartile range=13.5–26.0) managing their condition in the past month. At M3, the mean FACT-G score was 69.3 (SD=19.8). The mean EQ-5D VAS score was 65.4 (SD=19.2). The mean FACIT-Fatigue score was 27.9 (SD=13.7), which is lower than that of the US general population (mean=43.6 [SD=12.6]) and comparable to that of patients with cancer and anemia (23.9 [SD=12.6]). According to the WPAI, employed participants had an average of 17.8% (SD=28.3%) absenteeism, 34.2% (SD=28.7%) presenteeism, and 43.5% (SD=32.4%) reduction in work productivity in the past week. PRO findings were comparable between M0 and M3. CONCLUSIONS: Despite receiving currently available treatments, adults with TDT continue to experience substantial and sustained humanistic burden and indirect impacts.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23drahospcr29126309-pdf.pdf?sfvrsn=8a45eeb4_0","title":"ISPOR23_Drahos_PCR29126309.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126309","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Potential Association of Remdesivir and Hyperkalemia: A Disproportionality Analysis in USFDA Adverse Event Reporting System Database","id":"591e0a45-6a06-4d38-bf4d-1343cb79c688","sessionCode":"EPH43","topDisplay":"Das A, Vajapu M Ramaiah University of Applied Sciences, Bangalore, KA, India","locationCode":"442","description":"\r\n\t<div>BACKGROUND: Signal detection is one of the most advanced and promising techniques in the world of pharmacovigilance. Remdesivir is approved for emergency use by the US Food and Drug Administration (FDA) for patients with coronavirus disease 2019 (COVID-19). Its benefit- risk ratio is still being explored because data in the field are rather scant. On the other hand hyperkalemia is a potentially life-threatening electrolyte disorder. Severe hyperkalemia can occur suddenly and can cause life-threatening heart rhythm changes (arrhythmia) that cause a heart attack. Even mild hyperkalemia can cause heart related problems over time if not treated. OBJECTIVES: To evaluate the potential association of Remdesivir with risk of Hyperkalemia by analyzing the spontaneous reports through disproportionality analysis. METHODS: Data were obtained from the public release of data in FAERS. Case/non-case method was adopted for the analysis of association between Remdesivir use and Hyperkalemia. The data-mining algorithm used for the analysis were Reporting Odds Ratio(ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>, PRR≥2 were considered as positive signal. RESULTS: A total of 7 DE’s associated with Remdesivir use and hyperkalemia were reported. The mean age of the patients of Remdesivir associated events was found to be 75 years [95% CI]. The reports by gender were distributed with a male to female ratio of 3:1, though gender was not revealed in 3 reports. The data mining algorithms exhibited positive signal for hyperkalemia (PRR: 2.349, ROR: 2.354) upon analysis as those were well above the pre-set threshold. Three case reports were identified which strengthened these findings and highlighted the importance of laboratory parameters for the early detection of hyperkalemia CONCLUSIONS: The current study found a potential risk of hyperkalemia with the use of Remdesivir and there is an urgent need to thoroughly investigate the same and take the necessary action to avoid or minimize the risk.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126043","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"97c2e725-3c74-4625-997f-a72378c5a557","parentId":"00000000-0000-0000-0000-000000000000","title":"Generics","urlName":"Generics"},{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Review of Indication-Based Pricing Practice in Switzerland","id":"70c78e3a-d68d-459c-a843-13a9498935b6","sessionCode":"HPR30","topDisplay":"Ringger D1, Darlington O2, Mumford A3 1Initiate Consultancy, Zug, Switzerland, 2Initiate Consultancy, Cardiff, UK, 3Initiate Consultancy, Northampton, UK","locationCode":"532","description":"\r\n\t<div>OBJECTIVES: Understand the prevalence of indication-based pricing (IBP) in Switzerland. METHODS: We identified active ingredients with multiple net prices listed using the Speciality List (SL) from December 2022. RESULTS: IBP is a pricing approach in which the cost of an active ingredient is adjusted based on the specific indication for which it is used to treat. In some European countries, IBP is implemented to reflect the value of the product's indications portfolio. Generally, this is achieved by applying a single \"weighted\" price based on the value of each indication (e.g., Germany) or by setting individual prices for each indication (e.g., Switzerland). In other countries, the price for the first indication is reimbursed for all indications (e.g., Netherlands). In Switzerland, the list price for active ingredients remains the same, but the net prices (i.e., the price after discount is applied) may vary depending on the indication for which it is used. According to the SL as of December 2022, there are 20 medicines (excluding generics and biosimilars) with indication-based discounts. These are all oncology products, and the types of discounts per active ingredient can vary. The discounts may include combinations of publicly available discounts, confidential discounts, and budget caps. CONCLUSIONS: Despite its potential benefits, the implementation of IBP can be challenging for healthcare systems due to lack of data tracking of different uses of the same medicine. From a manufacturer's perspective, without IBP, there is an incentive to only focus on smaller/high-value indications rather than expanding the use of existing active ingredients to treat additional conditions. The implementation of indication-based discounts in Switzerland allows manufacturers to align the net price of a medication with its value. This approach also reduces the risk of list price erosion when introducing a new indication and provides flexibility in combining different types of discounts for the same active ingredient.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/review-of-indication-based-pricing-practice-in-switzerland126156-pdf.pdf?sfvrsn=67c59278_0","title":"Review of indication-based pricing practice in Switzerland126156.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126156","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Impact of Different Discounting Rates on Cost-Effectiveness Outcomes in Chronic Disease Populations: Hemophilia A As an Exemplary Disease","id":"c0230dcb-c761-4554-a22f-13bd7217e6c6","sessionCode":"EE89","topDisplay":"Bolous N, Chen Y, Devidas M, Reiss U, Bhakta N St. Jude Children's Research Hospital, Memphis, TN, USA","locationCode":"333","description":"\r\n\t<div>OBJECTIVES: AAV-mediated gene therapy (AAVGT) is a novel treatment offering curative effects for several genetic diseases. The high upfront cost of AAVGT and the uncertainty around durability of its effectiveness are posing challenges for health economists. The ISPOR taskforce compiled a list of special considerations, including exploring different discounting rates (DRs). We examined the impact of different DRs when comparing AAVGT to alternative treatments in persons with hemophilia A. METHODS: We conducted a microsimulation Markov model using a lifetime horizon to analyze the cost-effectiveness of AAVGT preceded and followed by standard half-life (SHL) factor VIII prophylaxis (Pro) compared to lifelong on-demand (OD) SHL and extended half-life (EHL) and lifelong Pro with SHL and EHL. In the base-case scenario, we used 3% DR for both costs and quality adjusted life years (QALYs). We conducted 6 scenario analyses varying the DR: 1) 0% for both costs and QALYs, 2) 5% for both costs and QALYs, 3) 4% costs, 1.5% QALYs, 4) 4% costs, 2% QALYs, 5) 5% costs, 1.5% QALYs, and 6) 5% costs, 2% QALYs. RESULTS: Base case results showed AAVGT–SHL not cost-effective compared to OD–SHL or OD–EHL with incremental cost-effectiveness ratio (ICER) of $1,060,000/QALY and $1,050,000/QALY, respectively and dominant compared to Pro–SHL and Pro–EHL. Varying DR did not change the results with one exception, with 0% DR, AAVGT–SHL became cost-effective instead of dominant, compared to Pro–SHL with ICER of $140,000/QALY. AAVGT–SHL remained dominant compared to Pro in all other scenarios. Compared to OD, AAVGT–SHL was not cost-effective in any of the scenarios with ICER ranging between $460,000/QALY–$1,340,000/QALY. CONCLUSIONS: Although the variation in DR changed the cost-effectiveness outcome in only one scenario, from dominant to cost-effective, the range of ICER varied widely depending on different DRs, indicating the significant influence of different DRs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023-bolous-discounting127434-pdf.pdf?sfvrsn=c9f3689f_0","title":"ISPOR2023-BOLOUS-Discounting127434.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127434","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Differential Target MULTIPLEXEDTM Spinal Cord Stimulation in Sweden","id":"1da0ea2e-41f5-4fc3-aff6-13f34a6611d1","sessionCode":"EE91","topDisplay":"Holm A1, Eggington S2, Gasquet N3 1Medtronic Danmark A/S, Copenhagen, Denmark, 2Medtronic International Trading Sarl, Tolochenaz, VD, Switzerland, 3Medtronic, Minneapolis, MN, USA","locationCode":"334","description":"\r\n\t<div>OBJECTIVES: Differential Target MultiplexedTM (DTM) Spinal Cord Stimulation (SCS) has been shown to be more effective than conventional SCS (C-SCS) in reducing pain in patients with chronic lower back pain (LBP). This study assessed the cost-effectiveness of DTM-SCS compared to C-SCS and to conventional medical management (CMM), from the Swedish payor and societal perspectives. METHODS: A one-year decision tree phase was followed by a long-term Markov phase, with health states partitioning patients according to level of pain relief and continuation of therapy. Data from randomized controlled trials were used to determine health outcomes at one year, with long-term outcomes modelled to incorporate treatment discontinuation and associated worsening of symptoms. Utility weights were applied to each health state to reflect changes in quality of life according to efficacy, and mortality was applied using Swedish life tables. Cost data included: device acquisition and implantation, device replacements, adverse event management, drug- and non-drug pain therapy, treatment withdrawal, and societal costs due to work absenteeism. One-way and probabilistic sensitivity analyses were undertaken to explore decision uncertainty. Costs and effects were discounted at 3% per year, and separate analyses were performed using payer and societal perspectives. RESULTS: Over 15 years, the pairwise ICERs were 25,166 kr (C-SCS vs. CMM), 15,932 kr (DTM-SCS vs. CMM) and 4,035 kr (DTM-SCS vs. C-SCS). One-way sensitivity analyses demonstrated the robustness of the results, and at a threshold of 500,000 kr per QALY, DTM-SCS was predicted to be the most cost-effective intervention (99.6%). Similar results were obtained when taking a societal perspective, with both SCS forms dominating CMM. CONCLUSIONS: These results strongly suggest that DTM-SCS is cost-effective from both payer and societal perspectives, and support its wider uptake in the Swedish health care system to manage chronic low back pain in patients with chronic LBP.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/dtmceswedenposterv2127003-pdf.pdf?sfvrsn=2e42de88_0","title":"DTM_CE_Sweden_Poster_v2127003.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127003","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Value Pyramid to Guide Asthma Interventions in the UK","id":"f6c477c7-b277-4e49-b868-1411063a7061","sessionCode":"EE72","topDisplay":"Tomini F Queen Mary University of London, Sutton, SRY, UK","locationCode":"315","description":"\r\n\t<div>OBJECTIVES: Two guidelines for the management of people with asthma are available in the UK, the British Thoracic Society (BTS)/Scottish Intercollegiate Guidelines Network (SIGN) and the National Institute for Health and Care Excellence (NICE). However, only NICE reviewed the health economic evidence. Differences between the two guidelines’ recommendations raise further issues when it comes to choosing value for money interventions. The aim of this article is to propose a cost-effectiveness value pyramid of asthma interventions in the UK guided by the available cost-utility evidence. METHODS: We followed a three-stage approach. Firstly, a systematic review identified cost-utility studies in asthma management. Secondly, the review was extended to cost-utility studies of interventions recommended by BTS/SIGN and NICE in wider patient populations. The results were then ranked as per value pyramids presenting the available evidence on cost-effectiveness of asthma interventions in UK separately for adolescents/adults (12+ years old) and children (6-14 years old). RESULTS: The most cost-effective treatments or interventions were: smoking cessation interventions and services (ICER £13 - £3,601/QALY) and flu vaccination (£2,996-£3,158 in adults and£2,294 - £4,751 in children), outpatient asthma clinic (£1,378-£6,776), specific subcutaneous immunotherapy (£6,975 in both adults/children), ICS+LABA combination inhaler (£7,604 - £13,706), and temperature-controlled laminar airflow devices (£8,915 in both adults/children). Several treatment options recommended for asthma management by BTS and/or NICE were not included in the pyramids in absence of any economic evidence. CONCLUSIONS: Lack of cost-effectiveness evidence leads to possible confusion when choosing asthma interventions providing the most benefits in terms of incremental health benefits per additional Pound spent. While our proposed study provides more guidance in this respect, we have also identified several gaps in the cost-effectiveness evidence. Future studies should focus on assessing cost-effectiveness of interventions like SABAs, theophylline, oral steroids, immunosuppressant, bronchial thermoplasty, allergy avoidance, exercise and other therapies where evidence is missing.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/asthma-pyramid-poster--ispor126973-pdf.pdf?sfvrsn=acc646f3_0","title":"Asthma Pyramid Poster _ ISPOR126973.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126973","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"},{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Cost-Utility Analysis Comparing a Clinical Decision Support Software to Prescriber Decision Alone for Drug-Drug Interactions from an U.S. Payer Perspective","id":"bff3e99e-3562-4aed-b856-157c61286238","sessionCode":"EE85","topDisplay":"Gómez-Lumbreras A1, Villa Zapata L2, Akibova G2, Malone DC1 1Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 2Mercer University College of Pharmacy, Atlanta, GA, USA","locationCode":"327","description":"\r\n\t<div>OBJECTIVES: To avoid the potential harm of drug-drug interactions (DDIs), clinical decision support (CDS) systems using electronic health records have been installed in multiple healthcare systems. We aim to estimate whether DDI-CDS systems are cost-effective compared to prescribers’ decisions alone considering DDIs. METHODS: A cost effectiveness model was developed from a U.S. healthcare system payer perspective comparing a DDI CDS alert software to prescriber’s alone decision for patients with a prescription order that includes a potential DDI. The population of interest included individuals of 72+/- 10 years or older. The model incorporates the risk of override of the DDI alert and of the physician prescribing the potential DDI. The primary health states are severe adverse event (SAE), including life threatening event, hospitalization, and medically significant event; minor AE (mAE); and no AE. As death due to DDI has been estimated in patients admitted to hospitals, we included this probability in the hospitalization branch. Disutility values were used to calculate quality adjusted-life-years (QALYs). Endpoints included costs, QALYs, and incremental cost-effectiveness ratios (ICERs) with a willingness-to-pay (WTP) threshold of $150,000 per QALY. RESULTS: Prescriber’s alone decision had an incremental cost of $23 compared CDS-DDI ($511 vs. $488, respectively), providing similar QALYS (0.85 and 0.87 respectively). CDS-DDI alert was dominant compared to prescriber’s alone decision. The utility of a mAE, followed by the probability of DDI alerts being overridden are the most relevant variables. The cost-effectiveness acceptability curve indicates there are no WTP values where the DDI-CDS alert has a lower probability of being more cost-effective than the physician’s prescribing decision alone. CONCLUSIONS: This analysis suggests that CDS-DDI alerts are cost-effective compared to prescriber's decision alone. Regardless that most DDIs are overridden, DDI CDS is a cost-effective tool to avoid harm.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127721","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Estimating the Costs of Familial Hypercholesterolemia Management Using Primary Claims Data","id":"42f290e4-d5a4-4d7d-b245-15d1384a436f","sessionCode":"EE66","topDisplay":"Passero L, Roberts MC University of North Carolina at Chapel Hill, Chapel Hill, NC, USA","locationCode":"308","description":"\r\n\t<div>OBJECTIVES: Familial hypercholesterolemia is a rare genetic condition increasing an individual’s risk of cardiovascular disease. Early diagnosis and access to lipid-lowering treatment are essential to prevent stroke, heart attack, and cardiac death. Limited understanding of familial hypercholesterolemia costs to payers prevents the economic assessment of optimal screening and treatment strategies. We sought to measure the direct medical costs of diagnostic lipid panel testing and pharmacotherapy for familial hypercholesterolemia from real-world data. METHODS: We analyzed administrative claims data from a regional commercial insurer from January 2018 to December 2020. Cohorts consisting of adults with hyperlipidemia and familial hypercholesterolemia were identified using the presence of ICD-10-CM diagnosis codes on 1 inpatient or 2 outpatient claims. We quantified the mean cost of lipid testing and prescriptions for statins, ezetimibe, and PCSK9 inhibitors in 2020 US dollars using winsorization. We also used linear regression to evaluate the effect of medication choice on cost to payers among statins and PCSK9 inhibitors. RESULTS: The mean cost of a lipid panel for diagnosing familial hypercholesterolemia was $83.27 among patients with hyperlipidemia. The mean charge for a 90-day supply of statins was $407.39 compared to $176.33 for a 30-day supply for patients with familial hypercholesterolemia. PCSK9 inhibitors generated the highest mean charge for lipid-lowering therapies at a mean cost of $739.60 for a 28-day prescription. The mean costs for PCSK9 inhibitors and statins also showed substantial variation within drug classes. CONCLUSIONS: While the cost for lipid panel testing is moderate, lipid-lowering pharmacotherapy has the potential to generate substantial costs in treating familial hypercholesterolemia as a lifelong condition. Further investigation is necessary to understand the cost of genetic testing as a potentially more accurate test for familial hypercholesterolemia diagnosis. Additionally, future studies should examine the cost-effectiveness of different screening and treatment strategies for managing elevated cardiovascular disease risk in affected individuals.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23passeroposter126248-pdf.pdf?sfvrsn=9890d7da_0","title":"ISPOR23_Passero_POSTER126248.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126248","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Development of a Valid Qualitative Standardized Interview Manual","id":"b4e847e0-f38c-47ac-9065-15d5b264dcee","sessionCode":"PCR50","topDisplay":"Kongsoe JH1, Mubekapi-Musadaidzwa C2, Casper R2 1Clinigma, Copenhagen, 84, Denmark, 2Clinigma, Cape Town, South Africa","locationCode":"806","description":"\r\n\t<div>OBJECTIVES: The authors developed a qualitative standardized interview manual (SIM) that can be readily used for capturing and analyzing patient-experience data, tailoring for various conditions and phases of drug development. The SIM seeks to build upon current methods for instrument development to address gaps in systematic qualitative methodologies. METHODS: Following the methodology in the FDA’s PFDD series, the SIM creation included an iterative process with a systematic literature review, consultation with PRO experts, and a series of cognitive interviews. Each step was documented in an item-tracking matrix summarizing the creation, deletion, and modification of item content. RESULTS: Following PRISMA guidelines, a qualitative literature search resulted in 23 articles focused on the effect of investigational drugs/treatments in relation to patients’ disease and treatment experiences, satisfaction, and trial experiences. The review resulted in a framework of seven modules written for pre-, interim, and post-trial implementation. Subsequently, expert consultation furthered the scope, applicability, and adaptability of the modules including burden of disease, patient preference, patient satisfaction, trial participation, treatment outcome, meaningful change, and benefit-risk assessment. Modifications more directly connected qualitative questions to commonly used PROs, including the SF-36, EQ-5D, and the WHO-DAS 2.0. Further, instructional content was augmented to clarify instrument adaptability. Cognitive interviews with people experiencing a particular condition verify the SIM is meaningful with relevance, comprehension, and completeness, and explore health literacy, recall periods, and response options with resultant modifications. A sample of case study results from this phase will be presented to show how it can be tested in future studies. CONCLUSIONS: With the expectations for improved content validity in interview manuals yet the need for more efficient solutions to integrate patient voice, the application of the FDA iterative developmental process proved constructive, even though labor-intensive, in developing a qualitative interview manual for use in drug development.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/pcr50-clinigma-sim-posterisporus-2023127304-pdf.pdf?sfvrsn=2e761dce_0","title":"PCR50 Clinigma SIM Poster_ISPOR_US 2023127304.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127304","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost and Benefits of Offering Transanal Irrigation Therapy to Medicare Beneficiaries with Spinal Cord Injury Related Neurogenic Bowel Dysfunction Who Failed Standard Bowel Care","id":"82ee661d-8437-4580-bb0d-160cb8536484","sessionCode":"EE13","topDisplay":"Rodriguez G1, Martinson M2, Kirshblum S3 1University of Michigan, Anne Arbor, MI, USA, 2Technomics Research, LLC, Minneapolis, MN, USA, 3Kessler, nj, Montenegro","locationCode":"213","description":"\r\n\t<div>OBJECTIVES: To determine the cost of adding Transanal Irrigation (TAI) to the Medicare program and reducing osteomy care over a 10-year period in persons with spinal cord injury (SCI) related neurogenic bowel dysfunction (NBD). METHODS: Using a Markov model, we projected the 10-year cost of TAI for 5,000 Fee-For-Service (FFS) Medicare beneficiaries with SCI related NBD who failed standard bowel care (SBC). We assumed TAI is used daily and TAI cost to be equal to Medicaid TAI fee schedule. The model also simulated the proportions of beneficiaries who have colostomy to manage NBD using the probabilities for colostomy with and without TAI published by Emmanuel 2016. Colostomy is an invasive procedure that may be associated with its inherent costs and complications. The model evaluates the cost to Medicare, including costs for the ostomy surgery and supplies using Medicare FFS payment rates. RESULTS: Over 10 years, total undiscounted cost to Medicare for the beneficiary cohort on SBC was approximately $45.7 million. Assuming 14% of beneficiaries adopted TAI, the total cost to Medicare would be $96.6 million. Incremental Medicare spending on TAI over 10 years was $78,358 per each patient who used TAI daily. The incremental TAI cost was offset by a 62% relative reduction in the risk of colostomy, from 28.6% using SBC ($8,603 per patient) to 10.8% using TAI ($3,208 per patient). CONCLUSIONS: Adding daily TAI as a Medicare benefit would result in additional cost of $50.8 million over 10 years while substantially reducing the probability of ostomy. This model is conservative in nature as TAI can be also be used every other day and its use has been shown to decrease secondary complications of SCI including the rate of UTIs, fecal impaction, incontinence, etc.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23rodriguezposteree13124152-pdf.pdf?sfvrsn=7fbff1c6_0","title":"ISPOR23_Rodriguez_POSTER_EE13124152.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124152","diseases":[{"id":"3f994852-a0d4-4706-9665-e4d867006d9a","parentId":"00000000-0000-0000-0000-000000000000","title":"Injury & Trauma","urlName":"injury-trauma"},{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Health Economic Evaluation of COVID-19 Vaccines: A Systematic Literature Review","id":"d2f9cb08-d1dd-45b9-80fd-17b9ecd0a89d","sessionCode":"EE98","topDisplay":"Li Y1, Guerra I2, Rtveladze K2, Leite J2, Vandoulakis M3, Eggendorfer L4, D'Alessandro M4 1IQVIA, London, UK, 2IQVIA, London, LON, UK, 3IQVIA, Athens, Greece, 4NOVA SBE, Lisbon, Portugal","locationCode":"342","description":"\r\n\t<div>OBJECTIVES: The COVID19 pandemic caused over six million deaths worldwide as of 2022 and made necessary the rapid development of vaccines. The objective of this Systematic Literature Review is to summarise the main evidence from economic evaluations of vaccines against COVID19. METHODS: Searches were conducted on PubMed on July 13th 2022. The selected papers considered COVID19 vaccination scenarios without population limits. The types of study design examined were cost-benefit and cost-effectiveness analyses. RESULTS: Overall, 16 articles from an initial list of 1842 were included in this review. Out of the 16 models, there were five Markov cohort models (three of them were combined with a decision tree model), four dynamic transmission models, three microsimulation models, three epidemiological models (without further information on the model structure) and one decision tree model. Model characteristics were considerably consistent between high-, middle- or low-income countries. Five studies considered both the healthcare and societal perspective, while seven studies reported only the former, and one only the latter. Two studied did not specify the study perspective. Ten of the studies did not consider any level of herd immunity, and no study considered cross-protection. Although eight studies used “naïve” comparisons between vaccines, none of the studies conducted thorough indirect treatment comparison. All the models suggest that vaccines are cost-effective as they prevent death and transmission, and reduce the severity of cases. Although the sources of effectiveness estimates were always stated, the details of those studies were rarely reported. Nevertheless, the outcome measures and the key parameters used in the models were generally clearly stated and justified. CONCLUSIONS: This SLR highlights several challenges for conducting Health Economic evaluations of COVID19 vaccines. The quality of the models and their estimates suffered from the very fast pace of COVID19 research. Therefore, economic evidence on vaccination programs requires additional rigorous research.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126817","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Gender and Racial Disparities and All-Cause Mortality in Bladder Cancer Patients in the U.S.","id":"0026910a-b3b1-4889-99eb-1827bf905a74","sessionCode":"EPH24","topDisplay":"Imran N1, Akincigil A2, Erim D3, Khan Z4 1Rutgers University, New Brunswick, NJ, USA, 2Rutgers University, Piscataway, NJ, USA, 3Parexel International, Titusville, NJ, USA, 4Zebgene LLC, Malvern, PA, USA","locationCode":"427","description":"\r\n\t<div>OBJECTIVES: Studies conducted up to two decades ago, suggest that sociodemographic characteristics affect bladder cancer mortality. African American race seems to be a strong predictor of poor survival. Female patients have higher bladder cancer mortality. The objective of this study is to examine recent data for sociodemographic differences in all-cause mortality among bladder cancer patients. METHODS: Patients with bladder cancer diagnosis between January 01, 2006, and January 31, 2022 were studied retrospectively from Precision Point Specialty Analytics (EMR) database, for sociodemographic differences. Log rank odds test, Chi-square test and Cox regression analysis were performed to analyze the association between all-cause survival rate and key explanatory variables specifically gender and race, controlling for age at diagnosis, tumor type and Medicare Region. RESULTS: Among 5,844 bladder cancer patients, 4486 were male, 1358 were females, 4801 Caucasian American, 299 African American, and 744 Other. The mean and median age at diagnosis was 51 years, with a mode of 53 years. 5, 10 and 15-year survival rates in females were better than males (p=0.0004) with no difference in survival rates across race (p=0.4616). More Caucasian American men and women than African Americans were diagnosed with bladder cancer (p=0.0156). Females diagnosed with bladder cancer had a lower risk of all-cause mortality compared to males, hazard ratio of 0.68 (p=0.0007). African Americans and patients belonging to other races had almost the same risk of all-cause mortality when compared to Caucasian American counterparts, hazard ratios 1.022 (p=0.9193) and 1.084 (p=0.5806) respectively. CONCLUSIONS: A strong statistical association exists between gender and all-cause mortality in bladder cancer patients. Compared to females, males had lower survival rates. No association was observed between all-cause mortality in bladder cancer patients and race. This underscores the need to further investigate disparity in bladder cancer specific mortality due to sociodemographic, socioeconomic, and racial differences.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/gender-and-racial-disparities-and-all-cause-mortality-in-bladder-cancer-patients-in-the-u-s-124942-pdf.pdf?sfvrsn=b5af2c75_0","title":"Gender and Racial Disparities and All-Cause Mortality in Bladder Cancer Patients in the U.S.124942.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124942","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Missing Patient Reported Outcome Data in Clinical Trials: An Overview and Simulation Study","id":"9705a479-9e13-4eb1-93a9-191af5dd9709","sessionCode":"MSR19","topDisplay":"McGinley JS1, Savord A1, Chan E2, Larbalestier A3, Liu Y2, Delong PS4, Wirth RJ1 1Vector Psychometric Group, LLC, Chapel Hill, NC, USA, 2Janssen Global Services, LLC, Raritan, NJ, USA, 3Janssen Research and Development, Allschwil, Switzerland, 4Janssen Global Services, LLC, Horsham, PA, USA","locationCode":"711","description":"\r\n\t<div>OBJECTIVES: Missing data occur in clinical trials and can have a negative impact on the results. In this study, we (1) outlined concepts related to missing patient reported outcomes (PRO) data, including patterns of missingness, missing data types (missing completely at random [MCAR], missing at random [MAR], missing not at random [MNAR]), and commonly used analytic strategies that address missingness (multiple imputation [MI], mixed model repeated measures [MMRM]), and (2) investigated the potential impact of missing data on PRO results in clinical trial settings. METHODS: A simulation study was conducted to empirically evaluate the impact of missing PRO data in clinical trials. The simulation aligned with a hypothetical clinical trial where a PRO instrument was captured for N=500 subjects (n=250 per treatment group) at 3 visits (baseline, 3 months, 6 months) and explored various types (MCAR, MAR, MNAR) and rates (0%, 20%, 40%) of missingness. Both MI and MMRM were used. RESULTS: Simulation results showed that when the missing PRO data were MCAR, descriptive statistics and model-based within and between-treatment group estimates were unbiased. However, when the PRO data were MAR, unbiased descriptive statistics were only obtained using MI, while unbiased model-based estimates were obtained using MI and MMRM. Findings also demonstrated that, regardless of the analytic strategy used (MI, MMRM), biases arose when missing data were MNAR. Supplemental simulation analyses suggested that capturing the reason(s) for missingness and integrating this information into MMRM as a covariate may help to reduce bias. CONCLUSIONS: Using MMRM and MI, researchers can handle missing data that are MCAR or MAR, but these approaches may not adequately address missing data that are MNAR. Future work could focus on designing a method for capturing information regarding reasons for missing data and developing analytic strategies that can leverage these insights to accurately characterize treatment effects.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23mcginleywirthposter123903-pdf.pdf?sfvrsn=1686fbe0_0","title":"ISPOR23_McGinleyWirth_POSTER123903.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123903","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Incorporating Added Therapeutic Benefit and Domestic Reference Pricing into Medicare Payment for Expensive Part B Drugs","id":"d35d0a36-c5b4-4730-8cb9-19b670cc886e","sessionCode":"HPR16","topDisplay":"DiStefano MJ1, Anderson KE2, Liu A1, Mattingly TJ3, Socal MP1, Anderson G1 1Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA, 2University of Colorado, Aurora, CO, USA, 3University of Utah College of Pharmacy, Park City, UT, USA","locationCode":"520","description":"\r\n\t<div>OBJECTIVES: This study identifies expensive drugs reimbursed by Medicare Part B and evidence for each drug’s added therapeutic benefit. A reimbursement policy for Medicare Part B that integrates added benefit assessment and domestic reference pricing is then modeled. METHODS: A retrospective analysis using a 20% nationally-representative random sample of traditional Medicare Part B outpatient and carrier claims was conducted from 2015 to 2019. Expensive drugs were defined as having average annual spending per beneficiary exceeding the average annual social security benefit ($17,532 in 2019). For expensive drugs identified in 2019, added benefit assessments conducted by the French Haute Autorité de Santé (HAS) were collected. For expensive drugs with a low added benefit assessment, comparator drugs were identified in the respective HAS reports. For each comparator, average annual spending per beneficiary in Part B was computed. Finally, potential savings from two reference pricing scenarios were calculated: reimbursing expensive Part B drugs with low added value at the level of each drug's 1) lowest cost comparator and 2) beneficiary-weighted average cost of all comparators. RESULTS: The number of expensive Part B drugs grew from 56 in 2015 to 92 in 2019. The share of overall Part B drug spending attributable to expensive drugs increased from 46.9% to 59.6%, while only 1.3% of traditional Medicare Part B enrollees were using these drugs in 2019. Of the 92 expensive drugs in 2019, 34 offer low added benefit. Implementing reference pricing for the expensive drugs with low added benefit could have saved an estimated $2.1 billion if prices were set based on spending for their lowest cost comparator, or $1 billion if prices were set based on the weighted average of spending for comparators. CONCLUSIONS: Reference pricing based on added benefit assessment could be used to address high drug launch prices or inform Inflation Reduction Act price negotiations.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123874","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Work Productivity Assessment in Clinical Trials and Subsequent Economic Modeling in Multiple Sclerosis (MS) in Two Health Technology Assessment (HTA) Archetypes","id":"1b39ff4d-7559-4bec-8b2f-1a012384bf09","sessionCode":"PCR17","topDisplay":"Hubscher E1, Harricharan S2 1Cytel Inc, Apex, NC, USA, 2Cytel Inc., Waltham, MA, USA","locationCode":"3B","description":"\r\n\t<div>OBJECTIVES: Productivity loss constitutes a substantial proportion of indirect costs in many health conditions. For chronic conditions, such as MS, productivity decrements and associated indirect costs may increase with disease progression; however, trajectories of symptom burden, absenteeism/presenteeism, and costs are not fully characterized. Several instruments are available to assess productivity in MS and can be used to capture societal costs for economic modelling and subsequent HTA. We explored the frequency and manner in which such measures are employed in clinical studies and models. METHODS: We conducted a review of trials in MS including productivity measures on clinicaltrials.gov and cross-referenced publicly available HTA assessment reports from NICE (UK) and TLV (Sweden). RESULTS: Results: Overall, 15 out of 37 trials including productivity were interventional, with cladribine, dimethyl fumuarate, ocrelizumab, and natalizumab the most common interventions. Ten studies were either phase 4 (n=7) or phase 3 (n=3). Among reported instruments, WPAI:MS (n=11) was used most often, followed by other forms of WPAI (either WPAI, WPAI: general health, or WPAI: specific health problem; n=11). The percentage of trials including productivity was low overall, but Nordic countries had higher rates than the UK. As expected, in all seven applicable assessment reports identified from NICE, productivity did not inform the economic model. Publicly available assessments from TLV, which considers the societal perspective, were scarce. An assessment of ocrelizumab reported uncertainty in the representativeness of published work-absence data in the model; however, inclusion of indirect costs had a major impact on the results in some comparisons. CONCLUSIONS: Productivity measures may be valuable to inform representative economic modelling in geographies that consider the societal perspective and can impact results; however, current use, and consideration and acceptance by HTA bodies is variable. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-us-2023wpai-in-ms23apr23-3127730-pdf.pdf?sfvrsn=44f7e888_0","title":"ISPOR US 2023_WPAI in MS_23APR23 (3)127730.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127730","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost Estimation of Published Heart Failure and Edema Events in Hyperkalemic Patients on Patiromer and Sodium Zirconium Cyclosilicate","id":"324f7696-b94a-4059-9b56-1a756cdac235","sessionCode":"EE3","topDisplay":"Kleinman N1, Kammerer J2, Thakar C3 1Kleinman Analytic Solutions, Philadelphia, PA, USA, 2CSL Vifor, Redwood City, CA, USA, 3University of Cincinnati, and Cincinnati VA Medical Center, Cincinnati, OH, USA","locationCode":"204","description":"\r\n\t<div>OBJECTIVES: Risk of real-world hospitalizations for heart failure (HHF), and edema hospitalizations or emergency department (ED) visits (edema events) were previously directly compared by Zhuo et al (J Card Fail 2022;28:1414–23) for patients on patiromer (PAT) or sodium zirconium cyclosilicate (SZC), and showed consistent numerical differences across all endpoints favoring PAT. Statistical significance was achieved on the secondary endpoint of edema events and in a subgroup of patients who did not have HF prior to index HHF event. These numeric differences warrant further investigation as they may have economic and/or clinical importance. METHODS: We designed a model to estimate adjusted economic offsets that combined respective PAT and SZC HHF (25.1 and 35.8; difference 10.7 [95% CI 2.6–18.8]) and edema event (3.4 and 7.1; difference 3.6 [95% CI 1.7–7.1]) rates/100 person-years from Zhuo et al, with mean costs derived from Optum’s de-identified Clinformatics® Data Mart (CDM) database (the database used by Zhuo et al): HHF ($31,186 [n=2,095,607]); edema events (hospitalization $37,651 [n=514,859]; ED $552 [n=441,342]); and 30-count mean K+ binder prescription costs (PAT $887 [n=34,578]; SZC $665 [n=13,181]). CDM data spanned 2019–2021, and costs were adjusted to 2021 US dollars. RESULTS: For this base case, PAT was associated with a mean savings estimate of $142,844/100 person-years (95% CI –$150,816; $465,243). Respective costs/100 person-years for PAT vs SZC were $852,555 vs $1,262,195 (difference $409,640 [95% CI $115,980–732,039]) for HHF and edema events, and $1,064,928 vs $798,132 (difference –$266,796) for K+ binders, totaling $1,917,483 for PAT vs $2,060,327 for SZC. CONCLUSIONS: This model demonstrates cost offset to drug price at relatively small numeric differences in event rates. Model outcomes were most affected by HHF cost and least influenced by edema ED visit cost. Limitation: CDM data extract may differ from that used by Zhuo et al.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kammererposteree3126322-pdf.pdf?sfvrsn=8167ab34_0","title":"ISPOR23_Kammerer_POSTER_EE3126322.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126322","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Extended Cost-Effectiveness Analysis of Varenicline for Smoking Cessation in Patients with Chronic Obstructive Pulmonary Disease in Thailand","id":"51975be4-b3e5-4fea-8c42-1b62f525fa42","sessionCode":"EE69","topDisplay":"Prasitwarachot R1, Boonmanunt S2, Pornsuriyasak P3, Thavorn K4, Patikorn C1, Chaiyakunapruk N1 1College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 2Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, 10, Thailand, 3Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 4Ottawa Hospital Research Institute, Ottawa, ON, Canada","locationCode":"317","description":"\r\n\t<div>OBJECTIVES: To estimate the distributional effects by income quintiles of adding varenicline to Thailand’s smoking cessation services on health and financial outcomes compared to the usual care among chronic obstructive pulmonary disease (COPD) patients. METHODS: We conducted an extended cost-effectiveness analysis (ECEA) to estimate incremental costs per quality-adjusted life years (QALYs) gained, out-of-pocket (OOP) payment, catastrophic health expenditure (CHE), and impoverishment averted by income quintiles from a household perspective using Markov model with a lifetime time horizon. Costs and transition probabilities were derived from a longitudinal data analysis of 4,814 patients in Thailand. Household incomes, household expenditure, and household medical OOP were obtained from interviews with 120 Thai participants. RESULTS: Adding varenicline to the smoking cessation services would increase 0.29, 0.30, 0.30, 0.31, and 0.30 QALYs for the poorest to the richest, respectively. OOP payment averted would be observed in the first five years, with a percentage reduction varying from the poorest to the richest of 4.4%, 2.8%, 1.8%, 1.4%, and 1.1%, respectively. Compared to the usual care, the percentage of individuals who would avoid CHE after using varenicline would be 11.09%, 5.79%, 5.79%, 0.51%, and 0%. The bottom income quintile would gain the highest CHE averted, while this benefit could not be observed in the top income quintile. Impoverishment averted was not found in any income quintiles as no individuals were impoverished in the usual care. CONCLUSIONS: The addition of varenicline to the smoking cessation services among COPD patients potentially increases health equity and enhances financial risk protection through increasing QALYs gained and reducing OOP payment and CHE, especially for the poor. Utilizing the results from this ECEA allows policymakers to consider the non-health benefits as a part of the decision-making process to include varenicline in Thailand’s national formulary to achieve the health system’s goal of preventing financial catastrophe.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23prasitwarachotposter126497-pdf.pdf?sfvrsn=75d14ad8_0","title":"ISPOR23_Prasitwarachot_POSTER126497.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126497","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Resource Utilization Among Patients with Transfusion-Dependent Beta-Thalassemia in Italy","id":"0b7085dd-436a-4db1-b233-1b6529b303da","sessionCode":"EE58","topDisplay":"Udeze C1, Dovizio M2, Veronesi C2, Degli Esposti L2, Li N1, Dang TXMP1, Forni GL3 1Vertex Pharmaceuticals Incorporated, Boston, MA, USA, 2CliCon Srl, Health, Economics & Outcomes Research, Bologna, Italy, 3Centro della Microcitemia e Anemie Congenite, Ospedale Galliera, Genoa, Italy","locationCode":"203","description":"\r\n\t<div>OBJECTIVES: Patients with transfusion-dependent β-thalassemia (TDT) require regular red blood cell transfusions (RBCTs) for survival. This study sought to understand the healthcare resource utilization (HCRU) among patients with TDT in Italy. METHODS: This retrospective cohort study utilized an administrative database of Italian regions and local health units to identify patients with ≥8 RBCTs over a 12-month period and ≥1 iron chelation therapy (ICT) prescription between January 1, 2011, and February 1, 2019. The index date was the first transfusion of the ≥8 RBCTs during a 12-month period. Eligible patients were required to be continuously enrolled for 1 year before and after their index date. Each patient was matched to 5 controls without disease by age, region, gender, and index year. Patients and controls were followed from index until death, exiting the database, or end of study period (February 1, 2020), whichever occurred first. Demographics and rate of HCRU (per-patient-per-year [PPPY]) were assessed at index and during follow-up, respectively. A t-test was used for significance testing for HCRU (P<0.05). RESULTS: A total of 214 patients met the inclusion criteria for TDT and were matched to 1,070 controls. The mean age of patients with TDT at index was 46.7 years, and 45.8% were male. Matched controls had similar demographics. Patients averaged 18.2 RBCTs PPPY. Compared to matched controls, patients had significantly higher mean utilization of prescriptions (20.30 vs 4.91; P<0.001), outpatient services (21.92 vs 1.58; P<0.001), and all-cause hospitalization (1.35 vs 0.09; P<0.001) (all PPPY). In 1 year, patients averaged 16.1 days in the hospital compared to matched controls, who averaged 1.5 days. CONCLUSIONS: This analysis shows the significant economic burden for patients with TDT in Italy, which is likely underestimated given the lack of data on emergency room admissions in the database.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23udezeee58125970-pdf.pdf?sfvrsn=84a4b99b_0","title":"ISPOR23_Udeze_EE58125970.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125970","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"An Updated Analysis of Hemophilia Patient Utility Study of Treatment Administration Impact: A Discrete Choice Experiment (DCE) Using Time Trade-Off (TTO) Methodology","id":"4bf8079b-ba8a-4774-b566-1c496d421852","sessionCode":"PCR33","topDisplay":"Benton M1, Hong D2, Skinner M3, Garrison L4, Karimi M5, Chen E6, Mead H7, Shi L1 1Tulane University, New Orleans, LA, USA, 2Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA, 3uniQure, Washington, DC, USA, 4CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA, 5Biomarin, London , UK, 6BioMarin Pharmaceutical Inc., Oakland, CA, USA, 7BioMarin Pharmaceutical Inc., Novato, CA, USA","locationCode":"742","description":"\r\n\t<div>OBJECTIVES: Hemophilia A treatments differ in the method and frequency of administration. This study aims to elicit preferences of adult males with hemophilia A (PWHA) and quantify the incremental impact of treatment attribute changes on health utility by utilizing a DCE and a DCE with Duration (DCE-TTO) methodology. METHODS: We performed an analysis of 119 PWHA (mean age 37 years, range 18-70) recruited from Tulane hemophilia treatment center, and the National Hemophilia Foundation who participated in a web-based or in-clinic survey. Treatment attributes were based on the core outcome set for hemophilia gene therapy (coreHEM) and included method and frequency of administration, mental health, chronic pain, and annual bleeding rate. For the DCE-TTO, 10, 15, and 20 year durations were used. 115 PWHA completed 10 DCE and 10 DCE-TTO tasks. Choices were analyzed using conditional logistic models. Socio-demographic data, clinical characteristics and EQ-5D-5L were obtained from medical records or were self-reported. RESULTS: Approximately 67% reported moderately burdensome treatment (24% treat > once/week). Mean EQ-5D VAS was 75 and mean EQ-5D-5L utility score was 0.684. In the DCE all attributes were statistically significant, with administration being the most important attribute (2-3 times IV infusion per week vs. 10-year durability utility of -1.99), mental health (always concerned vs. no concern utility of -1.37), bleeding (5 or more vs. none utility of -0.73), and finally chronic pain (yes vs. no utility of -0.36). In the DCE-TTO, treatment with multiple IV infusions weekly was associated with an annualized utility decrement (0.046 vs. 10-year durability, 0.019 vs. 5-year). Treatment with multiple SQ injections monthly was associated with an annualized utility decrement (0.037 vs. 10-year durability, 0.029 vs. 5-year). CONCLUSIONS: PWHA indicated that all coreHEM outcomes are important for treatment choices. A one-time IV treatment can provide important utility for PWHA over currently available treatments.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bentonposterv2126264-pdf.pdf?sfvrsn=fd6e6227_0","title":"ISPOR23_Benton_POSTERV2126264.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126264","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Crizotinib Versus Chemoterapy for First Line Treatment of Non-Small Cell Lung Cancer Alk+, from the Brazilian Public Healthcare System Perspective","id":"2e2d1a48-525e-4935-aade-1cfcd4c5ff89","sessionCode":"EE52","topDisplay":"Ferreira P1, Senna T2, Sebastião M2, Alexandre RF1, Almeida P1 1Pfizer, São Paulo, Brazil, 2Pfizer, São Paulo, SP, Brazil","locationCode":"200","description":"\r\n\t<div>OBJECTIVES: Lung cancer is one of the most prevalent cancers in men and women and has the highest mortality rate of all cancers except non-melanoma skin cancer. Approximately 85% of the cases are non-small cell lung cancer (NSCLC) and, among these, about 3% present the ALK+ translocation. The aim of this analysis is to compare effectiveness and incremental costs between crizotinib and standard chemotherapy in the ALK+ NSCLC treatment from the Brazilian public healthcare system perspective. METHODS: A cost-effectiveness analysis was developed using a partitioned survival model, which followed patients with advanced ALK+ NSCLC throughout a lifetime horizon, considering the transition through different health states (progression-free survival, progression, and death). The outcomes evaluated monthly were life years gained (LY) and quality-adjusted life years gained (QALY). RESULTS: Crizotinib provides gains in terms of LY (3.67) and QALY (1.84) when compared to standard chemotherapy, with the need for incremental costs, resulting in an ICER/LY of approximately BRL 42,000 and ICER/QALY of BRL 83,500. The ICER/QALY is only 2.4 times the Brazilian GDP per capita, which is within the recent established threshold for serious diseases (3 times Brazilian GDP per capita) CONCLUSIONS: Considering that crizotinib provides significant gains compared to chemotherapy in the treatment of advanced ALK+ NSCLC in first line, it was incorporated into the Brazilian public healthcare system in December 2022.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23ferreiraposterv2123865-pdf.pdf?sfvrsn=142124c7_0","title":"ISPOR23_Ferreira_POSTER_v2123865.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123865","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Translation and Cultural Adaptation of the Glaucoma Quality of Life-15 Questionnaire to the Romanian Population","id":"593d0b28-aa89-4770-b8fb-1e49edd41495","sessionCode":"PCR37","topDisplay":"Subtirelu S, Nicola CA, Turcu-Stiolica M, Turcu-Stiolica A University of Medicine and Pharmacy of Craiova, Craiova, Romania","locationCode":"746","description":"\r\n\t<div>OBJECTIVES: The purpose of this study was to translate/adapt and linguistically validate the Glaucoma Quality of Life-15 Questionnaire to Romanian language and population. METHODS: The study was conducted in three phases: forward translation (English to Romanian), back-translation to the English version and pilot-testing using cognitive interviewing techniques, respecting the ISPOR Principles of Good Practice. Two independent translators (specialized clinicians) were given the questionnaire for forward translation. Other two English and Romanian native speakers proposed the backward translation and, after reconciliation, English version was compared with the original instrument for consistency of translation. Finally, after harmonization of all translations, the Romanian version was evaluated in the pilot testing phase to improve the understanding of the translated instrument. RESULTS: The provisional forward Romanian questionnaire was pilot tested and administrated to a sample of 20 Glaucoma patients, unfamiliar with the instrument, to evaluate the content. The respondents were 50% male, with mean age of 57.15 years (SD=8.6years). The questionnaire was easy to complete with an average time=3.2, SD=0.7 minutes. Overall, 90% of the participants in the pilot study stated that did not have any difficulties completing it and 85% indicated that there were no modifications necessary for improvement, with an acceptable style and format of the questionnaire. CONCLUSIONS: This preliminary study illustrates that the documented linguistic validity was correctly done and can be used in future/ larger studies.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126956","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Economic Impact of Discontinuation and Relapse Rates Among Patients with Schizophrenia Newly Initiated on Lybalvi Versus Olanzapine during First Year Use","id":"a335e9de-83aa-4895-8c22-1ec5f82a21ff","sessionCode":"EE23","topDisplay":"Ching R1, Uhlyarik A2, Ahmed S2, Rashid N3 1Keck Graduate Institute, School of Pharmacy and Health Sciences, Sausalito, CA, USA, 2Keck Graduate Institute, School of Pharmacy and Health Sciences, Claremont, CA, USA, 3Keck Graduate Institute, School of Pharmacy and Health Sciences, Irvine, CA, USA","locationCode":"226","description":"\r\n\t<div>OBJECTIVES: Schizophrenia is associated with substantial economic burden on the US health care system. Olanzapine (OLZ), a 2nd generation antipsychotic (AP) treatment has been an effective treatment for patients with schizophrenia has been associated with weight gain and cardiometabolic sequelae. During 2021, the US Food and Drug Administration approved a combination of OLZ and samidorphan (OLZ/SAM [LYBALVI®]) for the treatment of adults diagnosed with schizophrenia or bipolar I disorder. OLZ/SAM has demonstrated clinical efficacy of olanzapine but with less weight gain. The rates of discontinuations to AP are very high in patients with schizophrenia, leading to relapse rates. It is important to understand the potential economic impacts of relapse rates in schizophrenia patients initiated on OLZ/SAM versus OLZ to inform health care decision makers. METHODS: A decision tree model from a US payer perspective was developed to examine the difference of relapse rates and the costs associated with these relapse rates among patients with schizophrenia who were initiated on OLZ/SAM or OLZ. Discontinuation rates were identified from clinical trials data and real-world data. Direct costs associated with inpatient and outpatient mental healthcare-related services were obtained from published studies and sources which included: psychiatric hospitalizations, emergency services, medication management, and outpatient individual therapy. Costs were inflated to 2022 US dollars. The mean direct incremental difference among the two groups was evaluated. RESULTS: The relapse rates for OLZ/SAM and OLZ were 36% and 62%, respectively. The mean direct cost of one relapse rate was $50,778, and upon calculating the costs associated with relapse rates between OLZ/SAM versus OLZ, there was a 40% higher mean direct cost for patients on OLZ. CONCLUSIONS: In this analysis, OLZ/SAM has 50% lower relapse rates during 1 year versus OLZ, and OLZ/SAM demonstrated a 60% cost-savings versus OLZ. OLZ/SAM could be considered as first line therapy due to better adherence measures.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127494","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Correlated Outcomes in Probabilistic Sensitivity Analyses When Treatment Effects Are Derived from a Network Meta-Analysis","id":"f99108a3-cf35-4c1c-b4c7-1fbacc74a349","sessionCode":"MSR21","topDisplay":"Disher T1, Szafranski K2 1EVERSANA, West Porters Lake, NS, Canada, 2EVERSANA, Burlington, ON, Canada","locationCode":"640","description":"\r\n\t<div>OBJECTIVES: <span class=\"NormalTextRun SCXW67168319 BCX0\" data-ccp-parastyle=\"First Paragraph\" data-ccp-parastyle-defn=\"{"ObjectId":"70225e47-ea98-49c2-aaa8-47c0cf4e87e3|32","ClassId":1073872969,"Properties":[469775450,"First Paragraph",201340122,"2",134234082,"true",134233614,"true",469778129,"FirstParagraph",335572020,"1",268442635,"24",335559740,"240",201341983,"0",335559739,"180",335559738,"180",469775498,"Body Text",469778324,"Body Text"]}\">Health economic models commonly include costs calculated via regression equations based on clinical outcomes derived from real world data. When the inputs of these regression equations are functions of treatment effects from NMA, there may be situations where failure to capture correlation in treatment effects across outcomes can lead to important bias. METHODS: We use a simple simulation of two correlated binary outcomes in a three treatment network where the outcomes are subequently input into a poisson regression specifying the log of the mean population cost being a function of an intercept term and the two binary variables. We show that in this situation (and any situation where the regression equation is non-linear) failure to capture correlation in outcomes within the baseline model results in inaccurate estimates of mean population cost, and failure to capture correlation in treatment effects leads to bias in the estimated cost differences. This could lead to important implications for decision making, particularly in the extreme case where treatment modifies the correlation between variables. RESULTS: (Same as above) CONCLUSIONS: In models where costs or benefits are calculated as some non-linear function of comparative efficacy outputs, multivariate NMA methods may be required to accurately capture differences in costs and benefits across therapies.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/disherszafranskibrownisporus202342x72124509-pdf.pdf?sfvrsn=64e728b_0","title":"Disher_Szafranski_Brown_ISPOR_US_2023_42x72124509.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124509","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evidence Generation Strategy and Insights for Rare Diseases: Case Studies of Mistakes Identified By NICE in Highly Specialized Technology (HST) Assessments","id":"4cad50e4-778f-41fb-b602-20b12f2ac5b5","sessionCode":"HTA9","topDisplay":"Aggarwal S1, Kumar S2, Topaloglu J3, Bela A4, Topaloglu O1 1NOVEL Health Strategies, Bethesda, MD, USA, 2NOVEL HEALTH STRATEGIES, COLUMBIA, MD, USA, 3Institute of Global Policy, Washington DC, DC, USA, 4NOVEL Health Strategies, Chevy Chase, MD, USA","locationCode":"615","description":"\r\n\t<div>OBJECTIVES: To develop evidence generation strategic insights and lessons for ultra orphan drugs based on mistakes identified by NICE during Highly Specialized Technology (HST) assessments. METHODS: A systematic review of all NICE HST HTAs was conducted. Case studies were designed to develop insights and lessons from NICE’s committee review of company submission. Assessments with mention of evidence lacking face validity were selected and reviewed in detail. The product, indication, category of evidence and specific concerns by NICE were reviewed to develop insights and lessons learned for future submissions. RESULTS: In 5 HST assessments NICE criticized the company submission for lacking face validity. For Atidarsagene autotemcel, NICE said collection of EQ-5D scores from the general public lacked face validity because challenging health states were rated as better than less challenging health states. For Burosumab, the committee said ICERs lacked face validity due to the choice of prior distributions for transition probabilities. For Migalastat, NICE questioned and reduced the infusion disutility, which was set to be similar as a disease complication. For Patisiran, the mortality hazard ratio was not accepted because it was not in line with previous natural history study. For Voretigene neparvove, the utility values, including a negative score, from a survey of ophthalmologists was questioned because it likely focused more on vision than patient quality of life. CONCLUSIONS: Case studies of mistakes in previous submissions provides valuable lessons for companies to design evidence generation strategies for rare disease products. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127227","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Outcomes and Practice Patterns for Long-Acting Injectable Vs. Oral Antipsychotic Agents Among Hospitalized Patients with Schizophrenia in the United States","id":"2ccabaf1-7759-4698-9a8d-213f9ee63367","sessionCode":"HSD3","topDisplay":"Kane JM1, Rubio JM1, Casciano J2, Dotiwala Z2, Hansen R3, Franzenburg KR4, Philbin M5, Thompson S6 1The Zucker Hillside Hospital, Northwell Health, Dept. of Psychiatry; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Dept. of Psychiatry and Molecular Medicine; Feinstein Institutes for Medical Research, Institute of Behavioral Science, Glen Oaks, NY, USA, 2eMAX Health, White Plains, NY, USA, 3Teva Branded Pharmaceutical Products R&D, Inc., North America Medical Affairs, Parsippany, NJ, USA, 4Teva Branded Pharmaceutical Products R&D, Inc., Global Medical Affairs, West Chester, PA, USA, 5Teva Branded Pharmaceutical Products R&D, Inc., Value Evidence and Outcomes, Parsippany, NJ, USA, 6Teva Branded Pharmaceutical Products R&D, Inc., Global Health Economics and Outcomes Research, West Orange, NJ, USA","locationCode":"539","description":"\r\n\t<div>OBJECTIVES: Treatment options for schizophrenia include oral antipsychotics (OAs) and long-acting injectable antipsychotics (LAIs). Previous studies have reported that patients taking LAIs have lower relapse/re-hospitalization risks; however, more patients are prescribed OAs than LAIs. Here, we explore differences in re-hospitalization rates after schizophrenia-related hospitalization for patients prescribed LAIs vs OAs at discharge. METHODS: The study included adults in the Premier Hospital Database (a US hospital-based, service-level, all-payer database containing records collected for billing purposes at the hospital level) with a schizophrenia-related hospitalization between December 2019 and June 2021 who were prescribed LAIs or OAs at discharge. The date of the first schizophrenia-related hospitalization during the study period is the index date. Prescribing patterns and re-hospitalization risk were analyzed for ≥3 months pre- and post-index. RESULTS: At discharge 23,336 (84%) patients were prescribed OAs vs 4293 (16%) prescribed LAIs (1,303 [30%] were prescribed atypical LAIs vs 2,990 [70%] prescribed typical LAIs). The most common OA prescribed was risperidone (26%), and the most common LAI was haloperidol (combined with haloperidol OA; 37%). Greater proportions of patients were re-hospitalized within 30, 60, and 90 days after discharge with OAs (11%, 15%, and 18%, respectively) vs LAIs (8%, P<.0001; 12%, P<.0001; 15%, P<.0001; risk reduction: 18%, 14%, and 10%), and after discharge with typical (9%, 13%, and 16%) vs atypical (7%, P=.012; 10%, P=.004; 13%, P=.004; risk reduction: 35%, 32%, and 26%) LAIs. CONCLUSIONS: Most patients with schizophrenia-related hospitalizations were prescribed OAs at discharge; however, patients prescribed LAIs had significantly less re-hospitalizations. Of those prescribed an LAI at discharge, most were prescribed a typical LAI; however, patients prescribed an atypical LAI had the lowest risk of re-hospitalization. These results suggest that prescribing an atypical LAI at discharge may result in lower relapse/re-hospitalization rates for patients with schizophrenia.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kaneposter-v2123186-pdf.pdf?sfvrsn=6599418b_0","title":"ISPOR23_Kane_POSTER V2123186.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123186","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Association between Administration Method, Socio-Demographic Characteristics, and Patient-Reported Outcomes for Glucagon-like Peptide-1 Receptor Agonists Among Diabetes Patients in Japan: A Cross-Sectional Patient Survey","id":"ddc98d9e-9046-488c-8324-21de3bb86810","sessionCode":"PCR6","topDisplay":"Murofushi T1, LoPresti M2, Onishi H1 1INTAGE Healthcare Inc., Chiyoda-ku, 13, Japan, 2INTAGE Healthcare Inc., Tokyo, 13, Japan","locationCode":"720","description":"\r\n\t<div>OBJECTIVES: In recent years, oral glucagon-like peptide-1 receptor agonist (GLP-1 RA) has become available. While an oral GLP-1 RA could simplify treatment compared to GLP-1 RA injections, it may also require an increase in administration frequency. This study examines the association between administration method (dosage form and administration frequency), socio-demographic characteristics, and patient-reported outcomes (PRO) under a real-world setting. METHODS: Data from the 2022 Patient Mindscape® survey was used. Patient Mindscape® is a Japanese nationwide PRO survey conducted annually among 500,000+ patients undergoing drug treatment for 80+ conditions. Patients that reported suffering from diabetes and administered GLP-1 RA within the last one year were included. Logistic regression models were used to identify factors associated with dosage form (injection or oral) and administration frequency (once daily or once weekly) for GLP-1 RA. Socio-demographic characteristics such as gender, age, and employment status and PRO such as drug adherence, treatment satisfaction, and health-related quality of life (HRQoL) were included as exploratory variables. HRQoL was estimated using EQ-5D-5L responses. A p value of less than 0.05 was considered statistically significant. RESULTS: 1,195 patients administered GLP-1 RA injections and/or oral therapy were analyzed. For association with dosage form, age (odds ratio [OR]: 0.99, 95% confidence interval [95%CI]: 0.97–1.00, p = 0.041), employment status (OR: 1.40, 95%CI: 1.05–1.86, p = 0.022), treatment satisfaction (OR: 1.15, 95%CI: 1.00–1.33, p = 0.046) and HRQoL (OR: 4.14, 95%CI: 1.60–10.69, p = 0.003) were statistically significant. However, there were no variables that had a statistically significant association with administration frequency. CONCLUSIONS: Among diabetes patients, oral GLP-1 RA may be a good treatment option in terms of optimizing patient-reported outcomes, but socio-demographic characteristics such as age and employment status may need to be considered when treatment is selected.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/murofushi-t-et-al-ispor-us-2023-posterdiabetes127812-pdf.pdf?sfvrsn=201efbfe_0","title":"Murofushi T et al ISPOR US 2023 poster_Diabetes127812.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127812","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Waiting for a Good Kidney: Do Patients Think It’s Worth It?","id":"fcc07e1f-7cb6-46f1-8784-22edf9cdc540","sessionCode":"PCR40","topDisplay":"Wu CH1, Gonzalez JM2, Yang JC2, Mehrotra S3, Reed S2, McElroy L4 1Duke University, Durham, NC, USA, 2Duke Clinical Research Institute, Durham, NC, USA, 3Northwestern University, Evanston, IL, USA, 4Duke Department of Surgery, Durham, NC, USA","locationCode":"800","description":"\r\n\t<div>OBJECTIVES: About 20% of all kidneys from deceased donors are discarded every year in the United States. A significant portion of these kidneys are considered of marginal quality clinically, leading to rejection by transplant centers. A recent stated-preference (SP) study showed that many patients would be willing to accept marginal kidneys if it meant avoiding years of waiting for an organ. We used the same SP data to study how the likelihood of accepting marginal kidneys changes with waiting time. METHODS: The original study identified 3 patient-preference classes: Class 1 (averse to additional waiting time but still expecting improvements in kidney quality), Class 2 (willing to accept marginal kidneys), and Class 3 (unwilling to accept a marginal kidney). Individual class-membership probabilities were derived with Bayesian procedures and later modeled using a fractional multinomial-logit regression. The regression associated class membership with self-reported waiting time for transplantation. The effect of waiting time on class-membership probabilities was allowed to change with patients’ health status and socioeconomic characteristics. RESULTS: A total of 152 pre-transplant patients provided SP data. We find that waiting time had a nonlinear effect on class probabilities, and longer waiting times were significantly associated with a greater likelihood of membership to Class 2 or Class 3. Insulin use (P=0.04) and patient socioeconomic status (P=0.03) had a significant effect on the probability of being in Class 2. On the other hand, the probability of being in Class 3 changed significantly with time on dialysis (P<0.01) and the patient level of physical function (P=0.04). CONCLUSIONS: The analysis of latent classes derived from SP data can yield important insights into time-dependent effects even when using cross-sectional data. We find that there are indeed systematic patterns in the preference phenotypes expected from patients as waiting time increases and that such patterns are sensitive to health status and socioeconomic factors.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23wuposterv2126519-pdf.pdf?sfvrsn=75383b03_0","title":"ISPOR23_Wu_POSTERV2126519.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126519","diseases":[{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Racial Disparities Among Adults Receiving Preventive Health Services for Cardiovascular Disease (CVD) in the United States","id":"dbec891f-c61f-451b-be18-2353867f0e5d","sessionCode":"PCR1","topDisplay":"Temedie-Asogwa T, Khalid J, Mgbere O, Essien EJ University of Houston, College of Pharmacy, Houston, TX, USA","locationCode":"716","description":"\r\n\t<div>OBJECTIVES: Cardiovascular diseases are the leading cause of death in the United States even though they are largely preventable and studies in. the US have established disparities in health outcomes. This study aimed to explore factors influencing racial and ethnic disparities in the use of preventive health services for CVD amongst adults in the US. METHODS: The household component of the Medical Expenditure Panel Survey data, 2018, was used to elucidate information about the use of preventive health service for cardiovascular diseases (CVD). The analytical cohort included all adults 18 years and above with no established CVD (including coronary artery disease, angina, heart attacks, arrythmias and heart failure), N=15,896 (Wt. N=179,854,904). Multivariable logistic regression was performed to examine racial/ethnic disparity in CVD preventive counselling services use, controlling for predisposing, enabling, and need factors. The nonlinear Blinder Oaxaca Decomposition (BOD) was used to identify the percentage of contribution of each predisposing, enabling, and need factors in explaining the existing racial/ethnic disparity in CVD preventive service use. RESULTS: Non-Hispanic Blacks were 56% (OR:0.044, 95%CI:0.38-0.83) less likely to use CVD preventive counseling services compared with non- Hispanic Whites, whereas no difference was observed between Hispanics and non-Hispanic Whites. The nonlinear BOD estimated a decomposition coefficient of -0.0015 indicating that the observed disparity would have been 68.2% higher (-0.0015/0.0022) if Hispanics had similar characteristics as whites. Although age, gender, educational status and marital status were significant factors (p<0.001) in the decomposition model, only marital status explained the racial/ethnic disparity. CONCLUSIONS: The study revealed the existence of disparities but the differences in the predisposing, enabling, and need characteristics of this cohort did not successfully explain the racial/ethnic disparity in CVD preventive service use. There is need for further studies that examine the correlates of preventive services including individual beliefs, behavioral patterns, and provider prescription patterns.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23temedie-asogwaposter127770-pdf.pdf?sfvrsn=8c42ae0f_0","title":"ISPOR23_Temedie-Asogwa_POSTER127770.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127770","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Cost-Utility Analysis of Artificial Urinary Sphincter Versus BSC in Severe Male Postprostatectomy Incontinence - Brazilian Public Health System Perspective","id":"74f1c25f-b888-40f8-a1c3-236e42a76f7c","sessionCode":"MT8","topDisplay":"Tortele H1, Rodrigues S2, Contó M3 1Boston Scientific, Santo André, SP, Brazil, 2Boston Scientific, São Paulo, SP, Brazil, 3Boston Scientific, São Paulo, Brazil","locationCode":"633","description":"\r\n\t<div>OBJECTIVES: Despite being considered the ''gold standard'' for the treatment of severe male postprostatectomy incontinence, the artificial urinary sphincter (AUS) is not incorporated and provided in the Brazilian public health system. The objective of the presented study was to evaluate the cost-utility of AUS in this perspective. METHODS: A decision tree model was developed to estimate incremental costs and quality-adjusted life years (QALYs) of AUS compared to best supportive care (BSC) in the Brazilian public health system perspective. Patients start the model with severe urinary incontinence resulting from radical prostatectomy. After entering the model, patients may undergo implantation of an artificial urinary sphincter or remain untreated for the health condition. For both choices, the patient can remain in the state of severe urinary incontinence (5 pads per day) or move to the state of complete continence (0 pads per day). Probability estimates, healthcare resources and utilities were obtained from published literature when available or by expert opinion. Uncertainty was analyzed using deterministic and probabilistic sensitivity analysis. RESULTS: AUS led to an expected gain of 1.49 QALYs versus BSC at an incremental cost of US$ 13,864 presenting an incremental cost-effectiveness ratio (ICER) of 9,332 US$/QALY. The results of one-way sensitivity analysis revealed that the key parameters with greatest impact on the ICER value are probabilities of the model's decision nodes and the QALY-measured outcome data of both urinary incontinence treatment options. CONCLUSIONS: AUS provided QALY gains when compared to BSC in patients with severe male postprostatectomy incontinence and is very close to the last cost-effectiveness threshold recently established by the Brazilian Public Health System, which is equivalent to 7,737 US$/QALY.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23tortele-hpostermt08127129-pdf.pdf?sfvrsn=9555af0d_0","title":"ISPOR23_Tortele H_POSTER_MT08127129.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127129","diseases":[{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Systematic Literature Review to Assess the Level of Evidence in Facioscapulohumeral Muscular Dystrophy","id":"8a62b5f8-baa8-4806-ab07-25ec60d5b184","sessionCode":"SA7","topDisplay":"Barnieh L1, Beckerman R1, Emich H1, Eichinger K2, Eldar-Lissai A3 1Maple Health Group, LLC, New York, NY, USA, 2University of Rochester Medical Center, Rochester, NY, USA, 3Fulcrum Therapeutics, Inc., Brookline, MA, USA","locationCode":"910","description":"\r\n\t<div>OBJECTIVES: Facioscapulohumeral muscular dystrophy (FSHD) is a rare, debilitating disease for which there are no approved pharmacological interventions. As the disease progresses, patients lose upper limb function and mobility, which results in a decrease in the ability to perform activities of daily living and independence; patients often live with chronic pain. This systematic literature review assessed the existing evidence base regarding clinical, economic and humanistic outcomes in FSHD. METHODS: A systematic literature review was conducted by searching PubMed, EMBASE and Cochrane Reviews databases for studies reporting on FSHD, with no limits on interventions, comparators, outcomes, study design or date of publication. In addition, three conferences not indexed in EMBASE were hand searched (limit of last three years). Screening was performed in two steps by two independent researchers at both the title and abstracts and full text review stage. Articles were categorized according to the topic reported, including: pharmacological and non-pharmacological treatments and outcomes; outcome measures and validation; humanistic burden and patient reported outcomes (PROs); disease classification; diagnosis; guidelines and economic burden. RESULTS: A total of 2,212 full texts and 774 conference abstracts were identified for review with 175 full texts and 177 conference abstracts meeting the pre-specified inclusion criteriad. Of the full texts included, the most reported topic was pharmacological and non-pharmacological treatments and outcomes (n=61), with outcome measures and validation being the second most reported topic (n=37). Among the conference abstracts, the most reported study topic was outcome measures and validation (n=69), with the second most reported topic disease classification (n=33). CONCLUSIONS: The main interests in FSHD research include outcomes related to pharmacological and non-pharmacological treatments, followed by the validation of outcome measures for use in research. Research efforts on minimizing the impact of the debilitating and progressive nature of FSHD should continue until a treatment is approved.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23eldarlissaiposter123843-pdf.pdf?sfvrsn=b307817_0","title":"ISPOR23_EldarLissai_POSTER123843.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123843","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient Reported Quality of Life and Adherence of Patients to Oral Oncology and Neurology Specialty Medications Provided By a Specialty Pharmacy","id":"dbeaace9-68ab-4822-9546-275a67fb69bd","sessionCode":"PCR26","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"734","description":"\r\n\t<div>OBJECTIVES: (1) Measure adherence to oral oncology (O) and neurology (N) SP-D/SPMTM and (2) compare quality of life (QoL) of patients in SP-D/SPMTM pre- and during-COVID19, given that specialty pharmacy drugs (SP-D) are high-cost medications that treat complex conditions. Improving adherence + quality of life (QoL) contribute to desired treatment outcomes. SP Medication Therapy Management (SPMTM) contributes to optimization of QoL and better adherence. METHODS: From 01/01/19 (Index Yr (IY))-12/31/2021 (End of Study (EoS)) conduct retrospective, observational study of n=1600 unique O+N patients’ QoL and adherence to oral SP-D. PA included EQ-5D-5L, having 5 dimensions with Likert scales (5-point) and a visual analog scale (VAS100). Dimensions summarized: Mobility (M), Self-Care (S), Usual Activities (U), Pain/Discomfort (P/D), and Anxiety/Depression (A/D). Likert scales summarized: None, Slight, Moderate, Severe, and Extreme plus VAS100 for Overall Health State (OHS). Calculate Dimension means for IY and EoS; compare for differences=improved/diminished QoL. The mean of adherence metric, Proportion Days Covered (PDC), calculated at IY and EoS. Pearson’s Correlation Coefficient (PCC) calculated for means of Dimensions vs PDC. RESULTS: Completed PAs=1600 (20% of 8000 offered). Difference in mean PDC between IY and EoS=0.0036 (0.39%). Differences between Dimension means IY and EoS: M=+0.02 (22.2%), S=-0.12 (110%), U=-0.02 (53.1%), P/D=-0.03 (15.9%), A/D=+0.24 (67.5%), OHS=-0.81 (15.1%). (“-”difference=improvement in Dimensions 1-5; “+” difference=improvement in OHS. PCC R2 + interpretations: M=0.0158, S=0.0227, U=0.01, P/D=0.0422, A/D=0.069, OAH 0.116, all indicating weak correlations. PDC IY=0.9325 and EoS=0.9361 (0.36% improvement). CONCLUSIONS: During the COVID19-Delta phase, PDC IY and EoS improved 0.36% with both higher than industry standard=0.8. On average all QoL Dimensions (except M and A/D) improved EoS compared to IY. Larger comparative studies suggested.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/posterisporboston-may2023-burruss-frazier-arikian127631-pdf.pdf?sfvrsn=254298a3_0","title":"Poster_ISPOR_Boston May2023 (Burruss Frazier Arikian)127631.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127631","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-per-Responder for Biologic Drugs Used in the Treatment of Plaque Psoriasis in France and Germany","id":"2ebb73c9-3fca-4ef8-a56c-27a331da0f89","sessionCode":"EE83","topDisplay":"Skowron F1, Mathiasen N2, Schnack H3, Danoe A3 1Hôpitaux Drôme Nord, Romans-Sur-Isere, France, 2LEO Pharma A/S, Ballerup, 84, Denmark, 3Incentive, Holte, 84, Denmark","locationCode":"326","description":"\r\n\t<div>OBJECTIVES: Advances in biologic drugs used to treat moderate-to-severe plaque psoriasis have greatly improved the outcomes for patients suffering from the disease. The objective of this study was to estimate the cost-per-responder of anti-IL17 drugs and other biologics used in the treatment of moderate-to-severe plaque psoriasis in France and Germany over a one-year time-horizon. METHODS: A cost-per-responder model of biologics used in psoriasis treatment was developed based on both induction and maintenance treatment periods. Anti-TNFs (adalimumab, etanercept), anti-IL17s (brodalumab, secukinumab, ixekizumab and bimekizumab), anti-IL12/23 (ustekinumab) and anti-IL23s (risankizumab and guselkumab) were included in the model. Efficacy data were identified through a systematic literature review of network meta-analyses that informed on various long-term Psoriasis Area and Severity Index (PASI) measures. The cost of drugs was based on dose recommendations as well as the pharmacy list prices in France and manufacturer prices in Germany. When biosimilar substitution was possible, the cheapest alternative was used. RESULTS: Among the anti-IL17s, brodalumab had the lowest cost-per-PASI100 responder in both France (€21,679) and Germany (€26,807) after one year, followed by bimekizumab (€26,369) in France and ixekizumab (€38,027) in Germany. Brodalumab also had the lowest cost-per-PASI90 responder among the anti-IL17s in both France and Germany after one year. Adalimumab had the lowest cost-per-PASI100 responder after one year among the anti-TNFs in both France (€23,418) and Germany (€38,264). Among the anti-IL23s, the lowest cost-per-PASI100 responder after one year was risankizumab (€20,969) in France and guselkumab (€28,902) in Germany. The cost-per-PASI100 responder for ustekinumab after one year was (€35,666) in France and (€72,078) in Germany. All results remained consistent over a three-year time horizon. CONCLUSIONS: Over a one-year time-horizon, risankizumab and brodalumab were the most cost-effective biologics in France and Germany within moderate-to-severe plaque psoriasis. Brodalumab was most cost-effective within the anti-IL17s, including the newly launched bimekizumab.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023skowronposter123866-pdf.pdf?sfvrsn=af7641f1_0","title":"ISPOR2023_Skowron_POSTER123866.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123866","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Retrospective Cohort Study of Patients with Venous Thromboembolism (VTE): An Analysis from a Healthcare Maintenance Organization (HMO) Perspective in Brazil","id":"8faa6c85-3092-47ef-bc20-27af81bfdbc5","sessionCode":"RWD2","topDisplay":"Busch J1, Reis Neto JP2 1Souza Marques University, Rio de Janeiro, RJ, Brazil, 2CAPESESP, Rio de Janeiro, Brazil","locationCode":"814","description":"\r\n\t<div>OBJECTIVES: VTE, that includes deep vein thrombosis (DVT) and pulmonary embolism (PE), affects 10 million people/year worldwide, being the second most common medical complication and a cause of excess length of hospital stay. Its incidence and economic burden are expected to increase as the population ages. This study examined the cost of patients care from an HMO perspective. METHODS: Using administrative databases, we identified all incident cases of DVT/PE from September/2019-August/2022. Annual rates of healthcare utilization and expenditure were categorized into patients treated with anticoagulants alone group, a sort of advanced therapies (AT) group (systemic thrombolysis (ST), catheter directed thrombolysis (CDT), mechanical thrombectomy (MT) or surgical embolectomy (SE)), and other treatments group. Descriptive summary statistics were produced, stratified by groups and statical test used to compare cost (significance p<.05). RESULTS: From total of 11,145 admitted, 437 patients (3.9%) were diagnosed with VTE–286 women and 151 men, mean(SD) ages of 72.5(15.3) and 73.9(14.0) years, respectively. Treatment consisted of anticoagulation alone were 80.5% of cases, AT were performed in 13 cases (3.0%) and 16.5% with other treatments. The VTE all-cause mortality in 36 months was 21.7%. Inpatient treatment, post-acute therapies, including rehabilitation, imaging and lab investigations cost were USD$9,628 per patient/year in anticoagulation alone group, USD$20,020 for AT and USD$2,238 for other treatments (p<.0001). In AT patients, the mean length of stay in the hospital after the procedure was 13.9 days. CONCLUSIONS: In the past decades, several changes in the prevention, diagnostic strategies, and management of venous thrombosis have been achieved. Costs for VTE treatment are considerable and increasing faster than general inflation for medical care services, with hospitalization costs being the primary cost driver. Results observed reinforce the need for targeted prevention of risk factors for VTE and improvements in in-hospital management to decrease morbimortality and optimize allocations of resources.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023arte-1final124813-pdf.pdf?sfvrsn=234435f2_0","title":"ISPOR 2023_arte 1_final124813.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124813","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Treatment Preferences Among Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma in the United States","id":"640adb26-8482-405a-8a27-27dcb1181c12","sessionCode":"PCR22","topDisplay":"Liu FF1, Collacott H2, Clarke H3, Michaels-Igbokwe C4 1Bristol Myers Squibb, Princeton, NJ, USA, 2Evidera, London, UK, 3Evidera, Bethesda, MD, USA, 4Evidera, Montreal, QC, Canada","locationCode":"731","description":"\r\n\t<div>OBJECTIVES: Chimeric antigen receptor (CAR) T cell therapy is a treatment option proven to be effective in trials and real-world clinical settings among patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The United States (US) Food and Drug Administration has approved three such therapies for R/R DLBCL. This study aimed to understand how patients with R/R DLBCL value benefits and risks associated with CAR T cell therapy. METHODS: A web-based best-best discrete choice experiment (BB-DCE) was administered to adults with self-reported diagnosis of R/R DLBCL. The BB-DCE included nine experimentally designed choice tasks consisting of three hypothetical treatment profiles, including a fixed profile representing standard of care (non–CAR T). Treatments were described by six attributes: two-year treatment success (probability of being alive and in remission), dosing schedule, administration location, risk of acute treatment reactions (cytokine release syndrome, neurological events), risk of serious infections, and severity of chronic side effects. A mixed logit model was used to estimate preference weights, calculate relative attribute importance (RAI), and quantify attribute trade-offs. RESULTS: Ninety-five US respondents completed the survey. Mean age was 61 years; 52.6% of respondents were male. Forty-three percent of respondents were eligible for stem cell transplant or had received it; 68% were currently on second-line treatment. Probability of treatment success had the largest influence on treatment preferences (RAI 45.3%), followed by risk of serious infections (RAI 19.6%) and acute treatment reactions (RAI 14.7%). Participants were willing to accept a 69.5% increase in risk of serious infections to increase chance of treatment success from 5% to 45%. No statistically significant differences in RAI were observed in subgroups by treatment line, stem cell transplant eligibility, or ECOG PS. CONCLUSIONS: Treatment efficacy was a key driver of preferences. Patients tolerated potential increases in treatment-related risks to improve chances of survival and remission at two years.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023liuposter125213-pdf.pdf?sfvrsn=69c9b1be_0","title":"ISPOR 2023_Liu_POSTER125213.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125213","diseases":[{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Validation of Novel Identification Algorithms for Nonfatal Myocardial Infarction Using Uniform Objective Criteria and Pooled Clinical Trial Data","id":"d60b8424-effd-49f9-ac08-285e8d26d3b4","sessionCode":"EPH4","topDisplay":"Ports K1, Chen W2, Saunders D2, Koduru B2, Aptekar J2, Spanias J2, Strait C2, Tso C2, Buderi R2, Gerome D3, Bourlon PL2, Saltzman S4, Jain T2, Talwai A2, Jain R2 1Medidata AI, Medidata a Dassault Systèmes company, San Diego, CA, USA, 2Medidata AI, Medidata a Dassault Systèmes company, New York, NY, USA, 3Medidata AI, Medidata a Dassault Systèmes company, Huntington, NY, USA, 4Medidata AI, Medidata a Dassault Systèmes company, Boston, MA, USA","locationCode":"409","description":"\r\n\t<div>OBJECTIVES: Nonfatal myocardial infarction (MI) is primarily identified using diagnostic code-based algorithms in real-world data (RWD). This investigation aimed to utilize pooled clinical trial (CT) data to identify clinical indicators to optimize RWD MI identification. METHODS: Anonymized historical CT data from the Medidata Enterprise Data Store was pooled on patients over 40 with established cardiovascular (CV) disease or CV risk factors. Algorithms were adapted from the MI identification criteria suggested by the Standardized Data Collection for Cardiovascular Trials Initiative (SCTI) and FDA and included only the information available in RWD. Algorithm-1 (A1) only included cardiac biomarker assessment and was augmented in additional algorithms by adding different combinations of ECG assessment, signs and symptoms, treatments, and all-cause hospitalization occurring within predefined timeframes (A2-A7). Using the clinical events committee adjudicated events as the gold standard, algorithm accuracy was assessed using positive predictive value (PPV) and sensitivity. RESULTS: A total of 40,866 patients were included in the analysis (median follow-up of 1.5 years), with 1133 adjudicated MI events. Cardiac biomarker assessment alone (A1) produced the highest sensitivity (99%) but low PPV (27%). The addition of ECG and hospitalization increased PPV (38%) with a slight reduction in sensitivity (95%). Algorithms that included signs and symptoms (sensitivity = 22%) and treatments (sensitivity = 66%) produced the lowest sensitivities without meaningful gains in PPV. CONCLUSIONS: High algorithm sensitivities indicate the validity of specific clinical indicators in MI identification. Low PPVs may be an artifact of not including test results and reflect confounding morbidities with similar diagnostic and treatment interventions. Including hospital discharge diagnoses, not available in CT data, may increase algorithm PPV when utilized with RWD. These findings can be incorporated in RW algorithms to identify MI in retrospective studies or prospectively in pragmatic trials and highlight pooled CT data's utility in identifying RW clinical events. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23portsposter126335-pdf.pdf?sfvrsn=27b953d_0","title":"ISPOR23_Ports_POSTER126335.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126335","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Algorithms for Identifying Immunocompromised Adults in Administrative Claims Data – a Targeted Literature Review","id":"66bd67e2-ac76-49b9-9079-289d299b79c0","sessionCode":"EPH51","topDisplay":"Stempniewicz N1, Steffens A2, Trenz H3, Khan S4, Ahlawat R4, Poston S5, Singer D5 1GSK, Norwalk, CT, USA, 2Optum, Eden Prairie, MN, USA, 3Optum, Lakeville, MN, USA, 4Optum, Gurugram, HR, India, 5GSK, Philadelphia, PA, USA","locationCode":"503","description":"\r\n\t<div>OBJECTIVES: In the United States, vaccination with recombinant zoster vaccine is recommended for herpes zoster (HZ) prevention in adults aged ≥19 years who are or will be immunodeficient or immunosuppressed because of disease or therapy. A targeted literature review was conducted to identify algorithms which can be applied to claims databases to identify immunocompromised populations for research or to target for HZ prevention. METHODS: A search of publications from January 2016 to August 2022 was conducted in the PubMed and Cochrane Review databases and supplemented with a review of publications cited by and citing 8 key pre-specified publications. Publications were screened against pre-specified criteria. RESULTS: Of 1,011 publications identified, 41 were eligible for full-text screening, of which 25 priority publications were selected. Algorithms identifying immunocompromised status were used to stratify analyses or as covariates in 12 publications, as an exclusion criterion in 9 publications, and as an inclusion criterion in 4 publications. All 25 publications used diagnoses from claims and/or clinical data to identify immunocompromised patients, and 20 also used immunosuppressive medications. Diagnoses and medications used varied across publications. For example, one publication identified immunocompromised populations using diagnoses for HIV/AIDS or leukemia/lymphoma, or use of antineoplastic, antiarthritic, or other immunosuppressant medications. In contrast, another publication identified immunocompromised populations using diagnoses for HIV/AIDS, solid or hematologic malignancy, bone marrow or organ transplant, rheumatologic or inflammatory condition, primary immunodeficiency or other immune conditions, chronic kidney disease or end stage renal disease, or use of medications including chemotherapeutic agents, antimetabolites, systemic steroids, or immunomodulators. CONCLUSIONS: There are several published algorithms for identifying immunocompromised populations that can be applied in administrative claims data. Diagnoses and medications for determining immunocompromised status varied across algorithms. Further research comparing algorithms is needed to support future use in research or to identify immunocompromised populations for HZ prevention.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23stempniewiczposter125062-pdf.pdf?sfvrsn=4f47ae82_0","title":"ISPOR23_Stempniewicz_POSTER125062.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23stempniewiczhandout125062-pdf.pdf?sfvrsn=1ae17f11_0","title":"ISPOR23_Stempniewicz_HANDOUT125062.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125062","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient Reported Outcomes in Psoriasis Over Time: Differences By Sex from Three Cross-Sectional, Real World Studies in the United States","id":"5858092c-fab9-4863-bd30-28e10d67ceda","sessionCode":"HPR12","topDisplay":"Rottier E1, Castellano G1, Piercy J2, Green D1 1Adelphi Real World, Bollington, UK, 2Adelphi Real World, Bollington, CHE, UK","locationCode":"515","description":"\r\n\t<div>OBJECTIVES: To identify differences in patient reported outcomes (PROs) between sexes in patients with psoriasis over time. METHODS: Data were drawn from three Adelphi Psoriasis Disease Specific Programmes™, real-world cross-sectional studies of dermatologists and consulting patients in the United States in 2016, 2018 and 2022. In each study, around 80 dermatologists provided demographic and clinical data for their next 1-10 consulting patients aged ≥18 years with a confirmed psoriasis diagnosis, not currently participating in a clinical trial. The same patients completed a voluntary questionnaire containing attitudinal questions, the Dermatology Life Quality Index (DLQI) and Work Productivity and Activity Impairment (WPAI) PROs. Non-missing data were analyzed. Fisher’s exact tests were used to compare women and men in binary categorical variables, and t-tests for numeric variables. RESULTS: Overall, 283, 352 and 206 patient-reported questionnaires were collected in 2016, 2018 and 2022, respectively; 44%, 49% and 51% of the patient sample were women, 77%, 80% and 77% were identified by their dermatologist as white/Caucasian and mean age (SD) was 46.9 (15.4), 43.4 (15.5) and 45.2 (15.7) years, respectively. Women reported higher burden compared to men in 2016. A lower proportion of women reported no pain/discomfort (57% women versus 74% men, p=0.004), while a higher proportion reported severe skin itch/soreness/pain/stinging (24% versus 11%, p=0.006) or joint pain/stiffness/mobility in 2016 (44% versus 28%, p=0.007). Mean DLQI and WPAI activity impairment scores were also greater in women in 2016 (DLQI: 5.95 versus 3.78, p=0.001; WPAI: 20.39 versus 14.75, p=0.041). Any observed differences between sexes in these five PROs were not statistically significant in 2018 and 2022. CONCLUSIONS: These findings indicate that women were more burdened in 2016 compared to men, a trend not observable in 2018 and 2022. This indicates a reduction in the gap between sexes in psoriasis over time.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23piercyposter124123-pdf.pdf?sfvrsn=60b0dddd_0","title":"ISPOR23_Piercy_POSTER124123.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124123","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Amyotrophic Lateral Sclerosis Disease Progression on Health Care Resource Use and Health-Related Quality of Life Using MiToS Staging and ALSFRS-R: Analysis of a Real-World Cross-Sectional Survey","id":"f3dcb686-2d8e-44fe-a38a-29064316c10b","sessionCode":"EE32","topDisplay":"Gebrehiwet P1, Brekke J2, Rudnicki S2, Mellor J3, Wright J3, Earl L3, Ball N3, Iqbal H3, Thomas O3 1Cytokinetics, Incorporated, Daly City, CA, USA, 2Cytokinetics, Incorporated, South San Francisco, CA, USA, 3Adelphi Real World, Bollington, UK","locationCode":"232","description":"\r\n\t<div>OBJECTIVES: To evaluate healthcare resource use (HCRU) and health-related quality of life (HRQOL) in people living with amyotrophic lateral sclerosis (ALS) according to Milano-Torino staging (MiToS) and ALS Functional Rating Scale-Revised (ALSFRS-R) total scores. METHODS: In the Adelphi ALS Disease-Specific Programme™, a multinational point-in-time survey (July 2020 to March 2021) of neurologists and their consulting patients with ALS, neurologists completed questionnaires for demographics and HCRU, and patients (or caregivers) completed the EQ-5D-5L. The cohort was analyzed according to MiToS staging, a tool measuring ALS progression from stages 0–5 (0–4 reflecting 0–4 functional domains lost; stage 5 is death). Mean HCRU (ALS-related hospitalization and durable medical equipment [DME] use) and HRQOL (EQ-5D-5L, US value set) were evaluated for each stage. The analysis was repeated using ALSFRS-R quartiles as a measure of progression. RESULTS: Of 1003 patients (mean 61.4 years; 63% males), 68% were in MiToS stage 0, 11% stage 1, 8% stage 2, 5% stage 3, and 8% stage 4. The mean number of ALS-related hospitalizations in the past 12 months increased from stage 0 to 2 and then declined, perhaps reflecting transition to hospice care (stage 0=0.18, stage 1=0.54, stage 2=1.05, stage 3=0.97, stage 4=0.84). Hospitalization duration, healthcare provider consultations, and professional caregiver support increased with MiToS stages. DME (mobility, communication, therapeutic, and respiratory aids) items used increased across stages 0–4 (mean 1.43, 3.41, 5.00, 5.34, 5.84). The EQ-5D-5L worsened from stage 0 to 2, plateauing at stages 3 and 4 (mean 0.53, 0.28, -0.05, 0.01, 0.01). Analysis using ALSFRS-R quartiles showed consistent results. CONCLUSIONS: In people with ALS, HCRU increased and HRQOL deteriorated with disease progression, as measured by MiToS staging and ALSFRS-R. Effective treatments that lower HCRU and delay HRQOL deterioration are needed to reduce the economic and humanistic burden of ALS for patients as well as healthcare systems.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23-gebrehiwetposter123309-pdf.pdf?sfvrsn=2aebf24b_0","title":"ISPOR23_ Gebrehiwet_POSTER123309.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23-gebrehiwethandout123309-pdf.pdf?sfvrsn=f24162cd_0","title":"ISPOR23_ Gebrehiwet_HANDOUT123309.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123309","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Effect of COVID-19 Pandemic on Substance Use Trends in LGBTQIA+ Youth","id":"0bef94e5-e113-433d-8b28-29816c3cac1e","sessionCode":"EPH20","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"421","description":"\r\n\t<div>OBJECTIVES: The COVID-19 pandemic has lead to an increase in substance abuse in underprivileged populations as a coping mechanism. Elucidating the disparities faced by this group can better prepare future programs in supporting LGBTQIA+ youth in periods of hardship, determine risk factors that increase substance use in this group, and incorporate changes in medical and school programs to prevent these events from recurring. METHODS: We used a systematic literature search on Pubmed to filter literature that was published since December 2019 and used Boolean search operators to create a variation of 56 search terms that was used as queries. The subsequent articles were collected and their abstracts were evaluated and relevant articles were subjected to complete paper data collection and analysis, where we collected information such as race/ethnicity, sexuality, age range, and health disparities for homelessness in each study. RESULTS: We found 67 unique papers on Pubmed, and 11 unique papers that fit the inclusion and exclusion criteria. Five papers were cross-sectional, four were longitudinal, one was a cohort study, and one was an expert opinion piece. SGM that were Black and Latinx saw an increase in solitary substance use associated with concurrent increases in anxiety and depression. Multiple articles mention the use of substance use, along with social media and interacting with social circles, as a method of coping during COVID-19 quarantine, isolation, loss of job, and other desolating effects of the pandemic on society. Interestingly, one study found a decrease in drug use prevalence among SGM and trans men, but an increase in frequency among those who continue to use drugs. CONCLUSIONS: LGBTQIA+ youths were disproportionately affected by the pandemic in an increase in substance use in available literature. Additional research is also needed to characterize how this population was affected in terms of homelessness, financial need, and food insecurity.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127784","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessing Risk of Bias in Systematic Literature Reviews: Which Tools Are Most Commonly Used?","id":"a826f054-ba5c-4bab-8af2-29bb3a317b20","sessionCode":"SA14","topDisplay":"Young V, Zile I, Bejawn K, Carter P HEOR Ltd, Cardiff, UK","locationCode":"916","description":"\r\n\t<div>OBJECTIVES: Systematic literature review (SLR) guidance for best practice recommends the use of risk of bias (RoB) tools to determine the reliability of included studies. The aim of this research was to review which tools are most commonly used to assess bias in published SLRs. METHODS: SLRs were identified via a pragmatic search using Ovid MEDLINE® 2021–2022 and selected for inclusion by a single reviewer if they exclusively included either randomised controlled trials (RCTs) or real-world evidence (RWE). Key data were extracted (disease area, study design and RoB tool). RESULTS: SLRs of RCTs (n=45) most commonly used the Cochrane tools (ROB and ROB2). The original tool was used more frequently than the updated ROB2 tool (62.2% vs. 17.7%, respectively). The Jadad scale was the second most commonly used tool (13.3%). SLRs of RWE studies (n=82) were more diverse in the selection of RoB tools. A total of 18 different tools were used, including the Newcastle–Ottawa scale (NOS), 46.3%; Joanna Briggs Institute (JBI) tools, 11.0%; ad hoc tools adapted from previous publications, 11.0%; and the ROBINS-I tool, 3.7%. CONCLUSIONS: The Cochrane handbook is considered the gold standard for SLRs. Therefore the findings are not unexpected, in that the Cochrane tools were most commonly used in published SLRs of RCTs. However, the majority of SLR authors used the original tool and not the updated ROB2, which requires assessment per outcome. The reasoning for authors’ selection of the older tool should be investigated. In SLRs of RWE studies there was a greater diversity in the tools used. The ROBINS-I tool, recommended by the Cochrane handbook, was used in just 3.7% of SLRs. The frequent use of ad hoc tools for RWE may reflect a greater difficulty in selecting tools appropriate for the range of study designs in this area.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126066","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Taptest and Continuous Lumbar Drainage in Comparison to Standard Care in Suspected Idiopathic Normal Pressure Hydrocephalus from the Perspective of the Brazilian Unified Health System","id":"d3b05545-593d-4add-944b-29f582399bfa","sessionCode":"EE36","topDisplay":"Braga A, Morais QC, Leite BR, Barros B, Magliano C Instituto Nacional de Cardiologia, Rio de Janeiro, RJ, Brazil","locationCode":"228","description":"\r\n\t<div>OBJECTIVES: Three symptoms — impaired gait, cognition, and incontinence — define idiopathic normal pressure hydrocephalus (iNPH). To predict whether iNPH patients will benefit from shunt surgery, the tap test (TT) or continuous lumbar drainage (CLD) may be employed. This study's goal is to evaluate the cost-effectiveness of TT and CLD in comparison to the standard of care, in which all patients with suspected iNPH underwent shunt surgery, from the perspective of the Brazilian Public Health System. METHODS: It was developed a decision tree model. The analysis considered the expenditures associated with TT, CLD, clinical consultations, and shunt surgery, as well as the accuracy of the tests and the likelihood that the procedure would be successful and any risks, such as stroke, significant bleeding, and meningitis. Utilities were based on a study that assessed the profitability of shunt surgery for iNPH patients. RESULTS: Based on slight QALYs losses (0.02 and 0.01) and cost increases (U$ 88.90 and U$ 176.47) for TT and CLD, respectively, usual care dominated both strategies. While skipping shunt surgery in 13.4% and 6.4% of patients who might benefit, TT and CLD lowered the number of needless procedures by 26.9% and 22.6%, respectively. The likelihood that an operation would be effective, its cost, and its utility had the biggest effects on ICER. CONCLUSIONS: Disregarding the modest magnitude of losses in QALYs and the small rise in expenses, there is still a trade-off in using TT and CLD to indicate shunt surgery for patients with suspected iNPH. While these strategies can help patients by preventing unnecessary shunt surgeries, some of those who would benefit would be mistakenly thought to be avoiding shunt surgery.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bragaee36poster-pdf126495-pdf.pdf?sfvrsn=b7627d5e_0","title":"ISPOR23_BRAGA_EE36_POSTER.pdf126495.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bragaee36handout-pdf126495-pdf.pdf?sfvrsn=32cb286d_0","title":"ISPOR23_BRAGA_EE36_HANDOUT.pdf126495.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126495","diseases":[{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Barriers to Persisting on Prophylactic Treatment for C1-Esterase Inhibitor Deficient Hereditary Angioedema; Observations from Community Immunology","id":"53424efa-4875-42f0-9ab2-2a065ae3fc06","sessionCode":"RWD23","topDisplay":"Raasch J1, Lumry WR2, Milligan S3, Riedl M4 1Midwest Immunology, Plymouth, MN, USA, 2AARA Research Center, Dallas, TX, USA, 3Trio Health Analytics, Louisville, CO, USA, 4US HAEA Angioedema Center, San Diego, CA, USA","locationCode":"833","description":"\r\n\t<div>OBJECTIVES: Prophylactic therapies are an important tool in HAE management though persistency on therapy may be suboptimal. To determine reasons for discontinuation, we reviewed office visit notes and EMR data generated from community care. METHODS: Data: PIONEER-HAE, a database containing EMR, continuity of care documents, and extracted visit note data, specific to patients managed by the Consortium of Independent Immunology Clinics (CIIC). Unstructured data were extracted into electronic forms by clinically-trained scribes and included attack details, on demand treatment, symptoms onset and diagnosis, family history, comorbidities, prophylactic treatment initiation, discontinuation, and reasons for discontinuation. Form data were subjected to logical checks, random audit (1-2%), and tertiary data review after combining with CCD and EMR data. Patient selection: Type I or II HAE treated with FDA-approved prophylactic drugs between 2018-2022. Drug episodes, defined as prophylactic drug-specific treatment without drug-free periods of >90 days, occurring between 2018-2022 were examined. RESULTS: Study population characteristics (n=183): 63% (116) female, mean (median) age 43 (43) years with 15% (27) ≥ 65 and 5% (9) <18 years old, predominantly white (87%, 116/134), commercial insurance coverage (73%, 134), and type I HAE (90%, 164). Drug episodes (n=292): 14% (40) androgens, 2% (5) anti-fibrinolytics, 39% (114) C1-esterase inhibitors, 46% (133) kallikrein inhibitors. As of Dec 2022, 174 drug episodes were active. For the remaining 118 discontinued episodes, 91 had documented discontinuation reasons: 26% (24/91) lack/loss of efficacy, 23% (21/91) comorbids or observed/anticipated adverse events (e.g. weight gain, concern over liver damage), 23% (21/91) patient preferences (e.g. anticipated pregnancy, prefer different drug), and 16% (15/91) payer/payment issues (e.g. denied, can’t afford). CONCLUSIONS: In this study of prophylactic HAE treatments, 74% of evaluable episodes were discontinued for reasons other than lack of efficacy. These data serve as an important first step towards 1) awareness of real-world factors impacting persistency and 2) optimized disease management.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23milliganposterrwd23p123960-pdf.pdf?sfvrsn=94350fac_0","title":"ISPOR23_MILLIGAN_POSTER_RWD23_p123960.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123960","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Hemophilia Brazil","id":"c361bfd3-91f8-46f5-b5fc-2a22a75b23f8","sessionCode":"EE63","topDisplay":"Etges AP1, Schneider N1, Roos E2, Hosokawa M3, Reboucas T4, Cerqueira M5, Mata V6, Polanczyk CA2 1National Health Technology Assessment Institute, Porto Alegre, RS, Brazil, 2National Health Technology Assessment Institute, Porto Alegre, Brazil, 3Centro de Hematologia e Hemoterapia da Unicamp, Sao Paulo, Brazil, 4Ceará Hematology and Hemotherapy Center, Fortaleza, Brazil, 5Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti-HEMORIO, Rio de Janeiro, Brazil, 6F.Hoffmann-La Roche, SAO PAULO, SP, Brazil","locationCode":"304","description":"\r\n\t<div>OBJECTIVES: Hemophilia A is a rare disease characterized by uncontrolled and persistent bleeding. The mainstay of treatment in patients with hemophilia A is to monitor patients in accredited blood centers continuously. This study estimated the direct and indirect costs per patient with hemophilia type A in Brazil. METHODS: This is applied prospective observational research with retrospective data collection in patients followed at 3 referral blood centers from Brazil. Time-driven Activity-based Costing (TDABC) method was used to guide the data collection and analyses of direct costs. The indirect costs were estimated based on interviews. Patients were stratified in groups of age ranges (0-11;12-18 or older than 19) and, according to inhibitor status for the cost analyses, calculated as the annual cost per patient. The non-parametric Mann-Whitney test was used to confirm the differences in costs between groups. The costs are expressed in Brazilian national currency (R$) in 2022. RESULTS: Data from 140 patients were analyzed; 53 are 0-11, 29 are 12-18, and the remaining are older than 19. Only 14% had inhibitors, and most were 0-11 years old (n=12). The median cost per patient per year was R$450,831 (IQR R$219,842; R$785,149), and it was possible to demonstrate that older patients had higher costs (p=0.001; median cost: 0-11yrs - R$299,320; 12-18 yrs-R$521,936; ≥19yrs R$718,969). There were no significative differences between patients with or without inhibitors (p=0.18; median cost: R$702,444 and R$440,752, respectively). CONCLUSIONS: This study is innovating by providing cost information for hemophilia type A using a microcosting technique. The variation in costs across patient age ranges and justified by the health care multiprofessional service suggests the importance of considering that in health policies. This research was financed by the company Produtos Roche Químicos e Farmacêuticos S/A of Brazil. The Institute of Health Technology Assessment was responsible for conducting the study, writing the manuscript and editorial review.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124925","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Clinical Effectiveness of Pacemaker in High-Risk Patients with Cardiovascular Diseases: A Systematic Review and Metanalysis","id":"f4a0afca-72a8-466f-b46f-2a44f0aed631","sessionCode":"CO7","topDisplay":"Seshu P1, Kachroo K2, Sharma J3, Rm K4, Varalakshmi G5 1Kalam Institute of Health Technology, Visakhapatnam, AP, India, 2Kalam Institute of Health Technology, Visakhapatnam, India, 3Andhra Pradesh MedTech Zone, Andhra Pradesh, India, 4Kalam Institute of Health Technology, AMTZ- A JBI Affiliated group, Visakhapatnam, India, 5Andhra Pradesh Medical Technology Zone (AMTZ), Vishakhapatnam, AP, India","locationCode":"106","description":"\r\n\t<div>OBJECTIVES: A cardiac pacemaker (PM) is a medical device that uses electrical impulses delivered by electrodes to contract the heart muscle and regulate the heart rate. The main purpose of this device is to maintain a proper heart rate. Pacemakers are essential not only for the treatment of arrhythmias and heart failure, but also for the treatment of cardiovascular diseases. Therefore, this review hypothesizes that cardiovascular disease patients receiving treatment 'with or without pacemaker may increase or decrease the risk of mortality. The objectives of this study were to analyse the pacemaker evidence to conduct a systematic review to determine the clinical efficacy of pacemaker implantation in high-risk patients requiring surgery with outcomes with reduced of risk mortality. METHODS: A comprehensive search was performed at various electronic databases using PubMed, Web of Science, Google Scholar and Cochrane. A PRISMA method is used to curate and collocate the studies. Quantitative data were pooled into statistical meta-analyses using the Cochrane Review Manager (RevMan) to compare clinical efficacy with and without pacemakers RESULTS: A total of 3334 articles were obtained and after evaluation, 10 articles were accepted that answered the research questions and met the criteria for systematic review and meta-analysis. Therefore, the metanalysis found that the risk of mortality was increased in patients treated without a pacemaker and decreased mortality in those patients treated with a pacemaker showing (risk ratio 1.23, (1.15 to 1.32) with a 95% confidence interval. CONCLUSIONS: In this review we found that pacemakers played an important role in patients’ recovery and reduced risk of Mortality. This adds to the confidence that pacemakers will become more prevalent in the next few years.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/co7poster124258-pdf.pdf?sfvrsn=1b79ab4a_0","title":"CO7_Poster124258.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124258","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Budget Impact Analysis of a Non-Invasive Temperature-Controlled Radiofrequency Device for the Treatment of Nasal Airway Obstruction","id":"82efba02-a281-431c-b53e-2ac341f53ea5","sessionCode":"EE71","topDisplay":"Yong M1, Hollemon D2, Baxter J3, Hernandez B3, Hirst A4, Bryning S4, Fox A4, Smith G4, Hughes R4, Wolf S3, Ow R5 1Stanford University, California, CA, USA, 2Aerin Medical, San Jose , CA, USA, 3Aerin Medical, San Jose, CA, USA, 4Adelphi Values PROVE, Bollington, UK, 5Sacramento ENT, Sacramento, CA, USA","locationCode":"313","description":"\r\n\t<div>OBJECTIVES: Nasal airway obstruction (NAO) is a common condition that presents with congestion and feeling of fullness in the nasal cavity. Chronic NAO presents a significant economic burden and current treatments for NAO can be invasive and costly. The objective of this study is to determine the budget impact of a non-invasive temperature-controlled radiofrequency (TCRF) device for the treatment of NAO. METHODS: A budget impact model with a 4-year time horizon including treatment, monitoring, medical resource use and adverse event costs was developed. The eligible population was severe/extreme NAO, defined as a NOSE score ≥ 55, for which nasal valve collapse (NVC) is the primary cause or a significant contributor. The budget impact was calculated for two scenarios: a reference scenario of functional rhinoplasty (nasal valve repair) with inferior turbinate reduction (ITR) performed in the hospital outpatient department, which reflects current clinical practice where TCRF is not available as a treatment option. The new scenario reflects treatment of the nasal valve and inferior turbinates with a TCRF device and an ITR at an in-office setting. Uncertainty within the model structure and input parameters was assessed using one-way sensitivity analysis and scenario analysis. RESULTS: Over the 4-year time-horizon, the net budget impact showed that the introduction of the device is likely to provide cost-savings due to reductions in the number of surgeries in addition to costs avoided from resolving complications and the lower procedure cost of the device relative to surgical comparators. Cost savings were also estimated when standard of care represented a mix of surgical interventions and medical management. The results were robust when varying parameter values in sensitivity analyses. CONCLUSIONS: The results of this budget impact analysis suggest a non-invasive TCRF device for severe/extreme NAO is likely to provide cost savings over current treatment options while potentially improving outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023hirstposter---ee71-v10125983-pdf.pdf?sfvrsn=1d6c0cc6_0","title":"ISPOR 2023_HIRST_POSTER - EE71 v1_0125983.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125983","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Alopecia Areata: Targeted Review of Adverse Events Associated with Clinical Studies of Treatments","id":"1ccc57bf-ac11-4096-a1b8-2c7cefee911e","sessionCode":"EPH39","topDisplay":"Alsawady M1, Borecka O1, Llewellyn S2 1Vitaccess, Oxford, UK, 2Vitaccess, Oxford, OXF, UK","locationCode":"439","description":"\r\n\t<div>OBJECTIVES: Alopecia areata (AA) is a common autoimmune disease characterized by sudden patchy hair loss. Although a few treatments have been reported to have a beneficial effect, assessment of adverse events (AEs) in clinically controlled studies remains insufficiently established, thereby compromising the safety profiles of treatments. This targeted review aimed to quantify the most frequently reported AEs in clinical studies, including phase II, III, randomized controlled trials, and other prospective randomized studies for the treatment of AA. METHODS: Study publications from the last 15 years (January 1, 2008 to December 31, 2022) were identified through targeted searches of the PubMed database and Google Scholar. Study titles and abstracts were screened, then study design details and data on AEs by treatment were extracted and checked for accuracy by two independent reviewers. Both systemic and topical treatments were considered. The five most frequently reported AEs that occurred in participants receiving treatment were recorded for analysis. RESULTS: Sixteen clinical studies reporting AEs associated with four topical and 12 systemic therapies used in the treatment of AA were included. The most frequently reported AEs were headaches (n=213), nasopharyngitis (n=189), upper respiratory tract infections (URTIs; n=188), acne (n=151), and folliculitis (n=49). Two out of five most common AEs were dermatological and two respiratory. The most frequently reported AEs associated with systemic treatments were headaches, URTIs and nasopharyngitis, while for topical treatments, they were headaches, nasopharyngitis and pruritus, in order of frequency. CONCLUSIONS: AA treatments are associated with high rates of AEs, particularly of dermatological and respiratory nature, which highlights the evident need for therapies with improved safety profiles. To this effect, conducting large-scale, double-blind, placebo-controlled clinical trials is of paramount importance to confirm the efficacy and safety profiles of therapies used in the treatment of AA, particularly as published literature in this area remains scarce.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23llewellynpostereph39124594-pdf.pdf?sfvrsn=cc5b87b2_0","title":"ISPOR23_LLEWELLYN_POSTER_EPH39124594.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124594","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Trust and Customer Satisfaction with Services Provided By Pharmacy Staff","id":"f9aa024b-60c1-4720-8b17-2ca84bd1adc4","sessionCode":"PCR41","topDisplay":"Barseghyan A1, Nazaryan L2, Simonyan MH2 1Yerevan State Medical University after Mkhitar Heratsi Yerevan, Yerevan, KT, Armenia, 2Yerevan State Medical University, Erevan, Armenia","locationCode":"801","description":"\r\n\t<div>OBJECTIVES: To ensure the rational use of drugs, it is necessary that patients receive drugs in accordance with their clinical needs, in doses corresponding to individual characteristics, for an adequate period of time and at the lowest cost for them. This explains the important and irreplaceable role of pharmacists. Pharmacists have a responsible role to carry out proper self-medication, as well as taking on the functions of assisting in the selection of an over-the-counter drug. The aim of the work is to determine the level of consumer confidence in the pharmacy staff, as well as factors influencing the choice of a pharmacy. METHODS: The study was conducted by questionnaire survey of 383 consumers in Yerevan and the regions in 2021. and the first quarter of 2022. The questionnaire was written in Armenian. In this study, descriptive statistics methods were used. To analyze the results, the SPSS software package (version 12.0) was used. RESULTS: It was shown that the population does not have a stable trust in primary care doctors (44%) and pharmacy personnel in general (61%), but has a high degree of trust in the preferred pharmacy (74%) and its staff (76%). The study also showed that 41% of respondents with pain symptoms used the self-medication method. CONCLUSIONS: It is necessary to take a number of measures to increase the role of pharmacists and trust in them, which will allow better control of the process of self-medication, as well as reduce the number of errors in self-medication and adequately control the treatment of pain symptoms.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123706","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Benchmarking of Budget Impact Results: An Updated Systematic Review of US Budget Impact Analyses","id":"8f133bb6-7613-4090-962e-2d2bb7ac1d81","sessionCode":"SA10","topDisplay":"Liu R1, Botteman M2 1OPEN Health, Bethesda, MD, USA, 2Formerly of OPEN Health, Bethesda, MD, USA","locationCode":"915","description":"\r\n\t<div>OBJECTIVES: To inform drug formulary decision-making, US reimbursement authorities commonly require budget impact analyses (BIA), typically reported as budget impact (BI) per member per month (PMPM). However, proper interpretation of BI PMPM is hampered by the lack of accepted pre-specified PMPM thresholds defining a financially acceptable BI. We updated a prior systematic review of published US BIA to establish PMPM benchmarks and assess how BIA authors qualitatively interpreted their own results. METHODS: Systematic PubMed/Embase searches (01/2003-11/2022) were conducted to identify full-text, peer-reviewed, US-based BIAs that reported pharmacotherapy BI PMPMs. Base case BI PMPM (inflated to 2022 value) and authors’ interpretations were analyzed descriptively by PMPM quartile. RESULTS: We identified 78 BIA reporting BI PMPM. The median (interquartile range [IQR]) PMPM was USD cent (¢) 1.4 (-0.2, 4.6) across all 78 estimates and ¢2.3 (1.3, 7.0) across 57 non-negative estimates (i.e., PMPM>¢0). Among PMPM>¢0, 86% were reported with interpretations. These were more frequently provided for lower versus higher PMPM quartiles: Q1 (i.e., lowest quartile), 100%; Q2, 86%; Q3, 86%; Q4 (i.e., highest quartile), 73%. Among the most common terms used to describe financial acceptability for PMPM>¢0, interpretation patterns by quartile (ordered here from lowest to highest) were ambiguous (“minimal”: 21%/29%/7%/13%; “small”: 29%/36%/21%/0%; “modest”: 14%/0%/21%/13%). When stratified by interpretation term, the median (IQR) PMPM was lowest for “minimal” (n=10, ¢1.4 [0.5, 2.4]), followed by “limited/low/negligible/neutral” (n=7, ¢1.6 [1.2, 8.8]), “small” (n=12, ¢1.6 [1.2, 2.2]), “moderate/manageable/affordable/justifiable” (n=7, ¢3.3 [1.9, 5.4]), “modest” (n=12, ¢5.4 [1.7, 9.8]), no interpretation (n=8, ¢6.6 [2.1, 19.7]), and “considerable” (n=1, ¢209.3). CONCLUSIONS: We provide updated benchmarks for BI PMPM. Additional research is needed to establish benchmarks to guide BI interpretation that account for various factors like therapeutic area, disease burden, and disease rarity. Until then, authors might want to refrain from providing potentially misleading qualitative judgment regarding BI acceptability.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-us-2023bia-slr-posterfinal2023apr23126363-pdf.pdf?sfvrsn=1871ddf6_0","title":"ISPOR US 2023_BIA SLR poster_FINAL_2023Apr23126363.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126363","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Public Disclosure of Clinical Research Is an Important Factor for Evidence-Based Decision-Making: Is the Current Evidence Being Disclosed in a Timely Manner?","id":"e317050a-33f2-4efc-afd4-2d406685a3a6","sessionCode":"SA8","topDisplay":"Jadhav V1, Dsouza I2, Ogata H2, Bhole VM2 1Bioviser Inc., Mumbai, MH, India, 2Bioviser Inc., Boston, MA, USA","locationCode":"911","description":"\r\n\t<div>OBJECTIVES: According to World Health Organization, the main findings of clinical trials should be submitted for publication, preferably open access, in a peer-reviewed journal within 12 months of study completion. The Food and Drug Administration Amendments Act mandates reporting summary results in the database of ClinicalTrials.gov within 12 months of study completion. We therefore assessed the proportion of completed trials on psoriasis that have publicly disclosed the primary results within 2 years of primary completion date, either as a publication or on ClinicalTrials.gov. METHODS: We recorded the “primary completion date” of psoriasis phase 1-3 clinical trials completed in 2000-2020. We also recorded the “first posted results date” on ClinicalTrials.gov and the “first primary online publication date” from literature search, and earlier of these two dates was identified as the “results revealed date.” Next, the difference in “primary completion date” and “results revealed date” was calculated. RESULTS: Of 706 completed clinical trials, only 67.6% had revealed the results (44.8% first presented as journal publications and 22.8% reported on ClinicalTrials.gov). Among 477 studies that revealed the results, mean (SD) time to first public disclosure of primary results was 31.5 (25.1) months (41.8 [31.3] for ClinicalTrials.gov and 26.2 [16.6] for scientific publications). The results of 6.5%, 29.9%, and 31.2% trials were revealed in ≤1 year, 1-≤2 years, and >2 years, respectively. Recent studies were disclosed more often (~70%) vs those starting before 2006 (47%). CONCLUSIONS: Compliance to public disclosure of clinical trial results is poor but improving with time. However, low compliance to CONSORT guidelines between 2000 and 2010 may have impacted our results. Prompt public disclosure of clinical trial results can provide real-time clinical trials data to physicians and help them make evidence-based, informed decisions, thus paving the way for real-world outcomes research and eventually improving the quality of healthcare and patient outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23dsouzaposter125348-pdf.pdf?sfvrsn=3fdfe1f8_0","title":"ISPOR23_D'SOUZA_POSTER125348.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125348","diseases":[{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Role of Prescribed Controlled Substance Acquisition As Potential Triggers of Opioid Overdose: A Case-Crossover Study","id":"58837d15-0322-4d08-9945-2d8846f53a79","sessionCode":"EPH37","topDisplay":"Smith A, Peng C, Porter A, Martin B University of Arkansas for Medical Sciences, Little Rock, AR, USA","locationCode":"437","description":"\r\n\t<div>OBJECTIVES: The role of prescribed opioids and benzodiazepines as risk factors for opioid overdose (OOD) are well established, however, their role as potential ‘triggers’ of OOD has not been formally investigated. The objective of this study was to utilize a case-crossover design to evaluate the temporal relationship between controlled substance acquisition and OOD. METHODS: This study utilized the Arkansas Prescription Drug Monitoring Program (PDMP) data from 2014 through 2020 to assess controlled substance acquisition and fatal and non-fatal OOD using linked death certificate, inpatient discharge and emergency department data. All persons residing in Arkansas who experienced an OOD or had ≥ 1 AR PDMP prescription fills were included. Controlled substance (CS) characteristics were described in the 7 days prior to overdose and compared to the CS characteristics in 11 weekly (7 day) control windows prior to overdose. Binary CS variables indicating presence or absence of: any CS, opioid, benzodiazepine, opioid and benzodiazepine, stimulant, sedative, carisoprodol, and pregabalin were created. Additionally, cumulative morphine milliequivalents were calculated for each time window. Conditional logistic regression models were estimated and adjusted odds ratios for each CS characteristic after accounting for other CS and prior overdose events are reported. For sensitivity analysis, time windows were adjusted to 3-day intervals. RESULTS: A total of 2,818,135 individuals (45.10% male; 39.94 mean age) were included, of which 28,670 (1.02%) experienced ≥1 OOD(s). There was a significant association between OOD and the acquisition of a CS (OR=1.856; p<0.001), opioid (OR=1.982; p<0.001), benzodiazepine (OR=1.358; p<0.001), opioid and benzodiazepine (OR=2.302; p<0.001), stimulant (OR=0.723; p=0.029), and carisoprodol (OR=1.490; p<0.001) in the 7 days prior to an OOD event. A similar relationship was found in the sensitivity analysis. CONCLUSIONS: The recent acquisition of a CS prescription, specifically opioids, benzodiazepines, and carisoprodol, was associated with increased risk of OOD.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/eph37allensmithposterfinal127239-pdf.pdf?sfvrsn=c2dccaa1_0","title":"EPH37_AllenSmith_poster_final127239.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127239","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Challenges in Establishing a National Health Technology Assessment Agency in the United States: Insight from Low- and Middle-Income Countries","id":"36279877-5bdf-46cb-8a29-2e9d1c73583e","sessionCode":"HTA11","topDisplay":"Kelleher DP Yale University, New Haven, CT, USA","locationCode":"616","description":"\r\n\t<div>OBJECTIVES: In 2022, legislators in the US responded to a long-standing problem of high drug costs for patients by giving the government the power to negotiate in its Medicare program. To engage this new negotiation power, the government’s Centers for Medicare and Medicaid Services (CMS) may need to formally avail itself of health technology assessments (HTAs). As the US considers establishing a national HTA agency to conduct HTAs through Medicare, it will face numerous challenges. This paper seeks to identify some of those challenges using insight from low- and middle-income countries (LMICs) with recently established national HTA agencies. METHODS: Examining the challenges that LMICs with recently established national HTA agencies faced is potentially more appropriate than examining the challenges similar agencies faced when being established in industrialized countries, as such agencies were likely established over 20 years ago. To select appropriate LMICs to include in the literature search, three criteria were used. Whether the country had established a designated national HTA agency; was a member of an international HTA group; had published its EQ-5D-5L value set. RESULTS: Two countries that met all criteria were India and Indonesia. Both national HTA agencies faced challenges pertaining to Capacity for HTA; Data infrastructure; Priority-setting for HTAs; Stakeholder/policymaker engagement and support. CONCLUSIONS: A national HTA agency in the US could look to initially improve capacity for HTAs by partnering with leading US academic centers while working with non-profit and private providers of HTAs. A newly established national HTA agency based in CMS would need robust data gathering systems and agreements with various health care providers, researchers, and agencies to access such data that may only be feasible through a government-backed national HTA agency. Such an agency could prioritize HTA topics based on stakeholder input or use alternative processes that consider spending and geographic variation.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kelleherposter126128-pdf.pdf?sfvrsn=6668622c_0","title":"ISPOR23_Kelleher_POSTER126128.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126128","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"PDCI's Biopharmaceutical Ecosystem Index: Where Does Canada Rank on Its Attractiveness for New Medicine Launch?","id":"14abf5f4-47f3-4766-a529-2f25afbb2748","sessionCode":"HPR17","topDisplay":"Abunassar C1, Dowson JP2, Fleming M2, Loschmann C2, Scott V2, Burt M2 1PDCI Market Access, Kingston, ON, Canada, 2PDCI Market Access, Ottawa, ON, Canada","locationCode":"518","description":"\r\n\t<div>BACKGROUND: Recent literature shows Canada receiving fewer or delayed new medicine launches in recent years versus comparator countries. OBJECTIVES: The objective of PDCI’s Biopharmaceutical Ecosystem Index (the Index) is to rank 14 countries on their relative attractiveness for new medicine launch. METHODS: Recognizing that global pharmaceutical manufacturers’ decisions on whether and when to launch a new medicine in a country are complex and multifactorial, Index authors convened an independent Editorial Advisory Board, composed of biopharmaceutical experts and experts on pharmaceutical policy and patient access issues to identify and weight indicators and measurements that commonly influence a global biopharmaceutical decision-maker’s perspective of a country’s launch attractiveness. Following an extensive literature review on each measurement, authors scored each country on eight indicators under three technical areas: Development & Commercialization Infrastructure, Regulatory Landscape and Access Environment. Authors then weighted the scores on each indicator to produce a composite attractiveness score for each country. RESULTS: Canada ranks 10th out of 14 countries on its attractiveness for new medicine launch, putting it ahead of Italy, Norway, Belgium, and Spain which ranked 11th to 14th, respectively. Canada trailed the other countries in the analysis, which were (in order of overall attractiveness ranking, from first to ninth): the United States, Germany, United Kingdom, Japan, France, Australia, Sweden, Switzerland and Netherlands. CONCLUSIONS: This study was conducted to better understand the potential underlying reasons for fewer or delayed Canadian launches of new medicines in recent years, and to shed light on which indicators or policies can have the greatest impact on Canada’s attractiveness for new medicine launches. The goal is to help Canadian policy makers and biopharmaceutical leaders engage in constructive dialogue towards creating the best possible system for Canadian patients to access new innovative medicines in the years to come. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23abunassarposter124046-pdf.pdf?sfvrsn=ac8ac01f_0","title":"ISPOR23_Abunassar_POSTER124046.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124046","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Understanding and Assessing the Patient Experience of Symptoms for Polycystic Liver Disease (PLD): Development of a New Disease-Specific Symptom Patient-Reported Outcome Measure (PROM)","id":"5319dcf5-7851-4fac-a394-2f59e73cf09d","sessionCode":"PCR8","topDisplay":"Brod M1, Pfeiffer KM1, Waldman LT1, Olevik A2, Axling U2, Johnsson M2 1The Brod Group, Mill Valley, CA, USA, 2Camurus AB, Lund, Sweden","locationCode":"721","description":"\r\n\t<div>OBJECTIVES: PLD is a rare condition in which multiple cysts develop in the liver. Approximately 20% of patients experience a high symptom burden. Limited patient-centered research exists for this condition, and much of the patient-reported data results from generic measures. To address this gap, a disease-specific PROM, the PLD-Symptom was developed. METHODS: A non-interventional, qualitative study following FDA guidelines was conducted. Data were collected from the literature and individual telephone interviews, following semi-structured interview guides, with 4 clinical experts and 30 adult respondents (United States and United Kingdom). Information was coded based on adapted grounded theory. A draft theoretical model of PLD signs/symptoms and draft items were generated, underwent translatability assessment, and were cognitive debriefed (n=12) employing “think aloud” methodology. RESULTS: Respondents were mostly female (77%), average age 51.2 (range, 32-72), 67% had polycystic kidney disease, and average time to initial diagnosis 8.5 years (range, 0-25). Experts (3 hepatologists, 1 nurse) identified 21 symptoms in total. All but 3 of these were also reported by respondents who reported 40 symptoms in total. Saturation (95%) was reached by the 19th interview. Symptoms most frequently reported included bloating (n=27, 90%), abdominal/stomach pain (n=26, 87%), tired/low energy (n=25, 83%), and abdominal/stomach increase (n=25, 83%). Symptoms were included in the draft measure if endorsed by at least 40% of participants (or 35-39% if high conceptual importance), rated bothersome by most respondents, experienced at least once a week by most respondents, potentially responsive to treatment, and proximal symptoms. Eleven symptoms met criteria for inclusion. Cognitive debriefing resulted in a validation-ready, 10-item measure. All final items and instructions were found to be relevant, understandable, and consistent with the intended meaning. CONCLUSIONS: The PLD-Symptom can be considered to have strong content validity based on the concept elicitation data. Psychometric validation is now needed to confirm measurement properties.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23brodpcr8poster-symptomsv2123797-pdf.pdf?sfvrsn=46f52503_0","title":"ISPOR23_Brod_PCR8_POSTER-SYMPTOMS_V2123797.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123797","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Risk Factors and Healthcare Costs Associated with Long Bone Fracture Non-Union – A US Claims Database Analysis","id":"a2747c31-e077-49d5-b290-2fa65d273754","sessionCode":"EE22","topDisplay":"Vanderkarr M1, Ruppenkamp J1, Vanderkarr M2, Holy C3, Blauth M4 1Johnson & Johnson MedTech, New Brunswick, NJ, USA, 2DePuy Synthes, Inc., Bay Village, OH, USA, 3Johnson & Johnson, Somerville, MA, USA, 4DePuy Synthes, Solothurn, Switzerland","locationCode":"223","description":"\r\n\t<div>OBJECTIVES: Non-union is a common complication following long bone fractures, often requiring significant incremental healthcare resources. The payer cost of long bone non-union in patients with or without concurrent infection is not well documented. Our study evaluated 2-year incremental healthcare costs of non-union in patients with fractures. METHODS: Patients within IBM® MarketScan® Commercial Claims and Encounters database with long bone (femur, humerus or tibia) fracture in the inpatient setting, and a surgical fracture repair procedure, from Q4 2015 to most recent, were identified. Exclusion criteria included: polytrauma and amputation at index. Outcomes: diagnosis of non-union in the 2-year post-index, concurrent infection, reoperation, and total healthcare costs. Variables: age, gender, comorbidities, fracture characteristics and severity. Descriptive analyses were performed on all three cohorts separately. Crude and adjusted rates of non-union (using Poisson regressions with log link) were calculated. Marginal, incremental cost of care associated with non-union, infection and reoperation, were estimated using a Generalized Linear Model (GLM) with log link and gamma distribution. RESULTS: 12,770, 13,504 and 4,805 patients with surgically-treated femoral, tibial and humeral fractures were identified, respectively. Two-year post-index rates of non-union reached 8.5% (8.0%-9.1%) (femoral fracture), 9.1% (8.6%-9.7%) (tibial fracture), and 7.2% (6.4%-8.1%) in humeral fracture cases. Infected non-unions affected < 1% of femoral and humeral fractures, and 2% for tibial fractures. All tibial non-union patients were reoperated by 2 years, however only 71% of femoral non-unions, and 68% of humeral non-unions were already reoperated. The increased marginal cost of femoral, tibial and humeral non-union at 2-years post-index averaged $45,633 ($23,913-$67,352), $40,409 ($30,295-$50,523) and $33,308 ($14,603-$52,013), respectively, prior to reoperation and without concurrent infection. Reoperations added $16K-$34K incremental costs. When infection was also present, costs increased by $46K-$87K. CONCLUSIONS: Non-union is associated with significant incremental costs. Without concurrent infection, non-union conditions add between $33K-$46K costs. Concurrent infection results in an additional $46K-$87K.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23holyee22healthcare-costs-non-union125707-pdf.pdf?sfvrsn=519731bc_0","title":"ISPOR23_Holy_EE22_Healthcare Costs Non-union125707.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125707","diseases":[{"id":"3f994852-a0d4-4706-9665-e4d867006d9a","parentId":"00000000-0000-0000-0000-000000000000","title":"Injury & Trauma","urlName":"injury-trauma"},{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"6ae07959-4147-40c8-9c6d-598f96469a9d","parentId":"00000000-0000-0000-0000-000000000000","title":"Surger","urlName":"surger"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Development of an Individualized Cost-Utility Prediction Framework Based on Markov Model and Deep Learning for Patients with GI Tract Tumors","id":"191db6c0-0174-4099-8a66-2fcdb335b551","sessionCode":"PCR25","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"735","description":"\r\n\t<div>OBJECTIVES: Classical Markov models often use fixed values as transition probabilities between states, which limits their clinical applications in real-world due to ignoring the impact of individualized characteristics on disease progression. In this study, a framework for cost and utility prediction in patients with GI tract tumors was developed based on Markov and deep-learning algorithms. METHODS: In this study, a Markov model with a cycle period of 6 months and containing initial, progressive and death states was set, and a prediction model for the prediction of total cost and transfer probability between states was established based on Deep Neural Networks and CatBoost using electronic medical record data (EMR) from 456 patients with 1,956 follow-up visits. Health utilities, assessed by EQ-5D-5L, were obtained from 530 patients in a cross-sectional process, and a model for predicting health utility values was developed based on EMR and CatBoost. The results of the above three prediction models were used as parameters for the Markov model to establish a Deep Learning-Markov model framework, and a web application platform was developed for use by interested parties. RESULTS: The training rounds of the transfer probability, cost, and health utility value prediction models were 10,000, 1,000, and 1,000, and RMSEs were 0.35, 1711.7625, and 0.0934, respectively. The training loss of each model is continuously reduced and successfully converged. The deep learning-Markov model framework and application platform developed based on the models can output the life year, QALY and ICER for individual patient under different treatment regimens. CONCLUSIONS: In this study, we developed a model that can be used to individually predict long-term cost-utility data for patients, which can provide individualized cost and utility values to help the selecting high-value treatment options for oncology patients and has potential clinical application.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127715","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Keratometry, Intraocular Pressure, and Visual Acuity at the Onset of Ophthalmic Conditions in the Real-World Setting","id":"98a36bac-75ba-4a6f-8a0f-30252674e48a","sessionCode":"CO36","topDisplay":"Rasouliyan L, Kumar V, Althoff A, Chang S, Long S OMNY Health, Atlanta, GA, USA","locationCode":"136","description":"\r\n\t<div>OBJECTIVES: The objective of this research was to characterize ocular curvature (OC), intraocular pressure (IOP), and best-corrected visual acuity (BCVA) at the onset of wet age-related macular degeneration (AMD), dry AMD, dry eye syndrome (DES), and glaucoma in the real-world setting. METHODS: Patients from 3 specialty ophthalmology networks from the OMNY Health Database with a diagnosis code for wet AMD (ICD-10: H35.32*), dry AMD (ICD-10: H35.31*), DES (ICD-10: H04.12*), or glaucoma (ICD-10: H40*) were included if they had at least 1 corresponding eye measurement at first diagnosis. Snellen visual acuity metrics were converted to logarithm of minimum angle of resolution (LogMAR) values. Descriptive statistics for OC, IOP, and BCVA measurements were generated for the poorer- and better-seeing eyes separately at the first occurrence of each diagnosis code. RESULTS: At least 1 of the specified eye measurements was available in 5,123, 42,602, 129,683, and 120,725, wet AMD, dry AMD, DES, and glaucoma patients, respectively. OC values in the poorer-seeing eyes were similar across all conditions (mean values ranged from 43.9 to 44.4 diopters) with slightly lower values observed in the better-seeing eyes. Mean (quartiles 1-3) LogMAR BCVA values in the poorer-seeing eyes were 0.538 (0.301, 0.477, 0.699) for wet AMD, 0.331 (0.097, 0.301, 0.477) for dry AMD, 0.190 (0, 0.097, 0.301) for DES, and 0.238 (0.097, 0.176, 0.301) for glaucoma. Mean values in the better-seeing eyes for these conditions were associated with notably better vision (0.295, 0.184, 0.097, and 0.126, respectively). Mean IOP measurements in mmHg in the poorer-seeing (better-seeing) eyes were 15.4 (13.6), 19.0 (14.1), 17.3 (14.5), and 17.6 (15.8) for wet AMD, dry AMD, DES, and glaucoma, respectively. CONCLUSIONS: Results provide insight into characteristics of OC, IOP, and BCVA measurements at the onset of various ophthalmic conditions in the real-world setting. These values may help benchmark baseline measurements for these conditions.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-posterophthofinal127520-pdf.pdf?sfvrsn=afcb635f_0","title":"ISPOR Poster_ophtho_FINAL127520.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127520","diseases":[{"id":"e29b1bc3-a98e-49c1-8bc2-2975bb5fac5e","parentId":"00000000-0000-0000-0000-000000000000","title":"Sensory System Disorders (Ear, Eye, Dental, Skin)","urlName":"sensory-system-disorders-ear-eye-dental-skin"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Global Systematic Review on the Incidence of Nd:Yag Laser Capsulotomy Post-Cataract Surgery in Eyes Implanted with the Clareon Intraocular Lens (IOL) Implanted Eyes","id":"915e914a-d349-48a1-87b9-314085d32c11","sessionCode":"MT6","topDisplay":"Gateri L, Zhang J Alcon Vision, Fort Worth, TX, USA","locationCode":"634","description":"\r\n\t<div>OBJECTIVES: The improvements in surgical technique has made cataract surgery an increasingly safe procedure, posterior capsule opacification (PCO), however, remains the most common complication post-cataract surgery. PCO development has been associated with IOL design, IOL biomaterial, and other factors. Nd:YAG laser capsulotomy is used to treat clinically significant PCO. METHODS: An electronic search of MEDLINE, Embase, Cochrane Library, European and American Society for Cataract and Refractive Surgeons congress databases for articles published between Nov-01-2017 to Dec-31-2022 were included. Incidence of PCO requiring Nd: YAG post Clareon IOL implantation and the weighted average of Nd:YAG capsulotomy incidence was reported. RESULTS: Eight clinical trials encompassing Europe, Australia, Japan, Korea, and India reporting the incidence of PCO requiring Nd: YAG were identified. Nd: YAG incidence of 0.0% was reported in studies conducted in Australia (N=40), Spain (N=60), Korea (N=126), and India (N=151). In a multi-center (Japan), single-arm long term (N=20) study with subjects followed up for nine years a 5.0% Nd: YAG capsulotomy incidence rate was reported. In a prospective multi-center (Europe) single-arm study assessing the long-term (3-years) safety and effectiveness of the Clareon IOL, at one year (interim analysis) reported Nd: YAG incidence of 0.9% in the 1st eye (N=215) and 0.0% in the 2nd eye (N=209), at two years (interim analysis) Nd: YAG incidence was 1.4% in the 1st eye (N=215) and 1.9% in the 2nd eye (N=209), at three year (final analysis) reported Nd: YAG incidence of 3.3% in the 1st eye (N=215) and 6.7% in the 2nd eye (N=209). The weighted average YAG capsulotomy incidence at 1 year was 0.74%, 2 years was 1.47%, and at three years was 2.20%. CONCLUSIONS: Global clinical studies have demonstrated that Clareon IOL biomaterial and its squared edge design protect against PCO with low incidence rates of Nd: YAG capsulotomy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gateriposterversion-2-0124426-pdf.pdf?sfvrsn=df505d09_0","title":"ISPOR23_Gateri_POSTER_version 2.0124426.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124426","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Time-Dependent Profiling of Distinct Stages Prior to Breast Cancer Onset Using Free-Text Diagnosis Names","id":"94a07a36-56e2-4ef6-9720-325dd5124111","sessionCode":"RWD14","topDisplay":"Lorenzo R1, Holmes B1, Green F2, Loving J1 1Syapse, San Francisco, CA, USA, 2Syapse, San Diego, CA, USA","locationCode":"823","description":"\r\n\t<div>OBJECTIVES: Early detection of breast cancer (BC) is crucial in determining patient outcomes. Modeling the patient journey prior to BC diagnosis is therefore an important task. Patient diagnoses are often available as free text, and difficult to represent for predictive analytics. We introduce the use of sentence transformers, paired alongside a novel association through unsupervised clustering to yield highly relevant patient journey representations. METHODS: We generated a vocabulary of 9,915 diagnoses from patient visits at most one year before a BC diagnosis, inclusive of the BC diagnosis visit. We used the Biomed-Roberta sentence transformer to vectorize these diagnoses. We clustered using silhouette scoring for optimal cluster number, and found centroids. These were again clustered to group similar concepts to clinically-relevant categories. Patients were selected, either 6 months or 3 weeks before BC diagnosis by randomized, equally-weighted patient assignment. Diagnoses up to a year prior were vectorized. We created an XGBoost model trained using these vectors to classify the two groups (75/25 train/test split). RESULTS: Expert review established cluster quality and confirmed all breast cancer diagnoses in a single cluster. In the BC diagnosis cluster, all units were breast-related, and 228/237 were breast cancers. Non-BC members were breast deformities or genetic susceptibility to BC. Max silhouette score was 0.87. XGBoost classified 23,521 patients as 6-month or 3-week with an accuracy of 75%, F-score of 0.73. Relevant clusters to BC diagnosis included limb pain and nausea. CONCLUSIONS: We showed signal separating patients at critical time points prior to BC diagnosis. This signal was found using the relative position of patient diagnosis in vector space; we have demonstrated that valuable insights into patient status and progress can be found using unsupervised clustering. This work, while early, establishes a technique that we are developing towards early-prediction capabilities.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/syapseispor2023poster-1vprint126328-pdf.pdf?sfvrsn=627ed9d0_0","title":"Syapse_ISPOR2023_Poster 1_vPrint126328.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126328","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Screening for Clinically Relevant Drug-Drug Interactions between Direct Oral Anticoagulants and Antineoplastic Agents: A Pharmacovigilance Approach","id":"e376a195-2673-4aa4-9f01-34305700760a","sessionCode":"EPH1","topDisplay":"Truong B1, Hornsby L1, Fox BI1, Chou C1, Zheng J2, Qian J3 1Auburn University, Harrison College of Pharmacy, Auburn, AL, USA, 2Auburn University, College of Sciences and Mathematics, Auburn, AL, USA, 3Auburn University Harrison College of Pharmacy, Auburn, AL, USA","locationCode":"407","description":"\r\n\t<div>OBJECTIVES: Use of direct oral anticoagulants (DOACs) in patients with cancer remains suboptimal due partly to concerns with their potential drug-drug interactions (DDIs) with antineoplastic treatments. However, the clinical relevance of these DDIs is unknown. METHODS: We conducted a pharmacovigilance study of adverse event (AE) reports from the US Food and Drug Administration Adverse Event Reporting System from 01/01/2004 to 12/31/2021. AE reports containing both DOAC and antineoplastic agents with CYP3A4/P-gp inhibitory or inducing activity (i.e., kinase inhibitors (KIs), hormonal therapy, chemotherapeutic agents, immunomodulating agents (IMAs)) were included (n=36,066). The corresponding outcomes were bleeding or stroke, identified by MedDRA dictionary version 25.0. We employed disproportionality analyses (DPA), logistic regression models (LR), and Multi-item Gamma-Poisson Shrinker (MGPS) algorithms (Empirical Bayes Geometric Means (EBGM) and 90% credible intervals (90% CIs)) to identify safety signals of DDIs by antineoplastic therapeutic class and by individual drugs. RESULTS: The highest bleeding rates in each drug class were the combination of DOACs with neratinib (39.08%, n=34), tamoxifen (21.22%, n=104), irinotecan (20.54%, n=83), and cyclosporine (19.17%, n=227). The highest rate of stroke was found for prednisolone (2.43%, n=113). No signal of DDIs by antineoplastic therapeutic class was detected using MGPS algorithms [EBGM (EB05-EB95)=1.02 (0.97-1.08) for DOACs-KIs, 1.22 (1.15-1.30) for DOACs-hormone, 1.22 (1.16-1.27) for DOACs-chemotherapy, 0.66 (0.63-0.69) for DOACs-IMAs, and 1.05 (0.90-1.21) for DOACs-inducers]. Findings from DPA and LR approaches agreed with MGPS. DOACs-neratinib was the only DDI signal detected [EBGM (EB05-EB95) = 2.71 (2.03-3.54)] for an individual antineoplastic drug. CONCLUSIONS: No signal of DDIs between DOACs and antineoplastic agents was detected, except for DOAC-neratinib. Our findings support the hypothesis that most DDIs were not clinically relevant. The DDIs between DOACs and neratinib should be further examined in future research.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23truongposter124799-pdf.pdf?sfvrsn=216b3d5c_0","title":"ISPOR23_Truong_POSTER124799.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124799","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Exploratory Investigation of Factors Influencing Late Diagnosis in Merkel Cell Carcinoma in the United States","id":"07e744a3-5fcc-4035-ae7b-349ca03f7c48","sessionCode":"MSR9","topDisplay":"Mbous Y1, Al-Mamun M2 1West Virginia University School of Pharmacy, Morgantown, WV, USA, 2West Virginia University, Morgantown, WV, USA","locationCode":"701","description":"\r\n\t<div>OBJECTIVES: Merkel cell carcinoma (MCC), a rare and aggressive neuroendocrine carcinoma of the skin presents significant diagnostic challenges (i.e., diagnosis time varies 1-54 months, with a median of 3 months) for non-specialist health professionals. The objective of this study was to investigate the factors that may lead to a delayed MCC diagnosis. METHODS: We conducted a retrospective cohort study with electronic health record (EHR) from TriNetX for West Virginia University up to September 2022. Early and late accurate diagnosis was ascertained by means of a custom clinician-aided algorithm, where current procedural codes of standard MCC diagnostic procedures (biopsy, tomography, imaging, immunohistochemistry) were used to select relevant MCC patients. The early diagnosed had these procedures conducted within 90 days of MCC diagnosis and the late diagnosed, outside of this interval. Recursive feature elimination was used to select variables from the demographics, diagnosis, medications and laboratory files. Two machine learning classification models were developed: logistic regression and LASSO, and class imbalance was resolved using the Synthetic Minority Oversampling Technique. RESULTS: Of 285 MCC patients, 193 EHR listed at least one of the standard diagnostic procedures. From those, 124, 69 were diagnosed early and late, respectively. K-fold cross validation on the training set (80%) produced an average accuracy of 87.5%. Predictions on the testing set (20%) using logistic regression showed an accuracy of 92%, a weighted precision and sensitivity of 93%, 92%. LASSO showed an accuracy of 92%, a weighted precision and sensitivity of 89%, 86%. Top five features of importance included diagnoses of hematochrosis, chronic kidney disease, nausea with vomiting, the presence of urogenital implants, and a BMI of ≤ 19.9. CONCLUSIONS: This study revealed new factors of importance in the delay of accurate MCC diagnosis. Future studies are needed to explore the change in these factors across time.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126446","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Digital Hyper Modelling &AMP; Personalization in Healthcare","id":"b8c11ffc-4199-4328-80f2-34a8b18d5d25","sessionCode":"RWD37","topDisplay":"Chaddha N1, Vishwakarma M2, Bhattacharjee B3, Minocha T4 1Optum, Delhi, India, 2Optum, Noida, UP, India, 3Optum, NOIDA, UP, India, 4Optum, Gurugram, India","locationCode":"901","description":"\r\n\t<div>OBJECTIVES: This analysis explored the application & effectiveness of “Digital Twinning” hyper modelling & personalization in Healthcare. METHODS: The analysis showcased the interoperability of “Digital Twinning” in HealthCare Marketing. Health digital twins are the virtual representations (“digital twin”) of patients (“physical twin”) and its application have been primarily focused to aid robotic surgery, accelerated precision medicine applications, accelerating the evaluation of clinical interventions, manage inventories and complex supply chains. We in digital analytics world, attempted to explore Digital Twinning Hyper-modelling over static cohorts/persona, tapping in actions, behavior, thoughts, mindset, triggers, outcomes with help of Real-World Data & web APIs. Time frame for this analysis was from July 2020 to August 2022. RESULTS: Real Time Member/Prospect Segmentation/Output on visiting web-traffic (sample size ~50K average per day). Persona-led Journey Outcome Propensity Modelling & Event-based decisions/paths nurturing/personalization on a sample set (0.1%) as a test resulted in conversion upliftment (+18%). Accuracy of the model was 73% as per the test period. This study would be focusing on multiple Healthcare Digital Platforms based services for better understanding of the personalized behavior of members. CONCLUSIONS: Digital twins hyper modelling represents the logical evolution of cohort segmentation and holds lots of potential to target, retarget or suppress targeting as per the nature/need of the Digital Twin. This engine provides next best actions to prevent churn, uplift cross-selling, rapid personalization, dynamic-segmentation and nurturing for meaningful experiences</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126808","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Predictors of Health-Related Quality of Life across Rare Diseases: An Online Survey","id":"c4768c3d-f0d8-4c95-9d86-36f4d21b989d","sessionCode":"PCR225","topDisplay":"Rao A1, Yabumoto M2, Ward-Lev E1, Naik H1, Halley M3 1Stanford University School of Medicine, Palo Alto, CA, USA, 2Seattle Children's Hospital, Seattle, WA, USA, 3Stanford University School of Medicine, Stanford, CA, USA","locationCode":"741","description":"\r\n\t<div>OBJECTIVES: Rare diseases contribute substantially to population morbidity and mortality. Understanding health related quality of life (HRQoL) across rare diseases is essential for evaluating new genomic technologies used in rare diseases (e.g., genomic sequencing), but most HRQoL studies focus on a single or small group of diseases. Our study aimed to identify patient- and disease-specific characteristics associated with differences in HRQoL across rare diseases. METHODS: We conducted an online Facebook survey with rare disease patients and their caregivers utilizing a systematic sample of rare diseases with varying prevalence from the Orphanet database. Patients/caregivers completed the EQ-5D-5L or proxy version and measures of sociodemographic and disease characteristics. We calculated utility scores for US participants using population norms and conducted multivariate linear regression to examine predictors of EQ-5D-5L Visual Analogue Scale (VAS), Utility scores (US only), and each of the five EQ-5D dimensions. RESULTS: In total 1,053 individuals with 103 different rare diseases participated, including 660 patients and 393 caregivers. Median VAS score was 71 (IQR 52-85), Utility was 0.786 (IQR 0.630-0.832) and domains ranged from 1 (IQR 1-2) for Mobility to 3 (IQR 1-3) for Anxiety. Having a disability was significantly associated with poorer scores across all outcomes, and lower disease prevalence was associated with poorer VAS, Utility, Mobility, Activities and Self-Care (p<0.001). Utility scores were also positively correlated with income (p=0.048). Lower VAS scores were associated with lack of a genetic diagnosis (p=0.025), younger age (p=0.034), unemployment (p=0.016) and urban location (p<0.001). Lack of a genetic diagnosis also was associated with poorer scores for Pain (p=0.001) but better scores for Self-Care (p<0.001). CONCLUSIONS: Our results suggest that certain sociodemographic and disease characteristics may be predictive of HRQoL. Our findings fill an essential gap in knowledge regarding HRQoL across rare diseases and may be used for evaluating diagnostic and therapeutic interventions in the future. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23halleyposter127869-pdf.pdf?sfvrsn=c582abbf_0","title":"ISPOR23_Halley_Poster127869.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127869","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"COVID-19 Premature Mortality Productivity Losses: Real World Information Analysis","id":"026a05ac-79e1-41ed-a794-375ae345832a","sessionCode":"EE21","topDisplay":"Tanaka E1, Tanaka GK2, Kuabara R3, Massuda EM4, Assunção-Costa L5, Tafla C6, Nunes RMZ7, Furlan LHP8 1TNK INSTITUTION, CURITIBA, PR, Brazil, 2TNK Health Economics Outcome Research Brazil, CURITIBA, Brazil, 3GOIANIA STATE HEALTH CARE, GOIANIA, GO, Brazil, 4UniCesumar, MARINGÁ PR, Brazil, 5STATE UNIVERSITY OF SOUTHWEST BAHIA, Salvador, BA, Brazil, 6Nilo Health Care, Curitiba , PR, Brazil, 7UNIMED JOÃO PESSOA, JOÃO PESSOA , PB, Brazil, 8UNIMED FED PR, CURITIBA, Brazil","locationCode":"146","description":"\r\n\t<div>OBJECTIVES: The aim of this analysis is to compare information regarding COVID-19 premature mortality productivity costs/ losses in Brazil. METHODS: The states (S1 versus S2) in northern Brazil randomly chosen had criteria of similarity, tropical climate in most of the study period and population number. The study was carried out from March 2020 through November 2021 (20 months ). The reference of salaries to calculate possible losses due to deaths was obtained through accredited institutions, paylab, that study this specific information. Scenario A (Sc. A) = salary R$ 8.613,17 / month , scenario B (Sc. B) R$ 1.281,51 / month. Worker’s age range from 15 to 64 years. The regional gross domestic product (GDP) was not used due to biases. RESULTS: S1, 4,059 million inhabitants, 419,077 cases of confirmed COVID-19 , 8,948 deaths . In the following scenario, salary R$ 8,613.17 / month, (S1, Sc. A) the accumulated losses totaled R$ 1,541,412,903.20 (USD 280,256,891.49 at the rate 1 USD = 5,50 BRL), and (S1, Sc. B) totaled R$ 229,339,029.60 (USD 41,698,005.38). S2, 3,561 million inhabitants, 382,265 cases of confirmed COVID-19, 7,518 deaths . Considering the following scenario, salary R$ 8,613.17 / month, (S2, Sc. A) the accumulated losses totaled R$ 1,295,076,241.20 (USD 235,468,407.49 at the rate 1 USD = 5,50 BRL), and (S2, Sc. B) R$ 192,687,843.60 (USD 35,034,153.38). CONCLUSIONS: We estimate premature mortality productivity costs associated with COVID-19 across two states in northern Brazil are high and the conclusion is that the productivity losses based on regional GDP are difficult to detail. Further studies are needed to mitigate this situation.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/poster-covid-19-pdf-para-ispor-boston-usa-2023123611-pdf.pdf?sfvrsn=76494f4b_0","title":"POSTER COVID 19 PDF __PARA ISPOR BOSTON USA 2023123611.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123611","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Comparison of the Effectiveness of Aliskiren and Ramipril for Hypertension: A Meta-Analysis","id":"049e1c3d-a22a-4803-86c2-380e6a0f328f","sessionCode":"CO6","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"110","description":"\r\n\t<div>OBJECTIVES: Aliskiren and ramipril are cornerstones in the treatment of hypertension. Aliskiren is a renin inhibitor, while ramipril is an angiotensin converting enzyme inhibitor. We aim to meta-analyse and compare the effect of aliskiren with ramipril in hypertensive patients after weeks 8 and 24 by measuring the mean difference in systolic blood pressure (mdSBP) and the mean difference in diastolic blood pressure (mdDBP). METHODS: The search was conducted using the PubMed and Cochrane library databases for eligible randomized clinical trials (RCTs) without year and language restrictions to perform a meta-analysis. RESULTS: All randomised trials were systematically reviewed whose effects were compared when Aliskiren was presented with Ramipril in hypertensive patients. Four studies were included: two studies (carried out for around 2 months with 1653 patients randomized) and two studies (carried out for around 6 months with 968 patients randomized). There was a significant difference in the mdSBP (mean difference 3.15 mmHg, CI 2.13–4.17, I2 = 84%) and mdDBP (mean difference 1.2 mmHg, CI 1.12–1.2, I2 = 0%) at 24 weeks. After 8 weeks, the mean difference of diastolic blood pressure was found to be significant (mean difference 0.85 mmHg, CI 0/73-0.97, I2 = 0%), but the mean difference of systolic blood pressure was found to be non-significant (mean difference 0.0 mmHg, CI -0.17-0.17, I2 = 100%). CONCLUSIONS: Aliskiren was found to show significant improvement in both systolic and diastolic blood pressure compared with ramipril after 24 weeks.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123532","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Simulating the Impact of First-Line Treatment Choice on Survival Among Patients with Locally Advanced/Metastatic Urothelial Carcinoma Considered Cisplatin Ineligible","id":"682a9e62-1122-4056-8cc2-3a5dd69c524e","sessionCode":"CO24","topDisplay":"Galsky M1, Sonpavde GP2, Bloudek B3, Farrar M4, Hepp Z4, Timmons J3, Dillon R5, Powles T6 1Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2AdventHealth Cancer Institute, Orlando, FL, USA, 3Curta Inc., Seattle, WA, USA, 4Seagen Inc., Bothell, WA, USA, 5Astellas Pharma Inc, Northbrook, IL, USA, 6Barts Cancer Centre, Queen Mary University of London, London, UK","locationCode":"128","description":"\r\n\t<div>OBJECTIVES: The rapidly evolving treatment landscape for locally advanced or metastatic urothelial carcinoma (la/mUC), and challenges associated with trial design have limited direct comparison of outcomes with different therapies/sequences. Modeling can estimate the impact of therapeutic sequences ahead of real-world data (RWD) availability. Modeling was used to estimate median overall survival (mOS) among patients with la/mUC considered cisplatin-ineligible, treated with four treatment options/sequences. METHODS: mOS was estimated for a simulated cohort of treatment naïve patients with la/mUC from initiation of four treatment options/sequences: 1) enfortumab vedotin (EV) + pembrolizumab; 2) gemcitabine+carboplatin (G/C)±maintenance avelumab followed by EV; 3) pembrolizumab followed by EV; 4) G/C followed by pembrolizumab, then EV. For each option/sequence, mOS was the composite curve based on best-fit OS curves for each treatment informed by published trials (EV-103 Dose Escalation/Cohort A, JAVELIN Bladder 100, KEYNOTE-045/-052/-361) using the previously published oncology simulation model framework. Progression from each treatment was based on PFS curves of published trials and assumed all patients received first-line treatment. Attrition during second- (38.3% treatment rate) and third-line (33.2%) was based on published RWD. Sensitivity analyses varied second- and third-line treatment rates. RESULTS: The model estimated a mOS of 26.5 [95% credible interval [CI]:18.7-37.9] months for EV+pembrolizumab; 14.4 [95% CI:12.4-16.4] months for G/C±maintenance avelumab then EV; 11.9 [95% CI:10.3-13.3] months for pembrolizumab then EV; and 12.7 [95% CI:10.9-14.7] months for G/C then pembrolizumab then EV. Sensitivity analyses varying treatment rates across second- and third-line treatments (20%-60%) showed small variations in mOS for treatment options/sequences: 14.1-14.8 months for G/C±maintenance avelumab then EV; 11.2-12.7 months for pembrolizumab then EV; and 12.6-12.8 months for G/C then pembrolizumab then EV. CONCLUSIONS: Model results, while limited by data inputs, estimated longer mOS with first-line EV+pembrolizumab than alternative options/sequences, indicating the clinical value of selecting effective therapies upfront and the importance for future studies of this combination.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/co24-galsky-et-al-simulating-the-impact-of-first-line-treatment-choice-on-survival-among-patients-with-locally-advanced-metastatic-uro127379-pdf.pdf?sfvrsn=e19be06f_0","title":"CO24. Galsky et al. Simulating the impact of first-line treatment choice on survival among patients with locally advanced metastatic uro127379.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127379","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Systematic Review of Pharmacological and Non-Pharmacological Migraine Management Strategies Among Community Dwelling Adults","id":"e4e5b9d8-832e-4456-9063-3aca40437956","sessionCode":"CO37","topDisplay":"Marupuru S, Almatruk Z, Axon D, Slack M University of Arizona, Tucson, AZ, USA","locationCode":"137","description":"\r\n\t<div>OBJECTIVES: Migraine is a prevalent condition associated with high levels of disability and is often underdiagnosed and undertreated. The purpose of this systematic literature review was to identify the types of pharmacological and non-pharmacological strategies that community dwelling adults report using to manage migraine. METHODS: A systematic literature review of relevant databases, grey literature, websites, and journals was conducted from January 1, 1989, to December 21, 2021. Study selection, data extraction, and risk of bias assessment were completed independently by multiple reviewers. Data were extracted for migraine management strategies and categorized as opioid medications, non-opioid medications, medical, physical, psychological, or self-initiated strategies. Data were also extracted for efficacy and satisfaction. RESULTS: A total of 20 studies were included. Sample sizes of study participants ranged from 138 to 46,941. The mean age was 34.7 to 79.9 years. Data were typically collected using self-administered questionnaires (9 studies), interviews (5 studies), online surveys (3 studies), paper-based surveys (2 studies), and retrospective databases (1 study). Community dwelling adults with migraine reported they primarily used medications, specifically, triptans (range 9-73%) and non-steroidal anti-inflammatory drugs (NSAIDs; range 13-85%) to manage migraine. Common non-pharmacological strategies included consulting physicians (range 14-79%) and heat or cold therapy (35%). Use of other non-pharmacological strategies was low. Efficacy and satisfaction with migraine management strategies were reported in 11 studies. Risk of bias was typically low or unclear for most components assessed, with some studies having high risk of bias for conflict of interest due to pharmaceutical company sponsorship. CONCLUSIONS: The primary migraine management strategies identified were triptans and NSAIDs, consistent with practice guidelines for migraine management. Reported use of non-pharmacological management strategies was limited indicating that more study is needed to establish high-quality evidence for the effective use of non-pharmacological strategies for migraine.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023marupuruposter123371-pdf.pdf?sfvrsn=dbad51fc_0","title":"ISPOR2023_Marupuru_POSTER123371.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123371","diseases":[{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Development and Testing of a Modified EQ-5D for Intellectually Disabled Adults","id":"9ea8ca54-29ae-4e6c-9af4-3ae523dfb1d2","sessionCode":"PCR18","topDisplay":"O'Dwyer J1, Meads D1, Bryant L1, Kind P2, Hulme C3 1University of Leeds, Leeds, UK, 2University College London, London, UK, 3University of Exeter, Exeter, UK","locationCode":"728","description":"\r\n\t<div>OBJECTIVES: Approximately 7.4 million people in the USA have an intellectual disability (ID). This population experience some of the greatest health inequalities, losing 22-26 life years compared to the general population. Whilst there are clear health inequalities, this population is often excluded from research and they have difficulty completing questionnaires such as the EQ-5D. A modified EQ-5D-3L was developed for adults who have mild to moderate ID. METHODS: Qualitative cognitive think aloud interviews with carers of adult with ID were undertaken to explore key difficulties experienced with the EQ-5D. Results were incorporated with findings from a systematic review of adaptations to quality of life measures for this population. Alternative wording and structure of a modified EQ-5D-3L, with images, was developed through an iterative design process with focus groups and stakeholders. The performance of a modified EQ-5D-3L was examined using test-retest interviews with adults with ID where adapted, standard and proxy EQ-5D versions were completed. RESULTS: Between September 2020 and June 2021, 64 participants from across England consented to participate. We found that a modified EQ-5D-3L is acceptable, reliable and valid. Four of five domains and three of five domains show stronger test-retest reliability than the standard EQ-5D-3L and proxy-completed versions, respectively. Over 85% of participants preferred completing the modified EQ-5D-3L compared to the standard EQ-5D-3L. CONCLUSIONS: The modified EQ-5D-3L was well-accepted by participants, easier to administer and understand. Full statistical results will be reported. The EQ-5D-3L modified for adults who have ID will help facilitate measurement of their health-related quality of life and inclusion in research. Research is underway incorporating this modified version in economic evaluations.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23_odwyer_poster_v3-2.pdf?sfvrsn=86ba0e3f_1","title":"ISPOR23_ODWYER_POSTER_V3-2"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127071","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluating Community Resilience through Social Media during the First Infection Wave Peak after Reopening in Beijing, China","id":"d32b7ee2-293d-4320-abe1-3b57e6e57483","sessionCode":"EPH11","topDisplay":"Zhang L, Zhang S, Jian W Peking University, Beijing, 11, China","locationCode":"415","description":"\r\n\t<div>OBJECTIVES: In the month that followed December 7, 2022, China gradually lifted almost all of covid-19 pandemic restrictions, and then the number of infected grows rapidly with large demand for conventional medicines. Following the sudden reopening, this study aims to explore the community resilience outcomes of users in the most popular Chinese social media platform Weibo. METHODS: We chose Beijing, one of the first reopening large cities in China, as our sample area. We collected all COVID-19-related continuous Weibo posts with geotagged between December 8, 2022 and January 7, 2023 using search terms of “Help” posts and three conventional drugs of COVID-19 which are already in shortage on the market. Word clouds and coding schemes were used to analyze the contents and review the users’ needs and replies they received, specifically whether users’ medication access problem was addressed through a neighborhood-level efforts. RESULTS: A total of 30652 posts were retrieved that include reposts and reposts with replies. Over two-third of the COVID-19 related posts were seeking drugs, with 79% demands has been solved. For all the posts which received solution, about 65.82% received supports from the neighborhood-level, while 34.18% were resolved with government assistance. The posts with community support were more time-efficient. The number of posts receiving government support grows over time, which was less in the first two weeks and then has a significant increase after December 23, 2022. CONCLUSIONS: Our study demonstrated the community support were more timeliness than government assistance. We also indicate that enhancing community resilience is a critical response to public health emergencies.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23zhangposterv3126866-pdf.pdf?sfvrsn=4caaf76b_0","title":"ISPOR23_Zhang_POSTER_V3126866.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126866","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Factors That Determine the Cost of Adverse Events in Intensive Care Units of Two University Hospitals in Bogotá, Colombia","id":"fa6565d7-2735-4d71-90e5-3b9157a8a92c","sessionCode":"PCR53","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"807","description":"\r\n\t<div>OBJECTIVES: To establish the factors that determine the cost of adverse events in intensive care units of two university hospitals in Bogota, Colombia. METHODS: A retrospective cohort study was conducted where the study population was the patients in which adverse events were reported in the intensive care unit of the Hospital Universitario Nacional and the Clínica Universitaria Colombia, the time horizon comprises the years 2019 to 2022; where through a multiple linear regression model the factors associated with the cost of adverse events were determined. RESULTS: A total of 369 patients were included with a median age of 63 years, 232 men (62.9%) and 137 women (37.1%); The Apache median was 13 points, and the Charlson comorbidity index median was 5. For adverse events, 252 (68.29%) were reported passively, 223 (60.43%) were preventable, and 267 events (72.36%) were not serious. The events had a median cost of 549,671 COP per patient and the variables related to a higher cost were: general hospital stay, stay until the event, charlson Comorbidity Index, reporting system, severity, general stay until the event, musculoskeletal Diagnostic Related Group, events related to safe care, pharmacovigilance and technovigilance CONCLUSIONS: It was possible to establish the factors of the patients, adverse events and care that determine the cost of adverse events in the intensive care units of hospitals and university clinics in Bogotá; finding that the general hospital stay, the Charlson index, the reporting system and severity are positively related to costs. The factors that were found to be associated with a lower cost are the stay until the event, admission diagnosis related to the musculoskeletal system or presenting an event related to safe care, pharmacovigilance or technovigilance.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125480","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Delayed Care Among Low-Income Adults during the COVID-19 Pandemic: A US Population-Based Study","id":"3760127d-faaa-4329-a139-3d43ee640674","sessionCode":"PCR12","topDisplay":"Han J Fairleigh Dickinson University, Florham Park, NJ, USA","locationCode":"723","description":"\r\n\t<div>OBJECTIVES: To characterize delayed care patterns by income status during the COVID-19 pandemic among US adults. METHODS: This study analyzed the 2020 Medical Expenditure Panel Survey Full Year Consolidated Data File. The study defined low- or middle-income individuals as those in families with income less than 400 percent of the poverty line and selected covariates using Anderson's Behavioral Model of Health Services Use. The sociodemographic and health-related variables were compared by income status using chi-square tests. The sampling weights were applied to account for complex survey design and generate nationally representative estimates. RESULTS: A total of 21,234 US adults answered the COVID-19-related questions, about 46.9% including low- or middle-income adults. During the COVID-19 pandemic, compared to high-income adults, a lower proportion of low/middle-income adults reported delaying medical care (15.8% vs. 17.5%; p=0.005) or dental care (21.1% vs. 30.0%; p=<.0001). However, before the pandemic, low/middle-income adults than high-income adults were more likely to defer medical care (9.2% vs. 4.5%; p=<.0001) or dental care (17.3% vs. 7.3%; p=<.0001) to save costs. Prescription drug filling was not affected much by the COVID-19 pandemic for both low/middle- (1.9%) and high-income adults (1.2%). During the pandemic, low-or middle-income adults were more likely to self-rate their physical (16.7% vs. 7.4%; p=<.0001) and mental health (12.7% vs. 6.4%; p=<.0001) as fair or poor. Most high-income adults, as opposed to low/middle-income counterparts, were covered by private insurance (86.3% vs. 52.6%), non-Hispanic white (71.1% vs. 54.4%), and had a usual source of care provider (75.4% vs. 67.9%). CONCLUSIONS: High-income US adults appeared to experience more COVID-19-related delays in health care compared with low- or middle-income counterparts. Multivariable regression will be conducted to produce the adjusted estimates of delayed care prevalence.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127884","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Challenges and Opportunities with Quantifying Comprehensive Health Economics of Diagnostic Imaging Modalities Using Radiopharmaceuticals: A Case Study in Coronary Artery Disease","id":"44213190-a83a-4fb3-99f0-3e25d1d42ddb","sessionCode":"MT1","topDisplay":"Ferko N1, Priest S1, Almuallem L1, Oliva Ramirez A1, Szabo E2, Cabra HA2 1EVERSANA, Burlington, ON, Canada, 2GE HealthCare, Miami, FL, USA","locationCode":"629","description":"\r\n\t<div>OBJECTIVES: The value of diagnostic tests often focuses on their performance (i.e., sensitivity, specificity, accuracy) and endpoints relevant for clinicians. As such, this presents an opportunity to design HEOR models to comprehensively quantify both short- and long-term outcomes derived from diagnostic procedures to improve the decision making process related with diagnostics tests. This research was designed to inform the development of a HEOR model framework to evaluate positron emission tomography (PET) and single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) modalities using radiopharmaceuticals, for coronary artery disease (CAD), incorporating short- and long-term perspectives. METHODS: A structured literature review identifying clinical and economic outcome studies associated with MPI PET and SPECT to diagnose CAD was conducted. RESULTS: The results demonstrated that for CAD, there are very few published economic evaluations, which use variable methodologies and reporting across a broad range of imaging modalities. The gap in outcomes evidence informed development of a multi-faceted valuation framework which includes the following parameters: diagnostic performance (i.e., sensitivity, specificity, accuracy), clinical utility (clinical behavior modification, e.g., earlier treatment), healthcare resource use (HCRU) efficiency (change in follow-up testing, e.g., fewer invasive tests), test-related complications, and clinical outcomes (e.g., earlier treatment leading to fewer adverse cardiac events). Challenges associated with connecting these disparate parameters in one model are discussed and demonstrate how a comprehensive evidence based HEOR model can substantiate the incremental costs associated with advanced imaging modalities for high-risk CAD patient subpopulations. CONCLUSIONS: This research highlights the need to segment CAD patients by CAD pre-test probability and prioritize subpopulations where underlying disease mechanisms and patient anatomical imaging challenges limit the performance of current imaging diagnostics. Finally, the value of HEOR model development and real-world evidence generation to show the clinical utility and impact on HCRU associated with advanced imaging diagnostics in CAD is also underscored.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127029","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Valbenazine Compared with Deutetrabenazine for the Management of Huntington Chorea","id":"c3cc90b7-d966-4030-ada8-3e83386536a1","sessionCode":"EE34","topDisplay":"Kim H University of Washington, Seattle, WA, USA","locationCode":"229","description":"\r\n\t<div>OBJECTIVES: To evaluate clinical and economic outcomes associated with valbenazine compared with deutetrabenazine in patients with Huntington Chorea. METHODS: We developed a Markov model simulating a three year time horizon with weekly cycles using clinical data from each phase III clinical trial of valbenazine and deutetrabenazine. Transition probabilities between four health states defined by patient’s Huntington Chorea severity were derived from the trials. Clinical outcomes included quality-adjusted life years (QALYs) and life-years. Time trade-off was used for utility inputs and wholesale acquisition cost was used for medication costs. Non-medication-related healthcare costs were assumed to be equivalent. Costs and outcomes were discounted at 3% per year and half-cycle correction was calculated. Fourteen unique parameters with low and high inputs were used for an one-way sensitivity analysis. RESULTS: Patients managed with valbenazine compared to those managed with deutetrabenazine were projected to gain more QALYs (0.95 vs. 0.94) at lower healthcare costs ($305,979 vs. $497,301) over 3 years. Both groups gained 2.74 life-years. With lower costs and higher QALYs, valbenazine was the dominant treatment strategy. One-way sensitivity analysis suggests the biggest change in incremental QALYs is observed with low input for the transition probability between mild and moderate/severe health states for patients taking valbenazine (+0.44 incremental QALYs). The biggest change in incremental costs is observed with high input for the annual cost of deutetrabenazine (+$87,165 incremental costs). CONCLUSIONS: Valbenazine is an economically dominant treatment for patients with Huntington Chorea.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kimposter124280-pdf.pdf?sfvrsn=8723a787_0","title":"ISPOR23_Kim_POSTER124280.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124280","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Comparison of Implant Surgery and Readmissions Costs for DBS and VNS","id":"062e5de4-1799-4c98-8c3d-3e9114959bec","sessionCode":"RWD34","topDisplay":"Lopes VG1, Santos A1, Zanini FE2, Araujo LD2, Shaw R3, Oliveira B4 1ATsaúde, São Paulo, SP, Brazil, 2Livanova, São Paulo, Brazil, 3LivaNova, Amersfoort, Netherlands, 4Livanova, Sao paulo, SP, Brazil","locationCode":"840","description":"\r\n\t<div>OBJECTIVES: Epilepsy affects all ages and is a common, disabling serious neurological disease often associated with comorbidities. The disease presents a heavy clinical, economic, and societal burden with a continued treatment gap that deserves the attention of healthcare decision-makers. A considerable number of patients do not respond satisfactorily to drug treatment and/or are ineligible for resective epilepsy surgery. Implant surgery offers a therapeutic option for these patients. Deep Brain Stimulation (DBS) and Vagus Nerve Stimulation (VNS) are neuromodulation devices that intervene directly in neural circuits and present interesting clinical results in seizure control. METHODS: A Brazilian supplemental health data sample was assessed with the objective of evaluating the cost of DBS and VNS procedures. For a sample of 812 surgeries, 43.6% (354) were related to DBS and 56.4% (458) to VNS. RESULTS: It was found that average surgery costs for DBS were 204% higher, with more than twice the number of in-hospital days for those patients compared to VNS treatment. The average cost of ICU stay for DBS was 49% higher than that of VNS, which might indicate the more invasive technique, complexity, and complications associated with DBS placement. Surgery complications showed that 20.1% of DBS patients presented with readmission events. This is compared with 0.9% of patients who received VNS. CONCLUSIONS: Accordingly, patients utilizing DBS had higher expenses than those using VNS based on overall surgical procedure cost(s) and readmissions six months post-index surgery. This may be indicative of the more invasive surgical technique, and post-surgical care and follow-up. In this analysis, VNS is associated with a reduction of hospitalizations and costs in drug-resistant epilepsy treatment. VNS may be an alternative for payers to consider when evaluating short-term costs, even with a higher isolated device cost compared to DBS.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23oliveiraposter127101-pdf.pdf?sfvrsn=658f4e03_0","title":"ISPOR23_Oliveira_POSTER127101.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127101","diseases":[{"id":"2841e9ac-e8b8-43de-803d-162258a38976","parentId":"00000000-0000-0000-0000-000000000000","title":"SDC: Neurological Disorders","urlName":"sdc-neurological-disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Long-Acting Injectable Antipsychotic Adherence Among Texas Medicaid Enrollees with Schizophrenia","id":"79d27ec0-01e5-473e-9047-3f66d0152616","sessionCode":"PCR15","topDisplay":"Chen S, Barner JC, Crismon ML, Richards KM, Smith TL The University of Texas at Austin, Austin, TX, USA","locationCode":"726","description":"\r\n\t<div>OBJECTIVES: Prior literature indicates long-acting injectable (LAI) antipsychotics (APs) have advantages over oral APs, including higher adherence rates and lower healthcare resource utilization. However, comparisons among individual LAI second generation antipsychotics (SGAs) have resulted in mixed findings since many studies did not adjust for confounders. This retrospective cohort study compared adherence for enrollees with schizophrenia by LAI SGA medication. METHODS: Texas Medicaid continuously enrolled adults (18-63 years) diagnosed with schizophrenia and with ≥1 LAI SGA claim during 2015-2019 were included. The index date was the date of the first LAI SGA prescription claim. Medication adherence was measured using proportion of days covered (PDC) during the 12-month follow-up period, with PDC ≥ 0.8 representing adherence. Inverse probability of treatment weighting (IPTW) was employed to balance demographic and clinical characteristics among the LAI SGA groups. Repeated measures ANOVA and logistic regression were used to address the study objective. RESULTS: Baseline demographic and clinical characteristics were comparable across the five LAI SGA groups after IPTW (N=4,422). Mean PDC was highest for paliperidone palmitate 3-month (PP3M)(0.91±0.20), followed by aripiprazole lauroxil 2-month (0.69±0.34), risperidone 4-week (0.64±0.34), aripiprazole monohydrate once monthly (0.63±0.33), paliperidone palmitate once monthly (PP1M) (0.62±0.33), and aripiprazole lauroxil once monthly (0.57±0.33). The majority (86.9%) of PP3M recipients were adherent—a significantly higher proportion than the other LAI SGA groups (aripiprazole lauroxil 2-month, 60.2%; risperidone 4-week, 44.8%; aripiprazole monohydrate, 44.3%; PP1M, 41.3%; aripiprazole lauroxil once monthly, 33.4%;p≤0.01). CONCLUSIONS: While results of previous research were inconclusive, this large observational real-world study showed that 3-month administration frequency was superior regarding LAI SGA adherence. There were no significant differences regarding 1- or 2-month administration frequencies.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23chenposter125714-pdf.pdf?sfvrsn=c927ee78_0","title":"ISPOR23_Chen_POSTER125714.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125714","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessment of Pharmacists' Awareness of Anemia Treatment during War Time in Ukraine","id":"0cd81caa-8f9c-4342-b565-3fb65b35cc07","sessionCode":"RWD31","topDisplay":"Maksymovych N, Zaliska O Danylo Halytsky Lviv National Medical University, Lviv, Ukraine","locationCode":"839","description":"\r\n\t<div>OBJECTIVES: In Ukraine, in 2020, the incidence of iron deficiency anemia among schoolchildren is 23.5%, among women of childbearing age 14-17%, among pregnant women - 27.5%. Anemia has consequences for future parenthood: premature birth, delayed intrauterine development of the fetus, increased perinatal morbidity, impaired child's intelligence, behavioral abnormalities in adulthood. And during the war in Ukraine, when pregnant women live under great psycho-emotional stress, there are anxiety, panic attacks, emotional burnout, improper nutrition, on which the body creates stress that causes anemia. The incidence of anemia among women increases during wartime. METHODS: Survey (using a Google forms), data analysis and evaluation. RESULTS: An online survey was conducted among 133 practicing pharmacists to determine pharmacists' awareness of knowledge and skills regarding the pharmacotherapy of anemia. In Ukraine standards for providing pharmaceutical assistance under martial law have not been developed since November 2022. It was found that pharmacists obtain information on medicines from online versions of professional books, textbooks, journals, methodological recommendations - 45.8%, information from drug manufacturers - 24.4%, Ukrainian pharmaceutical/medical portals - 13.7%, international databases Cochrane medicine, PubMed - 21%. It was found that: 68.7% of the respondents need to increase awareness of the treatment algorithm in accordance with the approved anemia pharmacotherapy protocol; 85.5% know about drugs that can cause anemia; 61.8% of pharmacists need information about new iron preparations, namely bioavailability, potential drug interactions, side effects. A total of 93.1% of pharmacists indicated that they need to explore and update their knowledge of proper pharmaceutical care when dispensing iron supplements CONCLUSIONS: The importance of pharmacists' awareness of the requirements of the treatment protocol and a thorough algorithm for providing pharmaceutical care is substantiated. It was established that 93% of pharmacists have an informational need to update their knowledge on the topic of anemia treatment for the effective provision of pharmaceutical care during wartime</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23maksymovychposter-123856-pdf.pdf?sfvrsn=c8ca9dd5_0","title":"ISPOR23_Maksymovych_POSTER 123856.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123856","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Highlighting the Multidimensional Benefits of a Drug Using Generalized Pairwise Comparisons","id":"3d3bd69c-ce99-4c01-a90e-41eb401f766c","sessionCode":"CO30","topDisplay":"Chiem JC1, Saad E2, De Backer M2, Salvaggio S2, Kosta S2, Barre E3, Deltuvaite-Thomas V2, Verbeeck J4, Buyse M5 1International Drug Development Institute (IDDI), Ottignies, WBR, Belgium, 2International Drug Development Institute (IDDI), Louvain-la-Neuve, WBR, Belgium, 3International Drug Development Institute (IDDI), Ottignies, Belgium, 4UHasselt, Diepenbeek, Belgium, 5UHasselt, Louvain-la-Neuve, WBR, Belgium","locationCode":"127","description":"\r\n\t<div>OBJECTIVES: A randomized phase III clinical trial was conducted to show that a drug could prevent severe adverse events (AEs) from cancer therapy. However, the efficacy analysis of the primary endpoint (incidence of severe AEs) was far less impressive in this trial than in earlier phase trials. Yet, the drug exhibited other signals of efficacy: it reduced the duration of severe AEs, and delayed their onset. Hence it was suggested to analyze three prioritized outcomes in a single analysis: incidence of severe AEs, duration of AEs in days, and time to onset of AEs in days. METHODS: We applied the novel statistical methodology of Generalized Pairwise Comparisons (GPC) to rigorously capture the multidimensional benefit of the drug. Using GPC and its quantitative multi-component metric, the Net Treatment Benefit, we provided statistical evidence that the overall effect of the drug consists in a composite of reduced occurrence, decreased duration and delayed onset of severe adverse events. RESULTS: While the univariate GPC on the occurrence of the toxicity results in a Net Treatment Benefit of 6.1% (p= .072, 95% CI: -4.9%, 17.1%), integrating the overall effect of the drug in a multivariate GPC leads to a significant Net Treatment Benefit of 18.5% (p= .001, 95% CI: 10.4%, 26.6%). CONCLUSIONS: GPC can highlight the multidimensional efficacy of a drug, enhancing the clinical relevance of the analysis for clinicians and patients, and making optimal use of the whole set of available data. By analyzing several outcomes in a single analysis, GPC has the potential of increasing the statistical power as well as the clinical relevance of the results.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23buyseposter126132-pdf.pdf?sfvrsn=a829e14f_0","title":"ISPOR23_Buyse_POSTER126132.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23buysehandout126132-pdf.pdf?sfvrsn=1f416c4d_0","title":"ISPOR23_Buyse_HANDOUT126132.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126132","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Retrospective Cohort Study of Veteran′s Affairs Data: Epidemiology, Treatments, Clinical Outcomes, and Burden of Immunoglobulin a Nephropathy","id":"62cdd005-3d8e-4a14-9ac2-43ff40324060","sessionCode":"EPH40","topDisplay":"Bensink M1, Goldschmidt D2, Zhou J3, Shi S3, Lin Y4, Shi L5 1Travere Therapeutics, Inc., Brisbane, QLD, Australia, 2Analysis Group, Inc., New York, NY, USA, 3Analysis Group, Inc., Boston, MA, USA, 4Tulane University, NEW ORLEANS, LA, USA, 5Tulane University, New Orleans, LA, USA","locationCode":"440","description":"\r\n\t<div>OBJECTIVES: Immunoglobulin A nephropathy (IgAN), the glomerular accumulation of IgA-containing immune complexes in the kidneys, may lead to damage of the glomerular filtration barrier which results in proteinuria, hematuria, and often kidney failure (KF). This study describes the epidemiology, treatments, clinical outcomes, and resource burden of patients with IgAN using United States Veteran’s Affairs (VA) data. METHODS: This study used data from the National VA Health Care Network from October 1999 to February 2021. Patients with ≥2 diagnoses of IgAN were included (first IgAN diagnosis as index date), and were required to have continuous enrollment for ≥6 months before and ≥12 months after index. Annual incidence and prevalence of IgAN were evaluated. Patient characteristics at index and treatments, healthcare resource utilization, and healthcare costs during the year following index were described. Overall survival and time to KF from index were assessed using Kaplan-Meier analysis. RESULTS: From 2000-2020, average IgAN incidence and period prevalence rates were 67.0 and 589.0 per million VA-enrolled veterans, respectively. Of 8,243 patients in the final cohort, median age at index was 63 years and 96% male. The most commonly used treatments during 12-month follow-up included statins (60%), ACE inhibitors (56%), and calcium channel blockers (47%). 31% of patients had an inpatient admission, with an average 26 days in the hospital and average 26 outpatient visits during 12-month follow-up. Average total healthcare costs were $30,754 during the 12-month follow-up, driven by inpatient ($12,823) and outpatient ($12,536) costs. Five- and ten-year survival rates were 76% and 51%, respectively. Median time to KF was 6.2 years, and 5-year rate of KF was 44%. CONCLUSIONS: Among the VA population, IgAN is associated with substantial clinical and resource burden. Safe and effective therapies approved for IgAN would significantly improve the lives of patients and reduce patient and healthcare system burden.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23zhouposterv2125540-pdf.pdf?sfvrsn=b67ec77f_0","title":"ISPOR23_Zhou_POSTER_V2125540.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125540","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Efficiency of the Cervical Cancer Program on the Budget Execution Processes during COVID 19 Pandemic Years 2020 - 2021 in Peru","id":"77ff6c37-361e-4a30-8ede-44241f9660c4","sessionCode":"HSD10","topDisplay":"Perez F1, Gutierrez-Aguado A2, Guarin D3 1Cayetano Heredia University, Lima, LIM, Peru, 2Universidad Continental, LIMA, LIM, Peru, 3Merck, Kenilworth, NJ, USA","locationCode":"544","description":"\r\n\t<div>OBJECTIVES: The study aims to determine the influence of the efficiency of the cervical cancer program on the budget execution during the COVID-19 pandemic years 2020- 2021. METHODS: Estimating the screened women and using a micro-costing analysis to estimate the cost of treating precancerous lesions and cervical cancer in the pandemic and a non-pandemic scenario during 2020 -2021. Finally, the estimation of the budget execution for the cervical cancer program led by the Ministry of Health in the pandemic and non-pandemic scenarios. The estimation in the study was through two scenarios determined, the pandemic and non-pandemic scenarios during the years 2020 and 2021. After that, it was determined the number of screened and non-screened women. The next step was the cost estimation of the low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesions (HSIL), and cervical cancer at different stages. Therefore, this information is necessary for the Peruvian Ministry of Health to provide healthcare services to patients who did not get screened in the years 2020 and 2021. RESULTS: The non-pandemic scenario would be spent USD 33,547,185 and USD 37,428,997 in 2020 and 2021, respectively. Conversely, in the pandemic scenario, spent USD 9,934,440 and USD 23,762,073 by 2020 and 2021. Therefore, by 2020 must be spent 68.7% of the budget, but only had been spent 20.3%. Moreover, in 2021, only 46.7% of the budget was spent when it should be 73.6% of the total budget. Therefore, USD 39,496,476 and USD 27,114,114 were not executed in 2020 and 2021, respectively. CONCLUSIONS: A total of USD 66,610,590 was the non-executed budget for the cervical program and needs to be reallocated in the following years to provide healthcare services to the women who did not get access to screening and treatment.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/127741posterupdate127741-pdf.pdf?sfvrsn=aeed2e76_0","title":"127741_POSTER_Update127741.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127741","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Tumor Treating Fields in the Treatment of Newly Diagnosed Glioblastoma Based on Real-World Data","id":"983916c7-a6d2-456b-bf8b-4550fc3d10f5","sessionCode":"EE90","topDisplay":"Xiang Y1, Xu Z2, Zhou S2, Liu S2, Chen Y2 1Fudan University, Chengdu, 51, China, 2Fudan University, Shanghai, China","locationCode":"337","description":"\r\n\t<div>OBJECTIVES: Glioblastoma (GBM) is the most aggressive and common primary brain malignancy. TTFields, a novel therapy that can be added to chemotherapy for the treatment of GBM, has proven efficacy in GBM treatment. At present, the evidence on health economics evaluation of TTFields therapy is limited. The objective of the study is to evaluate the cost-effectiveness of TTFields+TMZ compared with TMZ in newly-diagnosed GBM patients and provide economic evidence as a framework for policy and decision making in GBM treatment from Chinese context. METHODS: Outcomes for newly-diagnosed GBM patients were estimated over a lifetime horizon using partitioned survival model with three states: progression free state, progressed state, or death. The survival model was based on a . The long-term survival data were from GBM epidemiology literatures. Adverse event rates were derived from the EF-14 trial data, the pivotal Phase 3 study of TTFields in patients newly diagnosed with GBM. Cost data was obtained from the public literatures and database, which was validated by expert consultation. Utility values were obtained from published literature. Expected costs and quality adjusted life years (QALYs) of 15 years were calculated through Microsoft Excel from health system perspective. The willingness-to-pay threshold was 3-times the Chinese per capita Gross Domestic Product (GDP) in 2021, 242,928 CNY/QALY. A 5% discount rate was applied to costs and utilities. The results were analyzed by one-way and probabilistic sensitivity analyses. RESULTS: TTFields+TMZ was estimated to result in a mean increase of 682,206 CNY cost and 2.99 QALYs compared to TMZ alone. The incremental cost-effectiveness ratio (ICER) was 228,086 CNY per QALY gained. . Probability sensitivity analysis indicates that under the existing threshold, the probability of TTFields+TMZ being economical is 71.0%. CONCLUSIONS: The present cost-effectiveness analysis showed that adding TTFields to maintenance TMZ for newly-diagnosed GBM patients is cost-effective at a threshold 3-times the Chinese per capita GDP.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ee90-cost-effectiveness-analysis-of-tumor-treating-fields-in-the-treatment-of-newly-diagnosed-glioblastoma-based-on-real-world-data124991-pdf.pdf?sfvrsn=a483d70a_0","title":"EE90 Cost-Effectiveness Analysis of Tumor Treating Fields in the Treatment of Newly Diagnosed Glioblastoma Based on Real-World Data124991.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124991","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Clinical Pharmacist Interventions on Economic Outcomes in Women's Wellness and Research Center in Qatar","id":"6f3c40b4-d9b4-4219-9142-47a5cf171803","sessionCode":"EE105","topDisplay":"Abushanab D1, Al-Badriyeh D2, Abdul Rouf P3, Al Hail M3, Elkassem W4, Thomas B5, Elshafey N3, Eljilany I6 1Monash University, Melbourne, Australia, 2College of Pharmacy, Qatar University Health, Qatar University, Doha, Qatar, 3Hamad Medical Corporation, Doha, Qatar, 4Hamad Medical Corporation, Doha, DA, Qatar, 5Hamad Medical Coporation, Doha, Qatar, 6University of Florida, Gainesville, FL, USA","locationCode":"343","description":"\r\n\t<div>OBJECTIVES: Due to the constrained financial burden that the healthcare systems are currently facing, healthcare services need to demonstrate that they remain cost saving through proving continually the economic benefit of such services. We sought to evaluate the economic impact of interventions initiated by a clinical pharmacist in Women's Wellness and Research Center (WWRC) in Qatar. METHODS: This is a retrospective study of interventions initiated by clinical pharmacists within a women’s health setting in Hamad Medical Corporation. The study included interventions that took place in March 2018, July-August 15, 2018, and January 2019. The economic impact was measured via calculating the total benefit, defined as the sum of the cost savings and the cost avoidance associated with the interventions. Cost savings was defined as the reduced cost of therapy because of the intervention by subtracting the cost of after-clinical pharmacy intervention therapy from the cost of before-clinical pharmacist intervention therapy, while cost avoidance was defined as eliminating a potential increase in the costs related to adverse drug events (ADEs), by multiplying the estimated probability of an ADE in the absence of the intervention by the cost of an ADE. RESULTS: A total of 571 interventions were identified by the clinical pharmacists with the addition of a medication and discontinuation of a medication that is needed were the abundant intervention categories reported. The analysis projected a total benefit of QAR 564,475 (US$ 154,651), constituting cost avoidance of QAR 741,898 (US$203,260) and -ve resource-use cost savings of -QAR 177,423 (-US$ 48,609) over 3-month period. Clinical pharmacy interventions were robust in the sensitivity analyses. CONCLUSIONS: This study demonstrates significant total benefits from clinical pharmacy interventions, due to prevention in ADEs among hospitalized patients admitted to WWRC. Potentially, investing costs on hiring clinical pharmacist may significantly outweigh the savings from inappropriate use of medicines.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ee105124327-pdf.pdf?sfvrsn=ff1c102_0","title":"EE105124327.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124327","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"European Clinical Attitudes and Experiences of a Thulium Fiber Laser System: A Cross-Sectional, Multi-National Survey","id":"556f4a1c-3310-469d-b0fc-488bfe6e5760","sessionCode":"MT9","topDisplay":"Gibson S1, Popham G1, Spitzer M1, Graydus J2, Skodny P2, Hackmann M1 1Olympus Europa SE & Co. KG, Hamburg, HH, Germany, 2Olympus Corporation of the Americas, Center Valley, PA, USA","locationCode":"635","description":"\r\n\t<div>OBJECTIVES: Holmium:yttrium-aluminum-garnet (Ho:YAG) laser technology has long been established as the gold standard for endoscopic laser lithotripsy. However, interest in and use of Thulium Fiber Laser (TFL) technology for laser lithotripsy in the field of urology has grown. This study investigated European clinical attitudes and experiences of a TFL, the SOLTIVE Premium SuperPulsed System (Olympus Corporation, Japan), for stone management procedures. METHODS: An online, cross-sectional survey was administered to European physicians with prior SOLTIVE Premium experience for stone management procedures between June 2022 and September 2022. The survey was available in English, French, and German, with a combination of open- and closed-ended, numeric response, and Likert scale questions chosen to evaluate attitudes and experiences. Responses were collected anonymously, and complete responses analyzed using descriptive statistics. T-tests and chi-squared tests were used where appropriate, with p-values <.001 considered significant. RESULTS: 40 physicians from 12 European countries participated. In comparison to the use of Ho:YAG lasers for stone management procedures, 90%, 89% and 79% of respondents agreed that SOLTIVE Premium facilitates reduced procedure times (32% and 24% shorter than with Ho:YAG for ureteroscopy and percutaneous nephrolithotomy [PCNL] procedures), improved stone-free rates, and a reduced need for secondary stone procedures (13% and 6% fewer than with Ho:YAG for ureteroscopy and PCNL procedures), respectively. A significant proportion of respondents, 77%, expected use of SOLTIVE Premium to lead to a reduction in per-procedure consumable use (stone baskets [96%], access sheaths [35%], and stents [19%]). The choice of technology was not expected to significantly impact the need for an overnight stay following ureteroscopy or PCNL (59% of all SOLTIVE Premium procedures, and 61% with Ho:YAG were expected to require overnight stays). CONCLUSIONS: Among surveyed physicians with SOLTIVE Premium experience, there was a high level of agreement that the TFL technology improves resource-related outcomes compared to Ho:YAG for stone management procedures.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/soltive-premium-user-experience-surveyispor-poster125887-pdf.pdf?sfvrsn=83148308_0","title":"SOLTIVE Premium User Experience Survey_ISPOR Poster125887.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125887","diseases":[{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Adverse Event Reporting of Marketed Biosimilar and Biological Monoclonal Antibody Cancer Treatments in the United States","id":"ee605d81-b0d6-4b61-88c4-490b877cf8fc","sessionCode":"RWD30","topDisplay":"Xue X1, Truong B2, Qian J3 1Auburn University, Harrison School of Pharmacy, Auburn, AL, USA, 2Auburn University, Harrison College of Pharmacy, Auburn, AL, USA, 3Auburn University Harrison College of Pharmacy, Auburn, AL, USA","locationCode":"838","description":"\r\n\t<div>OBJECTIVES: By September 8, 2022, 10 biological monoclonal antibody (mAb) biosimilar products for cancer treatment had been approved and marketed in the United States (U.S.). These biosimilars were approved based on bioequivalence studies conducted among healthy volunteers, but their post-marketing investigations for safety are limited. This research aims to examine adverse event (AE) reporting patterns and disproportionate reporting signals for mAb biosimilars in the U.S. compared to their originator biologics. METHODS: The U.S. Food and Drug Adverse Event Reporting System database (January 1, 2004–December 31, 2021) was used to identify AE reports for Rituxan®, Avastin®, Herceptin®, and their biosimilars. Proportions of patient age and sex, as well as type of reporters of AEs were described for these reports. Reporting odds ratios (RORs) with 95% confidence intervals (CIs) were calculated to compare reporting disproportionality in serious, death, and specific AEs between mAb biologics/biosimilars (index) and all other drugs. Breslow-Day statistic was used to determine homogeneity in RORs between each mAb biologic–biosimilar pair at p<0.05. RESULTS: A total of 48,691 AE reports for these products were identified. Among identified AE reports, 2,219 (4.6%) were related to biosimilars and the rest were for biologics. Missing information of age and sex existed across all AE reports with studied mAb biologics and biosimilars. More AEs for all biologics, as well as Avastin® and Herceptin® biosimilars, were reported by health professionals, while consumers were the highest proportion of reporters for Rituxan® biosimilars (67.3%). We observed no risk signals of serious or death AE reporting for all three mAb biosimilars. However, a signal of disproportionate reporting of death was detected between Avastin® and its biosimilars. CONCLUSIONS: Our findings support the similarity in signals of disproportionate AE reporting between mAb originator biologics and biosimilars, except for death between Avastin® and its biosimilars.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23xueposter123235-pdf.pdf?sfvrsn=b4a11ac7_0","title":"ISPOR23_XUE_POSTER123235.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123235","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Uniting Claims and Electronic Health Records Data to Build a Predictive Model for Need of Palliative Care in Chronic Disease Patients in the US","id":"253382f7-d794-442e-a09b-492d372a3c94","sessionCode":"RWD5","topDisplay":"Verma V1, Brooks L2, Field S3, Daral S4, Gupta A4, Chawla S4, Anand S4, Nayyar A4, Dawar V4, Bhargava S5 1Optum, Gurgaon, HR, India, 2Optum, Basking Ridge, NJ, USA, 3Optum, Dallas, TX, USA, 4Optum, Gurugram, HR, India, 5Optum Tech, Eden Prarie, MN, USA","locationCode":"815","description":"\r\n\t<div>OBJECTIVES: To identify claims and electronic health records (EHR) data that can be used to build a predictive model for need of palliative care in patients with chronic diseases in the US. METHODS: A retrospective study using the Optum® de-identified Market Clarity Dataset (linked claims and EHR of patients) was done among adult (>=18 years) patients with >=1 claims and/ or EHR with a diagnosis or procedure code for Palliative care during 1st Jan 2019 to 31st Mar 2022. Only patients requiring Palliative care for the following 8 chronic diseases were included – hypertension, neoplasms, diabetes mellitus, depression, anxiety, chronic ischemic heart disease, COPD, and chronic kidney disease. Index date was defined as the first claim/ EHR with Palliative care code. Only patients with no Palliative care code in claims or EHR during preceding 6 months from index date were included. A control group of adult patients that didn’t require Palliative care but were matched on the 8 chronic diseases was identified (1:4 greedy match). Palliative care predictive model was built using demographic and claims data of cases and controls: <ol> <li>Potential demographic predictors: age, biological sex, race/ ethnicity</li> <li>Potential claims predictors: in preceding 6 months, history of inpatient hospitalization or ICU/ mechanical ventilation, number of healthcare interactions, other comorbidities, procedures, and medications received</li> </ol> RESULTS: Total 96,378 cases and 417,170 controls were included. Significantly higher proportion of patients aged >=50 years, males, and African Americans required Palliative care. Further, significantly higher proportion of patients that had inpatient hospitalization or ICU/ mechanical ventilation in preceding 6 months required Palliative care. We are currently identifying potential EHR predictors like clinical features, disability scores, and biomarkers that can make the model more accurate and robust. CONCLUSIONS: Claims and clinical data can be effectively used to predict need for Palliative care in patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/palliative-care-posterispor2023126945-pdf.pdf?sfvrsn=f73bbf79_0","title":"Palliative care Poster_ISPOR2023126945.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126945","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Utilization, Reimbursements and Prices Trends of Hepatitis C Virus Drugs in the US Medicaid Programs from 2001 to 2021","id":"2c1d7705-66f0-4650-a31b-498fe0b4f783","sessionCode":"EE20","topDisplay":"Gari M1, Alsuhibani A2, Alashgar A3, Guo JJ3 1University of Cincinnati, James L. Winkle College of Pharmacy, Crestview Hills, KY, USA, 2University of Cincinnati, James L. Winkle College of Pharmacy, Mason, OH, USA, 3University of Cincinnati, James L. Winkle College of Pharmacy, Cincinnati, OH, USA","locationCode":"219","description":"\r\n\t<div>OBJECTIVES: Hepatitis C Virus (HCV) is a significant global health issue that persists despite the availability of curative treatment options with Direct Acting Antivirals (DAAs). The objective of this study is to describe and analyze the utilization, reimbursement, and price trends of HCV medications in the Medicaid-covered population. METHODS: The primary data source was the state Medicaid drug utilization pharmacy claim files collected by the Centers for Medicaid and Medicare Services (CMS) from 2001 to 2021. A longitudinal retrospective and descriptive study was conducted to examine the annual secular trends of HCV medication utilization, reimbursement, and cost per prescription (proxy of price). The study evaluated all medications authorized for HCV treatment in the US, such as ribavirin (RBV), pegylated interferon alfa-2a (PEG-INFA2a), and DAA brand and generics (e.g., Boceprevir, Telaprevir, Simeprevir, Sofosbuvir, Ledipasvir/Sofosbuvir, Elbasvir/Grazoprevir, Daclatasvir, Sofosbuvir/Velpatasvir, and Glecaprevir/Pibrentasvir). The annual total numbers were calculated for number of prescriptions, reimbursements, and prices for each medication. RESULTS: The utilization of conventional PEG-INFA2a and RBV reduced as the newer DAAs were introduced. In 2011, the total number of prescriptions for RBV, PEG-INFA2a, and DAAs were 103,358, 192,529, and 12,074, respectively; while in 2021, they were 1,600, 1,215, and 119,496, respectively. New DAAs agents led to the discontinuation of several DAAs agents due to market competition and lower utilization. The overall cost of PEG-INFA2a and RBV was much lower than DAAs, averaging around $2,945, $797, and $16,725, respectively, resulting in a much higher reimbursement for DAAs. The DAAs agent with the highest total annual reimbursement is Harvoni, with over $2 billion in both 2014 and 2015. CONCLUSIONS: Despite the introduction of multiple DAAs agents, the drug prices remained high and unchanged during the study period. The increase in HCV incidence cases in recent years indicates accessibility issues for costly and effective DAAs medications.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gariposter126436-pdf.pdf?sfvrsn=c9b430cd_0","title":"ISPOR23_Gari_POSTER126436.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126436","diseases":[{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Chinese COA Overview of the Availability of Instruments in for Chinese Drug Development","id":"3e67f793-a7b6-427e-a774-4a26cdf4e561","sessionCode":"CO28","topDisplay":"Jarodia K1, Rudell K2, Heinrich M3 1Parexel International, Panchkula, HR, India, 2Parexel International, LONDON, LON, UK, 3Parexel International, London, LON, UK","locationCode":"126","description":"\r\n\t<div>OBJECTIVES: In view of the publication of the draft ‘Chinese Guidelines for the Application of Patient-reported Outcomes in Drug Clinical Research’ (December, 2021) we examined the availability of clinical outcomes assessment (COA) instruments in Chinese language. We explored therapeutic areas where the use of COA was well established (oncology, endocrine metabolism, rheumatology, dermatology, gastroenterology, and neurology) and checked for the availability of COAs translated into traditional or simplified Chinese as well as Mandarin or Cantonese dialects. METHODS: Translations available for each disease area were searched in the ePROVIDE database. The age group for selected COA instruments was adult population (18+). Only those COA instruments that had existing translations in Chinese (traditional or simplified, Mandarin or Cantonese dialects) were included in the final sample. RESULTS: A total of 60 instruments were identified in the pre-specified disease areas. The largest number of available COAs translated into Chinese language were found in the following disease areas: endocrine metabolism (n=22), rheumatology (n=13), followed by dermatology (n=10), oncology (n=7), gastroenterology (n=5) and neurology (n=3). The vast majority of identified COAs were patient reported outcome measures. CONCLUSIONS: Several COA instruments are available for the Chinese market already, but further use in drug development and suitability for Chinese regulatory opinion is still to be determined. Most instruments have been developed into traditional or simplified Chinese, rather than Chinese dialects spoken in specific regions. The availability of validated translations of COAs in Chinese language will allow sponsors to expand their clinical investigations to this region, making new treatments more accessible to Chinese patient populations.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporus23krudellco28127230-pdf.pdf?sfvrsn=679cf8fa_0","title":"ISPORUS23_KRudell_CO28127230.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127230","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"},{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Screening and Treatment (PAROXETINE VERSUS COGNITIVE BEHAVIOURAL THERAPY) of Post-Traumatic Stress Disorder (PTSD) in Wildfire Evacuees: A Cost-Utility Analysis","id":"e3158a61-467c-4f1d-b71c-4ace48dadd93","sessionCode":"EE26","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"","description":"\r\n\t<div>OBJECTIVES: Global climate change is resulting in dramatic increase in wildfires. Individuals exposed to wildfires experience a high burden of post-traumatic stress disorder (PTSD) and the cost-effectiveness of the treatment options to address PTSD from wildfires has not been studied. To conduct a cost-utility analysis comparing screening in combination with paroxetine or cognitive behavioral therapy (CBT) versus no screening in Canadian adult wildfire evacuees. METHODS: Using a Markov model, quality adjusted life years (QALY) and costs were evaluated over a 5 year-time horizon. All costs and utilities in the model were discounted at 1.5%. Deterministic and probabilistic sensitivity analyses were performed to elucidate the uncertainty in the incremental cost-effectiveness ratio (ICER) and incremental net monetary benefit (INMB) at willingness to pay (WTP) threshold (λ) of $50,000. RESULTS: No screening was dominated by Paroxetine arm (incremental cost: $-189.87, incremental effect: 0.021) while screening and CBT was cost-effective compared to no screening (incremental cost: $1945.27, incremental effect: 0.051, ICER: $36,703) but not screening and Paroxetine (incremental cost: $2135.14, incremental effect: 0.032, ICER: $66,723). In probabilistic sensitivity analyses, Paroxetine arm is cost-effective in 77% of the iterations, while CBT 55%, relative to no screening. The total number of stages, utility of remitted PTSD and utility of PTSD had the largest impact on the INMB comparing Paroxetine to no screening arm. CONCLUSIONS: Screening with Paroxetine was found to be cost saving while providing additional QALYs in wildfire evacuees. CBT was only cost-effective relative to no screening. Screening programs targeted at wildfire evacuees should be considered in regions at high risk of wildfires.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123639","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluation of Hyponatremia Risk Among Geriatric Patients Exposed to Selective Serotonin Reuptake Inhibitors (SSRIS) and Thiazide Diuretics","id":"a0f37986-31ff-48d5-9867-4afa3b5f1fdb","sessionCode":"CO12","topDisplay":"Matsuura T1, Tawfik Younis A2, Ben-Umeh K2, Malone DC2 1College of Pharmacy, University of Utah, Murray, UT, USA, 2College of Pharmacy, University of Utah, Salt Lake, UT, USA","locationCode":"114","description":"\r\n\t<div>OBJECTIVES: Hyponatremia is a common electrolyte disorder among the elderly that can cause serious adverse effects. The purpose of this study was to assess the risk of hyponatremia and the concurrent use of selective serotonin reuptake inhibitors (SSRIs) and thiazide diuretics in a geriatric population. METHODS: Two retrospective nested case-control studies were conducted with exposure to an SSRI or a thiazide diuretic. Patients of interest include individuals receiving Medicare A, B, and D benefits from 2017 to 2019. Cases were individuals with a diagnosis of hyponatremia. Controls were patients taking either an SSRI or a thiazide diuretic. A logistic regression was conducted to determine the odds of hyponatremia. Data analysis was conducted using SAS. RESULTS: A total of 551,298 patients with a mean age of 77.8 years (SD:± 8.0 years) were taking an SSRI, 70.5% of which were female and 90.7% were caucasian. A total of 701,007 were taking a thiazide diuretics with a mean age of 77.1 years (SD:± 7.2 years), 63.3% being female and 85.7% being caucasian. Among those on SSRIs, 76,037 had a diagnosis of hyponatremia, while among thiazide users 76,662 had a diagnosis of hyponatremia. Among SSRI users, the odds of hyponatremia with concomitant use of thiazide diuretics was 1.32 (95% CI: 1.30-1.34). For thiazide users, the odds of hyponatremia was 1.52 (95% CI:1.5-1.55) with concomitant use of SSRIs. CONCLUSIONS: The concurrent use of HCTZ and SSRIs is associated with a significantly increased risk of hyponatremia in the geriatric population. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23matsuuraposter127773-pdf.pdf?sfvrsn=50b3e289_0","title":"ISPOR23_Matsuura_POSTER127773.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127773","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Using Drug Package Insert Data to Identify Statin-Related Prescribing Cascades - an Evaluation of Findings from Side Effect Resource (SIDER) and Commercial Claims Data","id":"c83c5581-d5e8-4369-9d84-4c34cf093927","sessionCode":"EPH2","topDisplay":"Kulkarni P1, Morris EJ1, Walsh MG1, Schmidt S1, Pepine CJ2, Vouri SM1, Smith S1 1University of Florida, College of Pharmacy, Gainesville, FL, USA, 2University of Florida, College of Medicine, Gainesville, FL, USA","locationCode":"410","description":"\r\n\t<div>OBJECTIVES: Statin-induced adverse events may prompt additional pharmacotherapy resulting in prescribing cascades. We previously performed untargeted prescribing cascade signal detection using high throughput sequence symmetry analysis (HTSSA), identifying 57 plausible prescribing cascades. However, this endeavor requires access to big data sources and significant computational efforts; false positives are common. We evaluated whether a targeted approach – using Side Effect Resource (SIDER), a public database containing pharmaceutical package inserts data – captures similar findings more efficiently. METHODS: Anatomical Therapeutic Chemical level 4 codes, representing drug classes, and Medical Dictionary for Regulatory Activities (MeDRA) codes, representing statin-related adverse events were identified from SIDER and linked so that an adverse event for statin was an indication for another medication class. MeDRA codes were then dropped, leaving ‘statin-other medication class’ potential prescribing cascade signals. These signals were compared to empirically-derived signals from prior claims-based HTSSA (gold standard) to calculate sensitivity and specificity for SIDER signal detection. RESULTS: We detected 432 potential signals using SIDER, compared to 160 signals using HTSSA screening, with a sensitivity of 78.1% (125 of 160 signals) and specificity of 33.8% (128 of 379 signals). To assess predictive ability of SIDER, signals were screened to capture the 57 empirically-identified plausible statin-related prescribing cascades. Out of these, 46 were predicted using SIDER with a sensitivity of 80.7% and specificity of 31.5%. Conversely, SIDER predicted 79 signals that represented therapeutic escalation or clinically implausible prescribing cascades for statins. CONCLUSIONS: SIDER predicted plausible statin-related prescribing cascades, empirically identified by HTSSA, with high sensitivity; however, it had low specificity and 18% of the signals were implausible prescribing cascades. Our overall findings suggest that medication package inserts are not more efficient to identify potential statin-related prescribing cascades but may be useful combined with expert review to classify drugs and adverse events in distinguishing true from false positive signals.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kulkarniposter124858-pdf.pdf?sfvrsn=b080ab20_0","title":"ISPOR23_Kulkarni_POSTER124858.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124858","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Female-to-Male Surgical Sterilization Ratio As Another Indicator of the Gender-Equity Gap","id":"ab8f1fc2-6dd3-43d6-8467-4c8327c2be64","sessionCode":"EPH33","topDisplay":"Rosselli D1, Medina-Salazar J2, Soto-Rincón V2, Carvajal-Suárez C2, Rojas-Barreto J2, Díaz L2 1NeuroEconomix, Bogotá, D.C., CUN, Colombia, 2Pontificia Universidad Javeriana, Bogota, CUN, Colombia","locationCode":"433","description":"\r\n\t<div>OBJECTIVES: The literature shows female sterilization is safer (has less complications) and at least as effective, if not more, in preventing unwanted pregnancies. The objective of this study was to analyze female-to-male sterilization rates by region in Colombia, as an indicator of a health-related gender gap, using data from SISPRO, the official database, which registers 500 million patient contacts per year, almost 3 million of which are classified as surgical procedures. METHODS: We searched the Colombian Ministry of Health database for surgical sterilization procedures performed during the five-year period 2017 to 2021. For the analysis, Colombia was divided in 5 geographical regions (Amazon, Andes, Caribbean, Orinoco, and Pacific), and rates, based on 2019 population, as ascertained by DANE, the official statistics agency, were estimated for every 1000 females/males in each region. Costs, from a third-party payer perspective (the Colombian healthcare system) were converted into US dollars (USD) at the official exchange rate for 2019: 1 USD = 3,208 COP. RESULTS: During the five-year period, a total of 279,486 tubal sterilization procedures and 68,384 vasectomies were performed in Colombia, for an average female/male (F/M) ratio of 4.1. F/M ratios for each region varied notably, and were Amazon 7.7, Andes 3.0, Caribbean 26.0, Orinoco 3.9, and Pacific 5.9. Rates per 1000 males were more than 10 times higher in the Andes (4.04) than the Caribbean (0.36). Average cost , as reimbursed by the healthcare system to each health provider, was USD $95.16 for the male procedure, and USD $146.70 for females. CONCLUSIONS: From an economic perspective, male surgical sterilization would be the dominant intervention: safer, less costly and at least as effective, as compared with the female counterpart. Incentives should be implemented to increase its acceptance, particularly in the Colombian Caribbean region.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23rosselli01poster126235-pdf.pdf?sfvrsn=91d66118_0","title":"ISPOR23_Rosselli01_POSTER126235.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126235","diseases":[{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Assessment of Efficacy and Safety of Natalizumab Versus Fingolimod in Patients with Relapsing-Remitting Multiple Sclerosis: Systematic Review and Meta-Analysis","id":"9049f031-0642-449e-8e9e-4cab13bc5cab","sessionCode":"CO39","topDisplay":"Almalki Z Prince Sattam Bin Abdulaziz University, Al Kharj, Saudi Arabia","locationCode":"139","description":"\r\n\t<div>OBJECTIVES: The efficacy and safety of natalizumab versus fingolimod for relapsing-remitting multiple sclerosis (RRMS) had conflicting results, according to data from various medical centers across the globe. Therefore, we performed a systematic review and meta-analysis of data from real-world evidence (RWE) studies to evaluate the efficacy and safety Parameters of Natalizumab Versus Fingolimod. METHODS: MEDLINE, EMBASE, and the Cochrane Library databases were searched for RWE studies, which were performed to evaluate the efficacy and safety of natalizumab versus fingolimod up to April 2022. Review Manager 5.3 software was used to assess the data. The risk ratio (RR) and mean difference (MD) were analyzed and calculated with a random effect model. RESULTS: Pooled data from 14 studies, including 5380 patients, has demonstrated a similarity in the number of patients free of relapse between NTZ and FGL (RR 1.08, 95%CI 0.97 to 1.20, P = 0.17). Additionally, there was no significant difference between both groups, with the pooled MD of 0.06 (95% CI, −0.16 to −0.28), P = 0.60. Compared with the FGL group, the MRI outcomes results showed that the NTZ group could have a lower risk of increased gadolinium-enhanced lesions in T1(RR 0.52, 95%CI 0.24 to 1.14, P=0.15). Serious adverse events assessed the safety outcomes. We combined the data collected from the eight observational studies and found that NTZ showed a nonsignificantly lower risk of adverse events (RR -0.04, 95%CI -0.13 to 0.04, P = 0.31). CONCLUSIONS: In a real-world setting, Real‐world studies have demonstrated that NTZ had a clinical advantage over FGL in lesion volume in patients with active RRMS. No significant differences in the RR for the safety outcomes. <quillbot-extension-portal></quillbot-extension-portal></div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127062","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Adverse Drug Events Associated with Immune Checkpoint Inhibitors Atezolizumab, Nivolumab and Pembrolizumab: A Descriptive Retrospective Pharmacoepidemiologic Analysis Using FAERS Database 2014-2021","id":"3954f7ba-5768-4a9d-a2ba-4dce98300a40","sessionCode":"EPH25","topDisplay":"Singh A1, Hincapie AL2, Guo JJ2, Shin YE2 1University of Cincinnati, James. L. Winkle College of Pharmacy, Cincinnati, OH, USA, 2University of Cincinnati, James L. Winkle College of Pharmacy, Cincinnati, OH, USA","locationCode":"425","description":"\r\n\t<div>OBJECTIVES: We describe and analyze the frequency and outcomes of adverse events longitudinally associated with these checkpoints. This information helps in gaining a more concise safety profile about immune checkpoint inhibitors and their relative consequences during the treatment. METHODS: The primary data source is the US FDA post-marketing adverse event reporting systems (FAERS) database from 2014 to 2021. We focused on three immune checkpoint inhibitors atezolizumab, nivolumab and pembrolizumab that have been mainly used for liver cancer and other treatments. All adverse events reported to FDA were analyzed with annual trends, frequency of AE reports, and outcomes (e.g., congenital abnormally CA, Death DE, life threatening LT, hospitalization HO, disability DS) for each inhibitor. RESULTS: Total AE 1,42,374, including Atezolizumab-21,796, Nivolumab- 81,717, and Pembrolizumab- 38,861 reported cases. Key AE outcomes associated with nivolumab - CA-27(0.03%), DE-25550(31.27%), DS-1286(1.57%), HO-32049(39.22%), LT-805(0.99%), with Pembrolizumab – CA-16(0.04%), DE-10806(27.81%), DS-1067(2.75%), HO-15318(39.42%), LT-511(1.31%) and with Atezolizumab – CA-0(0.00%), DE-4642(21.30%), DS-271(1.24%), HO-11159(51.20%), LT-290(1.33%). Most frequently reported cases of malignant neoplasm progression included- 1784(4.59%) with pembrolizumab, 2213 (2.71%) with nivolumab and 30 (0.14%) with atezolizumab. Acute kidney injuries were observed with 1811 (2.22%), 824 (2.12%), and 623 (2.86%) for nivolumab, pembrolizumab, and atezolizumab respectively. Anemia was-associated with Nivolumab 1502(1.84%), pembrolizumab 596(1.53%), and atezolizumab 695 (3.19%)}. Colitis was associated with atezolizumab 307(1.41%), nivolumab 1562(1.92%), and pembrolizumab 532(1.37%) respectively. CONCLUSIONS: Nivolumab had relatively higher number of AE reports. Some key AE were acute kidney injuries, malignant neoplasm progression, anemia and colitis. More study is needed to evaluate their safety profile and severe outcomes like deaths and hospitalization.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127309","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Utilization Among Medicare Fee-for-Service (FFS) Beneficiaries in 2019 By Historically Redlined Status of Place of Residence","id":"d51f7b06-b5cd-4071-83ed-4ff4445e45a1","sessionCode":"EPH52","topDisplay":"Russo E, Wix DA, Bradford G, Rubin D Milliman, Windsor, CT, USA","locationCode":"500","description":"\r\n\t<div>OBJECTIVES: In the late 1930s, “redlining” practices, which considered the racial composition of an area, were used to indicate the level of security for real-estate investments in 239 United States cities. Our objective was to compare healthcare utilization between individuals residing in historically redlined and non-redlined areas to better understand the association between this discriminatory practice and health resource utilization in the U.S. METHODS: We mapped Medicare FFS Beneficiaries to historical Home Owner’s Loan Corporation (HOLC) categories of lending risk using their 5-digit zip code of residence in the 100% Research Identifiable Files for calendar year 2019. Zip codes often contain more than one HOLC category and therefore a member’s claim data and enrollment are used more than once. We used standardized counting rules from Milliman’s Health Cost GuidelinesTM–Grouper software to organize a summary of medical claims and analyzed differences in average risk score, allowed costs (spend), and utilization by HOLC categories of “hazardous (previously redlined) and “best” (previously non-redlined). Results were normalized for differences in population demographics (age, gender, and risk scores) where appropriate. RESULTS: We identified 6.6 million Medicare FFS beneficiaries with an average risk score of 1.9 and average spend of $971 per member per month (PMPM) reside in previously redlined areas and 4.0 million beneficiaries with an average risk score of 1.2 and average spend of $877 PMPM in previously non-redlined areas. We observed the greatest differences in healthcare utilization as follows: outpatient dialysis utilization was 52%, inpatient substance abuse disorder utilization 37%, and psychiatric intensive outpatient service utilization 36%, higher for the previously redlined areas as compared to the previously non-redlined areas. CONCLUSIONS: In addition to the well-documented long-lasting impacts of the redlining practices of the 1930s, including the ongoing racial wealth gap, our findings demonstrate disparities in current health resource utilization in historically redlined areas as well.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/healthcare-utilization-among-medicare-fee-for-service-beneficiaries-in-2019-by-historically-redlined-status-of-place-of-residence126450-pdf.pdf?sfvrsn=71605b6_0","title":"Healthcare Utilization Among Medicare Fee-for-Service Beneficiaries in 2019 By Historically Redlined Status of Place of Residence126450.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126450","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Disease Modifying Therapy (DMT) Utilization and Health Care Resource Utilization (HCRU) Among Adults with Multiple Sclerosis (MS) in a United States-Based Real-World Cohort","id":"1c70def7-d37d-43a2-a1de-502f48309101","sessionCode":"EPH23","topDisplay":"Friedler H, Chen J, Dusendang JR PicnicHealth, San Francisco, CA, USA","locationCode":"423","description":"\r\n\t<div>OBJECTIVES: This study aimed to describe the utilization of disease modifying therapies (DMTs) and healthcare resource utilization (HCRU) among adult patients with Multiple Sclerosis (PwMS) receiving care in the United States (US). METHODS: This study analyzed data from the PicnicHealth MS Cohort, which contains de-identified, patient-level data abstracted from structured and unstructured medical records of consented PwMS receiving care in the US. PwMS ≥18 years old enrolled September 2020 through August 2022 were included. Descriptive statistics for patient characteristics, DMT use, and HCRU were reported. RESULTS: Of 2,864 PwMS included, mean (SD) enrollment age was 48 (12) years. Among patients with non-missing data, 80% were female, 78% white, and 91% non-Hispanic/Latino. Most patients with known subtype (N=2,121) had relapsing-remitting MS (65%) and 59% of all PwMS had ≥1 documented relapse. Almost half (48%) of PwMS had documented cane or walker use, and 23% had documented wheelchair or scooter use. Median (Q1,Q3) observation time was 4 (2,7) years. PwMS received care at 4 (2,7) sites and saw 9 (5,18) providers; 96% of PwMS had a visit with a neurologist, 78% with primary care, 30% with physical therapy, and 13% with occupational therapy. All PwMS had ≥1 outpatient visit and 59% had ≥1 hospitalization. Almost all (92%) patients had a brain/orbit/head/spinal MRI. Most PwMS (86%) had a record of DMT treatment. The most common DMTs were glatiramer (32%), ocrelizumab (32%), dimethyl fumarate (26%), and interferon beta-1a (23%). Of patients with DMT treatment recorded, 56% had ≥1 reason for discontinuation documented; patients most commonly discontinued due to side effects/poor tolerance (28%), inefficacy (21%), and contraindication (10%). CONCLUSIONS: Most PwMS in this study had ≥1 hospitalization and the most common reason patients discontinued a DMT was side effects/poor tolerance. Further research is needed to understand how to improve treatment for PwMS while reducing disease progression and relapse-related HCRU.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23friedlerposter125087-pdf.pdf?sfvrsn=26da2339_0","title":"ISPOR23_Friedler_POSTER125087.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125087","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Management of HIV Drug Resistance in the United States: Achieved Success and Areas for Improvement","id":"b871c55c-ae22-4b65-a849-50daf2dec2d9","sessionCode":"EPH12","topDisplay":"Hyatt H1, Lilley J1, Shenoy A1, Lodaya K2, D'Souza F1 1Boston Strategic Partners, Inc., Boston, MA, USA, 2Boston Strategic Partners, Inc., PHILADELPHIA, PA, USA","locationCode":"414","description":"\r\n\t<div>OBJECTIVES: Genetic mutations in HIV can confer resistance to antiretroviral therapies (ART), known as HIV drug resistance (HIVDR). This study assessed management of HIVDR in the United States over time. While previous reports have focused on mutations that confer drug resistance to any ART class, this is the first study to report prevalence of medication switching due to HIVDR. METHODS: Using ICD-10 and Current Procedural Terminology codes, de-identified patient records from a U.S. electronic health record database were used to determine clinical characteristics and prevalence of HIVDR between January 2012 and November 2022. Cases of transmitted HIVDR were determined as initiation of ART within one year of a positive HIVDR panel. Acquired HIVDR (due to spurious mutations) was determined as a switch in ART regimen in conjunction with an HIVDR panel performed within one year of the medication switch. Prevalence was determined as the number of annual transmitted/acquired HIVDR cases divided by the annual number receiving ART. RESULTS: Males comprised 72.6% of HIVDR cases. Black individuals comprised the largest proportion (44.6%) followed by white (18.3%), Asian/Pacific Islanders (0.9%), and Hispanics (0.7%). From 2012 to 2022, annual prevalence of transmitted HIVDR decreased from 1.6% to 0.8%, and annual prevalence of acquired HIVDR decreased from 0.8% to 0.4%. Most patients with acquired HIVDR received new medication 0-30 days after an HIVDR panel (66.4%); however, 12.6% of patients did not initiate new ART regimens until >181 days after. CONCLUSIONS: These findings demonstrate that HIV management efforts in the U.S. have resulted in clear progress in treating people living with HIVDR; however, HIVDR affects specific populations to a greater extent than others, highlighting the immediate need for continued efforts in developing targeted HIVDR management. Notably, the low prevalence of Hispanics may be due to sampling bias within the database.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/finaleph12haydenhivdrispor2023126310-pdf.pdf?sfvrsn=f73bf2bc_0","title":"Final_EPH12_Hayden_HIVDR_ISPOR2023126310.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126310","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Balancing National Financial Stability with Commercial Expectations of Return on R&AMP;D Investment: A Review of Price Discounts for the Reimbursement of Oncology Drugs in Brazil","id":"f71c41b8-2c27-4637-93fc-5157c94c298c","sessionCode":"HTA6","topDisplay":"Libanore A1, Cuellar Bolas L2, Perez-Kempner L3 1Parexel International, São Paulo, SE, Brazil, 2Parexel International, Madrid, Spain, 3Parexel International, Lebrija, SE, Spain","locationCode":"611","description":"\r\n\t<div>OBJECTIVES: With Brazil becoming a key reference country in Latin America, pricing discussions at the country level have regional implications. Bargaining behavior in pricing and negotiations for oncology products in Brazil is leading to more price discounts and subsequent sub-optimal revenue goals for manufacturers. This study aims to investigate the common price discounts applied to innovative oncology drugs in Brazil. METHODS: We analyzed all oncology drugs that received a positive recommendation from the Brazilian HTA agency (i.e., CONITEC) within the last 4 years (i.e., 2019-2022). For these, we identified their approved public list price and the reimbursed price set by the manufacturer during the HTA appraisal process. Descriptive analyses were conducted to assess the discount level offered. RESULTS: From 2019 to 2022, 11 oncology drugs received a positive recommendation for reimbursement in Brazil. Of these, 5 involved innovative biologics and 6 innovative small molecules. The average discount offered by manufacturers was 28.8% ± 20.1%. The lowest discount offered was 4.6% for the use of blinatumomab in pediatric B-cell acute lymphoblastic leukemia, which involved a price reduction from $1,767.58 to $1,685.57 per vial. The highest discount offered was 78.2% for the use of crizotinib in metastatic non-small cell lung cancer, which involved a price reduction from $5,630.52 to $1,228.94 per package with 60 capsules. Discounts were mostly driven by clinical uncertainties and additional discussions on efficiency and affordability. CONCLUSIONS: As manufacturers are looking to launch in Brazil, CONITEC is routinely seeking discounts on the public list price of oncology drugs to provide positive HTA recommendations. Understanding the local pricing landscape and the associated challenges, the clinical and economic drivers for discounts negotiations, and defining value-oriented submission strategies prior to the HTA appraisal is critical to ensure profitable revenues that align with commercial expectations and the financial sustainability of the healthcare system.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporus23lperezkempnerhta6r1125833-pdf.pdf?sfvrsn=b43801a5_0","title":"ISPORUS23_LPerezKempner_HTA6_r1125833.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125833","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Long Working Hours and the Use of Prescription Sedatives Among the U.S. Labor Force","id":"55b56c5b-5299-4b20-af1b-525c7860b25b","sessionCode":"EPH42","topDisplay":"Ezekekwu E, Johnson CE, Karimi S, Antimisiaris D, Lorenz D University of Louisville, Louisville, KY, USA","locationCode":"443","description":"\r\n\t<div>OBJECTIVES: The demands of a round-the-clock service and globalized society have led to an increase in long working hours. This trend has been accompanied by a corresponding rise in sleep disorders. Additionally, sedative-tranquilizers have been reported as the third most commonly misused drug class in the U.S. Given the prevalence of long working hours among the U.S. working population, it is expected that there will be a continued increase in the use of sleep aid medications among this population, along with an associated increase in substance abuse to aid sleep. METHODS: We utilized the 2010-2019 Medical Expenditure Panel Survey (MEPS) data. Sleep aids and medications with sedation as a side effect were identified. Furthermore, we employed different regression models ranging from multivariable linear regression, Tobit regression, Heckman regression, multivariable logistic regression, and logit regression to ensure consistency, robustness, and reliability of associations between working hours and the use of medications. RESULTS: Overall, a sample of 81,518 observations, aged 18 years and above was analyzed, representing 243,944,187 individuals in the U.S. Working 56hours or more per week was significantly associated (p < 0.05) with an increased odds of using sleep aids and medications with sedative properties by 13% (Adjusted Odds Ratio, aOR =1.13, 95% Confidence Interval, CI=1.01:1.26) and 9% (aOR=1.09, 95% CI=1.03:1.16), respectively more than that among those who worked fewer hours. Working females in our study had a higher likelihood (aOR=1.11, 95% CI=1.05:1.19) of using sleep aids when compared to males. At the same time, people working in professional services had the highest likelihood (aOR=1.31, 95% CI=1.14:1.50) of using sleep medications. CONCLUSIONS: Our study revealed that long working hours were significantly associated with an elevated use of sleep aids and medications with sedative properties among U.S. workers. Specifically, female workers and individuals working in professional services had the highest likelihood of using sleep medications.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23ezekekwuposter126952-pdf.pdf?sfvrsn=97075ac8_0","title":"ISPOR23_EZEKEKWU_POSTER126952.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126952","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"e29b1bc3-a98e-49c1-8bc2-2975bb5fac5e","parentId":"00000000-0000-0000-0000-000000000000","title":"Sensory System Disorders (Ear, Eye, Dental, Skin)","urlName":"sensory-system-disorders-ear-eye-dental-skin"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Characterization of Patients with Duchenne Muscular Dystrophy across Previously Developed Health States","id":"54a46e1b-1df8-471c-b9a5-53462159a4c4","sessionCode":"PCR28","topDisplay":"Muntoni F1, Goemans N2, Posner N3, Signorovitch J4, Johnson M4, Gomez-Lievano A4, He C4, Dorling P5, Beaverson K6, Alvir J7, Mahn M3, Ward SJ8, McDonald C9, Vandenborne K10, Mercuri E11 1University College London, London, UK, 2University Hospitals Leuven, Leuven, Belgium, 3Pfizer Inc., New York, NY, USA, 4Analysis Group, Inc., Boston, MA, USA, 5Chiesi USA, Cos Cob, CT, USA, 6Pfizer, New York, NJ, USA, 7Pfizer, Collegeville, PA, USA, 8Collaborative Trajectory Analysis Project (cTAP), Cambridge, MA, USA, 9University of California, Sacramento, CA, USA, 10University of Florida, Gainesville, FL, USA, 11Fondazione Policlinico Universitario \"Agostino Gemelli\", Roma, Italy","locationCode":"743","description":"\r\n\t<div>OBJECTIVES: The natural history of disease progression in Duchenne muscular dystrophy (DMD) has been categorized into eight health states based on the input from clinicians, patients, and caregivers by Project HERCULES. The current study uses natural history data to further characterize patients with DMD by health state. METHODS: Patients from nine data sources (five clinical trial placebo arms, one real-world data and three natural history data) were categorized into eight health states based on the model reported by Project HERCULES: two ambulatory states, one transfer state, and five non-ambulatory states. State definitions were modified and verified, with clinical input, to account for data availability. Demographic and functional measures were characterized within each health state. RESULTS: The study included 1,175 patients across 5,296 visits (4,989 ambulatory and 307 non-ambulatory visits). Patients were predominantly white and not Hispanic or Latino. Within each health state, substantial variation was observed for each functional measure assessed, but on average, patients were older and exhibited worse ambulatory function, pulmonary capacity, upper limb function and cardiac function for each subsequent health state. North Star Ambulatory Assessment (NSAA) total score was 23.7 (IQR 20-30) for early ambulatory patients, 12.7 (IQR 9-16) for the late ambulatory, and 3.8 (IQR 2.8-5) for transfer patients. Spirometry as measured by FVC%-predicted was 93.0±0.7 for ambulatory and transfer patients and was 77.2±1.7, 69.3±4.6, 42.3±1.2, 39.2±1.3, and 20.6±1.6 for the five respective non-ambulatory health states. Until the last health state (requiring full ventilation), over approximately 80% of patients were on steroids (either deflazacort or prednisone), with approximately 70% of patient visits using them daily. CONCLUSIONS: Health states proposed for DMD disease progression showed concordantly worsened function for later health states across different domains, including ambulatory, pulmonary, upper-limb and cardiac function. These findings further characterize health states and their interpretation in economic modeling and decision-making.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/pcr28-ispor-dmd-ctap-042423b124565-pdf.pdf?sfvrsn=14f4782f_0","title":"PCR28 ISPOR DMD cTAP 042423b124565.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124565","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"What Is the Wider Carer and Family Burden in Leber’s Hereditary Optic Neuropathy? a Mixed-Methods Study","id":"3408f0c9-e4fe-4e17-8de7-5381c0714a6f","sessionCode":"EE65","topDisplay":"Williams E1, Lawrence C2, Bojakowski S3, Lloyd A2 1Acaster Lloyd Consulting Ltd, London, LON, UK, 2Acaster Lloyd Consulting Ltd, London, UK, 3GenSight Biologics S.A., Paris, France","locationCode":"305","description":"\r\n\t<div>OBJECTIVES: Leber’s Hereditary Optic Neuropathy (LHON) is a rare, maternally inherited mitochondrial disease, causing central vision loss due to optic neuropathy It typically emerges in young adulthood and can be very difficult for people to adjust to, which anecdotally leads to a substantial impact on the wider family. This study was designed to describe the burden for informal carers and family members using qualitative and quantitative methods. METHODS: In-depth interviews were conducted with informal carers and family members (aged 18+) of patients diagnosed with LHON from the UK. Interviews explored how daily activities were affected as well as physical, social, emotional, work, educational and financial impacts. Alongside the interviews, three measures were administered to quantify HRQL and burden for family members: EQ-5D-5L, CarerQol-7D, Work Productivity and Activity Impairment Questionnaire (WPAI). RESULTS: Nine informal carers and family members participated in the study. Participants had a range of roles (parent, N=5; partner/spouse, N=3; sibling, N=1). Qualitative findings revealed substantial burden for many carers and family members. The most prominent impacts were emotional (e.g., guilt, devastation), including many participants who described the specific emotional impact of LHON being an inherited disease (8/9 participants were women). Impacts to daily life, social life and relationships, work, and finances were also described. Standardised measures identified little impact on HRQL (EQ-5D-5L =0.89), but some carer related burden (CarerQol-7D =78.4). The WPAI revealed an overall work impairment of 15% and activity impairment of 37%. CONCLUSIONS: Qualitative interviews with carers and family members gave participants the opportunity to describe the impact of LHON on their lives. However, the burden described in the qualitative data was incongruent with the quantitative measures, particularly the EQ-5D-5L. This demonstrates the value of conducting mixed-methods research to understand the impact of disease and the importance of selecting measures which capture population-relevant concepts.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23lawrence-ee65poster126714-pdf.pdf?sfvrsn=255d14bb_0","title":"ISPOR23_Lawrence EE65_POSTER126714.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23lawrencehandout126714-pdf.pdf?sfvrsn=ae721b9b_0","title":"ISPOR23_Lawrence_Handout126714.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126714","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Costs Associated with Micro- and Macro-Vascular Complications Among Populations with Metabolic Syndrome: A Nationwide Analysis","id":"9e741d94-99f0-4989-8b85-546c80d54a04","sessionCode":"EE6","topDisplay":"Yang CT1, Chong KS2, Chang YH2, Ou HT1 1National Cheng Kung University, Tainan, TNN, Taiwan, 2Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, TNN, Taiwan","locationCode":"210","description":"\r\n\t<div>OBJECTIVES: Metabolic syndrome (MS) increases the risks of vascular complications. However, as time goes by, how vascular consequences following MS result in economic burden to individuals remains uncertain. This study aimed to quantify the impact of vascular complications on healthcare costs among populations with MS. METHODS: Individual-level data from two nationwide-representative databases in Taiwan, namely the National Health Interview Survey and the National Health Insurance Research Database, were linked and utilized in this study. Adults having any three of the following criteria in 2013 were identified as MS cases: (i) body mass index ≥27 kg/m2, (ii) hypertension, (iii) diabetes, and (iv) hyperlipidemia. Study subjects were followed from MS confirmed until death or the end of 2019, whichever came first. Annual healthcare costs associated incident microvascular (i.e., retinopathy, nephropathy, and neuropathy) and macrovascular complications (i.e., cardiovascular and cerebrovascular diseases) following MS confirmed were estimated and adjusted using a multivariable generalized estimating equation model. Costs are presented as United States dollars (USD) in year 2021. RESULTS: Over a median follow-up of 6.7 years, nephropathy (34.5%) and cardiovascular diseases (19.2%) were the most commonly developed micro- and macro-vascular complications, respectively, among individuals with MS. The annual healthcare costs for a male and female subject with MS and without any vascular complications were USD 1,304 and 1,360, respectively. Once microvascular complications occurred, retinopathy, nephropathy, and neuropathy significantly increased the healthcare costs by 24%, 26%, and 30%, respectively. The magnitude of increase in healthcare costs were more substantial when cardiovascular (167%) and cerebrovascular diseases (100%) occurred. CONCLUSIONS: Effective strategies for prevention of vascular complications (e.g., health behavior modifications, timely medical interventions) are urgently needed for people living with MS and thereby alleviate associated economic burden. Additionally, cost estimates from this study are useful for parameterizing future modeling-based economic evaluations of intervention in this population.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ms-population-horizon-final-version-final126592-pdf.pdf?sfvrsn=106b37ee_0","title":"MS population horizon final version-final126592.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126592","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Heterotopic Ossification in Palovarotene-Treated and Untreated Individuals with Fibrodysplasia Ossificans Progressiva: Matched and Weighted Analyses","id":"00684990-2b72-4c23-8c57-54bb399429a8","sessionCode":"CO32","topDisplay":"Al Mukaddam M1, Baujat G2, Cheung AM3, De Cunto C4, Hsiao EC5, Keen R6, Marden J7, Signorovitch J7, Boing E8, Marino R8, Strahs A8, Pignolo RJ9 1Departments of Orthopaedic Surgery and Medicine, The Center for Research in FOP and Related Disorders, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA, 2Département de Génétique, Hôpital Universitaire Necker-Enfants Malades, Institut IMAGINE, Université Paris Cité, Paris, France, 3Department of Medicine and Joint Department of Medical Imaging, University Health Network, University of Toronto, Toronto, ON, Canada, 4Pediatric Rheumatology Section, Department of Pediatrics, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina, 5Division of Endocrinology and Metabolism, the UCSF Metabolic Bone Clinic, the Institute of Human Genetics, and the UCSF Program in Craniofacial Biology, Department of Medicine, University of California San Francisco, San Francisco, CA, USA, 6Centre for Metabolic Bone Disease, Royal National Orthopaedic Hospital, Stanmore, UK, 7Analysis Group, Inc., Boston, MA, USA, 8Ipsen, Cambridge, MA, USA, 9Department of Medicine, Mayo Clinic, Rochester, MN, USA","locationCode":"132","description":"\r\n\t<div>OBJECTIVES: Fibrodysplasia ossificans progressiva (FOP) is an ultra-rare, genetic disorder characterized by progressive heterotopic ossification (HO), leading to cumulative disability. Post hoc analyses of HO volume changes observed during the phase III MOVE trial (NCT03312634) versus a non‑interventional natural history study (NHS; NCT02322255) allow further evaluation of palovarotene for the treatment of FOP. METHODS: Mean annualized HO volume changes assessed by low-dose whole-body computed tomography from baseline until last available assessment were compared for patients receiving palovarotene (MOVE) and patients who did not receive treatment beyond standard of care (NHS) using 2-sample t-tests. The analysis excluded patients who transitioned from the NHS to MOVE. Propensity score matching and weighting were conducted to adjust for baseline differences between the independent groups. Scores were estimated via multivariable logistic regression on baseline age, sex, age-adjusted baseline HO, baseline CAJIS, and time since last flare-up. Sensitivity analyses compared HO volume change with square-root values or with reductions in HO volume coded as zero. RESULTS: Overall, 61 untreated individuals (mean follow-up: 25.8 months) and 58 patients receiving palovarotene (mean follow-up: 15.6 months) were included in the propensity score analyses; 39 were successfully matched with balanced baseline characteristics. A statistically significant difference in mean annualized HO volumes between matched untreated (24.1x103 [±45.3x103] mm3) and treated (5.6x103 [±20.7x103] mm3) individuals was observed (−18.5x103 [±8.0x103] mm3; p<0.05), equating to a 76.9% lower annualized HO volume increase in treated patients. Sensitivity analyses with varying specifications, including stabilized and unstabilized weights, square root transformation, and recoding HO volume reductions as zero, all yielded similar directions of effects with varying statistical significance. CONCLUSIONS: Propensity score matched and weighted analyses revealed significantly lower annualized increases in HO volume in patients who received palovarotene treatment, supporting its potential as a therapeutic option in FOP.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23boingco32poster125069-pdf.pdf?sfvrsn=3f29c061_0","title":"ISPOR23_Boing_CO32_POSTER125069.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125069","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Impact of Substantial Improvements in HBA1C and Weight Loss on the Medication Preferences of People with Type 2 Diabetes","id":"2b6a7bbb-8345-4fb3-a5cb-556bd069bcd0","sessionCode":"PCR5","topDisplay":"Gelhorn H1, Osumili B2, Brown K3, Ross M1, Schulz A1, Fernandez G1, Boye K4 1Evidera, Bethesda, MD, USA, 2Eli Lilly and Company, UK, BRC, UK, 3Eli Lilly and Company, Indianapolis, IN, USA, 4EuroQol Research Foundation, Greenwood, IN, USA","locationCode":"719","description":"\r\n\t<div>OBJECTIVES: A novel glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 receptor agonist that has recently been approved in several countries for the treatment of type 2 diabetes (T2D) and results in substantial HbA1c reductions and weight loss. The current study aimed to quantify the preferences of people with T2D for the treatment features of this new medication compared with another available product. METHODS: Injection naive people with T2D in the US and UK completed an online survey with a discrete choice experiment with 5 attributes: type of delivery system, frequency of nausea, frequency of hypoglycemia, HbA1c reduction, and weight reduction. Attributes and levels were based on a head-to-head clinical trial of 3 doses (5mg, 10mg, 15mg) of tirzepatide versus semaglutide 1mg. A multinomial mixed logit (MXL) model was used to analyze data by country. Predicted preference for each dose of tirzepatide versus semaglutide 1mg was estimated. RESULTS: Half of participants (N=620; US=301; UK=319) were female (US=50.8%, UK=50.5%), with a mean age of 60.8 (12.7) and 58.9 (12.5) years in the US and UK. The order and magnitude of relative attribute importance (RAI) differed between countries. In the US HbA1c reduction (26.3%), and delivery system (20.9%) were the most important, versus hypoglycemia (32.8%) and HbA1c reduction (21.6%) in the UK. Participants preferred greater HbA1c improvements, the single-dose pen, lower hypoglycemia, greater weight reductions, and lower frequency of nausea. Predicted preference for tirzepatide (5, 10, and 15mg) is 95.6% in the US and 86.3% in the UK. A study limitation to be considered is that the preferences of the participants in this study may not be generalizable to all people with T2D. CONCLUSIONS: HbA1c reduction and frequency of hypoglycemia are key drivers of the medication preferences of people with T2D. Overall, people with T2D are likely to prefer tirzepatide medication profiles over semaglutide 1mg.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/dv-010702gelhorn-et-alispor-us-2023poster07apr2023123808-pdf.pdf?sfvrsn=a56f512b_0","title":"DV-010702_Gelhorn et al_ISPOR US 2023_Poster_07Apr2023123808.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123808","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identifying Equity-Relevant Subgroup Effects in Alzheimer’s Disease: A Literature Review to Support a Distributional Cost-Effectiveness Analysis","id":"12638eef-6639-4c7c-948e-56e4cda0815e","sessionCode":"EE31","topDisplay":"Voehler D1, Synnott P1, Majda T2, Ollendorf D1, Lin PJ1, Kowal S3 1Tufts Medical Center, Boston, MA, USA, 2Genentech, Inc, San Francisco, CA, USA, 3Genentech, Inc, Alameda, CA, USA","locationCode":"231","description":"\r\n\t<div>OBJECTIVES: Given the emergence of new therapies for Alzheimer’s disease (AD), it is critical to understand the impact of access factors on health equity. Distributional cost-effectiveness analysis (DCEA) can quantify tradeoffs between overall health gains and underlying impacts on health equity. Our objective was to support development of a DCEA for AD by summarizing the existing literature across race, ethnicity, and social determinants of health (SDOH). METHODS: We searched biomedical literature databases, the Tufts CEA Registry, and grey literature for English-language studies that investigated the impact of race/ethnicity and SDOH on AD outcomes relevant to economic modeling, including incidence, demographics, disease progression, care setting, caregiver burden, and costs. RESULTS: Our search yielded 8,744 results and 27 relevant references. Two studies stratified data elements by SDOH and limited data were found for Asian and Native populations. We identified robust evidence for Black, non-Hispanic White, and Hispanic subgroups related to AD prevalence and patient characteristics at diagnosis. For example, several studies reported higher prevalence and delayed diagnoses among Black and Hispanic participants compared to non-Hispanic White participants. Subgroup-specific evidence for mortality, utilities, caregiver burden, out-of-pocket costs, and long-term care costs was limited and will require assumptions to be incorporated into DCEA. However, the DCEA can explore distributional trends in some of these inputs (e.g., out-of-pocket expenditures, which the all-cause dementia literature suggests are lower for Black and Hispanic subgroups). CONCLUSIONS: Literature on the distributional impacts on AD epidemiology is robust and can be modeled in DCEA. Further evidence and assumptions are needed to estimate impacts for some outcomes or across subgroups defined by SDOH. DCEA can help evaluate distributional impacts of emerging AD therapies and guide policies affecting access to these therapies, including Medicare’s coverage with evidence development policy for monoclonal antibodies and prescribing requirements to confirm amyloid positivity.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporvoehlerposter126185-pdf.pdf?sfvrsn=34b6e561_0","title":"ISPOR_Voehler_POSTER126185.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126185","diseases":[{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identifying a Relationship between Preoperative Albumin Levels and Postoperative Outcomes in Joint Arthroplasty: Real-World Evidence","id":"4fcfb25a-abd8-48c9-baee-5833d3ba65ff","sessionCode":"CO42","topDisplay":"Amy M, Lodaya K, Lilley J, D'Souza F, Shenoy A Boston Strategic Partners, Inc., Boston, MA, USA","locationCode":"141","description":"\r\n\t<div>OBJECTIVES: Malnutrition defined as human serum albumin (HSA) levels below 3.5g/dL has been linked to adverse postsurgical outcomes in joint arthroplasties. To identify a more clinically relevant HSA level, this study evaluated postoperative adverse events based on preoperative HSA levels. METHODS: Using a de-identified US electronic health record database (Cerner Real-World Data), patients over the age of 18 who underwent hip, knee, or shoulder arthroplasty between November 2015 and November 2019 were identified via ICD-10 codes. Patient baseline characteristics, hospital length of stay (LOS), number of outpatient visits, incidence of surgical site infections, incidence of prosthetics infections, and death were evaluated. RESULTS: A total of 11,946 patients were identified (median age 68; 61% female). A student t-test found significant increases in LOS in patients with lower baseline HSA within the range of 2.7 – 4.3g/dL. A generalized linear regression model with gamma distribution and log link showed that a 1g/dL increase in HSA was associated with a 0.28 day decrease in LOS (p-value<0.001). Incidence of prosthetic infections were shown to significantly increase as HSA dropped below 3.8g/dL, and an adjusted logistic regression model showed that HSA levels were associated with the likelihood of developing a prosthetic infection (estimate = −2.098, p-value<0.001). There were no statistically significant differences detected for presurgical HSA levels and the number of outpatient visits. Surgical site infections and mortality were not analyzed due to low incidence. CONCLUSIONS: Findings from this analysis suggest that patients are at risk of increased LOS and prosthetic infection rates when HSA levels fall below 3.8g/dL, a level within the normal albumin range. Future studies should determine if presurgical medical interventions such as albumin infusion may improve patient outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/finalco42mayapreopalbuminarthroplastyispor2023123397-pdf.pdf?sfvrsn=d2c929c3_0","title":"Final_CO42_Maya_Preop_Albumin_Arthroplasty_ISPOR2023123397.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123397","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identification of Patients Diagnosed with Rare and Emerging Diseases Utilizing Real-World Claims Data - A Case Study of African and American Trypanosomiasis","id":"6b4115a5-2803-40c0-b6c9-5872ed00b614","sessionCode":"SA1","topDisplay":"Madaj K1, Brauneis J2, Menon J3, Seshadri V4, Vossen C5 1Syneos Health, UNIONTOWN, OH, USA, 2Syneos Health, Barcelona, B, Spain, 3Syneos Health, Aarhus, Denmark, 4Syneos Health, Morrisville, NC, USA, 5Syneos Health, Amsterdam, NH, Netherlands","locationCode":"904","description":"\r\n\t<div>OBJECTIVES: The purpose of medical claims data is to support payment for care. Due to large sample sizes, administrative claims databases have the potential to provide pivotal insights into patients diagnosed with rare, orphan, or emerging diseases. This study aimed to explore patient profiles of African trypanosomiasis and American trypanosomiasis, both vector-borne parasitic diseases, using a US claims database and to compare this to previously published patient profiles. METHODS: From Jan 1, 2021 – Jun 30, 2022, eligible patients with two outpatient or one inpatient ICD-10 diagnosis code for African trypanosomiasis (sleeping sickness) or American trypanosomiasis (Chagas disease) were identified within the US claims database and analyzed separately. De-identified patient-level demographics, clinical characteristics, and payer information were reviewed. RESULTS: A total of 756 unique patients were identified: 54 patients with African and 702 patients with American trypanosomiasis. Patients with African trypanosomiasis had a mean age of 41.7 years, were mostly male (63%), and mostly resided in the South (37%) or the Northeast (31%) of the US. Patients with American trypanosomiasis had a mean age of 54.3 years, 48% was male, and mostly resided in the South (40%) or West (33%) of the US. Top co-diagnoses included endocrine, nutritional, and metabolic diseases for both African and American trypanosomiasis patients (96% and 88%, respectively). Of insured patients (95%), most utilized a commercial payer (50% with African and 58% with American trypanosomiasis) or Medicaid (26% with African and 15% with American trypanosomiasis). CONCLUSIONS: Using real-world claims data we were able to obtain patient profiles for a rare disease (African trypanosomiasis) and a common, emerging disease (American trypanosomiasis), similar to that of previously published work. This information supports the use of claims data for describing patient populations in rare, orphan, or emerging diseases as well as drug development within these populations. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23madajpostersa1-127627-pdf.pdf?sfvrsn=eab3cf64_0","title":"ISPOR23_Madaj_Poster_SA1 127627.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23madajhandoutsa1127627-pdf.pdf?sfvrsn=54814df_0","title":"ISPOR23_Madaj_Handout_SA1127627.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127627","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Design and Rationale of a Global Prospective Observational Study of Real-World Management of Patients with Atrial Fibrillation at High Risk of Stroke- Gardenia","id":"d372e697-a81d-4382-b274-5a27daaf8f21","sessionCode":"CO8","topDisplay":"Kakkar A1, Bonaca M2, Giugliano RP3, Bloomfield D4, Pieper K1, Yi BA4, Salter J4, Freedholm D4, Parkar S4, Glasspool J4, Kayani G1, Fox KAA5 1Thrombosis Research Institute, London, UK, 2CPC Clinical Research/CPC Community Health, Aurora, CO, USA, 3TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA, 4Anthos Therapeutics, Cambridge, MA, USA, 5University of Edinburgh, Edinburgh, UK","locationCode":"109","description":"\r\n\t<div>OBJECTIVES: Anticoagulants reduce the risk of stroke in patients with atrial fibrillation (AF). However, due to various causes, including concerns for bleeding, there is treatment variability, including undertreatment or non-treatment, especially in patients with high bleeding risk. The aim of the GARDENIA registry is threefold, 1) to understand the real-world usage of oral anticoagulants (OAC) in patients with AF and elevated risk of bleeding, 2) to evaluate the factors associated with treatment or non-treatment with OACs and adherence to guideline recommended doses of OACs and 3) to determine the incidence of clinical outcomes in this population in relation to the treatment strategy adopted. METHODS: GARDENIA is a global, multicentre, prospective, non-interventional study. The registry will aim to enrol up to 10,000 patients with AF or atrial flutter with a CHA2DS2-VASc score ≥2 (excluding female) and older age (≥70 years), reduced renal function, concomitant antiplatelet use, or history of clinically relevant bleeding. The registry will initially enrol AF patients with new onset or existing AF who have not been recently treated with OACs or have been deemed inappropriate to receive OACs by the treating physician. Subsequent enrolments will include untreated as well as patients on OACs or other stroke prevention strategies such as left atrial appendage occlusion. The patients enrolled will be followed up for 24 months. RESULTS: The registry will aim to evaluate (i) treatment persistence, all-cause mortality, risk of bleeding and incidence of stroke and systemic embolism in OAC-treated versus untreated patients (raw and baseline adjusted data) (ii) factors associated with treatment decisions in high-risk patients. CONCLUSIONS: The registry will provide evidence-based analysis to inform future studies in patients with AF and high-risk of stroke. The findings from this registry will also be used to inform future studies with abelacimab in patients with AF and high-risk of stroke.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126045","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Health Care Resource Utilization (HCRU) and Costs of First-Line Systemic Therapy (1LT) for Locally Advanced or Metastatic Non-Small Cell Lung Cancer (a/mNSCLC) - A Secondary Analysis of Claims Data from the United States (US)","id":"bdc18644-8847-41fe-9cf0-5a31443575bb","sessionCode":"EE43","topDisplay":"Spira AI1, Knoll S2, Smith TW2, Scotchmer A3, Bauer M4 1Virginia Cancer Specialists Research Institute and NEXT Oncology, Fairfax, VA, USA, 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 3Novartis Pharmaceuticals, London, UK, 4Novartis Pharma AG, Basel, BS, Switzerland","locationCode":"242","description":"\r\n\t<div>OBJECTIVES: To estimate HCRU, costs, and time to treatment discontinuation (TTD) during 1LT for a/mNSCLC, among commercially insured adults in the US eligible for treatment with 1LT for a/mNSCLC. METHODS: This real-world, retrospective cohort study analyzed US claims data (Optum® Clinformatics® Data Mart) covering 01JAN2019-30JUN2021, using an adapted, validated case-finding algorithm for identifying patients receiving 1LT in administrative claims data. Monthly per-patient HCRU and associated costs during 1LT for a/mNSCLC were calculated using descriptive analyses, stratified by type of 1LT regimen. Kaplan-Meier analyses were used to estimate TTD of 1LT. RESULTS: The analysis included 1,062 patients with a/mNSCLC receiving 1LT (48.7% women), with mean (standard deviation [SD]) age at 1LT initiation of 71.0 (8.0) years, and National Cancer Institute Comorbidity Index score of 1.1 (0. 7). Mean (SD) monthly per-patient HCRU included outpatient (10.3 [8.6]), emergency room (0.2 [0.5]), and inpatient (0.1 [0.3]) visits. Mean (SD) monthly per-patient total costs were US$ 36,744 (24,531); of these, US$ 33,703 (22,818) were lung cancer-related medical costs, and US$ 30,050 (21,077) were lung cancer-related costs during outpatient visits. Mean total monthly per-patient costs were US$ 44,678 among pembrolizumab plus platinum-based chemotherapy users (n=375), US$ 45,264 among pembrolizumab plus any chemotherapy users (n=392), US$ 45,682 among any chemotherapy plus any immunotherapy (n=396) users, US$ 33,371 among users of pembrolizumab only (n=257), US$ 31,774 among users of chemotherapy only (n=316), and US$ 31,119 among users of immunotherapy only (n=350). Overall, median TTD was 3.4 months (interquartile range [IQR]: 2.2, 6.1); patients receiving 1L chemotherapy only had shorter TTD (median: 2.4 months [IQR: 2.1, 3.7]) than patients in other subgroups. CONCLUSIONS: HCRU and associated costs of 1LTs for a/mNSCLC may change over time; up-to-date information is important for informing reimbursement decisions for new 1LTs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23spiraposterv2126342-pdf.pdf?sfvrsn=6b002dfd_0","title":"ISPOR23_Spira_POSTERV2126342.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23spirahandout126342-pdf.pdf?sfvrsn=a27effdf_0","title":"ISPOR23_Spira_HANDOUT126342.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126342","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Barriers to in-Person Focus Group Participation during the Third-Year of COVID-19 Pandemic: A Case Study of Colorectal Cancer (CRC) Screening in Underrepresented Groups","id":"7be16539-c315-4c21-a23d-5a43bc02d022","sessionCode":"EPH26","topDisplay":"Rasu R1, Miller-Wilson LA2, Kamt S3, White A4, Chhetri S3, Hittson-Smith R3, Fernandez D5, Sambamoorthi U6 1University of North Texas Health Science Center, Fort Worth, TX, USA, 2Exact Sciences Corporation, Madison, WI, USA, 3University of North Texas Health Science Center at Fort Worth, Argyle, TX, USA, 4University of North Texas Health Sciences Center, Fort Worth, TX, USA, 5Dallas-Fort Worth Community Health Workers Association (DFW-CHW), Fort Worth, TX, USA, 6University of North Texas Health Science Center, Denton, TX, USA","locationCode":"429","description":"\r\n\t<div>OBJECTIVES: In the process of conducting research to understand barriers to colorectal cancer (CRC) screening in underrepresented groups such as Blacks and Hispanics, it became evident that there were also barriers to recruitment in this population. This study assesses the challenges faced in recruitment of focus group participants regarding CRC screening practices among underrepresented groups. Since the COVID-19 pandemic, qualitative research participants have primarily been interviewed through online video or audio interactions. However, as restrictions on in-person interactions have been lifted, in-person focus groups are being increasingly considered. METHODS: The study investigators began recruitment through community health workers in August 2022, when COVID-19 vaccines were available for all adults (age>18 years). Eligible individuals were: age 45-75, Black or Hispanic, with Medicaid or no insurance, and no family history of CRC or diagnosis of certain colon-related diseases. We combined in-person and virtual recruitment strategies, including posting flyers in communities, advertising our study at health fairs, and on social media. Participants would receive a $50 gift card. RESULTS: Fifty-five met the eligibility criteria among 144 respondents, and 45 subjects (29 women and 16 men) agreed to be contacted. An average of 2.5 attempts were made per eligible subject. Unfortunately, we were able to recruit only four women (3 Hispanic and one non-Hispanic black). Traveling to the research site was a barrier to participation. Many subjects (49%) requested virtual participation (online video or audio interactions); some declined because the topic was too sensitive (considered taboo), and eligible men were reluctant to participate in-person. CONCLUSIONS: The requirement of in-person participation affected our recruitment goals, suggesting that COVID-19 has shifted the preferences of research participants to virtual interaction. In response to the eligible participant preferences, the study protocol has been revised to re-contact patients and schedule virtual FG sessions.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127695","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"An Assessment of Value-Based Health Care Elements in Colombia","id":"f36f6452-c59a-4cd3-8a9a-5c4b95c485a9","sessionCode":"HPR25","topDisplay":"van der Werf L, Amaya-Granados D, Hernández F IQVIA, Bogotá, CUN, Colombia","locationCode":"528","description":"\r\n\t<div>OBJECTIVES: Value-based healthcare (VBHC) shifts the paradigm from a supply-driven model to a patient-centered one, enabling decision makers to make the best use of finite resources while achieving improved outcomes. In this study we assessed the status of implementation of common VBHC domains in Colombia. METHODS: Regulations, policies, assessment reports and other publicly available documentation were reviewed in Colombia to establish country performance on six VBHC domains: Enabling policies, integrated healthcare, patient-centered outcome measurements, alternative payment models, Information technology infrastructure and stakeholder engagement. RESULTS: Favorable policies such as universal health coverage and the presence of a Health Technology Assessment body independent of payers/providers were found. The implementation of integrated healthcare has been one of the biggest challenges due to the fragmentation of the healthcare system. However, it is worth highlighting the recent health reforms that are shifting the paradigm towards integrated care delivery. Colombia has a robust healthcare information system; however, the availability of outcome data is still low. Different healthcare quality indicators are measured, most of them are mainly focused on process indicators, and the use of structured electronic health records appears to be limited. Regarding the cost measurements, information is collected on the use of health resources, as well as the cost of health services provided and health technologies. Capitation and fee-for-service payments are the most used payment models, although payers report outcomes-based and bundled payment initiatives. Finally, no formal stakeholder training on VBHC was identified. CONCLUSIONS: In Colombia, progress has been made in some of the individual domains of value-based health. There is a need to promote more initiatives to enable a successful transition to a value-based health system, specifically in the domains of integrated healthcare and stakeholder engagement. This diagnosis is important in view of the forthcoming health reforms in Colombia.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123911","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Characterization of Demographics and Concomittant Symptoms in Patients with Post COVID-19 Conditions or Long COVID","id":"b9d62013-c74f-4d42-8ab8-5c5126ffdc85","sessionCode":"EPH9","topDisplay":"Srinivasan S1, Morgan J2 1Deloitte Consulting, WILMINGTON, DE, USA, 2Deloitte Consulting, Boston, MA, USA","locationCode":"418","description":"\r\n\t<div>OBJECTIVES: Post COVID-19 conditions or long COVID continues to burden the healthcare system. With the introduction of new code in October 2021 to appropriately capture this condition (U09.9), we have enough data to understand the detailed demographic and clinical characterization of the patients with long COVID. As this new clinical entity continues to evolve, our study will provide insights for care management and planning. METHODS: We conducted a retrospective cohort study from a large deidentified database of US health insurance claims. The study population included all individuals with at least one ICD-10 code for COVID (U07.1) between June 1, 2021, and November 30, 2022. Individuals with at least one ICD-10 code for long COVID (U09.9), at least 7 days after COVID diagnosis were termed “Long COVID” patients. Index date was defined as the first long COVID diagnosis date. We also assessed the most prevalent diagnosis codes within the 30 days pre- and post-index to understand top symptoms. RESULTS: A cohort of 253,145 patients (62% female patients; 38% male patients) were identified. Among this cohort, 3.2% were pediatric patients aged 0 – 17 years; 73.3 % aged 18 - 64 years and 23.5 % aged 65+ years. Most prevalent symptoms that increased in the 30 day pre- and post-index: Nervous system symptoms (↑6 fold), fatigue (↑7 fold), Dyspnea (↑4.3 fold), esophagitis (↑1.6 fold) chronic kidney disease (↑1.3 fold) among others. CONCLUSIONS: Our findings indicate that long COVID is more prevalent in females, with fatigue and dyspnea emerging as top symptoms. These findings are consistent with the published literature. However, we uncovered additional symptoms such as nervous system symptoms, chronic kidney disease among others. Additional analysis is planned to evaluate the association of these symptoms with sociodemographic features to understand the health inequity aspects of long COVID.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23srinivasanposter124887-pdf.pdf?sfvrsn=26404688_0","title":"ISPOR23_Srinivasan_POSTER124887.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124887","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Retrospective Longitudinal Evaluation of the WHO’s Access, Watch and Reserve (AWARE) Classification and Patterns of Antibiotic Use and Resistance in a Primary Healthcare Facility in Rural District of Punjab, Pakistan","id":"8e3e2fc5-14eb-4016-b8dd-5c8f60789568","sessionCode":"HSD1","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"538","description":"\r\n\t<div>OBJECTIVES: The objective of this study was to monitor the magnitude of antibiotic consumption of “Access”, “Watch”, “Reserve” (AWaRe) and “Not Recommended” group as per World Health Organization (WHO) criteria. METHODS: A retrospective longitudinal study was conducted from January 2021 to January2022. The study was performed in a government hospital at a primary care level situated in a rural district of Punjab, Pakistan. Defined daily dose (DDD) value of every single antibiotic prescribed was calculated by the World Health Organization (WHO) guidelines. The type of (AWaRe) antibiotics given, their classes, ATC Codes, their strengths, routes, frequencies, doses, mono- and, combination antibiotic therapies, any culture sensitivity tests, review and stop orders, and any switch from the intravenous to the oral route was noted in all the admitted patients. RESULTS: The consumption of “Watch” group in indoor wards was 74.71% (114.5 DDD/100BD) whereas in pre-surgical and post-surgical prophylaxis it was 92.72% (27.74DDD/100BD) and 53.16% (1.3DDD/100BD) respectively. Additionally, the consumption of “Access” group in indoor patients was 22.9% (35.11DDD/100BD) while in pre-surgical and post-surgical patients it was 5.02% (1.53DDD/100BD) and 37.73% (0.906DDD/100BD) respectively. Lastly, the utilization of “Not Recommended” group was 2.34% (3.6DDD/100BD) and 9.15% (0.195DDD/100BD) in indoor and post-surgical patients respectively. None of the antibiotics from ‘Reserve’ category were used in any of the admitted patients. CONCLUSIONS: Antibiotic use need to be monitored as no newer ones are in the process of discovery. With the studies of consumption trends at different hospital levels, health authorities need to implement strict controls to tackle irrational practices and the emergence of resistance.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126577","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Efficacy/Effectiveness of Extended Half-Life Factor VIII Concentrates on the Prophylaxis of People with Hemophilia A: A Systematic Review and Meta-Analysis","id":"8c28899b-2bbc-42c1-b09a-5e53becaf647","sessionCode":"HTA8","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"614","description":"\r\n\t<div>OBJECTIVES: The treatment of people with hemophilia A (PwHA) consists of infusing clotting factor VIII (FVIII), either as prophylaxis (to prevent bleeding) or on-demand (to stop a bleeding episode). The infusion frequency of prophylactic standard half-life (SHL)-FVIII concentrates can be burdensome for PwHA. Extended half-life (EHL)-FVIII concentrates were developed to facilitate the prophylaxis regimen by increasing the time between infusions, but higher trough levels of FVIII may be reached with more frequent administration. We aimed to evaluate the efficacy/effectiveness of EHL-FVIII concentrates compared with SHL-FVIII concentrates as prophylaxis of PwHA. METHODS: The study followed the PRISMA2020 statement. The search strategies (01/10/2022) were structured according to literature databases. Clinical trials and observational studies that evaluated prophylaxis with EHL-FVIII compared with SHL-FVIII were included. Two independent reviewers selected publications and extracted data using a standardized form. The bleeding rate outcomes (both annual or annualized) and the total consumed dose of FVIII (weekly) were analyzed. [PROSPERO CRD42021281642] RESULTS: Twenty-three publications evaluated alfarurioctocog-pegol, alfaefmoroctocog, and alfalonoctocog. Overall bleeding outcomes were lower for PwHA on EHL-FVIII than on SHL-FVIII prophylaxes: total bleeding rate (587 EHL-FVIII vs. 941 SHL-FVIII; standardized mean difference [SMD] -0.43, 95%CI -0.77 to -0.08; I2=87%; p=0.01), spontaneous bleeding rate (127 EHL-FVIII vs. 178 SHL-FVIII; SMD -0.29, 95%CI -0.52 to 0.06; I2=0%; p=0.01), and joint bleeding rate (139 EHL-FVIII vs. 139 SHL-FVIII; SMD -0.31 95%CI -0.55 to -0.07; I2=0%; p=0.01). However, the total consumed doses of FVIII were similar for EHL-FVIII and SHL-FVIII prophylaxes (504 EHL-FVIII vs. 867 SHL-FVIII; SMD -0.13, 95%CI -0.67 to 0.40; I2=95%; p=0.62). The methodological quality of the included publications was moderate in most studies. The certainty of the evidence was low for the total bleeding rate and very low for the total consumed dose of FVIII. CONCLUSIONS: EHL-FVIII prophylaxis has better efficacy/effectiveness than SHL-FVIII prophylaxis for PwHA, with a similar consumption.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123440","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Tools for Assessing Therapeutic Progress in Patients with Rett Syndrome","id":"ecd61258-5fb3-4fe8-bea7-5e6bdff00c1d","sessionCode":"CO22","topDisplay":"May D1, Bressler-Archambeau C2, Davuluri S2, Czerwinski B3, Smith-Hicks C4 1Acadia Pharmaceuticals, San Diego, CA, USA, 2Beacon, Part of Accenture, Portland, ME, USA, 3Independent Physical Therapist, Wilmington, NC, USA, 4Kennedy Krieger Institute, Baltimore, MD, USA","locationCode":"120","description":"\r\n\t<div>OBJECTIVES: Rett syndrome (RTT) is a rare and severe neurodevelopmental genetic disorder that mostly affects females. Therapeutic professionals (TPs) play a key role in day-to-day care for RTT patients. This study aimed to identify the tools that TPs in the United States use for assessment of progress in RTT patients, and to characterize the strengths and limitations of these tools as perceived by TPs. METHODS: TPs (physical therapists [PT], occupational therapists [OT], and speech and language therapists [ST]) and physicians who provide medical management and coordinate the care of RTT patients were interviewed in a semi-structured manner. Target sample included 20–25 TPs and 8–10 physicians representing diverse care settings (RTT Centers of Excellence, other outpatient and home health, and school-based care). A framework to evaluate the assessment tools was constructed based on the interview responses. RESULTS: A total of 17 TPs (6 PT, 6 OT, 5 ST) working in community-based (n=10), school-based (n=5), and other (n=2) settings were interviewed, alongside 9 physicians (3 pediatricians and 6 pediatric neurologists). TPs reported the use of 22 assessment tools, including 6 RTT-specific tools (3 global function assessments and 3 tools focused on mobility and motor function). Tools unspecific to RTT were used to measure global function (n=4), activities of daily living (n=6), and cognition, communication, and psychosocial functioning (n=6). TPs preferred assessment tools with good clinical validity, practical utility, and sufficient sensitivity to show therapeutic progress or response to treatment; however, selection of a particular assessment tool depended on the TP’s discipline, and the symptoms experienced by the patient. CONCLUSIONS: TPs utilize a wide range of tools for assessing therapeutic progress in patients with RTT. More standardized and consistent assessment by TPs may allow for greater understanding of patient’s therapeutic progress or response to treatment and facilitate goal setting.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23maypostertherapeutic-assessments-in-rtt123855-pdf.pdf?sfvrsn=e2510b4e_0","title":"ISPOR23_MAY_POSTER_Therapeutic Assessments in RTT123855.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123855","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Evidence (RWE) to Support Regulatory Submissions: Landscape Assessment &AMP; Review","id":"389e1bee-7768-4278-a06c-5f3cc0b390bc","sessionCode":"HPR14","topDisplay":"Alipour-Haris G1, Acha V2, Liu S2, Burcu M2 1University of Florida, Gainesville, FL, USA, 2Merck & Co., Inc., Rahway, NJ, USA","locationCode":"519","description":"\r\n\t<div>OBJECTIVES: To characterize regulatory applications with RWE in the pre-approval setting by design, approach, and other parameters in the U.S. and Europe. METHODS: RWE regulatory use cases were identified through systematic review and screening of publications (January 2016-June 2022) from PubMed, Embase, Web of Science, and from FDA/EMA regulatory review documents. Data was extracted and synthesized from eligible publications, and unique features such as RWD sources, study design, and endpoints used to support regulatory decision-making were characterized. Further, we conducted a detailed review and data extraction from FDA/EMA approval packages to provide additional information. RESULTS: After screening, the systematic review identified 85 regulatory applications with RWE. Of these cases, 31 were in the oncology and 54 were in the non-oncology therapeutic area. Most were for indications in adults only (N=42, 49.4%), while 13 were in pediatrics only (15.3%) and 30 were in both (35.3%). In terms of regulatory use, 59 cases (69.4%) were approved through an original marketing application, 24 (28.2%) were for label expansion, and 2 (2.4%) for label modification. Most also received special regulatory designations (e.g., orphan indication, accelerated approval, breakthrough therapy, fast track, and conditional). A variety of data sources were utilized including electronic health records (18.8%), claims (2.4%), registries (24.7%), prior clinical trials (14.1%), literature (29.4%), and site-based chart data (18.8%). The common endpoints in oncology use cases were overall survival, progression-free-survival, and objective response while a wide range of endpoints were used in non-oncology use cases. In 13 use cases, RWE was not considered supportive/definitive in the regulatory decision-making due to design issues such as small sample size, selection bias, and missing data. CONCLUSIONS: This review suggests that RWE is utilized in regulatory approval processes for new indications/label expansion across various therapeutic areas with wide a range of approaches and data sources.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23alipourharisposter127376-pdf.pdf?sfvrsn=67a870c4_0","title":"ISPOR23_Alipourharis_POSTER127376.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127376","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Durability of Efficacy and Safety of Roflumilast Cream 0.3% in Adults with Chronic Plaque Psoriasis from a 52-Week, Phase 2 Open-Label Safety Trial","id":"9c62d86a-4730-4d4c-ba3f-5f88bf581293","sessionCode":"CO45","topDisplay":"Lebwohl M1, Stein Gold L2, Gooderham M3, Papp KA4, Ferris LK5, Adam DN6, Hong HCH7, Kircik LH8, Zirwas M9, Burnett P10, Higham R10, Krupa D10, Berk DR10 1Icahn School of Medicine at Mount Sinai, New York, NY, USA, 2Henry Ford Medical Center, Detroit, MI, USA, 3SKiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada, 4Probity Medical Research and K Papp Clinical Research, Waterloo, ON, Canada, 5University of Pittsburgh, Pittsburgh, PA, USA, 6CCA Medical Research, Probity Medical Research and Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada, 7Probity Medical Research and University of British Columbia, Department of Dermatology and Skin Science, Surrey, BC, Canada, 8Skin Sciences, PLLC, Louisville, KY, USA, 9Dermatologists of the Central States, Probity Medical Research, and Ohio University, Bexley, OH, USA, 10Arcutis Biotherapeutics, Inc, Westlake Village, CA, USA","locationCode":"144","description":"\r\n\t<div>OBJECTIVES: Roflumilast cream is a potent phosphodiesterase 4 inhibitor recently approved in the United States for treatment of plaque psoriasis. An open-label trial was conducted to evaluate long-term safety (52 weeks) of once-daily roflumilast cream (NCT03764475). Durability of response was measured using Investigator Global Assessment (IGA) score of Clear or Almost Clear, percentage improvement in Psoriasis Area Severity Index (PASI) score, and reduction in body surface area (BSA) affected. METHODS: Patients who completed a parent, phase 2b, 12-week randomized controlled trial could continue on open-label roflumilast cream 0.3% (Cohort-1, n=230); patients naïve to roflumilast were also enrolled (Cohort-2, n=102). All psoriasis lesions (except scalp) were treated for up to 52 weeks. RESULTS: Overall, 73.5% of patients completed the study; 3.9% discontinued due to adverse events (AE) and 0.9% discontinued due to lack of efficacy. Treatment-related AEs were reported in 2.7% patients; none were deemed serious. Investigator tolerability assessments at each visit demonstrated 99% of patients rated “no evidence of irritation.” At Week 52, IGA Success (Clear/Almost Clear plus 2-grade improvement from baseline) was achieved by 34.8% of Cohort-1 and 39.5% of Cohort-2 patients. IGA Clear/Almost Clear was achieved by 46.8% of patients across both cohorts at week 12 and consistent through week 52 (44.8%). A 60.5% mean PASI improvement and 60.1% mean BSA improvement from baseline were observed at week 12 and consistent through week 52 (59.4% and 63.3%, respectively). Of the 185 patients who achieved IGA Clear/Almost Clear during the open-label trial, median durability of IGA of Clear/Almost Clear was 10 months (40.1 weeks); 50% maintained Clear/Almost Clear status for ≥10 months. CONCLUSIONS: In this long-term safety study, roflumilast cream was well tolerated with a safety profile consistent with the Phase 2b trial, and effectively maintained clear/almost clear skin with no tachyphylaxis observed. Sponsored by Arcutis Biotherapeutics, Inc.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23lebwohlposter125643-pdf.pdf?sfvrsn=c85edeec_0","title":"ISPOR23_Lebwohl_POSTER125643.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125643","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Inflation Reduction Act (IRA) on Commercial Plans’ Approach to Managing Drugs","id":"720ecff4-fef1-47ce-beed-604618f018fe","sessionCode":"HPR33","topDisplay":"Vyas H1, Chawla A2, Gotbetter W3 1Parexel, Richmond, VA, USA, 2Parexel, Fremont, CA, USA, 3Parexel, Newton, MA, USA","locationCode":"529","description":"\r\n\t<div>OBJECTIVES: The Inflation Reduction Act (IRA) of 2022 allows the government to negotiate prices of selected drugs covered under Medicare Parts B and D. Such drugs will be subjected to a maximum fair price (MFP), where the manufactures will be levied to discount their drug. As a result, commercial plans are also likely to revisit their formulary management strategy to adapt to the change in Medicare-levied prices. This research aims to describe the potential impact of IRA on pricing and management of drugs under commercial plans in response to IRA. METHODS: First, the IRA legislation and all associated PubMed articles related to drug pricing were identified and reviewed. Based on the review, a quantitative survey with multiple choice questions was prepared. Finally, insights were collected from survey responses of 10 administrators (pharmacy and medical directors) of key national/regional commercial plans and PBMs. RESULTS: Payers noted that IRA will impact drug prices both at launch and at the time of setting the MFP post-launch. They anticipate that manufacturers will launch at a premium price. As such, evidence threshold to support pricing are expected to rise, benefitting products with clear value differentiation. Additionally, to benchmark launch prices, commercial plans are likely to reference an ICER-like cost-effectiveness approach. For drugs negotiated under IRA regulations, commercial payers may further incorporate MFP into their decision making to negotiate higher discretionary discounts/rebates to force lower prices. Drugs not negotiated under IRA may also be subjected to restrictive management policies (e.g. exclusions of non-negotiated drugs in the non-protected class), as plans contend with mandated coverage of IRA-negotiated drugs. CONCLUSIONS: IRA is likely to accentuate the already increasing downward pressure on drug pricing. In response, manufacturers will need to develop new approaches, including economic modeling, for post-launch payer negotiations - potentially prior to implementation of IRA in 2026.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporus23vyasposterhpr33127560-pdf.pdf?sfvrsn=be2023d9_0","title":"ISPORUS23_Vyas_POSTER_HPR33127560.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127560","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"97c2e725-3c74-4625-997f-a72378c5a557","parentId":"00000000-0000-0000-0000-000000000000","title":"Generics","urlName":"Generics"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessing the Burden of Injection with Parenteral Hereditary Angioedema Therapies","id":"963d77bc-6a93-4afb-bb82-6097deda0ae1","sessionCode":"PCR32","topDisplay":"Soteres DF1, Cribbs K2, Czado S3 1Asthma & Allergy Associates, PC and Research Center, Colorado Springs, CO, USA, 2Alkemi LLC, New York, NY, USA, 3KalVista Pharmaceuticals, Inc., Cambridge, MA, USA","locationCode":"740","description":"\r\n\t<div>OBJECTIVES: Available literature suggests that parenteral HAE treatments are burdensome to patients. As the HAE therapeutic landscape evolves, gaining a better understanding of the patient-reported clinical, economic, and humanistic burden of parenteral HAE therapies is critical to addressing unmet treatment needs. METHODS: We conducted a targeted literature review (TLR) to assess the burden of parenteral HAE therapies on individuals with HAE. Searches were conducted in PubMed and Google Scholar. We prioritized peer-reviewed articles and conference proceedings published in English from January 1, 2017-November 1, 2022 for inclusion. We considered older articles, if relevant. RESULTS: We identified nine publications. Most studies were observational (78%) and conducted in the United States (67%). Studies reviewed only reported outcomes among adult patients. Adverse events were a concern, with one study reporting 98% of patients using icatibant had injection site reactions. In another study, patients taking on-demand therapy reported refusing self-administration due to fear of injection (69%), lack of skills (47%), interference in daily activities (44%), and financial constraints (33%). Significant humanistic and clinical burden was also reported across parenteral HAE therapies. One study found 19% of patients skipped their prophylaxis medication because injections or infusions were inconvenient. Another study found that the majority of patients (62%) who used a peripheral vein to administer treatment reported difficulty finding a usable vein, and more than half of intravenous prophylaxis users (51%) were dissatisfied with the length of time required to prepare and administer their medication. CONCLUSIONS: Parenteral HAE therapies are burdensome for patients, yielding significant clinical, economic, and humanistic impacts. Novel, easy to administer HAE treatments, especially in the on-demand space—where only parenteral therapies exist—may address unmet patient needs and improve treatment outcomes. Future research should examine injection burden among patient subpopulations (e.g., pediatrics/adolescents) to ensure therapeutic interventions are appropriately tailored.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23soteresposterv3123500-pdf.pdf?sfvrsn=819627f3_0","title":"ISPOR23_Soteres_POSTERV3123500.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123500","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Association of Inflammatory Chronic Conditions with Blood Pressure Control Among Adults with Hypertension in the United States","id":"d5edc72f-1259-442e-9d73-60ab3c84b931","sessionCode":"CO5","topDisplay":"Ikram M1, LeMasters T1, Shen C2, Misra R3, Sambamoorthi U4 1West Virginia University, Morgantown, WV, USA, 2Penn State College of Medicine, Hershey, PA, USA, 3West Virginia University School of Pharmacy, Morgantown, WV, USA, 4University of North Texas Health Science Center, Denton, TX, USA","locationCode":"107","description":"\r\n\t<div>OBJECTIVES: Inflammatory chronic conditions (ICCs) are risk factors for elevated blood pressure (BP) through inflammatory pathways. However, the factors, prevalence, and association of BP control in adults with ICCs and hypertension are largely unknown. METHODS: We used multiple cross-sectional cycles of the National Health and Nutrition Examination Survey (NHANES 2013-2018) data. Adults (> 18 years) with self-reported hypertension and those who participated in the examination component were included in the study (N = 6,117). High BP was defined as having systolic BP >130 mm Hg or diastolic BP > 80 mm Hg. Adults with any of the following chronic conditions asthma, chronic obstructive pulmonary diseases, rheumatoid arthritis, psoriatic arthritis, chronic kidney diseases, depression, cardiovascular disease, hepatitis, gout, and diabetes were considered as having ICC. Because of significant differences in the profiles of those with and without ICC, we used inverse probability weighting (IPW) to account for the selection bias. For example, a higher percentage of adults with any ICC used antihypertensive medications compared to no ICC (84.7% vs 62.5%). IPW-adjusted multivariable logistic regression on high BP was controlled for sex, age in years, race/ethnicity, education, income, marital status, insurance coverage, BMI, smoking status, exercise, general health, and polypharmacy. RESULTS: Overall, 55.6% of adults reported a high BP; A lower percentage of adults with ICC reported high BP (54.6% vs. 56.9%) compared to those without ICC. IPW-adjusted logistic regressions indicated that adults with any ICC had lower odds of high BP (AOR = 0.83, 95% CI = 0.72, 0.96, p < 0.011) compared to those with no ICC. CONCLUSIONS: One in two adults with hypertension reported high BP. Adults with self-reported hypertension and ICC were less likely to have high BP compared to those without ICC. Future studies with prospective cohort design are needed to confirm these findings. <quillbot-extension-portal></quillbot-extension-portal></div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127609","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Asthma Management Support Needs Among Young Adults: A Pilot Qualitative Study","id":"507902c5-08e1-41bb-b5e1-60f32cd7be04","sessionCode":"PCR35","topDisplay":"Popielaski C1, King A2, Jeminiwa R3 1Thomas Jefferson University, Smithtown, NY, USA, 2Thomas Jefferson University, Philadelphia, PA, USA, 3Thomas Jefferson University, Philadephia, PA, USA","locationCode":"745","description":"\r\n\t<div>OBJECTIVES: Young adults with asthma have difficulty adhering to their prescribed inhaled corticosteroids. We aim to explore the support needs of young adults living with asthma METHODS: Young adults (18-29 years old) diagnosed with asthma and prescribed a daily inhaled corticosteroid were purposively recruited to participate in the study. Semi-structured interviews were conducted with participants via a teleconferencing app, recorded, and transcribed verbatim. Thematic analysis was performed using NVivo software. The study received approval from the author's institutional review board. RESULTS: Four participants were recruited. Four themes emerged. 1) Support needs from clinicians include prescribing medications, assessing medication adherence, monitoring asthma symptoms, treating flare-ups, and educating on device use. Young adults believe collaboration between physicians and pharmacists may facilitate quicker medication refills. 2) Social support includes ensuring the availability of medications, monitoring adherence, and accompanying young adults to physician appointments. Social support for medication-taking comes mostly from family and, to a lesser extent, friends. Social support from family declines in emerging adulthood compared to when participants were younger. 3) Educational support: participants were interested in learning more about asthma, device use, the different medications, and their mechanisms of action. 4) Self-management support: Many participants admitted a need for a system to track inhaler use linked to clinicians to facilitate quicker refills, reminders to take medications daily, and ensuring availability of medications, especially during trips. Young adults have different experiences regarding the level of support received from clinicians, families, and friends. CONCLUSIONS: Young adults are receptive to guidance from healthcare providers to better understand and manage their asthma diagnosis. Young adults would benefit from increased support from family or friends in remembering to obtain medication refills and use their inhalers daily. Future studies may examine how to leverage family and friends to support young adults' medication use.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/asthma-ispor-poster127348-pdf.pdf?sfvrsn=be32ee3f_0","title":"Asthma ISPOR poster127348.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127348","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Psychometric Validation of the Electronic Hidradenitis Suppurativa (HS) Symptom Daily Diary (eHSSDD) and Electronic HS Symptom Questionnaire (eHSSQ) Using Data from the Phase 3 BE HEARD Trials of Bimekizumab in HS","id":"76b6c2bd-0da2-4dc3-a5f8-61128d3720b1","sessionCode":"MSR15","topDisplay":"Ingram JR1, Kirby J2, Ciaravino V3, Rolleri R4, Pansar I5, Lambert J3, Muller E6, Pelligra C7 1Cardiff University, Cardiff, UK, 2Penn State Milton S. Hershey Medical Center, Hershey, PA, USA, 3UCB Pharma, Colombes, France, 4UCB Pharma, Morrisville, NC, USA, 5UCB Pharma, Brussels, Belgium, 6UCB Pharma, Slough, UK, 7Evidera, Medellín, Colombia","locationCode":"709","description":"\r\n\t<div>OBJECTIVES: Assess the psychometric properties of the electronic Hidradenitis Suppurativa (HS) Symptom Daily Diary (eHSSDD) and HS Symptom Questionnaire (eHSSQ), developed to capture core participant-perceived HS symptoms. METHODS: Pooled, blinded data from participants with moderate-to-severe HS enrolled in the phase 3 BE HEARD I (NCT04242446) and II (NCT04242498) trials were analyzed (eHSSDD: N=934; eHSSQ: N=1,007). Average weekly scores (if ≥4/7 daily scores non-missing) were derived for the 5 eHSSDD items; simulation analyses were conducted to confirm this rule. Test-retest reliability was evaluated using intraclass correlation coefficients (ICCs) between baseline and Week (Wk) 4 (eHSSDD), or Wk32 and Wk36 (eHSSQ). Convergent/divergent validity was assessed between the eHSSDD and eHSSQ compared with relevant patient-reported outcomes (PROs; Dermatology Life Quality Index [DLQI], HS Quality of Life Questionnaire symptom subscale) and clinician-reported outcomes (ClinROs; International HS Severity Score System [IHS4], derived programmatically post-collection) at baseline and Wk16. Known-groups validity was assessed, comparing eHSSDD and eHSSQ scores between participant subgroups pre-defined using PRO/ClinRO measures (Patient Global Impression [PGI] of HS severity, Hurley Stage, IHS4, HS Physician’s Global Assessment [derived programmatically]). Responsiveness was evaluated by correlating changes from baseline to Wk16 in eHSSDD and eHSSQ scores with changes in PGI scales. RESULTS: At Wk16, eHSSDD and eHSSQ completion rates were 70.1% and 90.2%, respectively. Simulation analyses confirmed the appropriateness of the eHSSDD weekly scoring rule. Test-retest reliability analyses demonstrated good score reproducibility (ICC: eHSSDD: 0.80–0.86; eHSSQ: 0.73–0.84). Correlations between eHSSDD and eHSSQ scores and other PROs and ClinROs were generally consistent with predefined hypotheses, indicating good convergent/divergent validity. eHSSDD and eHSSQ scores discriminated between pre-defined subgroups at Wk16, confirming known‑groups validity. 16-wk changes from baseline in eHSSDD and eHSSQ scores and anchors were moderately-to-strongly correlated (>0.30), establishing responsiveness. CONCLUSIONS: eHSSDD and eHSSQ scores demonstrated good reliability, validity, and responsiveness in participants with moderate-to-severe HS.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23ingramposterhssddhssq125715-pdf.pdf?sfvrsn=76fcbc7a_0","title":"ISPOR23_Ingram_POSTER_HSSDD_HSSQ125715.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125715","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Parents' Preference and Perception for Childhood Obesity Prevention Strategies in China: A Survey-Based Experiment","id":"6953eb39-74a4-4ac6-a820-6129edd10cb9","sessionCode":"PCR27","topDisplay":"Ma X, Liu T, Chen X, Ming WK City University of Hong Kong, Hong Kong, Hong Kong","locationCode":"736","description":"\r\n\t<div>OBJECTIVES: Childhood obesity is among the most severe health concerns in China. The results of former studies on parents' preferences for preventing childhood obesity remain insufficiently fixed. This study aims to measure and quantify parents' preferences for strategies to prevent obesity in China. METHODS: A survey, including a set of discrete choice experiment (DCE) task choices, was utilized to measure parents' preferences and factors that affect parents' perception of approaches to prevent children's being obese or overweight. Participants were recruited from October 20, 2022, to December 30, 2022, using snowball sampling methods through social media platforms. And the inclusion criteria for this study were responding parents with at least one child over five years old. The multinomial logit model and (MNL) latent class model (LCM) were performed for statistical analysis. RESULTS: A total of 634 qualified respondents who completed the survey were included in the analysis. Generally, extra expense occupied the first place for parents (weighted importance: 32.48%), followed by daily sleeping duration and dietary mode. Parents prefer nine hours of sleeping time (OR: 1.286, 95%CI: 1.181–1.400, p<0.05, reference level: seven hours) with high-protein diet mode (OR: 1.115, 95%CI: 1.035–1.201, p<0.05, reference level: low-fat diet) and school instead of gym as their children's exercise location (OR: 0.704, 95%CI: 0.645–0.768, p<0.001, reference level: school). LCM identified and segmented two groups of parents. Both groups prefer an early-eating diet and high-protein diet mode. However, group 1 preferred school to be an exercise place with eight hours of sleep daily, and prefer to pay no expenses, while group 2 valued nine hours of sleep and willing to pay RMB 200 for the weight control plan. CONCLUSIONS: A collaborative effort by schools, families, and policymakers is required to guarantee children's sufficient exercise, sleeping time, and suitable dietary style.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/posterv1127873-pdf.pdf?sfvrsn=3399128d_0","title":"poster_V1127873.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127873","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Economic Burden Associated with Immune-Related Adverse Events Induced By Immune Checkpoint Inhibitors Among Older Adults with Non-Small Cell Lung Cancer","id":"d1560861-2ebe-4c1a-a07b-6165db4f4aa7","sessionCode":"EE37","topDisplay":"Rong Y1, Ramachandran S2, Bhattacharya K3, Yang Y4, Chang Y5, Earl S4, Bentley J3 1University of Mississippi School of Pharmacy, Amherst, MA, USA, 2School of Pharmacy, Oxford, MS, USA, 3School of Pharmacy, University, MS, USA, 4University of Mississippi School of Pharmacy, University, MS, USA, 5University of Mississippi School of Applied Sciences, University, MS, USA","locationCode":"301","description":"\r\n\t<div>OBJECTIVES: To estimate the impact of immune checkpoint inhibitor (ICI)-induced immune-related adverse events (irAEs) on health expenditures among older patients with non-small cell lung cancer (NSCLC). METHODS: A cohort study was conducted using SEER-linked Medicare claims data from 2007 to 2019. Fee-for-service Medicare beneficiaries aged 65 and older with a confirmed NSCLC diagnosis who had at least one claim for ICI were included. Patients with irAEs were identified if they had a new medical claim with an irAE diagnosis code during ICI treatment. The outcome of interest included all-cause per patient per year (PPPY) costs of care (adjusted to 2019 US dollars) occurring post-ICI initiation until death, as well as irAE-specific costs within 30 days after irAE occurrence. Multivariable generalized linear regression, adjusted for patient demographics, cancer characteristics, and other clinical variables, and recycled predictions were conducted to examine the difference in costs between patients with and without irAEs. For estimation of 30-day irAE associated costs, patients without irAEs were included as controls and randomly-assigned a shadow event date. Inverse probability of treatment weighting was used to account for the differential likelihood of having an irAE and covariate imbalance. RESULTS: A total of 8,175 NSCLC patients were included in the study cohort (3,826 in irAE group and 4,349 in non-irAE group), of which 46.80% developed an irAE. It was estimated that the total all-cause PPPY incremental cost associated with irAEs was $21,804.50 (95% CI: $21,703.88-$21,898.66). Most of this increase in costs was attributed to hospitalization, followed by office visits, and skilled nursing facility stays. Incremental 30-day irAE-specific costs ranged from $1,765.91 for skin-related irAEs to $8,975.99 for pneumonitis. CONCLUSIONS: Older patients with irAEs had higher medical cost burden from both Medicare and patient perspectives. Findings of this study help inform patients and payers about the risk-benefit profile of ICI use in older patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127033","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Outcomes of Nusinersen or Onasemnogene Abeparvovec (OA) Monotherapy, or Switching to OA from Nusinersen in SMA Patients Aged ≥6 Months","id":"70e772ab-4feb-4608-a6bc-619da307508f","sessionCode":"CO41","topDisplay":"Dabbous O1, Yang M2, Georgieva M2, Toro W1, LaMarca N1, Patel A1, Anderson A3, Akbarnejad H2, Reyna SP1 1Novartis Gene Therapies, Inc., Bannockburn, IL, USA, 2Analysis Group, Inc., Boston, MA, USA, 3Analysis Group, Inc., New York, NY, USA","locationCode":"140","description":"\r\n\t<div>OBJECTIVES: Disease-modifying treatments including nusinersen and OA have substantially improved SMA prognoses, but real-world data on treatment outcomes and health care resource utilization (HCRU) are limited. We sought to describe real-world clinical outcomes and HCRU in US patients with SMA aged ≥6 months when treated with nusinersen monotherapy, OA monotherapy, or switched to OA from nusinersen. METHODS: We conducted a retrospective chart review with outcomes summarized descriptively for patients at or before the index date (date of monotherapy initiation or switch to OA) who had medical information available for ≥1 follow-up visit. HCRU was summarized per patient-year (PPY). RESULTS: This analysis included 55 patients (19 nusinersen monotherapy; 21 OA monotherapy; 15 switching to OA from nusinersen). SMA phenotypes were type 1 (8/19; 4/21; 12/15), type 2 (8/19; 9/21; 1/15), type 3 (3/19; 5/21; 0/15), and undetermined (0/19; 3/21; 2/15), respectively. Improvement/maintenance of motor milestones from index was achieved by 8/19, 12/19, and 7/14 patients, respectively. Mean time-to-improvement (±SE) was 5.8 (1.4), 2.0 (0.4), and 4.7 (1.0) months, respectively. For patients treated with nusinersen monotherapy, OA monotherapy, or switching to OA from nusinersen, 12/19, 20/21, and 8/14 achieved/maintained normal cry function; 12/14, 18/18, and 9/11 improved/maintained speech function; and 10/17, 18/19, and 7/14 improved/maintained any eating function (e.g., thin liquids by mouth, some food consistency by mouth), respectively. Inpatient admission rates at baseline vs. follow-up were 1.06 vs. 0.65, 0.34 vs. 0.00, and 1.69 vs. 0.74; emergency room visits were 1.09 vs. 0.54, 0.26 vs. 0.34, and 1.25 vs. 0.50 PPY, respectively. CONCLUSIONS: Patients with SMA improved/maintained function across multiple outcomes after receiving OA at ≥6 months of age, regardless of prior nusinersen therapy. Time-to-improvement was shortest for patients who received OA monotherapy. Patients also experienced reductions in the rate of inpatient admissions, with no admissions after OA monotherapy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23dabbouschart-reviewposter124776-pdf.pdf?sfvrsn=aa1c579f_0","title":"ISPOR23_Dabbous_Chart Review_POSTER124776.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124776","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of CDK 4/6 Inhibitors in the Treatment of HR+/HER2- Breast Cancer: A Systematic Review","id":"5d7d4736-7c22-479c-b1d3-626fd8180927","sessionCode":"EE55","topDisplay":"Bhatt A, Nwosu J, Zhong L Texas A&M University, College Station, TX, USA","locationCode":"240","description":"\r\n\t<div>OBJECTIVES: Drug costs account for approximately 20% of the total cost of cancer care in the United States. High drug costs add to the economic burden to the health care system. The study aimed to systematically assess the cost-effectiveness evidence of Cyclin-Dependent Kinase (CDK) 4/6 inhibitors in the treatment of HR+/HER2- advanced breast cancer from a US societal/payer’s perspective. METHODS: A literature search was conducted on PubMed. Two independent reviewers: 1) screened title/abstract and assessed full text to determine whether studies met inclusion criteria; 2) used Drummond checklist to rate the quality of the studies; and 3) extracted key information from the identified studies. RESULTS: 201 records were identified from PubMed through keywords searching. After screening by title/abstract and full report assessment, 10 articles met the inclusion and exclusion criteria and were included in the final analysis. Among the 10 studies, 3 articles found CDK 4/6 inhibitors to be cost-effective in the treatment of HR+/HER2- breast cancer from a US societal/payer’s perspective. The remaining 7 articles found it not to be a cost-effective option with CDK 4/6 inhibitor drug costs being the main cost driver. CONCLUSIONS: CDK 4/6 Inhibitors remain novel in the treatment of HR+/HER2- advanced breast cancer. This study systematically reviewed cost-effectiveness evidence of this class of medication and provide insight on the value associated with the medications. Key healthcare stakeholders such as the payers and managed care organization can benefit from such evidence during formulary management and price negotiations with pharmaceutical manufacturers.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127504","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Etranacogene Dezaparvovec for the Treatment of Hemophilia B","id":"c2a85281-41d3-47c0-a527-63d91b9734c4","sessionCode":"EE555","topDisplay":"Sarker J1, Moradi A2, Whittington M2, Tice JA3, Herce-Hagiwara B2, Fahim SM2, Chu J3, Agboola FO2, Pearson S2, Rind DM2, Walton S1 1University of Illinois Chicago, Chicago, IL, USA, 2Institute for Clinical and Economic Review, Boston, MA, USA, 3UCSF School of Medicine, San Francisco, CA, USA","locationCode":"332","description":"\r\n\t<div>OBJECTIVES: Etranacogene dezaparvovec (Etranadez) is a new gene therapy for hemophilia B. This study assessed the cost-effectiveness of Etranadez compared with Factor IX (FIX), in hemophilia B patients without inhibitors eligible for prophylaxis. A special consideration in this assessment was employing a cost savings cap for the new therapy as the existing treatments come at exceptionally high costs. METHODS: Cost and QALY projections were performed using an evidence based semi Markov model. Important assumptions included no mortality effects of the drugs and use of bleed rates and Pettersson Scores to proportionally project short term costs and QALY implications as well as model longer term consequences of bleeds on joints. The model also features projected declines in efficacy in the gene therapy and eventual discontinuation whereby patients reinitiate FIX prophylaxis. After receiving gene therapy, patients are projected to have slight QALY gains and large cost offsets due to the cost of FIX prophylaxis. Consequently, we feature a cap on cost offsets of $150,000 per year as a scenario analyses to assess a value based price. RESULTS: Etranadez was associated with a lifetime QALY gain of 0.64 and cost savings of over $6 million in a conventional model as annual costs of Factor IX therapy exceed $700,000 per year. However, when the model is constructed to cap annual cost savings associated with the gene therapy to $150,000 per year etranadez is not found to be cost effective at a price of $3.5 million. Instead, we found a value based price would be $2,958,000 at a willingness to pay of $150,000 per QALY. CONCLUSIONS: In considering the cost-effectiveness of Etranadez as a new therapy, special consideration should be given to the existing high costs of Factor IX and the impact of capping cost savings associated with the new therapy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23sarkerposteree555124326-pdf.pdf?sfvrsn=f140c0_0","title":"ISPOR23_Sarker_POSTER_EE555124326.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124326","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Immunoglobulin a Nephropathy Patient Reported Health Utility and Quality of Life: Evidence from Real-World Data","id":"0fce1b0d-b4de-4356-9206-6488f4047018","sessionCode":"RWD21","topDisplay":"Lafayette R1, Aldworth C2, George A3, de Courcy J4, Golden K5, Kroes M6, Proudfoot C6, Ndife B7 1Stanford University Medical Center, Stanford, CA, USA, 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 3Novartis Healthcare Pvt. Ltd., Hyderabad, AP, India, 4Adelphi Real World, Bollington, UK, 5Adelphi Real World, Bollington, CHE, UK, 6Novartis Pharma AG, Basel, Switzerland, 7Novartis Pharmaceuticals Corporation, Brooklyn, NY, USA","locationCode":"831","description":"\r\n\t<div>OBJECTIVES: Immunoglobulin A nephropathy (IgAN) is a rare kidney disease with an annual incidence of ~25/1000000 worldwide. Approximately 50% of IgAN patients with proteinuria ≥1 g/day progress to kidney failure within 15 years. There are limited published health related quality of life (HRQoL) data from IgAN patients in clinical practice to date, here we report results from a multi-country study and describe patient-reported health utility and QoL split by proteinuria and estimated glomerular filtration rate (eGFR). METHODS: The Adelphi IgAN Disease Specific Programme was a point-in-time survey of IgAN-treating nephrologists and their patients in France, Germany, Italy, Spain, the UK (EU5), the US, China, and Japan, between June–October 2021. Physicians reported patient demographics and clinical characteristics. Patients completed: EQ-5D-5L (1 = perfect health – 0 = death, US tariff), EQ-VAS (0 worst to 100 best imaginable health) and Kidney Disease QoL (KDQOL; higher scores = better QoL). Patients who answered all of the above were split by proteinuria (P1<1g/day≤P2) and eGFR (G1≥45mL/min/1.73m2>G2), analyses were descriptive. RESULTS: Overall, 883 patients had matched physician reported proteinuria (536 (P1), 307 (P2)) and 894 eGFR (714 (G1), 136 (G2)) at survey. Mean patient age was 42 years, 56% of patients with matched proteinuria and 57% with matched eGFR were male respectively. Overall mean EQ-5D-5L scores at survey were 0.87 (P1) vs 0.79 (P2), and 0.86 (G1) vs 0.71 (G2). Overall mean EQ-VAS scores were 75.5 (P1) vs 67.5 (P2) and 73.8 (G1) vs 60.0 (G2). Overall mean KDQOL burden of kidney disease scores were 60.1 (P1) vs 46.7 (P2) and 56.9 (G1) vs 39.4 (G2). CONCLUSIONS: EQ-5D-5L, EQ-VAS and KDQoL results suggest worsening HRQoL and health utility with increasing IgAN severity (higher proteinuria/ lower eGFR) highlighting an unmet burden of disease.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23goldenposter125006-pdf.pdf?sfvrsn=3426a9cc_0","title":"ISPOR23_Golden_POSTER125006.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125006","diseases":[{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cardiac Implantable Electronic Device Centers’ Landscape in the Brazilian Public Healthcare: A 12-Year Real World Data Analysis","id":"3cd72885-5178-4713-a04f-649ea502e686","sessionCode":"RWD33","topDisplay":"Marcolino M1, Antonini Ribeiro R2, Polanczyk CA1 1Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil, 2National Institute of Science and Technology for Health Technology Assessment (INCT-IATS), Porto Alegre, RS, Brazil","locationCode":"842","description":"\r\n\t<div>OBJECTIVES: Cardiac implantable electronic devices (CIED) implantation procedures, available in the Brazilian Public Health System (SUS) for more than 30 years, are performed only in tertiary care centers. This research aims to explore CIED implantation centers' landscape in the Brazilian Public Healthcare System. METHODS: Open data of approved hospital admissions from 2008 to 2019 with CIED implantation (permanent pacemaker, implantable cardioverter-defibrillator [ICD], and cardiac resynchronization therapy [CRT]) reimbursed by SUS were obtained from the Hospital Information System through the Informatic Department of SUS (DATASUS). Individual admissions registers were used to identify and analyze the centers' geographic distribution, characteristics, and activity related to CIED implantation. RESULTS: In the period, SUS reimbursed 216,440 CIED implantations performed in 260 centers, 40.4% located in capital cities and most being classified as philanthropic institutions (60.8%). The number of centers conducting CIED implants varied yearly, increasing from 190 in 2008 to 226 in 2019 (+18.9%), with a mean of 213 centers. Geographically, most centers were in the Southeast region (n=151, 44.2%), with the states of São Paulo (n=52, 20%) and Minas Gerais (n=35, 13.5%) leading. All centers performed pacemaker implants; 151 (58.1%) implanted pacemakers exclusively, while 87 (33.5%) implanted ICD, 90 (34.6%) CRT, and 80 (30.8%) CRT with defibrillator. The mean (range) total and annual number of implants performed by center in the 12-year period was 832.5 (1; 6,183) and 75.1 (1; 662), respectively. North centers presented the lower mean total (671.4, range 15; 1876) and annual (37.9, range 1; 203) number of implants. CONCLUSIONS: Real World Evidence from the Brazilian Public Healthcare System indicates that CIED implantation centers have a heterogeneous geographic distribution. An increase in the number of active centers per year was identified. Also, there is considerable variability in the number of procedures and types of device implants performed by each institution.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/poster-ispor---id-127740127740-pdf.pdf?sfvrsn=f6bbace9_0","title":"Poster ISPOR - ID 127740127740.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127740","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Health Equity Frameworks – Healthcare System Actions and Priorities","id":"cac5b40c-56d1-49cf-9c2f-64b26764d979","sessionCode":"HPR29","topDisplay":"Gulaid A1, Goldman E2, Skaar J1, Dehipawala S3 1Trinity Life Sciences, New York, NY, USA, 2Trinity Life Sciences, Waltham, MA, USA, 3Trinity Life Sciences, Bellerose, NY, USA","locationCode":"525","description":"\r\n\t<div>OBJECTIVES: Health equity has been defined as attainment of the highest level of health for all people, regardless of race, ethnicity, disability, and/or other factors affecting access to care and health outcomes in healthcare delivery. Health equity is becoming a priority for payers and hospitals looking to improve patient outcomes. The objective of this research was to evaluate health equity frameworks currently used by payer and hospital organizations. METHODS: Targeted literature searches were conducted in PubMed and Google Scholar to identify papers evaluating health equity frameworks. Searches were supplemented with information from payer and hospital organizations, including annual reports, frameworks, and guidelines. Key search terms included, but were not limited to, “diversity,” “health equity,” “guidelines,” and other similar terms. RESULTS: Across identified sources, equitable policies at the organizational level and provision of culturally appropriate patient care were key trends. The Centers for Medicare & Medicaid Services (CMS) developed a framework for health equity focusing on active measures at the system and community levels and identified five priority metrics to evaluate program performance. Cigna developed guidelines focused on internal actions, including working with community partners for case management, policy reviews to ensure equitable practices, and incorporating health equity into reimbursement models. To support the advancement of health outcomes and reduction in barriers to care, the American Hospital Association developed an equity roadmap based on six pillars designed to establish community collaboration, systematic and shared accountability, and equitable organizational policies. CONCLUSIONS: Health equity is a key objective for healthcare systems in the United States and has been increasingly incorporated into frameworks within healthcare delivery organizations. Existing frameworks serve as reference points for all payers, hospitals, and other entities developing future guidelines. Further research is required to assess if framework implementation is advancing health equity, including the impact on real-world patient outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gulaidposter126417-pdf.pdf?sfvrsn=46cdc99f_0","title":"ISPOR23_Gulaid_Poster126417.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126417","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Key Features and Challenges of Cell and Gene Therapies Highlighted in Health Technology Assessment (HTA) Submissions","id":"d750a5e2-613d-4321-bf40-64bf6a705ea3","sessionCode":"HTA12","topDisplay":"Tran J1, Vu BK2, Campden R3, Zhou M4, Musat M5, Thakur D4 1Cytel Canada Health Inc., Montréal, QC, Canada, 2Cytel Inc., Montréal, QC, Canada, 3Cytel Inc., Vancouver, BC, Canada, 4Cytel Inc., Toronto, ON, Canada, 5Cytel Inc., Waltham, MA, USA","locationCode":"618","description":"\r\n\t<div>OBJECTIVES: Cell and gene therapies aim to manipulate genetic materials for the treatment of inherited or acquired diseases. They are a promising solution for managing diseases with few or no alternative therapies, but are often associated with potential risks and high costs. We sought to highlight the positive features and limitations cited by HTA agencies in submissions for cell and gene therapies. METHODS: HTA submissions from NICE, CADTH, HAS, and G-BA/IQWiG were searched for available completed submissions for cell and gene therapies. Positive remarks, uncertainties, and limitations highlighted by the HTA committees were identified and summarized. RESULTS: In total, 17 HTA submissions were reviewed, of which 11 incorporated an economic assessment. Most submissions received a positive recommendation (15/17). Two submissions were rejected by IQWiG because comparative effectiveness could not be established. The remaining submissions reported meaningful clinical benefit, despite some results derived from single-arm trials. Indirect comparison with real-world evidence (RWE) data was frequently reported as a limitation in assessing comparative effectiveness. Use of historical cohorts with incomplete patient characteristics or cohorts that did not fully match the population were the most common critiques of the evidence. Most economic models were deemed appropriate for decision-making despite their complexity. They were largely criticized for the use of utility values that lacked robustness or methodological limitations in the approach used to derive. The approach and assumptions for estimating long-term efficacy were important sources of uncertainty due to insufficient data and had an impact on cost-effectiveness. CONCLUSIONS: The uncertainties related to long-term outcomes and the high costs associated with cell and gene therapies are often surpassed by the significant benefits demonstrated in populations with high unmet need. The robustness of comparative effectiveness assessments is highly influenced by the choice of RWE data in the absence of randomized trials.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23thakurposterhta12125263-pdf.pdf?sfvrsn=28b8a76c_0","title":"ISPOR23_Thakur_POSTER_HTA12125263.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125263","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Hospital Resource Use in below-Knee Surgical Bypass Procedures with Eptfe Vascular Grafts with Heparin End-Point Covalent Bond in Critical Limb Ischemia Peripheral Arterial Disease (PAD) Patients","id":"a8132cbe-d64c-4aa2-95a8-65005f43939f","sessionCode":"EE4","topDisplay":"Iqbal K1, Pons M2 1WL Gore & Associates Ltd, Livingstone, WLN, UK, 2W.L. Gore y Asociados, S.L., Barcelona, Spain","locationCode":"205","description":"\r\n\t<div>OBJECTIVES: PAD is mainly caused by atherosclerosis that reduces blood flow to the limbs. Prosthetic vascular grafts are frequently used in lower limb bypass procedures in occluded or stenosed arteries. This study reviewed the hospital resource use reported in published literature for below-knee surgical bypass procedures using the GORE® PROPATEN® Vascular Graft with heparin end-point covalent bond. METHODS: A literature review of studies on GORE® PROPATEN® Vascular Graft with heparin end-point covalent bond was conducted. Articles were included if they were on below-knee bypass procedures on critical limb ischemia patients, published after 2010 and reported any type of hospital resource use e.g., hospital stay. Registries were excluded due to high risk of bias. Data was extracted and pooled using a weighted average method. RESULTS: 11 articles were reviewed and there were four articles in the final selection. Three studies reported hospital stay (n = 323 patients) and four studies reported operating room time for the bypass procedure (n = 340 patients). No other hospital resource use was reported. For below-knee surgical bypass procedures using the GORE® PROPATEN® Vascular Graft with heparin end-point covalent bond, the weighted average hospital stay was 6.6 days (per patient) and operating room time was 138 minutes (per patient). CONCLUSIONS: Clinical outcomes such as patency and complications are consistently reported in studies. Outcomes on hospital resource use are not consistently reported and are limited to hospital stay and operating room time. More reporting on hospital resources e.g., intensive care use, blood products and consumables used in treatment of complications, can assist decision makers understand the broader costs of the procedure in the patient treatment pathway.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23-iqbal-poster2124798-pdf.pdf?sfvrsn=e72ff4e_0","title":"ISPOR23-Iqbal-POSTER2124798.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124798","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Burden of Disease of Diabetic Macular Edema and Neovascular Age-Related Macular Degeneration in Panama","id":"f2bbb0eb-6f35-4c7f-b836-65a37c0fd1cd","sessionCode":"EE74","topDisplay":"Hidalgo J1, Ordoñez J2, Ávlia P3, Muñoz JM3 1AstraZeneca, Alajuela, A, Costa Rica, 2True Consulting, MEDELLIN, ANT, Colombia, 3Hospital Santo Tomás, Ministerio de Salud de Panamá, Ciudad de Panamá, Panama","locationCode":"319","description":"\r\n\t<div>OBJECTIVES: Diabetic Macular Edema (DME) and neovascular Age-related Macular Degeneration (nAMD) cause vision loss leading to morbidity and loss of health-related quality of life. Treatment in the country is based on laser (public market) and anti-vascular endothelial growth factor (VEGF) (private market). Our objective is to estimate the economic burden generated by these diseases in Panama to have information that allows decision-makers to estimate the magnitude of this problem in the country. METHODS: A bottom-up cost analysis was performed with ophthalmology and retinology experts from the country. Experts differentiated resources of the public and private healthcare systems and the costs of each one. A list of the most used health resources (identified from the scientific literature) was evaluated with each expert in the care of these patients, calculating the probability and frequency of their use; finally, every expert identified the differences in healthcare processes, avoiding the halo effect. Finally, the costs (USD 2023) from the tariff manuals and those reported by the experts were taken to build the model. RESULTS: The average annual cost of healthcare for a patient with DME in Panama is $18,725, 67% of which are indirect costs (a health caregiver and sickness pension for vision loss). The average annual cost of healthcare for a patient with nAMD in Panama is $16,288, 77% of which are indirect costs (a health caregiver and sickness pension for vision loss). Patients with DME and nAMD are treated in the public health system with laser only, while patients in the private health system receive treatment with laser and anti-VEGF. CONCLUSIONS: The annual cost of patients with DME and nAMD in Panama fluctuates between $16,288 and $18,725, and approximately 70% of them are due to health caregivers and sickness pensions for vision loss.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/02-bod-pty128008-pdf.pdf?sfvrsn=c397dfec_0","title":"02.BoD.PTY128008.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/128008","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Provider Nudges on Herpes Zoster Vaccine Series Completion during the COVID-19 Pandemic in the United States","id":"60265583-337f-4bb7-8a33-66c8625bc2ed","sessionCode":"HSD16","topDisplay":"Gatwood J1, Brookhart A2, Kinney O2, Hagemann TM1, Chiu CY3, Ramachandran S4, Gravlee E4, Hohmeier K1 1University of Tennessee Health Science Center, Nashville, TN, USA, 2Kroger Health, Cincinnati, OH, USA, 3University of Tennessee Health Science Center, Memphis, TN, USA, 4University of Mississippi, Oxford, MS, USA","locationCode":"610","description":"\r\n\t<div>OBJECTIVES: To determine the impact of a pharmacy-based, clinical decision support (CDS) tool on herpes zoster (HZ) vaccine series completion during the initial months of the COVID-19 pandemic across the US. METHODS: In partnership with Kroger Health, a pharmacy CDS tool alerted staff of patients due for their second HZ vaccine dose, which had been accompanied previously by a timed text message. Once operations changed due to COVID-19, the system limited outreach to only patients visiting the pharmacy. Primary outcomes included the proportion of patients receiving both doses within a Kroger-owned pharmacy (n=2,293) and the number of days between doses, both within and across two 32-week periods before and after the pandemic hit the US. Generalized estimating equation-based (GEE) logistic and linear regression models determined differences in completion rates and time to completion. RESULTS: During the observation period, 38,937 adults received at least one HZ vaccine dose, with 77.2% receiving both doses. Patients engaged by the CDS tool achieved 80.5% dose completion, versus 65.4% of those not intervened (p<0.0001), which was lower than in the period immediately before the pandemic (85.8%, p<0.0001). The dosing window averaged 119.4 days (SD: 26.91), which was the longest timeframe between doses since the HZ vaccine was launched and nearly one month longer than before the pandemic (93.0 days [SD: 28.02], p<0.0001). The odds of dose completion increased in areas of higher health literacy (OR: 1.01; 95% CI: 1.007-1.014), but decreased in areas of higher poverty (OR: 0.992; 95% CI: 0.988-0.995). Time to completion was slightly shorter (B=-0.04, p<0.05) in areas of higher health literacy. CONCLUSIONS: Despite changes in clinical processes, a nationwide community pharmacy was successful in completing HZ vaccine dose series for adults during the pandemic, suggesting that processes in community pharmacies can protect staff while remaining committed to providing preventive health services during public health crises.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126071","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessing the Impact of Early Albumin Administration in Patients Requiring Intravascular Resuscitation: Application of Machine Learning Techniques to Electronic Health Record (EHR) Data","id":"e09604df-5e3d-4a17-aae2-68730cbc8ab3","sessionCode":"MSR6","topDisplay":"Viayna E1, Ardiles T2, Runken MC2, Weimer I3, Zhang X3, Pathan F3, Lodaya K3 1Grifols International, Sant Cugat del Valles, B, Spain, 2Grifols SSNA, RTP, NC, USA, 3Boston Strategic Partners, Inc., Boston, MA, USA","locationCode":"646","description":"\r\n\t<div>OBJECTIVES: Exogenous human albumin administration has shown improved outcomes in patients requiring intravascular resuscitation (e.g., spontaneous bacterial peritonitis, and hepatorenal syndrome). However, its acute use in other conditions and liver disease-associated complications requiring fluid resuscitation is unclear. We applied machine learning (ML) techniques to electronic health records data from patients with anemia and gastrointestinal bleeding, alcoholic liver disease, hepatic failure, acute pancreatitis, and nephrotic syndrome, to identify subpopulations that may benefit from early albumin administration. METHODS: Using de-identified Cerner Real World Data and ICD-10-CM codes, we identified five cohorts receiving albumin during hospitalization between 10/1/2015–03/31/2021. Each cohort was 1:1 propensity score matched (PSM) on baseline characteristics and early albumin receipt (<24 hours of admission), using logistic regression and k-nearest neighbor models. Decision tree (DT) models were used to predict four outcomes: 30-day mortality (30DM), 90-day readmission, hospital length of stay, and hospital-free days. After model visualization, we identified relevant splits in the DTs to assess subgroups of interest. Once identified, the model conditions were applied to the full dataset to extract the subgroup. Significance testing was conducted using chi-square test. RESULTS: In total, 361,704 distinct patients were analyzed. After PSM, the most notable positive signal was observed for the 30DM outcome in the anemia with gastrointestinal bleeding cohort (N=10,388). DT models classified favorable outcomes for a subgroup (n=598) with no cirrhosis and severe anemia (baseline hemoglobin <7.0 g/dL). This prediction was validated on the full dataset where this subgroup had a 25.8% lower 30DM rate compared to those not receiving early albumin (p=0.04). CONCLUSIONS: Among five distinct cohorts, ML techniques were used to identify patient subgroups potentially benefiting from early albumin. Our findings indicate a viable methodology for patient subgroup selection and suggest that non-cirrhotic patients with severe anemia may benefit from early albumin.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/230414isporgrifolsalbuminml124428-pdf.pdf?sfvrsn=ed0a252_0","title":"230414_ISPOR_Grifols_Albumin_ML124428.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124428","diseases":[{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Minimization and Budget Impact Analysis of Venetoclax Versus Acalabrutinib for 1L and R/R Chronic Lymphocytic Leukemia in the Brazilian Public Healthcare System","id":"4d61a883-9aab-4b9c-868d-6a7e0a357c23","sessionCode":"EE53","topDisplay":"Mattos ER1, Follador W2, Campos L3, Antunes RC4, Biella C3 1Amaral Carvalho Hospital, Jaú, Brazil, 2TechValue Healthcare Consulting, São Paulo, Brazil, 3AbbVie, São Paulo, Brazil, 4AbbVie Brazil, São Paulo, Brazil","locationCode":"235","description":"\r\n\t<div>OBJECTIVES: To demonstrate the economic advantages of using venetoclax (plus obinutuzumab [VenO] or rituximab [VenR]) vs acalabrutinib monotherapy (Acala) in the first line (1L) and relapse or refractory (R/R) chronic lymphocytic leukemia (CLL) treatment under the Brazilian public healthcare system (SUS). METHODS: Similar efficacy between VenO, VenR and Acala on Overall Survival and Progression-Free Survival were demonstrated in both lines (1L and R/R respectively) by two network meta-analysis (Molica et al 2021;2020). The same similarity was shown in a head-to-head trial comparing Acala vs ibrutinib (Byrd et al 2021) and by an indirect comparison of VenR vs B-cell receptor inhibitors (Mato et al 2018). Assuming this similar efficacy, was developed a Cost-Minimization Analysis comparing these treatment options taking the drugs acquisition costs and comparing the costs per patient over 4-years. A Budget Impact Analysis (BIA) was developed considering the estimative for the number of high-risk patients to be treated by the Brazilian public healthcare system (3,183 patients/year for 1CLL and 694 patients/year for R/R). RESULTS: For 1L and R/R-CLL treatments, the 4-years direct costs of treatment show that VenO and VenR results in cost savings up to BRL 2,209,469 (-77%) and BRL 2,241,944.25 (-71%) per patient, respectively, when compared to Acala. These savings tend to be higher the longer the duration of treatment. BIA showed savings of more than 8 billion and 700 million in 5 years, for 1L and R/R-CLL treatments, respectively. CONCLUSIONS: VenO and VenR have shown evidence of being the only fixed duration treatment regimens that achieve a sustained CLL remission when compared to continuous Acala monotherapy, with similar prices and more convenient treatment for patients and healthcare providers. Therefore, Ven-based regimens imply in cost-savings and benefits in quality of life when compared to Acala, while the clinical outcomes remain favorable.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23biellaposter123904-pdf.pdf?sfvrsn=a0e9997_0","title":"ISPOR23_Biella_POSTER123904.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123904","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Comparing Cardiac Safety Profile of Metformin and Sulfonylureas in Colorectal Cancer (CRC) Patients with Type 2 Diabetes Mellitus (T2DM): Surveillance, Epidemiology and End Results (SEER) Medicare Analysis","id":"43331055-c4be-4c71-8e96-6b170dc6cc77","sessionCode":"EPH3","topDisplay":"Allen C1, O'Mara A2, Zyfi D2, Krishnamurthi J2, Patel NM2, Okoli OA2, Murimi-Worstell IB2 1Massachusetts College of Pharmacy and Health Sciences, VERONA, NJ, USA, 2Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA","locationCode":"408","description":"\r\n\t<div>OBJECTIVES: Colorectal cancer (CRC) patients with type 2 diabetes mellitus (T2DM) are at a higher risk of developing cardiovascular complications, in part due to T2DM treatments. We compared the cardiovascular safety of metformin vs sulfonylureas, two common T2DM therapies, in elderly patients with CRC and T2DM. METHODS: Retrospective cohort study in the SEER-Medicare database. CRC patients >65 years who were newly prescribed metformin or sulfonylurea during 2015-2019 were followed from the date of their first prescription until they developed a major cardiac event (MACE), died, or lost their insurance. The MACE composite outcome included heart failure (HF), stroke, myocardial infarction (MI), and death. Kaplan Meier survival curve with log-rank test was used to estimate the association between the two exposures and the composite outcome. Cox proportional hazard model was used to adjust for covariates. Descriptive statistics compared patient characteristics between groups at baseline. RESULTS: We identified 1865 CRC patients of which 1580 used metformin and 285 used sulfonylureas. Patients in the two groups differed in both demographic and clinical characteristics such as gender, age, Charlson Comorbidity Index (CCI) all of which were accounted for in the adjusted model. MACE outcome occurred at a statistically higher rate in the sulfonylurea group compared to metformin (15.1% vs 5.1%, adj. hazard ratio (HR) 3.4, 95% confidence interval (CI): 2.3 - 4.9). Moreover, age, CCI, cancer stage, and prior history of HF were independently associated with a higher risk of MACE. Secondary analysis limited to patients without a history of stroke, HF, or MI produced similar conclusions (9.3% vs 2.4%, adj.HR 4.5, 95% CI: 2.6 - 7.9). CONCLUSIONS: This study suggests a higher risk of MACE in CRC patients taking sulfonylureas instead of metformin as a first-line treatment for T2DM. Additional studies are needed to clarify this association.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/mcphs-postermetformin-sulfonylurea-crc-t2dm-safetyfinal-ispor-submission04242023127728-pdf.pdf?sfvrsn=a551781a_0","title":"MCPHS Poster_Metformin-Sulfonylurea-CRC-T2DM-Safety_Final-ISPOR-Submission_04242023127728.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127728","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Related Costs with Biological Therapy in Patients with Axial Spondyloarthritis (AXSPA): Real World Evidence from a Tertiary Hospital from Bogota, Colombia","id":"b850f025-7157-48e1-9279-6b60b601194f","sessionCode":"RWD9","topDisplay":"Calixto OJ1, Salguedo Madrid G1, Vera-Parra EC2, Meneses-Toro MA2, Saavedra GP2, Beltran-Ostos A2, Quitian Reyes H3, Bello JM1 1Universidad Militar Nueva Granada, Bogota, CUN, Colombia, 2Universidad Militar Nueva Granada, BOGOTA, Colombia, 3pontificia universidad javeriana, Bogotá, Colombia","locationCode":"819","description":"\r\n\t<div>OBJECTIVES: To describe the direct costs of patients diagnosed with Axial Spondyloarthritis (axSpA) at the Hospital Militar Central under conventional o DMARD therapy compared with biological therapy. METHODS: Economic evaluation study, estimation of direct costs of biological therapy in axSpA according to ASAS criteria. The methodology of costing by procedures and the identification of costing sequence, quantification and valuation of resources was used. With a complementary sensitivity analysis. The costs are presented adjusted in US dollars for 2022. RESULTS: 162 patients with a diagnosis of axSpA were included (117 Ankylosing spondylitis [AS] and 45 Psoriatic arthritis [PsA]) were included, AS 63.2% men, age 46.4 ± 13.7 years. The use of medication was DMARDs 49.6%, NSAIDs 64.1%, anti-TNF 40.2%, and anti-IL-17 2.6%. PsA 55% men, age 50.7 ± 12.9 years. The use of medication was DMARDs 51.1%, NSAIDs 31.1%, anti-TNF 24.4% and anti-IL-12/23 2.2%. AS average annual direct costs / patient was $565.3 NSAID group, $464.5 DMARDs group, and $9,751.2 biological therapy group. PsA average annual direct costs / patient was $277.9 NSAID group, $715 DMARDs group, and $10,608.6 biological therapy group. CONCLUSIONS: The costs related to axSpA are like those reported in the literature when adjusted for the purchasing power of parity. Understanding this aspect is the starting point to promote a more efficient distribution of the limited resources destined to the management and control of AS and PsA.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123834","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Active Surveillance for Safety Monitoring of COVID-19 Vaccines in Saudi Arabia","id":"5545fb57-32f6-465a-88b3-6bb62c8d2320","sessionCode":"EPH47","topDisplay":"Alhabardi S1, Alhusayni L2, Aljebreen M2, Alzamil A3, AlSwead M4, Alrohaimi M2, Alharbi F2 1Saudi Food and Drug Authority, Riyadh, Saudi Arabia, 2Saudi Food and Drug Authority, Riyadh, 01, Saudi Arabia, 3Almaarefa University, Riyadh, Saudi Arabia, 4Princess Nourah bint Abdulrahman University, RIYADH, Saudi Arabia","locationCode":"446","description":"\r\n\t<div>OBJECTIVES: It is generally accepted that the world will not return to the pre-pandemic normally situation until safe and effective vaccines become available. However, the rare and unknown adverse events following immunization (AEFIs) are not usually detected in the clinical trials. Thus, monitoring the safety of coronavirus disease of 2019 (COVID-19) vaccines in real-world population is essential. Therefore, the Saudi Food and Drug Authority (SFDA) performed a post-marketing safety surveillance of AEFIs following administration of COVID-19 vaccines. METHODS: A prospective cohort study conducted and followed subjects who received COVID-19 vaccines from the first day of vaccination for seven days after the first and second doses, then biweekly for three months. All information from the vaccinee (demographic information, vaccine type and AEFIs) were collected by phone through a standardized online questionnaire. Baseline characteristics and AEFIs were analyzed descriptively by SPSS software. AEFIs classified according to medical Dictionary for Regulatory Activities (MedDRA). RESULTS: 544 subjects of 8867 agreed to be part of the study. Among them, 218 subjects completed the study. Out of 218, 87 (39.91%) individual received Pfizer-BioNTech vaccine, 45(20.64%) received Oxford/AstraZeneca vaccine, 5(2.3%) individual received Moderna vaccine, and 81 (37.2%) received two different COVID-19 vaccines. The reported events were categorized to system organ class (SOC) according to MedDRA. The most reported SOCs were skin and subcutaneous tissue disorders (n=66 with Pfizer-BioNTech vaccine, n=34 with Oxford/AstraZeneca vaccine, n=5 with Moderna vaccine), nervous system disorder(n=20with Pfizer-BioNTech vaccine, n=18with Oxford/AstraZeneca vaccine, n=3with Moderna vaccine) infections and infestations (n=23 with Pfizer-BioNTech vaccine, n=33 with Oxford/AstraZeneca vaccine, n=4 with Moderna vaccine), musculoskeletal and connective tissue disorders (n=53with Pfizer-BioNTech vaccine, n=46 with Oxford/AstraZeneca vaccine, n=7 with Moderna vaccine). Only 10 (4.6%) cases were serious and required medical intervention. CONCLUSIONS: The preliminary results shows the short-term safety profiles of included COVID-19 vaccines are acceptable in Saudi Arabia.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23alharbiposter125428-pdf.pdf?sfvrsn=f825b47b_0","title":"ISPOR23_Alharbi_POSTER125428.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125428","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient Survey Completion By Touchpoints in a Mailed Survey Methodology","id":"e7f51541-d1b8-4f30-bd32-6c20c23f0f52","sessionCode":"MSR16","topDisplay":"Carlyle M1, Belland A1, Webb N2, Essoi B1, Allenback G3 1Optum, Eden Prairie, MN, USA, 2Optum, Orlando, FL, USA, 3Optum Life Sciences, Las Vegas, NV, USA","locationCode":"710","description":"\r\n\t<div>BACKGROUND: Researchers are often challenged to increase survey completion without overburdening respondents. Evaluating survey completion by touchpoint may provide guidance on the best number of touchpoints to use. OBJECTIVES: To review survey completion by touchpoint across multiple direct-to-patient mailed survey studies. METHODS: A total of 7,901 patients responded to 7 direct-to-patient, mailed surveys across a range of therapeutic areas. Surveys were fielded between 2016 and 2022. Patients were identified from the Optum Research Database (a large, national administrative claims database) using study-specific inclusion criteria and were invited to participate by mail. All studies included three touchpoints: initial mailed survey packet, reminder postcard (sent 2 weeks later), and second mailed survey packet to non-responders (sent 2 weeks later). Two studies utilized a fourth touchpoint (a third mailed survey packet) for select cohorts with limited sample size to increase response rates. Most studies utilized a post-paid $25 incentive. Insurance type, fielding year and study methodology were assessed for impact on response rate. RESULTS: On average, respondents required 1.8 touchpoints and 25.5 days to return completed surveys. Among respondents, half of completed surveys (50.9%) were received following the first touchpoint, 19.3% following the second touchpoint and 29.8% following the third touchpoint. There was little difference in timing of receipt of completed surveys by insurance type. In studies that utilized four touchpoints, touchpoints three and four contributed 33.6% of received responses. CONCLUSIONS: With nearly 30% of completed surveys occurring following a third touchpoint, data continues to support the use of up to three touchpoints for optimal response to direct-to-patient mailed surveys. In studies with a limited sample, a fourth touchpoint may be useful to increase response rates.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23carlylemsr16v2poster127575-pdf.pdf?sfvrsn=de9e833d_0","title":"ISPOR23_CarlyleMSR16_V2_POSTER127575.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127575","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Pharmacogenetic HLA-B*58:01 Testing to Prevent Allopurinol-Induced SJS/TEN in Vietnamese Population: A Cost-Effectiveness Analysis","id":"4b139413-6e73-4a74-b2f1-6cef4155b2a1","sessionCode":"EE94","topDisplay":"Duong K1, Nguyen DV2, Chaiyakunapruk N1, Nelson RE3, Malone DC1 1Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 2Department of Internal Medicine, Respiratory, Allergy & Clinical Immunology Unit, Vinmec Healthcare system, Hanoi, Viet Nam, 3Division of Epidemiology, School of Medicine, University of Utah, Salt Lake City, UT, USA","locationCode":"338","description":"\r\n\t<div>OBJECTIVES: HLA-B*58:01 is strongly associated with allopurinol-induced SJS/TEN in Vietnamese population. However, there is a paucity of the cost-effectiveness of genetic testing for at risk populations. The purpose of this study was to assess the cost-effectiveness of HLA-B*58:01 testing to prevent allopurinol-induced SJS/TEN in Vietnamese population. METHODS: A Markov decision model from a healthcare payer perspective was developed to compare three strategies (1) No HLA-B*58:01 screening, patients initiate allopurinol (current practice); (2) HLA-B*58:01 screening, patients initiate allopurinol if HLA-B*58:01 positive otherwise probenecid is provided; and (3) no HLA-B*58:01 screening, patients initiate probenecid. A lifetime horizon and 1-year cycle length were applied. One-way sensitivity analysis and probability sensitivity analyses were performed to investigate the robustness of the results. A 3-time GDP per capita was used as the willingness-to-pay (WTP) threshold. RESULTS: Compared to the current practice, HLA-B*58:01 screening was expected to increase QALYs by 0.0069 and increase costs by VND 14,283,633 ($US 617), with an ICER of VND 2,070,459,122 ($US 89,398) per QALY. HLA-B*58:01 screening was not cost-effective at a predefined threshold. The probability of testing being cost-effective at the WTP threshold was 0.11. The ICER of the third strategy, only using probenecid, was much higher than the ICER of HLA-B*58:01 screening (VND 15,087,885,880 ($US 651,463) per QALY gained). Sensitivity analyses found that the prevalence of allopurinol-induced SJS/TEN was the most influential factor. CONCLUSIONS: HLAB*58:01 genetic testing screening prior to allopurinol is currently unlikely to be cost-effective in Vietnam with a 3-fold GDP WTP threshold from healthcare payer perspective.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23duongposter126193-pdf.pdf?sfvrsn=a523898d_0","title":"ISPOR23_Duong_POSTER126193.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126193","diseases":[{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Provision of Diet, Exercise, Cholesterol and Hemoglobin A1C Testing in Office Based Medical Visits Among Normal, Overweight, Obese, and Morbidly Obese Individuals in the US","id":"42b00a87-8ab4-4967-918f-6d6d2f14b9ba","sessionCode":"RWD6","topDisplay":"Iyer K Krupanidhi college of Pharmacy, Thane (west), MH, India","locationCode":"816","description":"\r\n\t<div>OBJECTIVES:Obesity is a global epidemic and leads to complications such as diabetes and dyslipidemia. The objective of this study was to examine the provision of diet, exercise, cholesterol and HbA1c testing in office based medical visits among normal, overweight, obese, and morbidly obese individuals in the US. METHODS:The 2018 National Ambulatory Medical Care Survey data was used to conduct the study. Main outcome was provision of diet/nutrition, exercise, weight-reduction counseling, cholesterol and HbA1c testing in normal (BMI:18-25), overweight (BMI:25-30), obese (BMI:30 – 40), and morbidly obese (BMI:40+) individuals. A logistic regression model was fit to examine main outcomes by BMI status. Survey weights are assigned to the sample visits to obtain national estimates. All models were adjusted for confounders: race, ethnicity, age, gender, MSA, and insurance status. Odds ratios are reported to describe differences in overweight, obese, and morbidly obese patients compared to normal weight patients. RESULTS:The weighted study sample consisted of 496,622,621 outpatient visits primarily white (84%), male (58%), covered by private insurance (57%). Multivariate analysis reveals that overweight, obese, and morbidly obese individuals received more HbA1c tests (OR, 1.02; CI, 1.01-1.03; OR, 3.47; CI, 2.31–5.2; OR, 9.01; CI, 4.88–16.66), and lipid profile tests (OR, 1.56; CI, 1.01-2.41; OR, 1.88; CI, 1.32-2.67; OR, 2.16; CI, 1.20-3.90) compared to normal weight patients. Similar trends were observed in the provision of diet/nutrition, exercise, and weight reduction counseling services (OR, 3.31; CI, 1.49 –7.35; OR, 7.51; CI, 2.85 –19.76; OR, 18.47; CI, 7.40– 46.10). CONCLUSIONS:Our study findings suggest that at risk individuals receive more weight-related services, such as testing for diabetes, cholesterol, diet, exercise, and weight reduction education compared to normal weight individuals. This study forms a baseline to examine disparity in provision of such services post-Covid (2019 and beyond) era given the disruption in the scarcity of health care professionals for such basic preventive services.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23iyerposterv2125338-pdf.pdf?sfvrsn=f01719a9_0","title":"ISPOR23_iyer_POSTERV2125338.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125338","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Venetoclax in Combination with Rituximab in Relapsed/Refractory Chroniclymphocytic Leukemia in Four Gulf Countries","id":"bc7118de-fca9-45a6-9129-6ea0c25af466","sessionCode":"EE45","topDisplay":"Hamad A1, Abdaljalil A2, Abdellatif HY3, Aladarbeh QT3, Al Farsi K4, Alhuraiji A5, Gamaleldin AM3, Hamadah A5, Ismail HA5, Osman HY6, Siddiqui M2, Taha RY1, Tannira M3, Pandita R5 1Hamad Medical Corporation, Doha, DA, Qatar, 2Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates, 3AbbVie BioPharmaceuticals GmBH, Dubai, United Arab Emirates, 4Sultan Qaboos University Hospital, Muscat, Oman, 5Kuwait Cancer Control Centre, Kuwait City, Kuwait, 6Tawam Medical Hospital, Al Ain, United Arab Emirates","locationCode":"233","description":"\r\n\t<div>OBJECTIVES: A cost-effectiveness analysis was performed to compare fixed duration venetoclax + rituximab with other treatments for the treatment of relapsed/refractory chronic lymphocytic leukemia in the public healthcare sector of four Gulf countries. METHODS: An existing model using a three-state partitioned survival framework was adapted to the public healthcare sector in Kuwait, Oman, Qatar and the United Arab Emirates (UAE). Inputs included disease epidemiology and local cost of treatment obtained via literature review and a two-round Delphi technique. Unit costs of medications, treatment administration, routine care and monitoring, and adverse event prophylaxis and management were considered. The time horizon for the cost-effectiveness model was 30 years (lifetime time horizon) and a discount rate of 3.5% was applied to costs and outcomes. Comparators included in the model were ibrutinib, fludarabine + cyclophosphamide + rituximab (FCR), bendamustine + rituximab (BR), ibrutinib + BR and acalabrutinib. RESULTS: In Kuwait, Qatar, Oman and United Arab Emirates, venetoclax + rituximab is a dominant strategy compared to acalabrutinib, ibrutinib and ibrutinib + BR due to the lower incremental cost (-$242,455, -$242,148, -$398,254 for Kuwait; -$292,609, -$134,051, -$243,747 for Qatar; -$46,921, -$47,892, -$194,793 for Oman; -$574,592, -$117,772, -$244,443 for UAE) and more QALYs gained (1.929, 1.928, 1.173 for Kuwait; 1.814, 1.813, 1.117 for Qatar; 1.473, 1.472, 0.921 for Oman; 1.851, 1.850, 1.129 for UAE), but not cost-effective compared to FCR or BR, due to the lower cost related to treatment with FCR and BR, despite the QALY gains for venetoclax + rituximab, at willingness-to-pay thresholds of 1 x GDP per capita ($32,373 for Kuwait, $50,806 for Qatar, $15,343 for Oman, $43,101 for UAE). CONCLUSIONS: Venetoclax + rituximab as a fixed treatment duration regimen is a cost-effective treatment option compared to BTK inhibitors (acalabrutinib and ibrutinib) in the Gulf region.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23hamadposter-ee45123125-pdf.pdf?sfvrsn=8371847c_0","title":"ISPOR23_Hamad_POSTER (EE45)123125.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123125","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of the Aspergillus Galactomannan Enzyme Immunoassay in the Brazilian Public Health System","id":"44456d1c-8577-418b-9a9b-6f41930276aa","sessionCode":"EE18","topDisplay":"Barros B, Magliano C, Morais QC, Leite BR, Leite LFDA, Mateus I, Braga A, Santos M Instituto Nacional de Cardiologia, Rio de Janeiro, RJ, Brazil","locationCode":"216","description":"\r\n\t<div>OBJECTIVES: Invasive aspergillosis (IA) is a fungal infection that has been linked to significant morbidity and mortality in severely ill immunocompromised patients. The gold standards for diagnosing IA, culture and microscopy, have limited sensitivity. When treating patients who have risk factors for the condition, the approach is frequently empirical. The galactomannan (GM) test may influence the prognosis of patients with suspected IA by enabling early diagnosis, which lowers the risk of needless therapy, adverse effects, and mortality. This study's goal was to evaluate the clinical and economic effects of integrating the GM test into the Brazilian Public Health System (SUS). METHODS: We investigated five strategies using life years gained (LYG) and “needless therapies avoided” as efficacy outcomes in a Markov model.: (i) culture; (ii) GM test with 0.5 optical density cutoff; (iii) GM test 1.0 cutoff; (iv) GM test 0.5 + culture; (v) GM test 1.0 + culture. Strategies were also compared according to the sample: bronchoalveolar lavage (BAL) or serum. The accuracy of these strategies was based on systematic reviews. The costs are based on a SUS perspective. Additionally, univariate and probabilistic analyses were carried out. RESULTS: When compared to culture, all GM test simulations revealed an increase in LYG and expenses. No matter the sample or cutoff, all demonstrated an incremental cost-effectiveness ratio of under USD 950.00. When comparing the cutoffs, the 0.5 was associated with a marginal improvement in LYG (0.02 (serum) to 0.03 (BAL)), but it was also associated with a rise in expenses (USD 43 (serum) to USD 97/ patient (BAL)) and the proportion of patients receiving unnecessary treatment (4.5% (serum) to 10.1% (BAL) false positives). CONCLUSIONS: The findings demonstrate that adding the GM test to the SUS would be cost-effective and improve survival rates. Higher GM cutoffs are associated with fewer inappropriate prescriptions without substantial clinical benefit losses.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23barrosposter123596-pdf.pdf?sfvrsn=86525c51_0","title":"ISPOR23_Barros_POSTER123596.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123596","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Targeted Literature Review of Disutilites for Type 2 Diabetes Treatment-Related Attributes","id":"cf51b995-a853-409e-b762-6f522a190791","sessionCode":"PCR4","topDisplay":"Liu X1, Xie S2, Guo W1, Wu J1 1Tianjin University, Tianjin, 12, China, 2Tianjin University, Hamilton, ON, Canada","locationCode":"718","description":"\r\n\t<div>OBJECTIVES: To synthesize the literature on eliciting disutilities associated with treatment-related attributes in type 2 diabetes (T2DM). METHODS: This review followed PRISMA guidelines. A literature search was performed in Pubmed and Embase from inception to October 25, 2022. Studies eliciting disutilities related to T2DM treatment-related attributes were included. Characteristics including country, sample size, perspective of preference, description of the attribute and response levels, and corresponding disutilities were summarized. RESULTS: A total of nine studies were included. Studies were conducted across seven countries, most studies (n=6) were conducted in the UK, followed by Canada (n=2), China (n=2), Denmark (n=1), Italy (n=1), South Korea (n=1), and Sweden (n=1), with three studies conducted in multiple countries. Sample size varied from 59 to 4060. The perspective of preference included T2DM patients (n=7) and the general public (n=3), with one study included both. Elicitation approaches used were time trade-off (n=5) and standard gamble (n=4). Eight treatment-related attributes were identified, including weight change (n=5), dosing frequency (n=4), gastrointestinal side effects (n=2), flexible dosing (n=2), administration requirement (i.e., reconstitution, waiting, and needle handling) (n=2), injection site reaction (n=1), fear of hypoglycemia (n=1), and HbA1c level (n=1). For the attribute of weight change, the response levels were set as ±2%, ±3%, ±5%, ±7%, with the utility ranged from -0.106 to 0.046. One study reported utility change per kilogram (0.0041 to 0.0073). Respondents showed a preference for weekly over daily administration (0.023 to 0.0947). One study reported the disutility of one additional injection (-0.021 to -0.015). The disutility for the rest of six attributes ranged from -0.04 to -0.006. CONCLUSIONS: This review provides evidence synthesize of published disutilities related to T2DM treatment-related attributes. T2DM treatment-related attributes have a nonnegligible effect on utility values. Weight change and dosing frequency were the most reported with the largest impact.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23liuposter127920-pdf.pdf?sfvrsn=edfa90bc_0","title":"ISPOR23_Liu_POSTER127920.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127920","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Health Care Use and Out-of-Pocket Costs after a Transitional Palliative Care Intervention for Rural Family Caregivers and Care Recipients: A Randomized Controlled Trial","id":"5c390535-f88f-4d4c-b8c3-6f52314cd210","sessionCode":"PCR9","topDisplay":"Kaufman B1, Huang RW2, Holland D3, Vanderboom C3, Ingram C3, Wild E3, Dose AM3, Styles C3, Gustavson AM3, Baer-Benson H3, Mandrekar J3, Griffin J3 1Duke University School of Medicine, Durham, NC, USA, 2Duke University, Durham, NC, USA, 3Mayo Clinic, Minneapolis, MN, USA","locationCode":"1B","description":"\r\n\t<div>OBJECTIVES: Rural family caregivers (FCGs) in the United States may experience physical, emotional, and financial burdens. This randomized controlled trial compares a transitional palliative care intervention (TPC) to support FCGs for seriously ill care recipients (CRs) to an attention control condition. We evaluated of TPC’s effect on healthcare use and out-of-pocket spending. METHODS: TPC FCGs received counseling via video calls for 8 weeks following CR discharge from the hospital. After discharge, a research assistant called all FCGs once a month for up to 6 months to collect self-reported healthcare utilization (e.g. outpatient, emergency department, and hospital), out-of-pocket healthcare spending (e.g. deductibles and coinsurance), and health-related travel costs (e.g., transportation, lodging, food) for FCGs and CRs. Incidence rate ratios (IRR) were estimated using negative binomial regressions with offset to account for censoring. RESULTS: The study included 282 FCG-CR dyads across 3 states. Days follow-up (95.5) and survey completion (3.6 surveys) were similar across arms. CR mortality was 48% by six months. TPC reduced nights in the hospital for CR (IRR = 0.746; 95% CI = 0.562 – 0.990) and increased emergency department visits for FCG (IRR = 3.579; 1.159 – 11.055). Across both groups, mean out-of-pocket spending for dyads was $770.61, with healthcare payments contributing $539.92 and travel expenses contributing $230.68. Total out-of-pocket spending was not significantly higher for TPC versus control; though TPC dyads reported greater total healthcare (IRR = 1.534; 1.211 – 1.943) and lodging (IRR = 3.412; 2.681 – 4.342) costs. CONCLUSIONS: This study contributes to evidence that palliative care interventions reduce unnecessary hospitalization for seriously ill patients. The TPC intervention may have increased trust and knowledge of health care systems, allowing rural FCGs to seek emergency care when they may not have otherwise. The financial burden on rural FCGs is substantial, and intervention design should consider impacts on out-of-pocket spending.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/finalisporposter125463-pdf.pdf?sfvrsn=dd72c33c_0","title":"FinalISPORPoster125463.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125463","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Economic Value and Learning Curves Associated with Laser Vision Correction","id":"b9b4085d-4f09-414c-a0f5-7089a751e8df","sessionCode":"EE75","topDisplay":"Zhang J1, Gateri L1, Hsiao CW2, Furnback W3 1Alcon Vision, Fort Worth, TX, USA, 2Alcon Inc., Fort Worth, TX, China, 3Real Chemistry Inc., Brick, NJ, USA","locationCode":"320","description":"\r\n\t<div>OBJECTIVES: Refractive surgeries are used to correct refractive errors by reshaping the cornea. Surgical technologies include laser-assisted in situ keratomileusis (LASIK) and small incision lenticule extraction (SMILE). A targeted literature review was conducted to examine the costs, time, and/or healthcare resource utilization (HCRU) and learning curves associated with the LASIK and SMILE technologies. METHODS: Searches were performed in MEDLINE with terms including “LASIK”, “small lenticule extraction”, “costs”, and “learning curve”. English-language studies published between 1/1/2002 and 9/1/2022 were included if they reported either the costs, time, and/or healthcare resource utilization associated with laser vision correction, or the learning curve associated with LASIK and/or SMILE. RESULTS: A total of 11 studies were found in this review, including 8 publications on the learning curve (SMILE [n=4] and LASIK [n=4]) and 3 on the costs, time, and/or HCRU associated with laser vision correction. SMILE was found to be associated with a steep learning curve for inexperienced ophthalmic surgeons with significantly worse UDVA and efficacy index (p<0.043), safety index (p<0.045), longer duration of docking/suction engagement (p=0.0.34) and duration for lenticule extraction (p<0.001) for their first 100 procedures compared with their next 100 procedures. Conversely, outcomes associated with LASIK were found to be consistent between attending/resident groups compared to non-resident surgeons. LASIK was associated with both time and cost savings for patients when compared to contact lenses and eyeglasses over 30 years. These savings were driven by fewer optometrist visits (4.7 vs. 12.2), optical center visits (41 vs. 117 compared to contact lenses and 18 vs. 50 compared to eyeglasses) and contact lens care hours (1,090 hours saved). Lastly, similar incremental cost-effectiveness ratios were reported for FS-LASIK and SMILE technology. CONCLUSIONS: While laser vision correction provides patients with long-term time and cost savings, there is a significant learning curve associated with the SMILE technology.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/contoura-economic-ispor-posterfinal126172-pdf.pdf?sfvrsn=90dd19ef_0","title":"CONTOURA Economic ISPOR Poster_final126172.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126172","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Risk of Incident Cardiovascular Events with Disease-Modifying Antirheumatic Drugs Combinations Among Adult Patients with Rheumatoid Arthritis: A Nested Case-Control Study","id":"c5949151-db48-4eb8-b218-72b25520af69","sessionCode":"EPH21","topDisplay":"Huang Y1, Agarwal S2, Chatterjee S3, Chen H4, Johnson ML5, Aparasu RR5 1Department of Pharmacy Administration, University of Mississippi, Oxford, MS, USA, 2Baylor College of Medicine, Houston, TX, USA, 3Boehringer-Ingelheim, Ridgefield, CT, USA, 4College of Pharmacy, University of Houston, Houston, TX, USA, 5University of Houston, College of Pharmacy, Houston, TX, USA","locationCode":"422","description":"\r\n\t<div>OBJECTIVES: Disease-modifying antirheumatic drugs (DMARDs) are the cornerstone of rheumatoid arthritis (RA) treatment. DMARDs targeting inflammation for disease control could reduce cardiovascular (CV) risk; however, each DMARD class with unique mechanistic pathways may have differential CV risk. This study examined the risk of CV disease (CV) associated with DMARDs in RA. METHODS: This nested case-control study used the MarketScan database (2012-2014), involving adult RA patients (aged ³18 years) initiating either a conventional synthetic (cs) DMARD, biologic DMARD, or targeted synthetic (ts) DMARD between Jan 1, 2013, and Dec 31, 2014 (cohort entry) and had no CV history. Cases were individuals with incident CV events identified using diagnosis codes or procedure codes from medical claims. For each case, ten age and sex-matched controls were selected using the incident density sampling with replacement. DMARD exposure was measured 90 days before the event date. Conditional logistic regression examined the CV risk associated with DMARDs in combination treatment or individual use, with reference to Methotrexate (MTX) monotherapy, adjusting for baseline confounders. Subgroup analyses were performed separately in DMARDs combination therapy users or individual DMARDs users, respectively. RESULTS: In total, 270 cases of incident CV events and 2,700 controls were included (mean [standard deviation (SD)] age: 54 [8]; 75.6% women). The commonly prescribed types of DMARDs therapies were csDMARDs monotherapy (n=795, 27.04%), followed by TNFi monotherapy (n=367, 12.48%), TNFi in combination with MTX (n=314, 10.68%). Compared with MTX monotherapy, overall use of DMARDs agents was not associated with the risk of CV, including various types of DMARDs combination regimens. The findings were similar across subgroup analyses. CONCLUSIONS: The study found no differential risk of CV events with DMARDs in combination therapy or monotherapy compared to MTX monotherapy in patients with RA.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-poster-cv-of-dmard-huang125612-pdf.pdf?sfvrsn=15ef009d_0","title":"ISPOR Poster-CV of DMARD-Huang125612.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125612","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Who Is Using Data from the French Health Data Hub?","id":"1af204ed-da47-4b08-8415-72f06cc14f2a","sessionCode":"RWD39","topDisplay":"Bakshi S, Briones A, Bavoux M Lifescience Dynamics, London, UK","locationCode":"903","description":"\r\n\t<div>OBJECTIVES: The Health Data Hub (HDH) provides “easy, unified, transparent and secure access” to national health data in France. Since August 2017, health data in France has been accessible to researchers – our study analyses the data requests for French Health data by researcher profile and type of data requested from HDH. METHODS: A register of projects containing data requests from 2017 to end of 2021 was obtained from HDH and analysed. RESULTS: A total of 5046 data requests were placed between Aug 2017 and Dec 2021. The annual number of data requests placed shows an increasing trend from 2017 to 2021 with a CAGR of 58% over 3 years. Whilst most applications are made by researchers from public/health agencies and academia, more than 20% of applications have been submitted by private researchers from industry, media and patient associations over the analysis period. The absolute number of annual applications by private researchers has shown a steady increase however, the proportion of applications made by these researchers declined from 27% in 2017 to 19% in 2021. 25% of all applications request data from insurance claims, 51% of applications from medical charts, 3% from registries/cohorts and 21% from other sources of data. 30% of applications request linkages from 2 or more sources of data. CONCLUSIONS: The HDH brings together health data sources in France at a national and regional level. Since 2017, as a result of new enabling legislation, the demand for data from HDH is increasing and researchers have been making use of possibilities of linkages within the various types of data sources available. Whilst the number of applications from private researchers and industry are increasing, there seem to be some barriers for industry researchers to access and analyse the data resulting applications from private researchers not keeping pace with the overall data request trends.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-poster-rwd39lifescience-dynamicsfinal127105-pdf.pdf?sfvrsn=af11cff_0","title":"ISPOR Poster RWD39_LifeScience Dynamics_final127105.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127105","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Sociodemographic Indicators and Quality of Life Impact of Major Depressive Disorder in the United States Using the Medical Expenditure Panel Survey","id":"bf500d38-c90e-4960-b8f2-73f5c8d038c6","sessionCode":"PCR14","topDisplay":"Chitnis A1, O'Callaghan L2, Fournier AA3, Cloutier M4, Gagnon-Sanschagrin P4, Maitland J4, Bellefleur R4, Greenberg P3 1Biogen Inc., Cambridge, MA, USA, 2Sage Therapeutics, Inc., Cambridge, MA, USA, 3Analysis Group Inc., Boston, MA, USA, 4Analysis Group, Inc., Montreal, QC, Canada","locationCode":"2B","description":"\r\n\t<div>OBJECTIVES: To compare sociodemographic indicators and quality-of-life outcomes between adults with and without major depressive disorder (MDD) in the United States. METHODS: Adults (≥18 years) were identified from Medical Expenditure Panel Survey (MEPS) data (2015-2019; panels 20-23). Adults with a score of ≥3 on the Patient Health Questionnaire-2 (PHQ-2; self-report) were classified into the MDD cohort; remaining adults were classified into the without MDD cohort. Sociodemographic indicators (household composition, marital status, employment, household poverty, education) and quality-of-life outcomes (12-item short form survey version 2 [SF-12v2] mental component score [MCS] and physical component score [PCS], 6-dimension short form survey [SF-6D] utility score) were compared between cohorts. Results were weighted using MEPS nationally representative person-level weights and adjusted for selected characteristics (e.g., gender, age, race). Raw proportions are presented along with adjusted outcome measures. RESULTS: Overall, 35,367 adults met sample selection criteria (2,468 with MDD; 32,899 without MDD). Mean age was 47.5 and 47.2 years among adults with and without MDD and 59.7% and 51.6% were female, respectively. Adults with MDD and without MDD differed across multiple sociodemographic indicators. Specifically, adults with MDD were 39% less likely to live with someone else (72.5% vs 81.3%), 51% less likely to be married (36.5% vs 54.0%), 58% less likely to have completed at least a bachelor’s degree (17.9% vs 34.6%), 68% less likely to be employed (42.8% vs 67.6%), and 3.5-times as likely to be living below the poverty line (27.5% vs 9.7%) versus adults without MDD (all p<0.001). Adults with MDD had a 16.6-point, 7.6-point, and 0.2-point lower SF-12v2 MCS and PCS score and SF-6D score, respectively, versus adults without MDD (all p<0.001). CONCLUSIONS: This real-world study highlights that MDD may be associated with multiple aspects of one’s life, including social networks through household composition and marital status, human capital through education and employment, and overall wellbeing.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23chitnissociodemographic-indicatorsposter125221-pdf.pdf?sfvrsn=416ac5c3_0","title":"ISPOR23_Chitnis_Sociodemographic Indicators_POSTER125221.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125221","diseases":[{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Long-Term Tramadol Use and One-Year Mortality in Patients with Chronic Kidney Disease in South Korea","id":"e5da1782-c0fd-46b9-aee1-747e608b0651","sessionCode":"CO38","topDisplay":"Kim M1, Suh HS2 1College of Pharmacy, Pusan National University, Seoul, South Korea, 2College of Pharmacy, Kyung Hee University, Seoul, Korea, Republic of (South)","locationCode":"138","description":"\r\n\t<div>OBJECTIVES: We aimed to assess the risk of long-term tramadol use in patients with chronic kidney disease (CKD) in South Korea. METHODS: We conducted a retrospective study using the National Health Insurance Service-National Sample Cohort ver. 2.2, which is a population-based sample cohort in South Korea. Patients (aged ≥ 12 years) who received one or more tramadol prescriptions after diagnosis with CKD between Jan 01, 2003, and Jan 01, 2019, were selected for the study population, excluding cancer patients except for non-melanoma skin cancer. The study population was classified into long-term users, defined as patients who had been continuously prescribed tramadol for more than 90 days, and short-term users were the others. The outcome was one-year all-cause mortality after the first calendar date of the tramadol prescription. The hazard ratio (HR) was estimated by the Multivariate Cox proportional hazard regression analysis, adjusting age, sex, and Charlson comorbidity index scores. Patients were stratified according to the CKD stages 1-5. RESULTS: Of the tramadol user in patients with CKD (n=6,397), the long-term user was 8.68% (7.16% for males vs. 10.07% for females, p<0.0001). The mean ages were significantly different (60.49 ± 15.77 years for the short-term users vs. 70.05 ± 12.04 years for the long-term users, p<0.0001). The proportion of the number of deaths in the long-term users was 8.11%, and that in the short-term users was 4.90%. In multivariate Cox regression analysis, long-term use in patients with CKD was not significantly associated with increased mortality (HR=1.08, 95% confidence interval 0.79-1.49, p=0.6187). Stratified analysis showed that in patients with any CKD stages, neither. CONCLUSIONS: Chronic pain in patients with CKD can control with tramadol, which is controversial due to a lack of evidence on safety. In South Korea, long-term tramadol use was not associated with increased one-year all-cause mortality among patients with CKD.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kimposter125311-pdf.pdf?sfvrsn=13afcdf7_0","title":"ISPOR23_Kim_POSTER125311.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125311","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Beyond Value Assessment: Payer Perceptions of ICER’s Policy Initiatives","id":"9985c456-cc0a-4e78-ab04-74e34b009fb1","sessionCode":"HTA15","topDisplay":"Buelt L1, Sauvageau G2, Huang D3, Westrich K4 1Xcenda/AmerisourceBergen, Cambridge, UK, 2Xcenda/AmerisourceBergen, Dallas, TX, USA, 3Xcenda, Carrollton, TX, USA, 4Xcenda, Herndon, VA, USA","locationCode":"622","description":"\r\n\t<div>OBJECTIVES: To assess how the Institute for Clinical and Economic Review (ICER) has evolved its policy scope beyond value assessments in the last 7 years and explore payer perceptions of ICER’s new policy initiatives. METHODS: Completed ICER assessments and policy papers published from 2016-2022 were counted to quantify ICER’s activities and output. Double-blinded, web-based surveys of US healthcare payers were fielded through Xcenda’s research panel, the Managed Care Network, in October 2020 (N=47) and June 2022 (N=51) to explore perceptions of ICER initiatives, including policy papers, Unsupported Price Increase (UPI) reports, and ICER Analytics. RESULTS: ICER has published 65 value assessments and 17 policy papers since 2016. ICER’s output of policy papers has increased in recent years (mean of 1.3 publications annually, 2016-2018 vs 3.7 annually, 2020-2022), whereas the number of value assessments has remained flat (mean of 9.3 assessments annually, 2016-2018 and 2020-2022). Payers perceive ICER’s policy initiatives to be of varying degrees of usefulness. In 2020, the subset of payers reporting familiarity with ICER initiatives found the policy paper on valuing cures to be the most useful initiative (42% reporting extremely or very useful [n=38 reporting familiarity]), followed by the UPI report (40% [n=40]); the policy paper on COVID-19 pricing models was viewed as least useful (22% [n=37]). In 2022, the most useful initiatives among payers reporting familiarity were ICER Analytics (51% [n=49]) and the policy paper on orphan drugs (45% [n=47]); the policy paper on fair access was perceived as least useful (29% [n=44]). CONCLUSIONS: ICER’s output of annual policy papers has increased over time, demonstrating ICER’s growing investment in policy initiatives. Payer perceptions of the usefulness of ICER initiatives vary, with ICER Analytics being the most useful in 2022. Additional research is needed to better understand how payers use ICER’s policy papers/initiatives to inform decision making.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bueltposter-pdf125597-pdf.pdf?sfvrsn=9a8f0380_0","title":"ispor23bueltposter-pdf125597.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125597","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Pembrolizumab Plus Nab-paclitaxel in Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) Whose Tumors Expressed Pd-L1 (CPS ≥10) in Colombia","id":"8139950d-929d-486b-9c15-75cb96753362","sessionCode":"EE84","topDisplay":"Urrego-Reyes J1, Lopez C1, Marrugo A. C1, Velasco JS2, Singla P3, Gotarkar S3, Huang M4, Haiderali A4 1MSD Colombia, Bogota DC, CUN, Colombia, 2MSD Mexico, CDMX, DF, Mexico, 3CHEORS, North Wales, PA, USA, 4Merck & Co., Inc., Rahway, NJ, USA","locationCode":"329","description":"\r\n\t<div>OBJECTIVES: The KEYNOTE-355 trial showed that programmed death receptor 1 (PD-1) inhibitor pembrolizumab, in the combined positive score (CPS) ≥10 population and combined with chemotherapy (nab-paclitaxel, paclitaxel or gemcitabine), improves survival over placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic TNBC. Based on those findings, pembrolizumab was approved in Colombia for that population. Likewise, atezolizumab plus nab-paclitaxel (A+NP), is another treatment option available for 1L metastatic TNBC. This study evaluated cost-effectiveness of pembrolizumab + nab-paclitaxel versus A+NP in CPS ≥10 population from a third payer perspective in Colombia. METHODS:: A three-state cohort-based partitioned survival model projected costs and outcomes over 47 years with 3% annual discounting. Health state occupancy was modeled using KEYNOTE-355 Kaplan–Meier curves for progression-free survival (PFS) and overall survival (OS). Indirect comparator (A+NP) was compared with pembrolizumab + nab-paclitaxel through a network meta-analysis using data from Impassion130 trial. Costs for initial and subsequent treatments, disease and adverse events management, and terminal care were included using public drugs and procedures lists prices. Time-on-treatment (ToT) for pembrolizumab + nab-paclitaxel was taken from KEYNOTE-355. The model used A+NP PFS as proxy for its ToT and assumed atezolizumab treatment duration of 2 years (equal to pembrolizumab + nab-paclitaxel). RESULTS: The analysis showed that pembrolizumab + nab-paclitaxel is dominant as compared to A+NP. With pembrolizumab combination therapy, patients accrued 0.846 additional life-years (LY) and 0.706 additional quality-adjusted life-years (QALYs), with reduced total costs of COP $2,022,278 over A+NP. The probability of being cost effective is 72.50% at willingness to pay threshold of COP $69,150,201. CONCLUSIONS: The results of this study suggest that compared to atezolizumab + nab-paclitaxel, pembrolizumab + nab-paclitaxel is a cost-saving option in first line treatment of patients with locally recurrent inoperable or metastatic TNBC whose tumors expressed PD-L1 (CPS ≥10).</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23urrego-reyesposter124520-pdf.pdf?sfvrsn=b80f6b92_0","title":"ISPOR23_Urrego-Reyes_POSTER124520.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124520","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Novel Cost Impact Analysis Framework and Model to Evaluate Medications for Opioid Use Disorder within the US Criminal Justice System","id":"123d024b-2be9-4277-8df3-77237178b36f","sessionCode":"EE27","topDisplay":"Huang D1, Flynn C2, Poole C1, Mullen W3, Gaiazov S4 1Xcenda, Carrollton, TX, USA, 2Indivior, West Simsbury, CT, USA, 3Indivior, N Chesterfield, VA, USA, 4Indivior, Clifton, VA, USA","locationCode":"224","description":"\r\n\t<div>OBJECTIVES: Opioid use disorder (OUD) is common among incarcerated, but access to FDA-approved medications for OUD (MOUD) is limited. The purpose of this study was to develop a novel model framework to assess the cost impact of implementing a MOUD program within the criminal justice system (CJS). METHODS: A targeted literature review was conducted using Ovid MEDLINE, Emcare (via Ovid), Embase, Econlit, and EBM Reviews databases to identify 8 previous economic evaluations of MOUD programs within CJS. Economic analyses and cost data on MOUD programs within CJS were limited. Stakeholders (correctional Medical Director and Clinical Advisor) and researchers were engaged to advise on model components, usability and to inform decision-making in MOUD coverage within CJS. A novel model framework was developed to assess program costs and cost offsets to CJS and taxpayers; and a cost impact model was built to compare scenarios providing MOUD (methadone, oral buprenorphine, buprenorphine extended-release, and extended-release naltrexone). We hypothesized that program implementation costs and potential cost offsets from reduced OUD-related events contributed to the total costs of MOUD programs. The pre-release phase (CJS perspective) and post-release phase (taxpayer perspective) were considered, each including direct costs of MOUD provisions and cost offsets from preventing OUD-related events. Direct costs included drug, facility, staff, and supply costs categorized as fixed, step-fixed, time-dependent, or variable costs. Pre-release cost offsets included staff costs avoided due to drug diversion, disciplinary infraction, and medical costs avoided due to overdose. Within six months post-release, avoided fatal and non-fatal overdose and recidivism were counted as costs offsets to continued MOUD treatment to taxpayers. RESULTS: N/A CONCLUSIONS: This cost impact analysis framework and model captured core components of CJS costs to assess the economic impact of implementing different MOUD programs within CJS. Future research will consider a broader societal perspective including costs associated with lost productivity and premature mortality.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor08may2023finalposterr23127431-pdf.pdf?sfvrsn=9c4b6476_0","title":"ISPOR_08MAY2023_Final_Poster_R23127431.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127431","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Qualitative Synthesis of Cognitive Debriefing and Usability Testing Studies to Inform Good Electronic Clinical Outcome Assessment Design","id":"4dd89d83-86cd-44b9-9a30-77c714f2bfef","sessionCode":"PCR51","topDisplay":"Gary S1, Davis-Aoki R2, Khakwani S2, Otero AV2, Temple-Wong M2, Hughes L2, McDowell B3 1Clario, Littleton, MA, USA, 2Clario, Philadelphia, PA, USA, 3Clario, Geneva, Switzerland","locationCode":"808","description":"\r\n\t<div>OBJECTIVES: Regulatory agencies are placing increasing importance on the patient voice in clinical drug development. The FDA’s Patient-Focused Drug Development guidances emphasize the importance of high-quality measures and recommend developers follow best practices when designing clinical outcome assessments (COA) to avoid common issues that could interfere with respondent understanding as intended. The gold standard for measuring respondent understanding is the cognitive interview or cognitive debriefing (CD). However, access to the findings of CDs across a diversity of therapeutic areas is limited. Therefore, the objective of this research was to perform a qualitative synthesis of cognitive debriefing and usability testing (CD/UT) studies of electronic COA (eCOA) across several therapeutic areas to ascertain common issues identified by patients/caregivers to help inform good eCOA design. METHODS: A retrospective analysis was performed of 55 CD/UT studies conducted between 2013 and 2022 using Clario eCOA devices. Study findings, such as interpretation or usability issues, were pooled to make recommendations on best practices for good eCOA design. RESULTS: Of 55 studies included in the analysis, 35 were CD for participant understanding with UT, 18 were CD for paper-to-electronic equivalency with UT, and 2 were UT only. A total of 132 assessments were included. Data were collected from 851 participants of which 17% were children/adolescents and 16% were caregivers. In all studies, UT was rated well, and issues with usability were rare. The most common feedback was preference for larger font size, highlighting the significance of the FDA’s recommendation for accessibility features. Interpretation issues included interpretation of clinical terms such as signs/symptoms (e.g. aura), recall period (e.g. time period of “yesterday”), or anatomical location (e.g. abdomen, nasal area). CONCLUSIONS: Qualitative synthesis of CD/UTs of eCOAs helps identify common issues with respondent understanding and key areas of focus when designing a COA. Further analysis will be done to reveal patient population-specific findings.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23garyposter126093-pdf.pdf?sfvrsn=cef8a22a_0","title":"ISPOR23_Gary_POSTER126093.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126093","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Psychosocial Disorders and Clinical Outcomes Among Older Adults with Atrial Fibrillation: The Sage-AF Study","id":"5b921b3e-7f39-4c73-ae3e-77d5acb0959a","sessionCode":"CO1","topDisplay":"Hamel A1, Mehawej J1, Filippaios A1, John K2, Mishra A3, Abu HO3, Lessard D1, Tisminetzky M1, Wang W1, Tran KV1, Paul T1, Saczynski J4, McManus D1 1University of Massachusetts Chan Medical School, Worcester, MA, USA, 2Tufts University School of Medicine, Boston, MA, USA, 3Saint Vincent Hospital, Worcester, MA, USA, 4Northeastern University, Boston, MA, USA","locationCode":"1A","description":"\r\n\t<div>OBJECTIVES: To examine the association between anxiety, depression, or both, and clinical outcomes, including mortality, stroke, major bleeding, and hospitalizations, among older adults with atrial fibrillation (AF). METHODS: We used data from the Systemic Assessment of Geriatrics Elements-AF study, which recruited from Massachusetts and Georgia clinics between 2016 and 2018 and enrolled patients with AF who were ≥ 65 years old and had a CHA2DS2-VASc risk score ≥ 2. Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) were used to determine the presence and severity of depression and anxiety, respectively. We used Cox proportional hazards regression models to examine the association between psychosocial disorders and clinical outcomes over the study period while controlling for several potentially confounding variables. RESULTS: A total of 1,244 participants (average age 75 years; 49% male; 85% non-Hispanic White) were included in this study. Roughly one-third (35.5%) of participants were classified as having moderate to severe depression, anxiety, or both. The presence of anxiety without depression was significantly associated with a higher risk of hospitalization [adjusted HR (aHR) = 1.43, 95% CI = 1.06-1.94] and major bleeding (aHR = 2.51, 95% CI = 1.32-4.76). Depression alone was significantly associated with a two-fold higher risk of mortality (aHR = 1.99, 95% CI = 1.20-3.31) but not hospitalization or major bleeding. The presence of both depression and anxiety was associated with a significantly higher risk of hospitalization (aHR = 1.40, 95% CI = 1.14-1.72) and mortality (aHR = 2.28, 95% CI = 1.37-3.77). CONCLUSIONS: Depression alone and depression with anxiety amongst older adults with AF were associated with a higher risk of mortality, while anxiety alone was associated with a higher risk of hospitalization and major bleeding. Early detection and comprehensive management of these psychosocial disorders remain paramount to the improvement of key clinical outcomes in adults with AF.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/sage-af-psychoutcomes-posterv4-1127093-pdf.pdf?sfvrsn=5370dbc6_0","title":"SAGE-AF Psych_Outcomes Poster_v4.1127093.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127093","diseases":[{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Awareness of Perinatal Depression Among Maternity Care Providers at Primary-Level in Yunnan Province, China","id":"f0f746dc-0402-431a-8d3d-7853bb4ea058","sessionCode":"EPH19","topDisplay":"Deng CY, Huang Y Kunming Medical University, Kunming, China","locationCode":"405","description":"\r\n\t<div>OBJECTIVES: To provide evidence for strengthening the capacity to prevent and control perinatal depression at primary-level. METHODS: A self-administered questionnaire was used to conduct a survey covering all the obstetric professionals and maternal health workers at county-, township-, and village-levels in a county in Yunnan Province, China in May 2022. Chi-square test and Spearman's rank correlation analysis were used to explore the potential strategy to improve the awareness of perinatal depression. A knowledge and skills training, including lectures on perinatal depression and practical exercises on various symptom assessment scales, was carried out and evaluated by pre- and post-tests design and McNemar's test. All statistical analyses were completed in Stata 15.1 software. RESULTS: A total of 623 maternity care providers completed the survey. The high awareness of perinatal depression was only 37.08%. There were 27.45% of providers who had met women with depressive symptom during work, but 69.98% had never received training on perinatal depression, and almost all (96.31%) had the desire to attend a training. Obstetric professionals or maternal health workers who worked at higher levels had higher levels of awareness of perinatal depression, but had less access to the training (P<0.05). Although there was no difference in awareness of perinatal depression detected among those who received training before (P>0.05), the proportion of providers with high awareness of perinatal depression was increased from 31.82% to 86.36% through the present training. CONCLUSIONS: Maternity care providers at primary-level had a low level of awareness of perinatal depression, but they had a strong willingness to participate in training. We recommend that the knowledge and skills training should be firstly given to obstetric professionals and maternal health workers at county-level. The positive and friendly atmosphere for perinatal depression prevention and control should be created by health campaign and experience exchange.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/eph19-awareness-of-perinatal-depression-among-maternity-care-providers-at-primary-level-in-yunnan-province-china124936-pdf.pdf?sfvrsn=99d6d5b_0","title":"EPH19-Awareness of Perinatal Depression among Maternity Care Providers at Primary-Level in Yunnan Province, China124936.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124936","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Innovative Treatments of HER2+ Breast Cancer in Peru","id":"164e6079-7e3a-44bd-af5e-78ba8c6f59b3","sessionCode":"EE573","topDisplay":"Figallo M, Delgado MF, Postigo R APOYO Consultoría, Lima, LIM, Peru","locationCode":"243","description":"\r\n\t<div>OBJECTIVES: Breast cancer is one of the oncological diseases with the highest burden in Peru due to constrained health resources, resulting in an increase of the mortality and disability of the disease. HER2+ breast cancer patients represent around 18% of all breast cancer patients in Peru and face a more aggressive disease and a higher risk of recurrence. Moreover, 49% of women in Peru are diagnosed in late stages of this disease. Therefore, this research aims to explore the cost-effectiveness of the use of innovative treatments for HER2+ breast cancer in Peru METHODS: A comparative analysis was performed to calculate incremental cost-effectiveness ratios (ICERs) for each disease’s stage according to WHO-CHOICE guidelines. Clinical guidelines from Instituto Nacional de Enfermedades Neoplásicas (INEN) were consulted to identify resource utilizations and unit costs. Effectiveness estimates were based on observational referential studies, modeling using a Markov transition probability matrix, and on information from INEN. Cost-effectiveness estimates are in 2019 United States dollars (US$) per disability adjusted life year (DALY) averted. RESULTS: It is estimated that the inclusion of innovative treatments (T-DM1) in stages II and III would cost $18,750 per DALY adverted in a scenario of greater early detection considering an increase of 8 percentage points in the early treatment access of the patients. The results suggest that the inclusion of innovative treatments (TDM1) would be cost-effective in HER2+ patients of stages II and III, under the thresholds defined by WHO-CHOICE guidelines. CONCLUSIONS: The results emphasize the importance for the governmetn to evaluate innovative schemes in the treatment of breast cancer that have shown better clinical results in patients in the context of high deficiencies and limitations of the public health system. Although these schemes imply a higher cost compared to current schemes, their inclusion would improve the effectiveness of treatments for patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23figalloposter123463-pdf.pdf?sfvrsn=fa9f7906_0","title":"ISPOR23_Figallo_POSTER123463.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123463","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Mapping of Health Technology Assessment in China: A Comparative Study between 2016 and 2021","id":"7bd8e754-e9b0-41b5-a655-7944ec35586d","sessionCode":"HTA22","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"627","description":"\r\n\t<div>OBJECTIVES: Health technology assessment (HTA) in China has recently expanded from pure academic research to include policy or decision-oriented practice, especially after the use of HTA evidence to update the National Reimbursement Drug List for the first time in 2017. This study aimed to compare changes in the level of HTA development from 2016 to 2021 and to inform policies and decisions to promote further development of HTA in China. METHODS: We conducted a cross-sectional and anonymous web-based survey to relevant stakeholders in China in 2016 and 2021 respectively. The mapping of HTA instrument was used to reflect the HTA development from eight domains. To reduce the influence of confounders and to compare the mapping outcomes between 2016 and 2021 group, we performed a 1:1 propensity score matching methodology in this study. Univariate analysis was performed to compare the differences in these two groups. We also compared the overall results with that of a mapping study that included ten countries. RESULTS: A total of 212 and 255 respondents completed the survey in 2016 and 2021 respectively. After propensity score matching methodology, 183 cases from the 2016 group and 2021 group were matched. Overall, the mean score of 2021 in most of the domains was higher than 2016 in China (P<.05), such as the level of HTA institutionalization and dissemination strategy, except for assessment. Although China scored significantly lower among the three developed countries, the overall HTA development score was comparable among the ten countries. CONCLUSIONS: Our study suggested the level of HTA development in China has made great progress from 2016 to 2021. Prior to HTA activities, more efforts should be made to the assessment process to ensure a higher quality of HTA evidence.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126655","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Opioid Use Among Migraine Patients Treated with Acute and Preventive Treatment","id":"74529ce3-da27-4797-acd1-7a66b07654a1","sessionCode":"HSD4","topDisplay":"Trenz H1, Khan S2, Singh KP3, Allenback G4, McPheeters JT5, Batra K6 1Optum, Lakeville, MN, USA, 2Optum Global Solutions, Noida, UP, India, 3Optum Global Advantage, Noida, UP, India, 4Optum Life Sciences, Las Vegas, NV, USA, 5Optum Life Sciences, Eden Prairie, MN, USA, 6Optum Global Solutions, Ghaziabad, UP, India","locationCode":"540","description":"\r\n\t<div>OBJECTIVES: Opioids are not part of guideline-recommended treatment regimen for migraine; however, migraine patients are still prescribed opioids in clinical practice. The study assesses the real-world opioid utilization among migraine patients initiating on newer acute (ubrogepant, rimegepant, lasmiditan) and preventive (galcanezumab, erenumab, fremanezumab) migraine therapies and on standard of care (triptans). METHODS: Adults aged ≥18 years with ≥1 claim for an acute or preventive migraine therapy or a triptan (brand or generic) were identified from the Optum Research Database during 01MAY2018-28FEB2022 (date of first claim=index date). Included patients had 6-month baseline and follow-up continuous health plan enrollment, ≥1 claim for migraine in baseline or follow-up, no evidence of their index drug type (acute/preventive/triptan) in baseline, and no diagnoses of pregnancy, HIV, malignancy, other headache types, and chronic pain during baseline or follow-up. Primary outcomes were opioid use and time to first opioid fill in follow-up by cohort (acute, preventive, triptan). RESULTS: Of the 13,953 migraine patients, 270,791 and 12,892 were in the acute, preventive and triptan cohorts, respectively. Overall sample average age was 40.7 years (standard deviation [SD]=13.9), majority female (75.6%), Caucasian (75.8%), and commercially insured (92.7%). About 5.7% of triptan cohort, 9.5% of preventive cohort, and 5.2% of acute cohort had ≥1 claim for an opioid in follow-up. Patients initiating on acute treatment had the longest time to first opioid fill (mean=74.1 days, SD=67.2), followed by triptan initiators (mean=72.8 days, SD=57.2), and preventive treatment patients (mean=68.3 days, SD=57.6). CONCLUSIONS: These findings suggest continued opioid use among migraine patients treated with both newer acute and preventive therapies and standard of care, highlighting the potential unmet pain management need for these patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023migraine-opioid-poster042423final126740-pdf.pdf?sfvrsn=e62c9150_0","title":"ISPOR_2023_Migraine opioid Poster_042423_final126740.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126740","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identifying the Patterns of Clinical Phenotypes Impacting Kidney Disease Progression: A Latent Class Analysis Approach","id":"29e2b876-15fa-489a-936f-7a81061d2c76","sessionCode":"MSR12","topDisplay":"Shahbazi MA1, Brothers T2, Mbous Y3, Ahmed I1, Al-Mamun M1 1West Virginia University, Morgantown, WV, USA, 2University of Rhode Island, Kingston, RI, USA, 3West Virginia University School of Pharmacy, Morgantown, WV, USA","locationCode":"703","description":"\r\n\t<div>OBJECTIVES: Numerous studies have confirmed an increased risk of Chronic Kidney Disease (CKD) progression after an incidence of Hospital-Acquired Acute Kidney Injury (HA-AKI). To date, no methods exist evaluating a patient’s progression from new onset AKI to CKD. Therefore, the objective of this study was to develop a datamining tool to identify key determining temporal and clinical phenotypes for kidney disease progression. METHODS: We conducted a retrospective study using electronic health record (EHR) data from TriNetX in patients (≥ 18 years of age) with CKD in West Virginia. The study samples were divided into 3 cohorts: AKI within 90 days of hospitalization, random AKI, and no AKI identified. The binary features were extracted temporally (i.e., years 1-3 prior CKD diagnosis) from the demographics, diagnosis, procedures, medications, vitals, and laboratory tables. A Latent class analysis (LCA) random forest-based machine learning approach was used to identify and categorize the phenotypes within each cohort. RESULTS: Among 75,033 CKD patients, (28.72%) experienced AKI prior to CKD, (17.79%) had AKI after CKD, and (52.35%) never experienced AKI. Cohorts 1-3 contains 7,442 patients (10%), 6,408 patients (8.5%), and 39,280 patients (52%), respectively. Temporal LCA analysis generated five distinct patient phenotype profiles within each cohort. When comparing cohort 3 (C3) to cohort 1 (C1) and cohort 2 (C2), a high prevalence of hypertensive disorders (C1-92%, C2-94.4%, C3-79.4%), type 2 diabetes (C1-59.4%, C2-62.9%, C3-43.5.%), disorders of lipid disorders (C1-78.4%, C2-83.4%, C3-71.1.4%), long-term drug therapy (C1-86.1%, C2-91.5%, C3-62.1%), and chronic obstructive pulmonary disease (C1-43.3%, C2-48.3%, C3-23.4%) were observed. CONCLUSIONS: Our results support phenotypes vary occur among different cohorts and across time. Thus, our proposed AI tool has the potential to identify and forecast distinct kidney disease trajectories to better allocate healthcare resources leading to improved clinical outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127714","diseases":[{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Burden of Psychiatric Health in Elderly Myasthenia Gravis Patients: A Nationwide Medicare Perspective","id":"be1578d4-9a6d-430c-b4fc-7be1b008084e","sessionCode":"EPH38","topDisplay":"Kohen Y1, Buser H1, Nair A1, Delise B1, Ricci JF2, Willmon R3, Park M4, Li J5 1Alira Health, Framingham, MA, USA, 2Alira Heatlh, Basel, BS, Switzerland, 3Alira Health, Toronto, ON, Canada, 4Alira Health, Berlin, Germany, 5Alira Health, Fort Collins, CO, USA","locationCode":"438","description":"\r\n\t<div>OBJECTIVES: Myasthenia gravis (MG) is a chronic autoimmune disease marked by heterogeneous presentations of progressive muscle weakness with a typical age of onset between 20-40 years. Treatment advancements have increased the lifespan of people with MG, but disease burden in older populations is not well-characterized. The objective of this analysis was to characterize the burden of MG among elderly Medicare beneficiaries in terms of the prevalence and association between muscle weakness and psychiatric health. METHODS: A retrospective analysis was conducted using Medicare claims (Q1 2019-Q3 2022 for patients with MG. Analysis eligible patients were identified via ICD-10-CM diagnosis codes for MG and were required to have >12 months of continuous Part A/B coverage; patients <65 were excluded. Prevalence of constitutional symptoms for malaise and fatigue/weakness (‘malaise/fatigue’) and mental health conditions for mood and major depressive disorders (‘mood/major depression’) was similarly determined. Likelihood of mood/major depression in the presence of malaise/fatigue was assessed via Wald test using R Statistical Software v4.2.2. RESULTS: 1,861 MG patients were eligible for analysis. Mean age was 77.9 years, 44.7% were female, and 91.1, 4.5, and 4.4% were White, Black, and Other race/ethnicity, respectively. Prevalence of malaise/fatigue and mood/major depression were 51.9 and 27.3%, respectively. Malaise/fatigue was associated with a greater odds of comorbid mood/major depression (OR 2.35, 95% CI: 1.90-2.91; p<0.0001). CONCLUSIONS: In this analysis the prevalence of malaise/fatigue and mood/major depression was common in Medicare-aged MG patients. That patients with malaise/fatigue were more than twice as likely to have comorbid mood/major depression demonstrates a significant association between physical mobility and psychiatric health. Adjusted longitudinal studies are needed to investigate a potential causal link. Despite this evidence gap, the burden of MG among older patients is substantial and represents an unmet need that does not appear to be addressed by current treatments.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23buserposter127321-pdf.pdf?sfvrsn=f326a847_0","title":"ISPOR23_Buser_POSTER127321.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127321","diseases":[{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"},{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"32899d5e-c0da-49ba-a7a9-fe47854c4dc5","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Wearable Technology Use and Quality of Life Among Adults with Hypertension in the 2022 US NHWS Population","id":"7b7d9bef-6baf-42cc-8da2-7dae1e28b3a7","sessionCode":"MSR2","topDisplay":"Modi K1, Gordon A2, Romero A2, Gupta S2 1Cerner Enviza, New York, NY, USA, 2Cerner Enviza, North Kansas City, MO, USA","locationCode":"643","description":"\r\n\t<div>OBJECTIVES: People with hypertension often face challenges in managing their condition, which can affect overall quality of life (QoL). With the increased use of wearable technology (WT), health monitoring reinforces symptom and disease management. Measuring QoL scales can help understand the impact WT has on well-being. METHODS: In the 2022 US National Health and Wellness (NHWS) database, self-reported use of WT for disease management was captured among a nationally representative sample (N=75,261). Those with a self-reported physician diagnosis of hypertension were included. Users of WT were propensity-matched to non-users using a 1:2 ratio on age, sex, and Charlson Comorbidity Index (CCI). QoL measures assessed were the RAND-36 and Euro-QoL Five Dimension Five Level Scale (EQ5D-5L), with higher scores indicating better QoL. After matching, bivariate results between WT users and non-users were assessed using T-test and Chi-square tests. Responses are reported in counts/proportions or means with standard deviations (SD). RESULTS: After matching, 7,770 adult US NHWS respondents were included in this study (2,590 WT users and 5,180 non-users). The mean population age was 62.16 (12.76) with 60.4% identifying as female. Among those who use WT, 1,872 (72.3%) reported exercising regularly compared to 2,876 (55.5%) non-users (p=<0.001). Mean BMI was higher among WT-users (30.33 (6.86)) in contrast to non-WT users (31.05 (7.61)) (p=<0.001). RAND-36 Global Health Score was also greater for WT-users (44.87 (11.87)) compared to non-WT users (48.78 (12.38)) (p=<0.001). Both the Physical and Mental Health Composite Scores of the RAND-36 conveyed a higher QoL among WT-users compared to non-WT-users (p=<0.001, p=<0.001, respectively). The EQ-5D-5L was also greater for those who use WT (0.798 (0.14)) than non-WT-users (0.775 (0.16)) (p=<0.001). CONCLUSIONS: Individuals who were users of WT consistently showed higher overall QoL across all measures. This study highlights the potential of WT on health and disease management. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23modiposter127066-pdf.pdf?sfvrsn=a6a09323_0","title":"ISPOR23_Modi_POSTER127066.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127066","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"a8f24b83-49b5-4fe2-a4a3-b30e5a263bb3","parentId":"00000000-0000-0000-0000-000000000000","title":"Nutrition","urlName":"Nutrition"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis and Budgetary Impact of Telescopic Rods for Treatment of Fractures and Correction of Bone Deformities in Children with Osteogenesis Imperfecta in the Brazilian Public Health System","id":"d7b11327-8279-4d6b-947e-7e3e3af44d2d","sessionCode":"EE29","topDisplay":"Morais QC1, Silva GMD2, Oliveira CR2, Clemente V3, Lucchetta R4, Nakata KCDF5, dos Santos DL6, Fonseca MCC7 1Instituto Nacional de Traumatologia e Ortopedia, Rio de Janeiro, RJ, Brazil, 2Instituto Nacional de Traumatologia e Ortopedia, Rio de Janeiro, Brazil, 3Instituto Nacional de Traumatologia e Ortopedia, Petrópolis, RJ, Brazil, 4Universidade Federal do Parana, Curitiba, PR, Brazil, 5Secretaria Estadual de Saúde do Mato Grosso, Cuiabá, Brazil, 6Secretaria de Ciência e Tecnologia da Bahia, Salvador, Brazil, 7Universidade Estadual de Feira de Santana, Feira de Santana, Brazil","locationCode":"227","description":"\r\n\t<div>OBJECTIVES: Osteogenesis imperfecta is a rare genetic disease characterized by bone fragility, recurrent fractures and bone deformities. Telescopic rods are used to correct deformities and prevent fractures, with the benefit of extending along with the child's growth, which avoids the need of revision surgeries to change it. The objective was to evaluate the efficacy, safety, cost-effectiveness and budgetary impact of telescopic rods in children with osteogenesis imperfecta in comparison with non-extensible implants for their incorporation into the Brazilian Healthcare System. METHODS: A rapid review of the literature, and economic evaluation were performed. RESULTS: The evidence from a single cohort study had poor quality because it used a retrospectively analyzed data from just 21 patients to outcomes: surgical revision implant failure and revision surgical implant-free survival. Telescopic nails had a surgical revision rate of 15.4% compared to 68.4% for non-extensible nails. Telescopic rods avoided 1.39 surgical revisions per patient over a nine-year period, at an incremental cost effectiveness ratio (ICER) ranging from R$ 12,412 to R$ 18,017, depending on the comparator. The variables that most influenced the model were: price of nails, number of implants used per surgery and revision rate surgery of the comparator implant. In the budget impact analysis, the current scenario (without telescopic rods) was BRL 2.2 million over 5 years and the proposed scenario (with rod) was BRL 5.8 million, resulting in an estimated budget impact an increase of R$ 3.6 million. CONCLUSIONS: The evidence had poor quality and was insufficient to ensure the incorporation of Telescopic nails into Brazilian Healthcare System. When compared to the options already available, such as non-extensible implants, the economic evaluation suggested that telescopic nails can provide the benefit to avoid revision surgery. However, the efficiency indicators (ICER) and budget feasibility demonstrated significant uncertainty about this technology.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23moraisee29poster125546-pdf.pdf?sfvrsn=6973675d_0","title":"ISPOR23_MORAIS_EE29_POSTER125546.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125546","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient Experience of Using Telehealth Services during COVID-19 in Dubai Health Authority: A Retrospective Cross-Sectional Electronic Survey","id":"92840650-8b33-4191-bb46-7f6b81598a06","sessionCode":"HSD18","topDisplay":"Alnakhi W, Almulla N Dubai Health Authority, Dubai, United Arab Emirates","locationCode":"606","description":"\r\n\t<div>OBJECTIVES: To examine patients’ telehealth usability during COVID-19 in Dubai. METHODS: A cross-sectional retrospective study adopted Telehealth Usability Questionnaire (TUQ). A total of 64,173 participants who used telehealth services during 2020 – 2021 were recruited from the electronic medical record to participate in electronic survey from October to December 2022. The survey was administered through DHA text messaging system. The survey examined participants’ characteristics and the six domains of TUQ with a Likert scale. Frequency, percentage, and weighted mean score percentages were used as descriptive statistics to analyze this data. RESULTS: A total of 1,535 participants completed the survey. The overall TUQ showed the mean age of users was 43.37 years (±11.67 SD). More than half of the users were females (65.21%), the majority were married (74.46%), of a UAE nationality (83.58%), had higher education (56.68%), and were currently working (57.13%). Consultations and COVID-19-related concerns (45.14%), medication refills (19.80%), and laboratory tests (18.24%) were the main reasons for telehealth visits. Weighted means of TUQ six domains were usefulness (87.11%), ease of use and learnability (86.98%), interface quality (85.73%), interaction quality (86.44%), reliability (79.48%), and satisfaction and future use (86.44%). CONCLUSIONS: Our study revealed high levels of usability and willingness to use telehealth services as an alternative modality to in-person consultations among the participants of the survey. Our results support the implementation of telehealth services in DHA; however, further studies are required to understand the applicability of telehealth after COVID-19 and how to further improve satisfaction.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporalzarounihsd18poster127987-pdf.pdf?sfvrsn=aa92def3_0","title":"ISPOR_Alzarouni_HSD18POSTER127987.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/isporalzarounihsd18handout127987-pdf.pdf?sfvrsn=7e8b299b_0","title":"ISPOR_Alzarouni_HSD18handout127987.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127987","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Real-World Examination of HBA1C Reduction and Target Achievement Comparing SGLT2 Inhibitors and GLP1 Receptor Agonists As Second-Line Augmentation to Metformin for Treating Type II Diabetes","id":"44d327a8-6f31-4a46-a782-7f821ae51abb","sessionCode":"CO9","topDisplay":"Chen J1, Yu T2, Gong CL3, Romley JA4 1University of Southern California, LOS ANGELES, CA, USA, 2Yale University, Arcadia, CA, USA, 3Children's Hospital Los Angeles, Los Angeles, CA, USA, 4University of Southern California, Los Angeles, CA, USA","locationCode":"111","description":"\r\n\t<div>OBJECTIVES: SGLT2 and GLP1 are increasingly used as second-line augmentation therapies added after metformin. We conducted an observational study to examine and compare the real-world performance of SGLT2 and GLP1 in terms of HbA1c reduction and target achievement. METHODS: Using claims from Optum’s Clinformatics® Data Mart, we selected metformin users who initiated SGLT2 or GLP1 between 01/01/2013 and 12/31/2019, in which the initiation date was the index date, with a 12-month baseline and follow-up period, respectively. Ordinary least square and logistic regressions were conducted to examine HbA1c reduction and target achievement between the two cohorts, controlling for baseline patient demographics and health status. RESULTS: In a preliminary (1%) sample, a total of 150 and 118 patients were identified in the SGLT2 and GLP1 cohorts. The average HbA1c before and closest to the index date was 8.33% for the SGLT2 cohort and 8.66% for the GLP1 cohort. SGLT2 users were more likely to attain the American Diabetes Association (ADA) target of HbA1c < 7% [OR: 2.524, CI: (1.398, 4.555), p = 0.0021], slightly more likely to achieve the Healthcare Effectiveness Data and Information Set (HEDIS) target of HbA1c < 8% [OR: 1.086, CI: (0.585, 2.017), p= 0.7931], and less likely to fall within the HEDIS standard of poor control of HbA1c > 9% [OR: 0.409, CI: (0.168, 0.999), p = 0.0497], compared with GLP1 takers by the end of the study period. Less HbA1c reduction was estimated for the SGLT2 cohort, compared with the GLP1 cohort (0.277, p = 0.1253), where 0.277 was the estimated difference of reduction level (follow-up HbA1c minus index HbA1c) by being in the SGLT2 cohort. CONCLUSIONS: The study results suggested that SGLT2 showed better achievement in three HbA1c targets by the end of the study period, while GLP1 was more efficacious in HbA1c reduction.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23chenposter127835-pdf.pdf?sfvrsn=69fdd663_0","title":"ISPOR23_Chen_POSTER127835.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127835","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Eliciting Preferences for Health Technology Assessment Criteria Using Analytic Hierarchy Process and Discrete Choice Experiment in Kenya","id":"d37a3c68-d6e1-480a-b6fe-7fa281b42418","sessionCode":"HTA16","topDisplay":"Obadha M1, Mumbi A2, Njuguna RG2, Orangi S2, Nguhiu P3, Ngaiza G4, Omollo H5, Njeru N6, Barasa E2 1Health Economics Research Unit, KEMRI-Wellcome Trust Research Programme, Oxford, OXF, UK, 2Health Economics Research Unit, KEMRI-Wellcome Trust Research Programme, Nairobi, Kenya, 3TB Monitoring Evaluation and Strategic Information Unit, Global TB Program, World Health Organization, Geneva, Switzerland, 4Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK, 5County Department of Health, Nairobi City County, Nairobi, Kenya, 6Ministry of Health, Nairobi, Kenya","locationCode":"624","description":"\r\n\t<div>OBJECTIVES: The study set out to elicit preferences for health technology assessment (HTA) criteria in Kenya using two Multi-Criteria Decision Analysis (MCDA) methods; Analytic Hierarchy Process (AHP) and Discrete Choice Experiment (DCE). METHODS: AHP and DCE were used to elicit preferences of Kenyan stakeholders in HTA as part of an MCDA study. The targeted stakeholders included policymakers/purchasers, providers, academics/researchers, patients, and the public (community-based organisations and non-governmental organisations). AHP was conducted in a one-day workshop with 23 stakeholders using expert choice software, while Computer-Assisted Personal Interviewing (CAPI) technique was used to administer the DCE to 272 stakeholders. The same HTA criteria were used for both exercises, namely, burden of disease, congruence with existing priorities, effectiveness of intervention, equity, and health systems capacity. RESULTS: In AHP, burden of disease was the most important criterion (36.39%) followed by effectiveness of intervention (23.89%), and health systems capacity (17.98%). Congruence with existing priorities was the least important criterion (8.50%). Across, the five stakeholder groups, burden of disease was the most important criterion except among the public, where effectiveness of intervention was the most important. Congruence with existing priorities was the least important across the stakeholder groups except providers, where equity was the least important. The relative importance estimates from the DCE showed that burden of disease was the most important criterion. Effectiveness of intervention was second, equity third, followed by congruence with existing priorities and health systems capacity. Across the stakeholder groups, burden of disease and effectiveness of intervention were the two highest ranked criteria in terms of relative importance. Health systems capacity was the lowest ranked criterion, except among policymakers where it was ranked third. CONCLUSIONS: The two methods showed that burden of disease and effectiveness of intervention were the two most important criteria for HTA in Kenya.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127864","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"},{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Non-Invasive Colorectal Cancer Screening Test Utilization and Expenditures Among Privately Insured Adults Aged 45-64 Years in the United States, 2015-2021","id":"2a422545-809e-4c6a-a1a7-80a491549b28","sessionCode":"HSD8","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"546","description":"\r\n\t<div>OBJECTIVES: Estimate changes in annual utilization and payments for non-invasive colorectal cancer (CRC) screening tests among individuals aged 45-64 years following the 2014 launch of a multitarget stool DNA (mt-sDNA) test. METHODS: Using 2015-2021 Merative™ MarketScan® Commercial Database, we assessed claims for non-invasive CRC screening tests--fecal immunochemical tests (FIT), fecal occult blood tests (FOBT), and mt-sDNA tests--per enrollee aged 45-64 years in a calendar year. We calculated annual utilization rates, mean total payments per individual, and the percentage of zero out-of-pocket (OOP) payments for each test type. RESULTS: Annual utilization of non-invasive CRC screening tests decreased, with 12% lower use in 2021 than in 2015. The utilization of FIT and FOBT tests decreased by 22% and 61%, respectively, while the utilization of mt-sDNA test increased from 11 to 1601 per 100,000 enrollees. Mean total payments for mt-sDNA, FIT, and FOBT were $522, $32, and $17 per individual in 2021, respectively. Mean total payment for any non-invasive CRC screening test increased 7.8-fold from $19 to $168. Percentage of paid claims for mt-sDNA tests with zero OOP payment increased from 36% in 2015 to 83% in 2017, reaching 97% in 2021. CONCLUSIONS: The rapid increase in use of mt-sDNA did not fully offset the decrease in use of FIT and FOBT. However, effective non-invasive screening may have increased overall since mt-sDNA screening may be less frequent than annual FIT or FOBT. The mean cost of testing per individual increased substantially with the substitution of mt-sDNA for FOBT and FIT. The percentage of zero OOP payments for mt-sDNA more than doubled in the years following an updated US Preventive Services Task Force recommendation statement that listed mt-sDNA among CRC screening options.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123978","diseases":[{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"},{"id":"97c2e725-3c74-4625-997f-a72378c5a557","parentId":"00000000-0000-0000-0000-000000000000","title":"Generics","urlName":"Generics"},{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Cost-Consequence Analysis of Adopting Chimeric Antigen Receptor T-Cell Therapy for Patients with Relapsed or Refractory Large B-Cell Lymphoma in Saudi Arabia: a Multi-Center Comparison","id":"0405a570-5c9c-4943-a664-80e060e15417","sessionCode":"EE51","topDisplay":"Al-Abdulkarim HA1, Alrajhi A2, Alzahrani M1, Alamoudi S3, Khan M3, Ball G4, Alharbi M5, Mereani W6 1National Guard Health Affairs, Riyadh, Saudi Arabia, 2AL Faisal University, Riyadh, Saudi Arabia, 3National Guard Health Affairs, Jeddah, Saudi Arabia, 4Gilead Sciences Canada Inc, Mississauga, ON, Canada, 5HEPA Solutions, Jeddah, CA, USA, 6Gilead Sciences, Riyadh, Saudi Arabia","locationCode":"300","description":"\r\n\t<div>OBJECTIVES: There is currently only 1 referral center in Saudi Arabia for patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL) prescribed chimeric antigen receptor T-cell (CAR T) therapy. In this study we assessed the potential economic consequences of broader adoption of CAR T treatment at tertiary hospitals versus referring patients for treatment either in-country or abroad. METHODS: These two scenarios were compared using a cost-consequence approach. The analysis considered costs associated with drug acquisition, related medical care, and referral allowances for treatment abroad. Current treatment-related costs for patients referred for treatment either in-country or abroad were obtained from national tender lists and tertiary hospitals business centers. Projected costs associated with CAR T treatment were then estimated for two tertiary hospitals that have advanced stem cell transplant centers, based on available evidence from Ministry of procurement and medical databases supplemented and validated through interviews with local experts. RESULTS: Over 18 months, 23 r/r LBCL patients were referred from two tertiary hospitals. The average cost (annualized) per patient referred for treatment in-country or abroad was estimated to be 4.36 million SAR. Conversely, the projected per patient average cost (annualized) for treatment locally at the two tertiary hospitals was estimated to be 1.7 million SAR and 1.4 million SAR, respectively. Compared to referrals, treating patients locally at tertiary hospitals was estimated to reduce required budgets by 61-68% annually. Similarly, reallocating current referral budgets toward treating patients locally at the two tertiary hospitals could potentially increase patients treated from 10 to 25 and from 13 to 40, respectively. CONCLUSIONS: These results suggest that implementing CAR T therapy locally at tertiary hospitals may help optimize allocation of CAR T spending by reducing budget needed to treat r/r LBCL patients or enabling more eligible patients to be treated.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23mereaniposter126596-pdf.pdf?sfvrsn=fff2c3c6_0","title":"ISPOR23_Mereani_POSTER126596.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126596","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Implementation of Guideline-Recommended Strategies for Stroke Prevention in U.S. Adults with Type 2 Diabetes: A Cost-Effectiveness Analysis","id":"c7ac6fec-fb24-43dc-856b-813f788829bb","sessionCode":"EE1","topDisplay":"Ye W1, Jiang X2, Kuo S3, Herman WH3, Li J1, Morgenstern L1, Lisabeth LD1 1University of Michigan, Ann Arbor, MI, USA, 2University of California, San Francisco, MI, USA, 3University of Michigan Medical School, Ann Arbor, MI, USA","locationCode":"208","description":"\r\n\t<div>OBJECTIVES: Substantial opportunity exists to enhance primary prevention of stroke in type 2 diabetes (T2D) patients. We aimed to evaluate the cost-effectiveness of improved implementation of seven current guideline-recommended strategies for primary stroke prevention in U.S. adults with T2D. METHODS: Based on National Health and Nutrition Examination Survey (NHANES) data from 2015-2018, we identified individuals with T2D aged ≥45 years without stroke history. We simulated stroke events, stroke-related quality-adjusted life years (QALYs), and healthcare costs for this population over a 10-year horizon using a microsimulation model, the Michigan Model for Diabetes, comparing seven scenarios each with full implementation of one of the seven primary prevention strategies versus a status-quo scenario. The status-quo scenario assumed that the level of implementation of each of the seven prevention strategies was the average national implementation level in 2015-2018. The enhanced scenarios assumed all individuals implemented particular strategy as soon as they became eligible. Analyses were performed from a health system/payer perspective. RESULTS: Full implementation of the well-controlled blood pressure (BP) strategy would result in approximately 237,200 fewer stroke events, 95,000 fewer stroke-related deaths, a gain of 0.05 QALYs, and savings of $24.6 billion (2014 US dollar) nationally. In contrast, fully-enhanced implementation of the well-control HbA1c level strategy cost $279 billion more nationally at a slight loss of 0.005 QALYs. Full implementation of guidelines related to statins, aspirin, warfarin treatment for atrial fibrillation, or smoking cessation would be cost-effective or cost-saving. The strategy of losing 5% weight for all overweight or obese individuals would not be cost-effective. CONCLUSIONS: Enhancing implementation of guideline-recommended strategies for BP control, and statins, aspirin, warfarin treatment, and smoking cessation for the U.S. adult T2D population without stroke history could potentially avert a large number of stroke events, improve quality-of-life stroke-related deaths, and be cost-saving.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23-ye-posterv2127653-pdf.pdf?sfvrsn=9ba19e91_0","title":"ISPOR23-Ye-Poster_v2127653.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127653","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evolution of Market Dynamics within Immunology after Biosimilar Introduction within Europe","id":"0832ccdb-e2d9-448f-992a-81eccd1ad6cb","sessionCode":"OP1","topDisplay":"Xin Q1, Keady S2, Bodin M3 1Biogen International HQ, Switzerland, Baar, ZG, Switzerland, 2Biogen International HQ, Switzerland, Baar, LON, Switzerland, 3Biogen International HQ, Switzerland, Baar, Switzerland","locationCode":"712","description":"\r\n\t<div>OBJECTIVES: To understand the European evolution of market dynamics following the introduction of biosimilars within the immunology area. METHODS: The report investigated 19 biologic molecules and 4 Janus kinase (JAK) inhibitors with approved immunology indications. Consumption was based on IQVIA MIDAS sales data (2017 to 2021). This reflected the first significant uptake of biosimilars in the immunology space in 2017. Molecule usage was measured in treatment days, derived from volume of standard units sold divided by average daily doses. To enable the comparison of molecule uptake across countries, a per-capita indicator treatment rate was used (dividing yearly total treatment days per molecule by population size). RESULTS: Within immunology, average consumption of anti-TNF molecules increased by 35% from 0.51 treatment days/capita in 2017 to 0.68 treatment days/capita in 2021. Whilst the use of reference molecules has decreased by 31%, biosimilar use has increased by 346% from 0.09 treatment days/capita in 2017 to 0.39 treatment days/capita in 2021. Significant increases in usage of interleukin inhibitors and JAK inhibitors (168% and 1,906% respectively from 2017 to 2021) were also identified. In 2021, the countries with the highest treatment rates of all investigated molecules (Ireland, Norway, and Sweden) had an average of 2.22 treatment days/capita, whereas the lowest treatment rate countries (Belarus, Bosnia, and Poland) had 0.14 treatment days/capita (a 16-fold difference). Poland has one of the highest biosimilar penetrations (above 70% in 2021). However, the usage of biologics is still relatively low. CONCLUSIONS: The use of approved immunological therapies has increased significantly since the introduction of biosimilars within Europe. However, there remains a substantial inequality, primarily between Eastern and Western countries. To mitigate inequalities, greater understanding of the combination of robust policies, risks and benefits of regionalized/centralized procurement models and promotion of sustainable pricing and reimbursement is required.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"bb8fd992-de86-4d1a-8bec-f6e2c928db96","parentId":"00000000-0000-0000-0000-000000000000","title":"Organizational Practices","urlName":"organizational-practices"}],"categoryIds":["bb8fd992-de86-4d1a-8bec-f6e2c928db96"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23keadyeuposter125408-pdf.pdf?sfvrsn=7283bc42_0","title":"ISPOR23_Keady_EU_POSTER125408.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125408","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Budget Impact of a Blood-Based Integrated Classifier Test to Down Classify Risk of Pulmonary Nodules in a US Medicare Payer Setting","id":"d34a8267-5a11-462e-9111-820564f06428","sessionCode":"EE38","topDisplay":"Smith M1, Le K2, Campbell D3, Migliaccio-Walle K4, Kang A5, Springmeyer S6 1Frederick Regional Hospital, Frederick, MD, USA, 2Biodesix Inc, spring hill, FL, USA, 3Curta Inc., South Kingstown, RI, USA, 4Curta Inc., Hollis, NH, USA, 5Curta Inc., Seattle, WA, USA, 6Biodesix Inc, Boulder, CO, USA","locationCode":"241","description":"\r\n\t<div>OBJECTIVES: An estimated 80% of pulmonary nodules (PNs) fall in a “low to moderate risk” category1 of lung cancer in which appropriateness of invasive procedure intervention is unclear. These PNs are frequently sent for invasive interventions only to be identified as benign. A blood-based integrated classifier (IC) can be utilized for PNs to reclassify nodules that are “likely benign” and avoid unnecessary interventions and complications. This study aimed to estimate the economic impact of a blood-based IC for PN risk assessment from a US Medicare payer perspective. METHODS: A budget impact model was developed to evaluate use of a blood-based IC test within a hypothetical 1 million-member US Medicare health plan over a 2-year time horizon. Blood-based IC test use within a Medicare payer system was compared to standard of care without the test. Model inputs included stage shifts in non-small cell lung cancer (NSCLC), procedures costs, and downstream costs. RESULTS: In a hypothetical Medicare health plan of 1 million members without the blood-based auto-antibody test, an estimated 1,701 patients would undergo invasive procedure to characterize their PN with approximately 1,102 identified as benign. An estimated $188,335,223 would be spent on nodule workup, invasive procedures, and cancer treatments. In the scenario with the blood-based IC test, it is estimated that there would be a 35.2% reduction in invasive procedures and an estimated savings of $3,506,824 over 2 years. The incremental cost per-member per-month (PMPM) is -$0.292. CONCLUSIONS: The model results indicate that the use of a blood-based IC test for patients with pulmonary nodules would likely result in a minimal budget impact, or true cost savings, from a US Medicare health plan perspective. References: 1. Tanner NT, et al. Chest. 2015; 148(6): 1405 – 1414. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127210","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Is Drug Novelty Associated with Greater Health Benefits?","id":"aacfd7f4-37e4-494a-9bd4-82a95df0f9ac","sessionCode":"HPR15","topDisplay":"Levine A1, Enright D1, Clifford K1, Kowal S2, Chambers J1 1Tufts Medical Center, Boston, MA, USA, 2Genentech, Inc., Alameda, CA, USA","locationCode":"517","description":"\r\n\t<div>OBJECTIVES: To examine the association between the magnitude of added health gains offered by new drugs and several drug novelty attributes. METHODS: We identified drugs approved by FDA from 1999-2018. For each drug-indication pair (e.g., vedolizumab for ulcerative colitis), we determined if the drug was included in FDA’s expedited approval programs: Priority Review (PR), Fast-track (FT), Accelerated Approval (AA), and Breakthrough Therapy (BT). Consistent with each program’s qualifying criteria, we categorized drugs using the following novelty attributes: (1) treats a serious condition (approved via any expedited approval program), (2) offers improvement over existing treatments (approved via PR, AA, and/or BT), and (3) addresses unmet clinical needs (approved via FT). To obtain added health gain estimates, we searched PubMed for relevant comparative- and cost-effectiveness studies reporting Quality Adjusted Life-Years (QALYs). We included only studies that compared the drug to the standard of care at the time of its FDA approval. We extracted estimates of incremental QALY gains from included studies. We compared incremental QALY gains for drugs with each novelty attribute to gains for drugs without that attribute using Mann-Whitney U and Kolmogorov-Smirnov tests. RESULTS: We included 660 studies pertaining to 345 drug-indication pairs. Drug-indication pairs intended to treat a serious condition had median gains of 0.27 QALY versus 0.02 QALY (p<0.01) for pairs without that attribute. Pairs offering improvement over existing treatments had median gains of 0.28 QALY versus 0.02 QALY (p<0.01) for pairs without that attribute. Pairs with the potential to address unmet clinical needs had median gains of 0.35 QALY versus 0.04 (p<0.01) QALY for pairs without that attribute. CONCLUSIONS: Drugs that have novelty attributes - (1) treats a serious condition (2) offers improvement over existing treatments, and (3) addresses unmet clinical needs - tend to be associated with larger health gains than drugs without those attributes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23levineposter125585-pdf.pdf?sfvrsn=d72de253_0","title":"ISPOR23_Levine_POSTER125585.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125585","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Comparison of All-Cause and Knee Osteoarthritis (KOA)-Related Costs of Newly-Diagnosed Koa Patients Treated with Multi-Injection IA-HAs: A Retrospective Database Analysis","id":"104a23f0-2d27-4847-9b93-836f8123b6a7","sessionCode":"SA9","topDisplay":"Nicholls M1, Guo K2, Chen YH3, Shen Y3, Chang Y4, Guo A2 1Virginia Mason Orthopaedics and Sports Medicine, Seattle, WA, USA, 2Ferring Pharmaceuticals, Parsippany-Troy Hills, NJ, USA, 3KMK Consulting Inc, Morristown, NJ, USA, 4KMK Consulting Inc, Secaucus, NJ, USA","locationCode":"912","description":"\r\n\t<div>OBJECTIVES: To compare all-cause and knee osteoarthritis (KOA)-related costs associated with procedures and visits of newly-diagnosed KOA patients treated with multi-injection IA-HAs (Intra-articular hyaluronic acid) in real-world practice. METHODS: A retrospective analysis of Merative MarketScan Research Database (1/1/2015 - 12/31/2019) was conducted to identify newly-diagnosed KOA patients ≥18 years old with ≥1 medical claim of multi-injection IA-HAs: 1% sodium hyaluronate (Euflexxa), hyaluronan (Orthovisc), sodium hyaluronate (Hyalgan) and sodium hyaluronate (Supartz FX) within 1/1/2016 – 12/31/2019, after a 12-month wash-out period. Continuous enrollment for at least 12 months after the first IA-HA claim is required. Total per patient per year (PPPY) all-cause costs and KOA-related total (medical + pharmacy) costs of the Euflexxa treated patient group within the 12-month follow-up were compared to that of the Orthovisc and Hyalgan/Supartz FX (same J-code) group. Costs include inpatient, ER, office, outpatient and others. A doubly robust method with generalized linear models (GLMs) and IPTW (inverse probability treatment weighting) was used. Covariates include age, gender, comorbidities, medication and intervention usage, treatment completion rate and number of injections in the initial IA-HA course. RESULTS: A total of 1,210,341 eligible KOA patients were identified. The Euflexxa group had 11,207 patients, Orthovisc had 10,235, and Hyalgan/Supartz FX had 8,483. The Euflexxa group had a 6.7% (p < 0.0001) and 4.0% (p < 0.0001) lower mean all-cause and KOA-related total (medical + pharmacy) costs respectively compared to the Orthovisc group, and a 0.9% (p = 0.0016) and 5.0% (p < 0.0001) reduction in mean all-cause cost and KOA-related total (medical + pharmacy) costs respectively compared to that of the Hyalgan/Supartz FX group. CONCLUSIONS: KOA patients treated with Euflexxa is associated with statistically significant lower KOA-related costs compared to that of Orthovisc or Hyalgan/Supartz FX. More research on treatment associated cost is warranted to potentially lower cost of patient care.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23guoposter127430-pdf.pdf?sfvrsn=e081509a_0","title":"ISPOR23_Guo_POSTER127430.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127430","diseases":[{"id":"3f994852-a0d4-4706-9665-e4d867006d9a","parentId":"00000000-0000-0000-0000-000000000000","title":"Injury & Trauma","urlName":"injury-trauma"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Biomarker Testing in Rheumatoid Arthritis Leads to Lower Total Cost of Care","id":"cd697533-efc3-4620-a509-84dbe6fa1fb6","sessionCode":"EE79","topDisplay":"McLarty S1, Arnold J2, Ascoli L3, Johnson K4 1CVS Health, Stamford , CT, USA, 2CVS Health, Chicago, IL, USA, 3CVS Health, Pawtucket, RI, USA, 4CVS Health, Orlando, FL, USA","locationCode":"322","description":"\r\n\t<div>OBJECTIVES: Rheumatoid arthritis (RA) affects less than 1% of the US population but contributes to $22.3 billion in total annual healthcare costs.1 Biomarker tests are used to diagnose and monitor RA. This study was conducted to determine the effects of biomarker testing on healthcare costs. METHODS: A study was conducted using medical and pharmacy claims from 1/2019 – 7/2022. Members were split into study arms by therapy (biologic vs methotrexate (MTX) monotherapy) and line of business (Medicare or commercial). The effect of biomarker use was calculated by comparing total costs per member per month (PMPM). Biomarkers were split into three categories: diagnostic, inflammation levels, and disease monitoring. Diagnostic tests include the rheumatoid factor and cyclic citrullinated peptide antibody. Inflammatory level tests included C-reactive protein and erythrocyte sedimentation. Multi-biomarker disease activity tests were included as disease monitoring biomarkers. Statistical significance was calculated using an ordinary least squares regression; p<0.05 was deemed significant. RESULTS: Diagnostic biomarkers saved $305.10 PMPM in the commercial MTX arm (n=7,760, p<0.01). Disease monitoring and inflammatory biomarkers showed non-significant added costs of $55.74 and $74.91 PMPM, respectively. Diagnostic biomarkers saved $875.09 PMPM, and disease monitoring biomarkers saved $242.32 PMPM in the commercial biologic arm (n=15,070, p<0.1). Inflammatory biomarkers insignificantly increased costs by $117.75 PMPM. Diagnostic biomarkers saved $134.18 PMPM in the Medicare MTX arm (n=13,964, p<0.01). Disease monitoring and inflammation biomarker tests insignificantly saved $41.61 and $122.94 PMPM, respectively. Diagnostic biomarkers saved $678.12 PMPM, and disease monitoring biomarkers saved $544.14 PMPM in the Medicare biologic arm (n=4,197, p<0.01). Inflammatory level biomarkers added an insignificant $97.45 PMPM. CONCLUSIONS: Members with diagnostic biomarkers had significant monthly savings. As innovative biomarker tests come to market, further analysis is required to understand their therapeutic and monetary value. 1. Shah, P. (2021, Sept 28). Mitigating the impact of RA. CVSHealth.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-ra-biomarker-utilization-poster123520-pdf.pdf?sfvrsn=fbc770ee_0","title":"ISPOR_ RA Biomarker Utilization poster123520.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123520","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Use of Living Systematic Reviews (LSRS) Beyond COVID-19","id":"fe02204d-fd9b-46bf-b6b9-86bc955d270e","sessionCode":"SA12","topDisplay":"Patel V1, Dabirvaziri P2, Tran J3, Richard ME3, Grieve S4, Thakur D5 1Cytel Inc., Toronto, Richmond Hill, ON, Canada, 2Cytel Inc., Vancouver, Vancouver, BC, Canada, 3Cytel Inc., Montreal, Montreal, QC, Canada, 4Cytel Inc., Toronto, Toronto, ON, Canada, 5Cytel Inc., Toronto, ON, Canada","locationCode":"914","description":"\r\n\t<div>OBJECTIVES: A LSR is a systematic review that is continually updated, incorporating new evidence as it becomes available. They are conducted in research areas where new evidence is constantly emerging on diagnostic methods, treatments, and outcomes. The objective of this study was to understand the current application of LSRs across research areas. METHODS: Embase, MEDLINE, and the Cochrane Database of Systematic Reviews were searched to identify LSRs. Only the most recent update of a LSR was included. Data regarding the indication, intervention, methods, frequency of updates, and funding were extracted. RESULTS: Of the 1,243 records identified, 126 LSRs were included for analysis. The first LSR was published in 2015, with a significant increase in the number of LSRs published starting in 2020, coinciding with the COVID-19 pandemic. The most common indication represented by LSRs was COVID-19 (72%), followed by oncology (10%). Other indications with LSRs included chronic pain, traumatic brain injury, and skin disorders, among others. While most oncology LSRs identified interventional randomized-controlled trials (RCTs) (85%), only 54% of COVID-19 LSRs were restricted to interventional studies, including a combination of RCTS and real-world observational studies. Oncology LSRs included common cancers such as prostate, renal, or multiple myeloma. Of the reviews that reported update frequency, 28% planned monthly, 12% yearly, and 12% weekly updates. Only 46% of LSRs were registered. The majority of LSRs were funded by government or research organizations. Objectives of LSRs varied, with most stating the need to maintain up-to-date databases; however, several studies used LSRs to facilitate network meta-analysis or mixed treatment comparisons. CONCLUSIONS: While LSRs were introduced over five years ago, their frequency increased during the COVID-19 pandemic. Apart from COVID-19, LSRs are commonly used in oncology settings. LSRs provide high-level, relevant, and up-to-date evidence, making them a useful tool for clinical and real-world research.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23thakurpostersa12126333-pdf.pdf?sfvrsn=ecf91d80_0","title":"ISPOR23_Thakur_POSTER_SA12126333.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126333","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Effects of Social Determinants of Health on Health Outcomes Among Patients with Obesity","id":"7a16c2e9-552d-43e6-954b-8704e2b2926c","sessionCode":"HPR2","topDisplay":"Gutlay C1, Kennedy L2, Saber J2, Irwin K2, Lee E3 1University of California Irvine, San Diego, CA, USA, 2Innopiphany LLC, Irvine, CA, USA, 3Innopiphany LLC, New York, NY, USA","locationCode":"2A","description":"\r\n\t<div>OBJECTIVES: The objective of this study was to identify which social determinants of health (SDoHs) are more impactful to the health outcomes of participants with obesity versus participants without obesity. METHODS: In order to detect differences in how each SDoH impacts health outcomes, our team compared results of statistical inference between disease and non-disease cohorts. The variables used for this process were comprised of demographic, socioeconomic, survey, and electronic health record data supplied by the All of Us (AoU) database. The AoU database, consisting of this data plus whole genome and Fitbit data, is collected from participants across the United States with a focus on diversity and inclusion. Forward stepwise linear regression and principal component analysis was used to examine the importance of SDoH categories on health outcomes, while lasso regression was used to identify the individual survey questions that are important to these outcomes. RESULTS: A review of the forward stepwise regression results for our obesity models yielded notable differences in SDoH importance from the non-obesity models. This method indicated that social and community context, such as discrimination or supportive relationships, had a greater impact on general health and quality of life for obese participants than non-obese participants. In contrast, features related to neighborhoods and built environment played a greater role in determining these outcomes for non-obese participants. Results from the lasso regression models found survey questions relating to supportive relationships (i.e. “How often do you feel isolated from others?”) to be important to an obese participant’s general health, whereas education and neighborhood conditions were also important for non-obese participants. CONCLUSIONS: This study was able to highlight key factors in determining participant health outcomes, which can be taken for further, more focused study with a policy perspective in mind.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023gutlay2poster125747-pdf.pdf?sfvrsn=46c36fd5_0","title":"ISPOR2023_Gutlay2_POSTER125747.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125747","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Tracking Progress Towards Equitable Maternal and Child Health in Yunnan: A Systematic Assessment for the Health Programme for Poverty Alleviation in China during 2015-2020","id":"f5f73629-66c3-452e-8728-875e309debcf","sessionCode":"HPR32","topDisplay":"Huang Y Kunming Medical University, Kunming, 53, China","locationCode":"537","description":"\r\n\t<div>OBJECTIVES: We present a systematic assessment in Yunnan, the main battlefield against poverty in China, to inform the impacts of the health programmes which aimed at preventing women and children from being trapped in or returning to poverty because of illness. METHODS: We analysed national and Yunnan policy documents related to maternal and child health programmes for poverty alleviation during 2015-2020. We adapted the longitudinal comparative evaluation design and the difference-in-difference technique to assess the changes in disparities in maternal and child health system inputs, service coverage, and health outcomes between poor and non-poor areas, and out-of-pocket payments between poor and non-poor populations before and after 2017. RESULTS: In total 12 policies and 15 programmes related to poverty alleviation for poor women and children in Yunnan were summarised. As a result of health system strengthening in Yunnan, the densities of licenced doctors, nurses, obstetricians, midwives, township health workers, and female village doctors had been increased substantially in poor areas. Although disparities existed in some of service coverage between poor and non-poor areas, the health programmes had narrowed the gaps in utilisation of facility birth, caesarean section, prenatal screening, and newborn screening across Yunnan. The out-of-pocket payments for inpatient care for serious illnesses among women and children with poverty registration had been considerably decreased to 10.0%. Paralleling the universal coverage, maternal deaths per 100,000 livebirths and child deaths per 1,000 livebirths had further declined in both poor and non-poor areas, and the impacts of health programmes on closing the gaps in child survivals across Yunnan were significant. CONCLUSIONS: Remarkable progress in equitable maternal and child survival has been achieved in Yunnan. The practices in Yunnan have showed the Chinese model in ending poverty by strengthening health system and implementing universal coverage the firm commitment, determined leadership, detailed blueprint, and social participation.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/hpr32-tracking-progress-towards-equitable-maternal-and-child-health-in-yunnan124937-pdf.pdf?sfvrsn=403f9bc8_0","title":"HPR32-Tracking progress towards equitable maternal and child health in Yunnan124937.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124937","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Analysis of Cost Consequence of Liver Transplantation in Colombia","id":"da6858ba-4a06-4e65-b9c5-878aade8fc2f","sessionCode":"HTA13","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"619","description":"\r\n\t<div>OBJECTIVES: To determine the cost-consequence of the liver transplant program of the Fundación Santa Fe de Bogotá University Hospital -HUFSFB compared to national and international centers of reference. METHODS: A disaggregated analysis of health outcomes and costs, of the liver transplantation program at HUFSFB compared to two national reference centers between the years 2018 to 2021 was performed. Outcomes focused on transplant success, occurrence of complications and costs of care for liver transplantation and its complications based on the tariff manual of the National Ministry of Health. The analysis was developed in three time horizons (short term understood as the first month after transplantation, medium term from 3 to 6 months and long term greater than one year). RESULTS: During the analysis period, it was shown that when comparing the absolute risk rate for the occurrence of transplant complications, HUFSFB presented a 12% lower risk rate compared to the two reference institutions; acute rejection, infections and biliary tract narrowing were the outcomes that presented the greatest reduction. Regarding costs, at one year of follow-up, the cost of transplantation and cost per complication event, HUFSFB represents 9% higher than national health centers. However, in the aggregate analysis, the medical practice of liver transplantation at HUFSFB represents a saving to the system of, on average, $19,845.6 USD at 2021 prices, due to the lower number of complications per patient. Thus, according to the prevalence of transplant candidates at the national level for the year 2021, if the procedure were performed at the HUFSFB liver transplant center, the potential savings for the Colombian General Social Security Health System would be $6,601,349.2 USD. CONCLUSIONS: The total in-hospital care savings for transplant patients at HUFSFB is 42%.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127042","diseases":[{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Improving Healthcare Deserts in Sub-Saharan Africa: A Health Improvement Pilot Study Leveraging a Global, Cloud-Based Telemedicine Platform","id":"3c1f12cc-fb99-4beb-8169-87d510f3d8fb","sessionCode":"HSD118","topDisplay":"Chavez S Medical Impact Ventures, Redondo Beach, CA, USA","locationCode":"607","description":"\r\n\t<div>OBJECTIVES: The objective of this project was to improve healthcare deserts in Sub-Saharan Africa through sustainable knowledge transfer and capacity-building leveraging an advanced cloud-based telemedicine platform. METHODS: In 2022, WTI and its network of partners delivered 2 telehealth devices as part of the effort to create a sustainable platform to address a known health desert in a previously abandoned clinic in the village of Opoji, in the state of Edo, Nigeria. Providers were trained in two cohorts. Global Experts for this project were organized with Providence Health and their Global and Domestic Engagement (GDE) department and trained in telementoring and teleconsulting. Local Specialists were first trained on the platform and then telementored by Global Experts. To better understand the health value outcomes of these interventions, observational research was employed to measure the improvement of patient-to-provider ratios. These ratios were baselined for average patient loads. RESULTS: As a result of the pilot, provider-to-patient ratios were improved. Prior to the WTI program, interventions were only available 5% of the time (9 hrs/wk vs 168 hrs/wk), with very basic expertise. After the Opoji Comprehensive Medical Center was reopened and the supporting physicians were scheduled, patients could be seen with a high level of global medical expertise 100% of the time (24 hours per day). CONCLUSIONS: Telemedicine technology can improve capacity-building in Sub-Saharan Africa with relatively minimal resource allocation in a replicable and scalable manner. Data collection for the pilot did have limitations. The opportunity to collect patient-reported outcomes, including patient satisfaction with telemedicine visits, exists but COVID and other barriers prevented researchers from fully implementing. By mentoring the local specialty hospital staff to deliver care by cloud-based devices, the program has developed an “Africans helping Africans” approach to achieve sustainable capacity building which can be built upon and further researched.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-wti-42x72127364-pdf.pdf?sfvrsn=f5a2a008_0","title":"ISPOR 2023 WTI 42x72127364.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/wti-status-report-05-01-23127364-pdf.pdf?sfvrsn=8b446f56_0","title":"WTI Status Report 05.01.23127364.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127364","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Baseline Characteristics on Indirect Treatment Comparisons (ITCS) in Fabry Disease: A Systematic Literature Review (SLR)","id":"22c87cac-4a6b-46d2-bb45-87faaabe1bfc","sessionCode":"EE64","topDisplay":"Azimpour K1, Tordoff-Gibson C2, Dorling P3, Koulinska I3, Laliman-Khara V4, Forsythe A5 1Chiesi Canada, Toronto, ON, Canada, 2Cytel, Inc, London, UK, 3Chiesi USA, Cos Cob, CT, USA, 4Cytel Inc., Waltham, MA, USA, 5Cytel, Waltham, MA, USA","locationCode":"307","description":"\r\n\t<div>OBJECTIVES: Patients with Fabry disease (FD), a rare metabolic disorder, present high heterogeneity in disease characteristics. With no interventional studies directly comparing treatments, it is important for indirect treatment comparisons (ITCs) to consider potential effect modifiers (EMs). We conducted a systematic literature review (SLR) of real-world evidence (RWE) in FD to identify patient characteristics which may impact clinical outcomes METHODS: An SLR was conducted using PRISMA guidelines by searching EMBASE, MEDLINE, and Cochrane databases (1946 through the search date of 1 August 2022) for full-text articles reporting clinical outcomes of RWE studies of pharmacological therapies for the treatment of FD. RESULTS: A total of 940 publications were identified. Of these, 92 original studies fulfilled the PICOS criteria. Several potential EMs in FD were identified: gender, age, early/delayed treatment, left ventricular hypertrophy (LVH), estimated glomerular filtration rate (eGFR), proteinuria, baseline presence of anti-drug-antibodies (ADAs), and prior enzyme replacement therapy (ERT). In two studies of ERT-treated patients, males presented worse renal outcomes than females. Four studies found both younger patients and those who received initial ERT before age 25 years experienced greater reductions in plasma-lysoGb3 and more favorable renal, cardiac, and biochemical outcomes. Three studies reported associations between LVH and reduced eGFR at baseline, and increased risk of cardiovascular, renal, and neurological events. Reduced eGFR and proteinuria were linked to faster annual eGFR decline despite ERT in two studies each; high baseline proteinuria was a significant indicator of renal disease progression. Baseline ADAs were associated with reduced treatment impact on plasma/urine-lysoGb3. Migalastat was effective in treatment-naïve patients whereas deteriorations in mean lysoGb3, eGFR, and left ventricular mass were observed in the prior-ERT group. CONCLUSIONS: This SLR identified several patient characteristics that impact the effectiveness of treatments in FD. Adjustments for these characteristics should be considered during ITCs to ensure un-biased outcomes</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23azimpourposter-ee64125979-pdf.pdf?sfvrsn=fcf0b09b_0","title":"ISPOR23_Azimpour_POSTER EE64125979.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125979","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Improvements in Symptoms, Impact of Treatment, and Satisfaction with Treatment Among Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma Treated with Subcutaneous Epcoritamab","id":"5d1ae52f-3241-4ef3-baf4-8808485150e2","sessionCode":"PCR20","topDisplay":"Kosa K1, Mutebi A2, Wang A3, Blaedel J2, Sacchi M2, Martin S1 1RTI Health Solutions, Ann Arbor, MI, USA, 2Genmab US, Inc., Plainsboro, NJ, USA, 3AbbVie, North Chicago, IL, USA","locationCode":"730","description":"\r\n\t<div>OBJECTIVES: To qualitatively understand patients’ experience of being treated with subcutaneous epcoritamab for relapsed/refractory non-Hodgkin B-cell lymphoma (R/R B-NHL). METHODS: A subset of patients in the phase 1/2 EPCORE NHL-1 (NCT03625037) trial of subcutaneous epcoritamab monotherapy for R/R B-NHL participated in interviews after completing their cycle 10 visit or upon early termination from the trial. In-depth, one-to-one telephone interviews were conducted and transcribed. Subsequently, a thematic analysis of the data identified dominant themes in patient reports. RESULTS: Twenty patients across 3 countries participated in the interviews, with 50% being male and a mean age (range) of 66 years (21–84). Patients had either large B-cell lymphoma (n=16/20; 80%) or follicular lymphoma (n=4/20; 20%). Most patients were previously treated with chemotherapy (n=19/20; 95.0%) and 55% (n=11/20) had prior chimeric antigen receptor redirected T-cell therapy. Of those who reported ≥1 symptoms at baseline, 88.2% (n=15/17) reported improvement in ≥1 symptoms, with fatigue (n=10/14; 71.4%), tumor size (n=5/7; 71.4%), and body pain (n=5/7; 71.4%) most frequently reported. At the time of the interviews, all patients reported that current symptoms were either mild or nonexistent compared with their baseline symptoms. More than half of patients reported that subcutaneous epcoritamab had a positive impact on their daily activities (n=11/18; 61.1%). In addition, some patients experienced positive impacts on their physical (n=7/16; 43.8%), emotional (n=7/18; 38.9%), and social functioning (n=7/17; 41.2%). Most patients (n=16/20; 80.0%) reported being either “very satisfied” or “satisfied” with subcutaneous epcoritamab as a treatment for R/R B-NHL. CONCLUSIONS: R/R B-NHL patients treated with subcutaneous epcoritamab reported improvements in symptoms associated with their disease, positive impacts of treatment on their functioning, and satisfaction with treatment. These results present a direct patient perspective of the changes experienced over the course of treatment and complement what was observed in the validated patient-reported outcomes instruments used in the clinical trial.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23mutebiposterv2126372-pdf.pdf?sfvrsn=8fdcfc10_0","title":"ISPOR23_Mutebi_POSTERV2126372.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126372","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Magnitude of the Association between Insulin Adherence Based on Prescription Fill Rate Measures and Glycemic Control: A Systematic Review and Meta-Analysis","id":"1f290226-cf0d-45d2-8cd3-885ed90c793d","sessionCode":"PCR2","topDisplay":"Nguyen D1, Liang X1, Nguyen S2, Veettil SK3, Tan CJ1, Patikorn C4, Brixner D1, Chaiyakunapruk N1 1Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 2Northwestern, Chicago, IL, USA, 3College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 4Department of Pharmacotherapy, College of Pharmacy, University of Utah, Bangkok, 10, Thailand","locationCode":"3A","description":"\r\n\t<div>OBJECTIVES: Despite studies measuring association of insulin adherence and glycemic control in type 2 diabetes mellitus (T2DM), the magnitude and significance of association remains unclear. This study aims to summarize evidence on the association between insulin adherence and glycemic control in adults with T2DM. METHODS: A search in Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, and PubMed from inception until October 2022 was performed. Full-text studies were included if insulin adherence, measured by prescription fills, and glycemic control were reported. Two reviewers independently assessed studies for eligibility and extracted data. A random effects model using the Dersimonian and Laird method was performed to assess the association of adherence on hemoglobin A1C (HbA1C). Heterogeneity was evaluated using the I² statistical test. Pre-specified sensitivity analyses were completed based upon 1) population overlap, 2) study quality, 3) small sample size (25th percentile), 4) unclear adherence definitions, and 5) prescription fill history collection method. RESULTS: There were a total of 11 articles found. Three cohort studies and one RCT involving a total 6,133 patients compared the HbA1C difference between insulin adherent and non-adherent patients. Compared to non-adherent patients, adherent patients had a HbA1C mean difference (MD) of -0.56% (95% confidence interval (CI) -0.84%, -0.28%, I2 = 46.16%). Five cohort studies and one RCT with a total of 12,330 patients evaluated a change in adherence on HbA1C. An increase in adherence of 1% was associated with an HbA1C MD of -0.05% (95% CI -0.08%, -0.02%, I2 = 71.45%). Sensitivity analyses revealed the findings were robust. CONCLUSIONS: Insulin adherence was significantly associated with an HbA1C reduction. Improvements in insulin adherence may result in an improved HbA1C. Given the focus on insulin affordability, insulin adherence may be used to assess clinical effectiveness of these policies given that fill data is more readily available than HbA1C measurements.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispornguyenposter124909-pdf.pdf?sfvrsn=d3dd52cc_0","title":"ISPOR_Nguyen_POSTER124909.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124909","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Do Children Experience Inequality of Opportunity in Childhood Malnutrition in Pakistan: Evidence from Pakistan Demographic and Health Survey","id":"4da6fdc6-ef0e-4c44-9043-88728a23fc9f","sessionCode":"HPR9","topDisplay":"Sriram S1, Naz L2 1Ohio University, Athens, OH, USA, 2Institute of Business Administration, Karachi , SD, Pakistan","locationCode":"512","description":"\r\n\t<div>OBJECTIVES: Pakistan has high prevalence of childhood malnutrition amongst developing countries. National Nutritional Survey 2018 showed 44% of children were stunted. Different circumstances have the potential to create inequality of opportunity in child health. This study aims to identify the drivers of inequality of opportunity in childhood malnutrition among children below five years of age in Pakistan. METHODS: This study used Pakistan Demographic and Health Survey, 2017-18 to identify the role played by various factors in inequality of opportunity in child malnutrition. Dissimilarity index (D-index) and Oaxaca decomposition of D-index, and Shapely decomposition were used to measure and decompose inequality in opportunity in stunting. Regional variation in child health under various circumstances was analyzed using GIS. RESULTS: The burden of stunting is exceptionally high in Pakistan. Prevalence of stunting in rural areas far exceeded the urban areas through 1990-2018. Shapely decomposition of the contributors of inequality in opportunity indicates that maternal education contributed to 24 % of total inequality for rural and 44% for the urban children. Water and sanitation contributed 22% to overall inequality in the rural and only 2% in urban areas, implying a critical part played by the lack of water and sanitation in rural areas. Wealth index predominantly contributed to inequality nationally and in the urban region. Southern regions have a high higher prevalence of stunting and higher proportion of households without adequate water and sanitation. Proportion of mothers without education and stunted children are largely concentrated in Baluchistan and Sindh. CONCLUSIONS: Lack of mothers’ education, inadequate access to water and sanitation services, and poverty are contributing factors to inequality of opportunity in stunting among under-five children in Pakistan. Understanding the critical part played by various circumstances would help policy makers to address the situation and take concrete steps to enhance equal opportunities for child health.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123236","diseases":[{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Age Comparisons across Real-World Evidence Research, Randomized Clinical Trials, and Surveillance, Epidemiology, and End Results (SEER) in Advanced Cancer","id":"b0220497-8cd4-4fc4-9cc9-893fbaf73260","sessionCode":"RWD18","topDisplay":"Schuler T1, Balanean A1, Asgarisabet P2, Gentile D1, Brown M1, Savill K1, Chopra D1, Klink A1, Swain R2, Feinberg B3 1Cardinal Health Specialty Solutions, Dublin, OH, USA, 2Cardinal Health Real-World Evidence and Insights, Dublin, OH, USA, 3Cardinal Health Specialty Solutions, ATLANTA, GA, USA","locationCode":"828","description":"\r\n\t<div>OBJECTIVES: We compared ages of patients with advanced melanoma, breast, lung, liver, or kidney cancer in recently completed real-world evidence (RWE) chart review studies, multinational randomized clinical trials (RCTs) upon which the RWE studies were based, and the most recently available Surveillance, Epidemiology, and End Results (SEER) data. METHODS: Age at first-line (1L) treatment initiation among 7 RWE studies (2020-2022) relative to 8 corresponding RCTs (completed in 2017 or later) was compared. Given the generally brief duration between advanced cancer diagnosis and 1L initiation, age at diagnosis in SEER (2017-2019) relative to age at 1L initiation among the same 8 RCTs was also compared. Comparisons were overall, and for 3 breast cancer and 2 kidney cancer RCTs using t-tests, including pooled means and standard deviations for RCTs. RESULTS: We collected demographics for 83,622 patients (RWE: 2,980, 3.6%; RCTs: 6,492, 7.8%; SEER: n=74,150, 88.7%). Mean age at 1L initiation was significantly higher when comparing all 7 RWE studies to all 8 RCTs (62.9 vs 59.3), and this was also the case for specific comparisons of RWE studies to 3 breast cancer RCTs (61.8 vs 56.0) and to 2 kidney cancer RCTs (65.7 vs 60.9), all P<.001. Mean age at 1L was significantly lower when comparing all 8 RCTs to age at diagnosis in SEER (59.3 vs 61.3), and this was also the case for specific comparisons of 3 breast cancer RCTs (56.0 vs 59.0) and 2 kidney cancer RCTs to SEER (60.9 vs 65.1), all P<.001. CONCLUSIONS: In advanced cancer, significant differences in age were observed between RWE studies and RCTs, and RCTs and SEER data. Older patients frequently receive more conservative treatment and experience worse outcomes compared with younger patients, yet treatment decision-making is largely guided by data from RCTs. Future RCTs should consider leveraging RWE to improve generalizability.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporagecomprwd18final-2126505-pdf.pdf?sfvrsn=74048f71_0","title":"ISPOR_AgeComp_RWD18_Final (2)126505.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126505","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identifying Clinical Subgroups/Clusters of Alzheimer’s Patients from Optum’s De-Identified Market Clarity Database Using Machine Learning Techniques","id":"76c84d4f-32ba-4af7-8ebd-897bcccd8bc3","sessionCode":"RWD12","topDisplay":"Verma V1, Markan R2, Khan S2, Brooks L3, Khandelwal H2, Dawar V2, Roy A2, Bhargava S4, Gaur A2, Kukreja I5, Nayyar A2, Paul A2 1Optum, Gurgaon, HR, India, 2Optum, Gurugram, HR, India, 3Optum, Basking Ridge, NJ, USA, 4Optum Tech, Eden Prarie, MN, USA, 5Optum, New Delhi, DL, India","locationCode":"811","description":"\r\n\t<div>OBJECTIVES: To identify and categorize Alzheimer’s disease (AD) patients into clinically relevant groups based on demographics, symptoms, and comorbidities. METHODS: AD patients were identified using Optum® de-identified Market Clarity Dataset, which links medical, and pharmacy claims with EHR data using ICD-9 and ICD-10 codes. Continuous eligible patients (3 years pre index) above the age of 60 with at 2 outpatient diagnosis (30 days apart) OR one inpatient diagnosis recorded between 1st January 2019 and 31st Dec 2020 were included in the analysis. Patients with no symptoms, associated co-morbidities and prior claim of AD in the pre-index period were excluded from the analysis. For identifying subgroups, we used ML techniques like K-Means with multiple correspondence analysis (MCA), Agglomerative Hierarchical, and DBSCAN. Silhouette score was used to determine the optimal number of clusters (K). RESULTS: Among 108,714 patients, mean age of 81 years and predominant female (61%) population was observed. 21 features were included in the study using K-Means, Hierarchical and DBSCAN algorithm and 5, 6, 4 clusters were observed respectively. K-means with MCA gave most consistent subgroups based on distance measures cosine and Eigen values. Hypertension was identified as prominent risk factor and was present in all the clusters. Cluster1(Mild) had 49.5k patients with hypertension~85% and diabetes~34%. Cluster2(Severe) had 31.8k patients with hypertension~97%, diabetes~67%, heart failure~63%, coronary artery disease~78%, Kidney-disease~69%, atrial-fibliration~53%. Cluster3(Moderate) had 5k patients with hypertension~91%, diabetes~50%, fall~20%. Cluster4(Onset) had 6k patients with no significant comorbidities. Cluster5(Caution) had 16k patients with hypertension~ 92%, fall~85%, confusion~54%, depression~45%, memory loss~ 41%. CONCLUSIONS: This study can be leveraged for personalized and targeted healthcare intervention among different clusters. The study can also be used to determine if clusters have similar genetic makeup increasing their risk of developing AD. Early intervention in such cases can thus be beneficial in slowing disease progression and reducing the overall cost of care.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/alzheimers-clusteringispor2023127490-pdf.pdf?sfvrsn=b56eb9be_0","title":"Alzheimer's Clustering_ISPOR2023127490.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127490","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Socioeconomic Inequalities in out of Pocket and Catastrophic Health Expenditures Among the Households in Pakistan","id":"e803e100-3d09-4d8d-b114-8b502c14732d","sessionCode":"HPR27","topDisplay":"Arif S University of Manchester, Manchester, IS, UK","locationCode":"534","description":"\r\n\t<div>OBJECTIVES: The analysis of health inequality is essential for providing the evidence on who is being left behind and informs equity-oriented policies, programs, and practices. Therefore, socioeconomic inequalities in Out-of-Pocket Health Expenditures (OOPHEs), Catastrophic Health Expenditures (CHEs) and contribution of different factors in inequalities are assessed in this study. METHODS: Three rounds of the Household Integrated Economic Survey (HIES,2007-08, 2011-12, and 2018-19) conducted by the Pakistan Bureau of Statistics (PBS) are used. These socioeconomic inequalities are measured through concentration curves, concentration, slop, and relative Index of Inequality (CI, SII, and RII). Decomposition analyses are conducted using methods developed by Wagstaff (2005) and Erreygers (2009). RESULTS: The distribution of OOPHEs and CHEs are found to be pro-rich and pro-poor, respectively. It was found that socioeconomic inequalities in OOPHEs and CHEs are increased over time (between 2007-08 and 2018-19). The findings of CI show that OOPHEs are more concentrated among the high socioeconomic group while the reverse is true for CHEs. The SII of OOPHEs increased by 0.88% and 1.32% from lower to higher income group across time. On the other hand, CHEs have decrease from 7% to 5 % over the same period. The findings of RII showed that probability of bearing the OOPHEs is higher for the richest group, while RII of CHEs shows the poorest group have to bear higher CHEs. CONCLUSIONS: The socioeconomics inequalities in OOPHEs and CHEs are estimated to be higher among the poorest group compared to the richest group. Poor households with CHEs, are at a higher risk of impoverishment, should be the focus of social protection initiative such as unconditional cash transfer programs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124470","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Drug-Associated Kidney Injury in Children: A Disproportionality Analysis of the FDA Adverse Event Reporting System","id":"ccb266de-1853-474a-9195-8cb0b4228f34","sessionCode":"RWD29","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"837","description":"\r\n\t<div>目标： OBJECTIVES: To identify suspected drugs associated with kidney injury in children by analyzing data from the FDA Adverse Event Reporting System. 方法： METHODS: We extracted and analyzed reports on drugs associated with kidney injury in children in FAERS from the first quarter of 2004 to the third quarter of 2022 using OpenVigil 2.1. Descriptive analysis was performed to characterize the features of children with drug-associated kidney injury. Disproportionality analysis was conducted to evaluate the association between drugs and kidney injury in children. Meanwhile, comparisons were performed with drug specifications to identify drugs with a potential risk of kidney injury in children that were not on the list. 结果： RESULTS: A total of 6347 children (28433 reports) had drug-associated kidney injury in FAERS. We identified 270 drugs associated with kidney injury in children. Of these， ibuprofen (644 cases, x2=1152.94, PRR=3.71) was associated with most cases of kidney injury in children. Among the 30 most frequently reported drugs, the top five drugs with the highest PRRs were gentamicin (157 cases, x2=1602.77, PRR=12.28), piperacillin (129 cases, x2=1003.24, PRR=9.77), amlodipine (271 cases, x2= 1861.46, PRR=8.98), vancomycin (295 cases, x2=1998.64, PRR=8.91), and ceftriaxone (251 cases, x2=1494.02, PRR=8.00). According to drug specifications, 21 drugs (70.00%) were classified as known nephrotoxins, and 9 drugs (30.00%) as potential nephrotoxins. 结论： CONCLUSIONS: Approximately a third of drugs associated with kidney injury in children are not recognized as nephrotoxin in the drug specifications. It is important to note that the potential nephrotoxic drugs should be paid more attention to and closely monitored in future clinical practice. In addition, further research is needed to determine the risk of these potential nephrotoxic drugs in children, to provide references for preventing and treating drug-associated kidney injury in children.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124893","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"NLP and Machine Learning to Automate Identification of Suspected Medication Errors from Real World Unstructured Narratives","id":"a420f2b0-58e5-4ca8-a920-8cf9d3a8384c","sessionCode":"MSR20","topDisplay":"Painter J1, Haguinet F2, Cranfield C3, Bate A3 1GlaxoSmithKline, Raleigh, NC, USA, 2GlaxoSmithKline, Wavre, Belgium, 3GSK, London, UK","locationCode":"708","description":"\r\n\t<div>OBJECTIVES: To use machine learning (ML) to determine whether or not unstructured text (e.g. safety reports) contains mention of a medication error (MedError) and if so, to further sub-classify those as error with stated adverse drug reaction, error without harm, intercepted error, or potential error. This classification is usually rules-based and requires manual review by trained safety scientists. ML models were built to automate this process, first identifying if narratives containing MedErrors or not, and then further identifying the correct sub-classification. METHODS: A balanced, random set of case narratives (N = 3,122) labelled by safety scientists as mentioning a MedError or not were collected for ML training. The narratives were processed using text vectorization, and all product names were masked to reduce potential bias. A Bernoulli naïve Bayes classifier was trained using 75% of the data, and 25% was held out to test model performance. Next, a multinomial naïve Bayes (MNB) classifier was built on 1,744 case narratives containing manually annotated sub-classifications. Performance was evaluated using cross-validation. Concordance with rules-based labels was then compared to a non-supervised clustering method using k-means for narratives not sub-classified. RESULTS: The binary classification for the detection of MedErrors had an F1-score of 86%. The MNB classifier for sub-classification had an F1- score of 66% averaged across sub-classes. Concordance between rules-based and unsupervised clustering had kappa of 0.05. CONCLUSIONS: Binary classification for the detection of MedErrors showed good performance, while sub-categorization with this data set was low, except for one sub-class, error with stated adverse drug reaction. Given the adjudged importance of accurate sub-categorization, the current value added is uncertain. More training data will be required in order to consider its potential use, while results suggest binary classification could be readily employed for screening unstructured text to determine whether a MedError is present or not.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023painterposter126837-pdf.pdf?sfvrsn=3967bcd1_0","title":"ISPOR2023_Painter_Poster126837.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126837","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Effectiveness of Intravitreal Ranibizumab and Aflibercept for Eyes with Central Retinal Vein Occlusion: A Multi-Institutional Cohort Study in Taiwan","id":"19d0c514-eea5-4c4d-af60-8d683f6d2e25","sessionCode":"CO35","topDisplay":"Liu C, Shao SC Keelung Chang Gung Memorial Hospital, Keelung, Taiwan","locationCode":"135","description":"\r\n\t<div>OBJECTIVES: Intravitreal ranibizumab and aflibercept is the mainstream therapy for central retinal vein occlusion (CRVO), a common cause of vision loss in adults. However, the long-term effectiveness of changes in central retinal thickness (CRT) and visual acuity (VA) post ranibizumab and aflibercept therapy remains unclear in Taiwan. METHODS: This retrospective cohort study analyzed the electronic medical records data from three hospitals in northern Taiwan. We included CRVO eyes newly initiating ranibizumab or aflibercept therapy during 2017-2019, and evaluated the 1-year and 2-year changes of CRT and VA, measured by Snellen charts, after therapy. The VA was converted to the logarithm of the minimum angle of resolution (LogMAR) VA for statistical analysis. We used the mixed model analysis to assess CRT and LogMAR VA changes between the baseline and different time points. RESULTS: We included a total of 73 and 61 CRVO eyes receiving ranibizumab (mean age: 65.0±15.0 years old; female: 49.3%) and aflibercept (mean age: 66.4±14.1 years old; female: 42.6%), respectively. In ranibizumab users, we found significant decreases in CRT after 1-year (527.3 vs. 338.6 μm, p<0.001) and 2-year therapy (527.3 vs. 316.0 μm, p<0.001), but the LogMAR VA remained stable after 1-year (0.92 vs. 0.93, p=0.97) and 2-year therapy (0.92 vs. 0.97, p=0.40). In aflibercept users, we found significant decreases in CRT after 1-year (606.5 vs. 355.3 μm, p<0.001) and 2-year therapy (606.5 vs. 301.0 μm, p<0.001), but the LogMAR VA remained stable after 1-year (0.89 vs. 0.95, p=0.30) and 2-year therapy (0.89 vs. 0.97, p=0.05). CONCLUSIONS: Our findings suggested significant reductions of CRT without clinical improvements of VA in CRVO eyes treated with intravitreal ranibizumab or aflibercept in Taiwan’s clinical practice. Future studies should determine the benefits of CRT reductions on other long-term visual outcomes in CRVO patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023co35final-version124032-pdf.pdf?sfvrsn=b5d991bf_0","title":"ISPOR 2023_CO35_final version124032.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124032","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Epidemiology of Fragile X Syndrome in the United Kingdom","id":"4f51f422-97ee-41c5-a47d-8df06a95ad9a","sessionCode":"EPH32","topDisplay":"Bitchell L1, Morgan C2, Jones B2, Stanfield A3, McKechanie A3, Cooper A4, Conway P5 1Human Data Sciences, Pontyclun, UK, 2Human Data Sciences, Cardiff, UK, 3The University of Edinburgh, Edinburgh, UK, 4Shionogi BV, London, OXF, UK, 5Shionogi BV, oxford, OXF, UK","locationCode":"432","description":"\r\n\t<div>OBJECTIVES: Fragile X syndrome (FXS) is a genetic condition associated with cognitive and intellectual impairment. In this study we aimed to explore the epidemiology of FXS from the primary care perspective of the United Kingdom. METHODS: Patients were selected from the Clinical Practice Research Datalink (CPRD) Aurum dataset, a primary care database with approximately 20% coverage of England. Data in CPRD is linked to secondary care data via Hospital Episode Statistics (HES). Patients with FXS were defined by the presence of a relevant clinical code in either the CPRD Aurum or HES datasets. Point prevalence of FXS was estimated for 1st of January 2019. FXS patients were matched 1:1 to a control cohort by age, gender and primary care practice. Co-occurring conditions (gastrointestinal problems, height impairment, mitral valve prolapse, otitis media, seizures, autism, attention deficit hyperactivity disorder (ADHD), obstructive sleep apnoea, sleep disorders, strabismus, tic disorder and toileting issues) recorded prior to 1st January 2019 were compared between cases and controls. RESULTS: 1,520 patients with FXS were selected and all could be matched to controls. The point prevalence of FXS was 11.46 (95% CI: 10.89-12.05) per 100,000 population. 65% of the FXS population were male and the mean age was 32. For the majority of the selected co-occurring conditions, there was a significantly higher prevalence for patients with FXS compared with controls; notably for gastrointestinal disorders (38% versus 27%; p<0.001), seizures (13.0% versus 2.6%; p<0.001), autism (22% versus 1.9%; p<0.001) and ADHD (9.5% versus 1.6%; p<0.001). CONCLUSIONS: The estimated prevalence of FXS derived from routine primary care data is comparable to that derived from published estimates. Patients with FXS had a significantly greater number of co-occurring conditions than controls, though due to the nature of some of the conditions studied the absolute prevalence may have been underestimated.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23conwayposter125386-pdf.pdf?sfvrsn=9ddb72c8_0","title":"ISPOR23_Conway_POSTER125386.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125386","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Price of Innovation – Oncology Treatments Expenditures: Case from Bulgaria","id":"f5f55392-9ed5-42aa-919f-8e3a87f8655f","sessionCode":"HTA7","topDisplay":"Raycheva R1, Kostadinov K2 1Medical University Plovdiv, Plovdiv, 16, Bulgaria, 2Medical University Plovdiv, Plovdiv, Bulgaria","locationCode":"612","description":"\r\n\t<div>OBJECTIVES: Beginning in late 2015, health technology assessment (HTA) has taken the lead as the essential tool for governing how new pharmaceuticals are introduced and used in Bulgaria. Since 2017, the National Health Insurance Fund (NHIF) has reimbursed for all oncology medications included on the positive drug list (PDL) following a positive HTA recommendation. The purpose of this study is to describe the evolution of total annual cancer treatments expenditures from 2017 to 2021 following the introduction of HTA as a tool for healthcare decision-making. METHODS: First, we identified HTA appraisals for oncology indications and medications that were uploaded to the National Council on Prices and Reimbursement of Medicinal Products (NCPRMP) website during the 5-year period of analysis; second, we checked the PDL inclusion date of these with positive HTA recommendation; and finally, we matched the medications' reimbursed expenses across all quarterly NHIF reports per year. RESULTS: From 152 HTA appraisals 52 (34%) were identified as treatments in oncology – 42 drugs and 2 diagnostic kits; 48 indications; 3 negative decisions for PDL inclusion. In 2017 six new therapies were included in the PDL and the reimbursement expenses were calculated on 24,223,975.3 EUR – 5.9% of the overall NHIF budget for drug therapies. The NHIF budget for pharmaceuticals increased by 41.1% throughout the studied period, from 408,303,176 EUR in 2017 to 693,823,083 EUR in 2021. As the number of PLD-included oncology medications increased (42 therapies), reimbursement costs rose to 233,821,787.1 EUR, representing 33.7% of the 2021 NHIF budget for therapeutics. Oncology medications' NHIF budget overrun for 2021 was estimated to be 40,237,556.4 EUR, or almost 14% overspend. CONCLUSIONS: Oncology therapies expenditures are increasing on an annual basis, accounting for one-third of total medication reimbursement expenses, despite the Bulgarian declining population on the one hand, and increased NHIF drug reimbursement capacity on the other.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23raychevaposter126756-pdf.pdf?sfvrsn=20b5e88_0","title":"ISPOR23_Raycheva_POSTER126756.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126756","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Group-Based Trajectory Modeling to Evaluate Adherence Patterns for Direct Oral Anticoagulant Among Patients with Atrial Fibrillation","id":"bb99d918-1877-4c59-b1e6-9096c75c6559","sessionCode":"RWD3","topDisplay":"Fatima B1, Mohan A1, Chen H1, Deshmukh AA2, Wanat M1, Essien EJ1, Paranjpe R1, Abughosh SM1 1College of Pharmacy, University of Houston, Houston, TX, USA, 2Medical University of South Carolina, Charleston, SC, USA","locationCode":"813","description":"\r\n\t<div>OBJECTIVES: Direct oral anticoagulants (DOACs) are the standard of care to prevent stroke and systemic embolism among patients with atrial fibrillation (AF). However, suboptimal adherence with DOACs is a major problem and increases risk of thromboembolic events. Group-based trajectory modeling (GBTM) is a robust method to identify underlying variations in the longitudinal adherence pattern and has advantage over single estimates of Proportion of days covered (PDC). The objective of this study was to assess distinct trajectories of DOAC adherence using GBTM and identify predictors associated with adherence trajectories. METHODS: This retrospective study was conducted among Texas Medicare Advantage Plan patients with AF who were prescribed a DOAC from July 2016 - December 2017, with one-year follow-up. Monthly PDC was modelled into logistic GBTM and assessed using 2-5 adherence groups. The final model was selected based on Bayesian information criteria value and clinical relevance. A multinomial regression model was conducted to identify predictors associated with distinct trajectories using adherent trajectory as reference group. RESULTS: Among 1969 AF patients included in the analysis, four distinct adherence trajectories were identified: adherent (36.8%); gaps in adherence (9.3%); gradual decline in adherence (29.7%); and rapid decline in adherence (24.2%). Significant predictors with suboptimal adherence associated with rapid decline trajectory included gender (OR:1.36, 95% CI: 1.03-1.80) and low-income subsidy (OR:2.32, 95% CI: 1.79-3.00). Significant predictors correlated with gaps in adherence trajectory were age (OR:1.71, 95% CI: 1.06-2.74), low-income subsidy (OR:3.48, 95% CI: 2.29-5.27), prevalent users (OR:1.60, 95% CI: 1.08-2.36) and hypertension (OR:2.09, 95% CI: 1.05-4.16). Significant factors associated with gradual decline trajectory included low-income subsidy (OR:1.77, 95% CI: 1.40-2.24), renal disease (OR:1.73, 95% CI: 1.03-2.91), and NSAID use (OR:1.61, 95% CI: 1.01-2.60). CONCLUSIONS: Findings suggest that DOACs adherence was suboptimal. Predictors identified can aid clinicians in developing tailored interventions to improve patient’s adherence.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporposter2023bilqeesfatima127128-pdf.pdf?sfvrsn=6b14b5f2_0","title":"ISPOR_POSTER_2023_Bilqees_Fatima127128.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127128","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Estimating a Cost-Effectiveness Threshold for Health Care Decision-Making in China: Oncology Prevention Versus Treatment","id":"25da87bd-947f-48c0-97c4-90b94f978754","sessionCode":"EE44","topDisplay":"Zhao Z1, Dong H2 1Nanjing University Of Chinese Medicine, Hangzhou, China, 2Zhejiang University, Hangzhou, China","locationCode":"302","description":"\r\n\t<div>OBJECTIVES: To estimate a Chinese cost-effectiveness threshold (CET) for oncology prevention and treatment using a contingent valuation survey. METHODS: We conducted a web-based survey from May to June 2022 to estimate the CET for oncology prevention and treatment among experts who offering consultation to government institutions nationwide. We surveyed 79 experts exploiting an online communication group from a national think-tank of health technology assessment and health economics. The respondents were asked to state their estimated CET for a hypothetical treatment and a preventive intervention using contingent valuation method. Differences between the estimated CET value under 2 scenarios was assessed using a matched samples t-test. Determinant factors on the difference value between the two estimated CET was calculated through a stepwise regression model. Statistical significance was inferred at P<0.05 and all analyses were conducted using IBM SPSS Software v.25.0. RESULTS: The response rate was 84.81% and all of the respondents (n=67) reported a CET value greater than zero for the hypothetical prevention and treatment. The mean CET for oncology prevention was estimated at 1.29 times of per capita Gross Domestic Product (GDP) of China (about $16197.24). Whereas the mean CET for oncology treatment was estimated at 1.90 times of per capita GDP of China (about $23856.40), which was significantly higher than the estimate CET for oncology prevention (P<0.0001). In the stepwise regression model, only 1 factor associated with research interests showed statistical significance. Respondents with expertise in health policy studies were associated with an increase in the difference value for the hypothetical prevention and treatment (P=.012). CONCLUSIONS: The findings contribute to the ongoing discussion on the appropriate CET in China by comparing the estimated CET in oncology prevention and treatment from the perspective of supply-side. Hence, the results can be used for supporting healthcare decision-making and defining priorities among health promotion projects.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125434","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Incorporating Equity into Health Technology Assessment: Recommendations from Two Expert Roundtables","id":"2c8d934c-0f2b-4445-a5d0-90d7185c019d","sessionCode":"HTA17","topDisplay":"Chapman R1, Onukwugha E2, Swenor B3, Son Rigby C4, Diaby K5, Spangler J1, Bright J1 1Innovation and Value Initiative, Alexandria, VA, USA, 2University of Maryland School of Pharmacy, Baltimore, MD, USA, 3Johns Hopkins University, Baltimore, MD, USA, 4Global Genes, Aliso Viejo, CA, USA, 5Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA","locationCode":"626","description":"\r\n\t<div>OBJECTIVES: Identify best practices to ensure health equity is integrated into health technology assessment (HTA). METHODS: In December 2022 and January 2023, the Innovation and Value Initiative (IVI) convened two virtual roundtables including discussants representing lived experience, patient advocacy organizations, researchers, payers, clinicians, and industry. Drawing from their expertise, review of published literature, and previous key informant interviews, the roundtables identified best practices within the context of domains essential to equity in HTA, including: “power, people and processes” (addressing power imbalances in HTA), “methods to measure and address equity impacts,” “data, inputs and infrastructure,” and “communication of HTA.” RESULTS: A recurring focus was the need for reframing power and representative participation in HTA, and demand for solutions and accountability for change in processes and methods used. Specific emerging themes included: <ul> <li>Patient/caregiver expertise and lived experience must be considered on par with other expertise, with co-investigator roles prioritized for people affected by HTA.</li> <li>Transparency, inclusiveness, and accountability are essential for meaningful change in HTA.</li> <li>Researchers and users of HTA should prioritize qualitative and mixed methods where appropriate.</li> <li>Data and analyses should include elements identified as important by patients and reflect perspectives of marginalized patient communities.</li> <li>HTA must incorporate appropriate methods to advance equity that are understandable and accessible to multiple stakeholders.</li> <li>HTA models should highlight data and infrastructure gaps and prioritize research questions that advance equity rather than “building models to data.”</li> </ul> CONCLUSIONS: The roundtables identified best practices, grouped into 1) near-term actions; 2) actions requiring further exploration, testing or development; and 3) up- and down-stream actions requiring leadership and resources that exist outside HTA. Near-term actions focus more on process, power, and accountability measures, as well as testing existing methods and approaches. However, wider attention to stakeholder roles and collaborative responsibilities of researchers and policy makers is needed for change.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/hei-rt-abstract-poster-sent20230424127566-pdf.pdf?sfvrsn=3c6ccaaa_0","title":"HEI RT Abstract Poster SENT20230424127566.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127566","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Deconstructing ICER Value Assessments: Which Components Do Payers Value Most?","id":"58351f8f-b27c-4b11-a6e4-916483a8bcb2","sessionCode":"HTA20","topDisplay":"Noonan K1, Loo V1, Hydery T2, Westrich K3 1AmerisourceBergen Xcenda, Carrollton, TX, USA, 2AmerisourceBergen Xcenda, Millbury, MA, USA, 3Xcenda, Herndon, VA, USA","locationCode":"623","description":"\r\n\t<div>OBJECTIVES: The Institute for Clinical and Economic Review (ICER) conducts 8-12 value assessments annually. These assessments contain various sections summarizing the effectiveness and value of treatments. Since there is limited evidence evaluating which components payers find most influential, we sought to assess payer perceptions on the utility of ICER assessments. METHODS: We examined data from double-blinded, web-based surveys fielded to payers through Xcenda’s Managed Care Network (MCN) to evaluate perceptions and utilization of value assessments in 2020 (N=47) and 2022 (N=51) and survey data from FormularyDecisions (FD) payer users accessing ICER assessments from 2018 to 2022 (N=3,876). FD users rated the usefulness of assessment sections on a 5-point Likert scale (1=not at all useful to 5=very useful). Results were summarized using descriptive statistics. RESULTS: The components reported as most influential in the MCN surveys were Comparative Clinical Effectiveness (80%), Long-term Cost-effectiveness (53%), Health-Benefit Price Benchmarks (50%), and Potential Budget Impact (43%). They found Policy Implications (23%), Other Benefits and Contextual Considerations (15%), Voting Questions (9%), and Patient Perspectives (1%) less influential and rated these sections as the most unclear or not well-designed. FD users consistently rated all sections at least somewhat useful (4.0), with the most useful sections identified as the Executive Summary (4.6) and the Comparative Clinical Effectiveness (4.5). The lowest-rated sections were comments from payers and manufacturers (4.2 and 4.1, respectively). CONCLUSIONS: This study shows that ICER value assessments holistically deliver useful information to payers. However, certain sections of ICER’s assessments may provide more utility than others to payers in their decision-making process. The Comparative Clinical Effectiveness section was consistently reported as one of the most influential and useful sections. As ICER’s assessments continue to evolve based on stakeholder feedback, it is recommended to reassess payer perceptions on the influence and utility of each component in the report.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023noonankposter125693-pdf.pdf?sfvrsn=70579ab6_0","title":"ISPOR2023_NoonanK_Poster125693.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125693","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Comparing the Health Care Utilization of Those with Limited English Proficiency and Use of a Language Interpreter to Similar Individuals without Use of a Language Interpreter at Mayo Clinic","id":"3d104314-4da7-4ba9-b100-92cd5b000359","sessionCode":"HSD19","topDisplay":"Kelleher D1, Barwise AK1, Borah B2 1Mayo Clinic, Rochester, MN, USA, 2Mayo Clinic College of Medicine and Science, Rochester, MN, USA","locationCode":"603","description":"\r\n\t<div>OBJECTIVES: Evidence is unclear on whether individuals with Limited English Proficiency (LEP) and access to a trained language interpreter have greater or less health care utilization compared to similar individuals without access to an interpreter. This paper seeks to examine the health care utilization of individuals with LEP at Mayo Clinic who used an interpreter compared to those who did not. METHODS: The first model examined intensive-care-unit (ICU) length-of-stay (LOS) using a negative binomial model. The second model examined where an individual was discharged to using an ordered probit model. The final model examined whether an individual was readmitted to hospital using a probit model. Each model used robust standard errors and controlled for a range of covariates including interpreter use. RESULTS: There were 3,835 hospitalizations in the dataset from 2008-2017. 1,532 hospitalizations had use of an interpreter and 2,303 did not. The incremental effect of an individual having used an interpreter compared to an individual not having used an interpreter is 0.57 days (p<0.01) in the ICU ceteris paribus. If an individual had used an interpreter, they were 11-percentage points less likely (p<0.01) to be discharged to home; three-percentage points more likely (p<0.01) to be discharged to further care; seven-percentage points more likely (p<0.01) to die compared to an individual who did not use an interpreter ceteris paribus. If an individual had used an interpreter, they were six-percentage points less likely (p<0.01) to have been readmitted to hospital compared to an individual who did not use an interpreter ceteris paribus. CONCLUSIONS: Individuals with LEP who use an interpreter may be more resource intensive initially but become resource-saving through their lower likelihood of hospital readmission compared to those without use of an interpreter. These findings can provide policymakers with insight on the benefit of interpreters and may provide the impetus for hiring more. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kelleherposter1126142-pdf.pdf?sfvrsn=1bede4ac_0","title":"ISPOR23_Kelleher_POSTER1126142.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126142","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Understanding the Experience of Patients with Primary Biliary Cholangitis and Pruritus","id":"3524d794-e2bc-46a4-bbea-92f49a264c4b","sessionCode":"PCR34","topDisplay":"Levy C1, Williams B2, Sowell F2, Serafini P3, Giao Antunes NT4, Zein C4, Dietrich J5, Addy C5, Vargas D5, Schattenberg JM6 1University of Miami School of Medicine, Miami, FL, USA, 2IQVIA, New York, NY, USA, 3Ipsen, Sao Paulo, SP, Brazil, 4Ipsen, Cambridge, MA, USA, 5Genfit Corp, Cambridge, MA, USA, 6University Medical Centre of the Johannes Gutenberg-University, Mainz, Germany","locationCode":"744","description":"\r\n\t<div>OBJECTIVES: Primary biliary cholangitis (PBC) is a chronic, cholestatic liver disease characterized by injury of the intrahepatic bile ducts and has debilitating impacts on health and quality of life. The study objectives were to capture PBC patients’ pruritus experience and pruritus impacts and develop a conceptual model for PBC as a disease, including the main related symptoms. METHODS: Physicians confirmed PBC diagnosis, specifying the stage of disease, and patients reported current and prior treatments. Qualitative concept elicitation interviews were conducted with patients diagnosed with PBC and with clinicians. Interviews were recorded and transcribed, then analyzed for qualitative insights. RESULTS: Twenty patients (aged 28-68 years) from US and Canada, diagnosed with PBC (mean 10.7 years since diagnosis) and experiencing pruritus, and four clinicians from US and Canada were selected for semi-structured qualitative interviews conducted by qualified, independent researchers. Overall, 41 signs/symptoms and 31 impacts related to PBC were reported across clinicians and patients. Close to half of patients interviewed were in stage 1 (45%) of the disease, and 70% reported experiencing moderate or severe pruritus. Fatigue (95%) was common, and other symptoms included sensitivity to cold, dry eyes, dry mouth, headaches, pain, upper right abdominal pain, skin color change, and skin surface change. Patients also reported PBC was associated with physical, emotional, cognitive, role functioning, social, and other impacts (e.g., sleep, lifestyle changes). CONCLUSIONS: Pruritus and fatigue have significant impact on quality of life of patients, making it difficult to sleep, leading to mental and physical fatigue. There is a high burden for patients living with PBC and experiencing pruritus, which underscores the unmet needs of this population.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/genfit-ipsenpatient-experience-with-pbcispor-posterfinal126410-pdf.pdf?sfvrsn=8378a614_0","title":"GENFIT-Ipsen_Patient Experience with PBC_ISPOR Poster_FINAL126410.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126410","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Importance of Considering Price Metrics and Market Dynamics in US Economic Evaluations: The Case of Sglt-2 Inhibitors in the Treatment of Type 2 Diabetes (T2D)","id":"0d3f5457-7e66-42a5-aafe-94069df3cee6","sessionCode":"EE7","topDisplay":"Willis M1, Neslusan C2, Nilsson A1 1The Swedish Institute for Health Economics (IHE), Lund, Sweden, 2Janssen Scientific Affairs, LLC, Titusville, NJ, USA","locationCode":"209","description":"\r\n\t<div>OBJECTIVES: In the US T2D market, prices reflect both branded and generic competition, within and across classes. Despite recommendations, comparative economic analyses usually hold relative prices constant and, equally unrealistic, often use list prices. Even the few analyses that use prices net of manufacturer rebates understate opportunity costs by excluding time-varying intermediary margins. We illustrate the implications of these choices by simulating canagliflozin 300mg vs. sitagliptin 100mg in treating T2D. METHODS: Health outcomes and costs associated with these treatment strategies were simulated starting at canagliflozin launch in 2014. List prices, net prices, and systemwide net expenditures (SNE) (i.e., the sum of intermediary margins and net price) were sourced from SSR Health data. Results using fixed 2014 prices were compared to results based on actual prices through 2021 and to results based on forecasted prices over 25 years using T2D market price trend data available in 2014. RESULTS: Canagliflozin was associated with fewer micro- and macrovascular complications, resulting in sizable cost offsets and greater longevity. Replacing fixed list prices with actual time-varying net prices reduced estimated canagliflozin and sitagliptin costs by 40% and 60%, respectively. Using fixed 2014 net prices versus actual time-varying net prices overestimated the difference in drug cost between canagliflozin and sitagliptin by 37%. Net total cost savings with canagliflozin were 11 times higher with time-varying actual SNE versus time-varying actual net prices. The 25-year results were more variable, driven by additional uncertainty introduced by modeling future prices. CONCLUSIONS: Results illustrate the sensitivity of comparative economic analysis to different price metrics and assumptions about future prices, as well as the importance of accounting for rebates paid to insurers and PBMs. Like other time-varying parameters routinely projected into the future, prices that reflect the current market and anticipated market dynamics should be used as per guidelines.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-sglt2-market-competition-posterfinal126037-pdf.pdf?sfvrsn=838638ca_0","title":"ISPOR 2023 SGLT2 market competition poster_FINAL126037.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126037","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Update on the LIVESTARTTM Artificial Intelligence (AI) Systematic Literature Review (SLR) Tool – Can It Aid in Limited Data Extraction for LIVEREFTM?","id":"4ee90cad-a776-46c4-8df1-94a7bf0ecac3","sessionCode":"MSR8","topDisplay":"Liu J1, Jafar R2, Girard LA3, Thorlund K4, Forsythe A4 1Cytel Inc., Toronto, ON, Canada, 2Cytel Inc., Vancouver, BC, Canada, 3Cytel Inc., Montreal, QC, Canada, 4Cytel, Waltham, MA, USA","locationCode":"700","description":"\r\n\t<div>OBJECTIVES: SLRs are labor-intensive and time-consuming, however, they are required for regulatory and health technology assessments (HTA). We have previously published the application of LiveSTARTTM in title abstract review stage. We now seek to explore whether LiveSTARTTM could be used for LiveRefTM limited extraction to increase efficiency of a global value dossier (GVD). METHODS: Data were extracted manually by two independent and experienced analysts. Seventy-eight datasets containing extractions from 6,377 congress abstracts and curated library references were used to train (4,782) and validate (1,595) an AI model in LiveSTARTTM for data extraction. Objective data including indication, population, country, study category, study design, treatment products, sample size, data source and reported variables were prepared. Subjective interpretation as quantitative and qualitative summaries were also included. The accuracy and Hamming scores were calculated. Accuracy is a measure of concordance between prediction and actual results for binary results, whereas Hamming score is used for non-binary outcomes. RESULTS: LiveSTARTTM validation showed an accuracy = 0.76 for the sample size variable, and Hamming scores of 0.9, 0.84, 0.65, 0.64, 0.53 and 0.5 for indication, category of evidence, treatment products, population, study design and reported variables, respectively. For subjective interpretations, LiveSTARTTM demonstrated good grammar, syntax and logical editing as assessed by a senior medical writer and value communication specialist. LiveSTARTTM extracted data from 1,595 abstracts in ≈30 minutes. LiveRefTM GVD update demonstrated a 264.5-hour reduction (99.8%) in time as compared to manual extraction. With the addition of the LiveSTARTTM title abstract review tool, a total of 3.29 weeks were saved in a GVD update project. CONCLUSIONS: With the combination of machine-assisted title and abstract review, and data extraction, LiveSTARTTM AI could potentially yield comparable accuracy with considerable time savings in an SLR project. However, full utilization will require the adoption by regulatory and HTA authorities.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/msr8ispor-2023liuposterfinal126853-pdf.pdf?sfvrsn=88cc37aa_0","title":"MSR8_ISPOR 2023_Liu_Poster_Final126853.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126853","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Participation in Colorectal Cancer Screening during the COVID-19 Pandemic in Japan","id":"c9ad31b6-b4c9-4fc7-b207-950fee8bb813","sessionCode":"HSD9","topDisplay":"Hamashima C1, Sano H2 1Teikyo University, Tokyo, Japan, 2Shiga University, Hikone, Japan","locationCode":"543","description":"\r\n\t<div>OBJECTIVES: Participation in cancer screening has been affected and has decreased due to the dissemination of the COVID-19 infection nationwide. In Japan, the COVID-19 disease has been disseminated since early 2020. We compared the direct impact of participation in colorectal cancer (CRC) screening during the pandemic. METHODS: The pandemic was disseminated in early 2020, it was the first confusing year affected by the pandemic. Based on the national cancer screening survey, the decreased rates of participants in 2020 were calculated, referred to those in 2018, and compared by a chi-square test. Correlation between decreased rates of participants in CRC screening and cumulative patients with COVID-19 infection was also calculated. RESULTS: The total number of participants in colorectal cancer screening was 5,115,993 and 4,404,775 in 2018 and 2020, respectively. Total participation in CRC screening decreased by 13.9% in 2020 compared with 2018. The decrease rate was lower in men than in women (13.2% vs. 13.9%, P<0.01). However, the decrease rates differed among age groups;19.1%, 14.2%, 24.0%, and 6.6% in those aged 40-49 years, 50-59 years, 60-69 years and over 70's, respectively. In providing CRC screening, rates reported by the mass survey decreased by a greater amount than those reported among GP practices (22.1% vs. 7.3%, P<0.01). Although participants' decrease rates differed among 47 prefectures, these were not correlated with cumulative patients with COVID-19 infection (correlation= -0.0279,, P=0.8525). CONCLUSIONS: Although participation in CRC screening decreased during the pandemic, the impact was different among age groups, providing systems and prefectures. Most GP practices could continue their regular activities, including cancer screening while avoiding COVID-19 infection. Insufficient medical resources including number of GPs might lead to decrease participation in CRC screening, particularly in rural areas. The results suggest revising a plan for supplying CRC screening in the post-pandemic era.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23hamashimaposter124891-pdf.pdf?sfvrsn=478ead8b_0","title":"ISPOR23_HAMASHIMA_POSTER124891.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124891","diseases":[{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Measuring Psoriasis Disease Activity in the Real-World Setting: Relationship between the Physician Global Assessment and Body Surface Area Product and the Psoriasis Area and Severity Index","id":"e0864119-4244-45b6-9c24-95110b32287f","sessionCode":"HSD12","topDisplay":"Althoff A, Rasouliyan L, Kumar V, Chang S, Long S OMNY Health, Atlanta, GA, USA","locationCode":"547","description":"\r\n\t<div>OBJECTIVES: Severity of psoriasis is a major factor in a physician’s treatment decision. The objective of this research was to evaluate the relationship between the Physician Global Assessment and Body Surface Area product (PGA x BSA) and the Psoriasis Area and Severity Index (PASI) for assessing disease activity in psoriasis patients in specialty dermatology networks in the United States (US). METHODS: Patients from 6 specialty dermatology networks within the OMNY Health Database with an indication of psoriasis (diagnosis code L40*) and with PASI, PGA, and BSA scores recorded on the same day from 2017 to 2022 were included. Demographic characteristics were tabulated at first score. The Spearman correlation coefficient between PGA x BSA and PASI was generated. Mean PASI score was computed by PGA x BSA quartile, and analysis of variance (ANOVA) was employed to assess the relationship. RESULTS: From the 254,306 psoriasis patients, 187 patients with 359 observations were included. Distributions of gender (57% male), race (52% white, 38% other, 10% black among known categories), age (35% ≥ 61 years, 61% 21-60 years, 4% ≤ 20 years), and region (52% South, 40% West, 8% Midwest) were tabulated. The Spearman coefficient between PGA x BSA and PASI was 0.83. Mean (standard deviation) PASI scores for PGA x BSA quartiles 1-4 were 1.4 (1.6), 6.9 (3.9), 10.4 (6.3), and 19.4 (13.4), respectively, demonstrating a monotonically positive relationship (ANOVA p < 0.001). CONCLUSIONS: Administering the PASI tool in the real-world setting is time consuming, and the strong correlation between PGA x BSA and PASI may offer an opportunity to measure psoriasis disease activity more efficiently in routine clinical practice. Additional analyses accounting for patient characteristics and other clinical factors would be beneficial to understand independent contributions of those factors to PASI score.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23althoffposter127516-pdf.pdf?sfvrsn=f78d5bef_0","title":"ISPOR23_Althoff_POSTER127516.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127516","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Accelerating Access to Promising New Pediatric Medicines in Canada: Comparing International Approaches to Regulation and Reimbursement","id":"6e051886-edd3-4943-bcdc-956d1742ab70","sessionCode":"HPR8","topDisplay":"Cressman C, Denburg A Hospital for Sick Children, Toronto, ON, Canada","locationCode":"511","description":"\r\n\t<div>OBJECTIVES: Existing policies on drug regulation, HTA methods, and funding mechanisms in most health systems rarely account for the unique needs of children, resulting in significant access constraints. The relevance of innovative, precision therapeutics is rapidly expanding, as are rising costs of the same, exacerbating pre-existing challenges. Our study sought to understand the policy and regulatory challenges related to the evaluation and reimbursement of innovative therapies for children. METHODS: Using in-depth interviews with experts and comparative analysis of policy documents, we identified the policy, legislative and regulatory environments across select Canadian and international jurisdictions. Specific attention is paid to therapeutic safety and efficacy, market authorization, and funding allocations for children. Focusing on rare disease and pediatric oncology further illuminates where and how policy dynamics impact access. Drawing on HTA scholarship and policy theory, a critical interpretive approach guided analysis. RESULTS: Health systems globally are grappling with challenges presented by precision technologies and pediatric therapies, namely uncertain benefit and high costs. Policies and regulations that address the unique socio-biological, economic, and ethical considerations inherent in precision child health are lacking but many efforts are underway to innovate clinical research and HTA methods. We describe distinct approaches to a similar set of challenges and identify how policy contexts (governance structures, processes, connections between regulatory and HTA activities) as well as stakeholders and societal values impact access. We highlight differences in policy priorities and attention, in the included sets of values and stakeholder voices, and in the HTA and regulatory pathways created to meet the needs of novel paediatric therapies. CONCLUSIONS: This work illuminates a shared set of challenges ripe for collaborative efforts at policy reform. We hope to provide provincial/territorial and federal policymakers with evidence-informed considerations for the design and implementation of policies to govern equitable and sustainable access to innovative therapies for children. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126479","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Utility Analysis of 13-Valent Pneumococcal Conjugate Vaccine in the Immunization of Children Under Five Years for the Prevention of Invasive Pneumococcal Disease and Pneumonia in the Brazilian Public Healthcare System","id":"72a4bb80-279e-4bd6-87bc-95d50f8c2caa","sessionCode":"EE99","topDisplay":"Alexandre RF1, Almeida P1, Sebastião M2, Ferreira P1, Senna T2 1Pfizer, São Paulo, Brazil, 2Pfizer, São Paulo, SP, Brazil","locationCode":"201","description":"\r\n\t<div>OBJECTIVES: Streptococcus pneumoniae (or pneumococcus) infections are still important causes of morbidity and mortality. In 2015, despite the decrease in the burden of pneumococcal disease due to the use of conjugate vaccines, an estimated 393,000 deaths worldwide in children under 5 years old were due to pneumonia. The aim of this analysis is to compare utility and costs between 13-valent pneumococcal conjugate vaccine versus the 10-valent for children under five years old. METHODS: A cost-utility analysis was developed, with a decision tree modeling, considering local data for the prevalence of invasive pneumococcal disease (IPD) and pneumonia, and data from the literature for effectiveness of the evaluated technologies, for the incorporation the use of PCV13 in the Brazilian public healthcare system. The model simulates a cohort of newborns vaccinated at birth with PCV13 or PCV10. Each year, a new cohort with the same characteristic is vaccinated, up to a five-year horizon. Effectiveness measures were QALY (quality-adjusted life years), LY (years of life lost), and number of events prevented (DPI) and pneumonia. RESULTS: The analysis showed that the average cost saving of using the PCV13 vaccine was -R$ 121,054,625.60, translated into an incremental effectiveness of 164 QALYs over five years. The incremental cost-effectiveness ratio was dominant at - BRL 737,368.53/QALY. CONCLUSIONS: The clinical evidence and the favorable result of the cost-utility analysis for PCV13, are consistent with the current WHO recommendation, published in 2019, which highlights that the choice of a type of vaccine in a country it must consider the conditions of the vaccination program, guarantee of supply, prices sustainable to the local reality, the local prevalence of the serotypes and the pattern of antimicrobial resistance of these serotypes. In this context, the data presented in analysis may contribute to justify the expansion of the use of PCV13.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23alexandreposter125429-pdf.pdf?sfvrsn=e39120d6_0","title":"ISPOR23_Alexandre_POSTER125429.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125429","diseases":[{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"},{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Systematic Literature Review to Assess the Modeling Approaches in Economic Evaluations of Health Interventions for Adult Binge Eating Disorders","id":"56142706-7ddd-4cc9-96be-95f10f3c91f8","sessionCode":"EE25","topDisplay":"Singh B1, Kaur G2, Kulkarni A3, Diaby K4 1Pharmacoevidence, Mohali, PB, India, 2Pharmacoevidence, SAS Nagar Mohali, PB, India, 3Otsuka Pharmaceuticals, Princeton, NJ, USA, 4Global Value and Real-World Evidence, Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ, USA","locationCode":"225","description":"\r\n\t<div>OBJECTIVES: The purpose of this research was to identify and summarize different modeling approaches used in published economic evaluations (EEs) of adult patients with binge eating disorders (BED). METHODS: A systematic search was performed using Embase®, MEDLINE®, and NHS EED databases to identify EEs assessing adult patients with BED published in English over the last ten years. Citation snowballing and grey literature searches were conducted to gather comprehensive evidence. Predefined extraction forms were used to capture (i) study characteristics (e.g., year of publication, time frame, country), (ii) modeling approaches; (iii) costs, utilities, and benefits; and (iv) discounting. RESULTS: A total of five studies from six publications were included. Three were journal articles, one health technology assessment report, and one conference abstract. Two studies each were a cost-effectiveness analysis and cost-utility analysis, whereas the remaining one was a budget impact analysis. The analysis was conducted from the healthcare system perspective in two studies, societal in one and both healthcare & societal perspective in another study. Two studies reported a time horizon of 1 and 1.25 years, respectively. These studies justified non-consideration of discounting due to less than two years of time horizon. Two studies reported model structure: one utilized Markov, and the second used decision-tree modeling. The Markov model comprised seven heath states; non-symptomatic BED; BED with sub-threshold BE behavior week(w)1; BED with sub-threshold BE behavior w2; BED with sub-threshold BE behavior w3; BED with mild BE behavior; BED with moderate BE behavior, and BED with severe and extreme BE behavior. The health states reported in the decision tree model were remission; no-remission; relapse; and no-relapse. CONCLUSIONS: The SLR highlights the scarcity of EEs of health interventions for adult BED and advocates for future research in this area.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23diabyposteree25126568-pdf.pdf?sfvrsn=7f34be2d_0","title":"ISPOR23_Diaby_POSTER_EE25126568.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126568","diseases":[{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Unnecessary Staging Imaging in Patients with Early Stage Breast Cancer Varies By Cancer Stage: Are We Choosing Wisely?","id":"fe597b9e-fdbd-4450-8585-96922bd708e6","sessionCode":"HSD6","topDisplay":"Vyas A1, Puggioni G2, Kamat S1, Kogut S1 1University of Rhode Island College of Pharmacy, Kingston, RI, USA, 2University of Rhode Island Department of Computer Science and Statistics, Kingston, RI, USA","locationCode":"542","description":"\r\n\t<div>OBJECTIVES: The American Society of Clinical Oncology’s Choosing Wisely (CW) initiative recommends against the use of staging imaging procedures in patients with early-stage breast cancer who are at the low risk of metastasis. The impact of CW on staging imaging in older patients with early-stage breast cancer by their cancer stage was examined. METHODS: A retrospective observational cohort study using the Surveillance, Epidemiology, End Results-Medicare linked database was conducted. Women age >66 years diagnosed with stage 0-II incident breast cancer during 2007-2015 were included (N=84,606). The proportion of patients with at least one claim of Positron Emission Tomography (PET), Computerized Tomography (CT), or radionuclide bone scans in three months prior to and three months following cancer diagnosis, were identified for pre- and post-CW periods. Separate interrupted time-series (ITS) analyses and segmented regressions were conducted to evaluate if CW reduced the rate of staging imaging use by cancer stage. RESULTS: In unadjusted analyses, staging imaging use declined during the post-CW period compared to the pre-CW period for each cancer stage (16.2% to 13.5% for stage 0, 29.3% to 22.3% for stage I, 44.0% to 37.7% for stage IIa, 59% to 56.1% for stage IIb). ITS analyses showed that there was a non-significant 0.003% point per quarter increase in the rate of staging imaging use resulting from CW for women with stage 0 breast cancer. However, for women with stage I cancer, there was a minor significant 0.07% per quarter decrease in the rate of staging imaging use resulting from CW. For women with stage IIa and IIb cancer, there was a significant 0.22% point and 0.28% point per quarter increase, respectively, in the rate of staging imaging resulting from CW. CONCLUSIONS: Our findings underscore the continuous challenge of reducing unnecessary medical procedures in women with breast cancer, especially those with relatively higher stage disease.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127458","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Occurrence and Severity of Depression, Antidepressant Use Among Alzheimer’s Disease (AD) Patients across Race/Ethnicity","id":"a2ae33b0-77b2-4acb-b881-96e658b81ce8","sessionCode":"RWD11","topDisplay":"Shen Y, LaFleur B Center for Health Outcomes & PharmacoEconomic Research (HOPE Center), Tucson, AZ, USA","locationCode":"821","description":"\r\n\t<div>OBJECTIVES: To examine racial disparities in depression occurrence in US AD participants, and disparities in depression severity and antidepressant use among adults with AD. METHODS: Using the 2005-2022 National Alzheimer’s Coordinating Center (NACC) database, we measured depression occurrence and severity in AD participants (N= 11,906) stratifying by race and ethnicity. Depression severity was assessed by the 15-item Geriatric Depression Scale (GDS-15). Use of an antidepressant was obtained using Multum/Lexi-Comp therapeutic drug categories and identified prescription antidepressants. RESULTS: Among AD participants, 47.6% had depression. There is a significant difference in depression occurrence between race/ethnicity groups. Compared to Whites, African Americans (AAs) and Asians have lower rates of depression participants (OR, 95%CI: 0.769, (0.682, 0.866) and 0.677, (0.524, 0.857, respectively)), while Hispanics have a higher rates (OR, 95%CI: 1.491, (1.267, 1.753)). Among participants AD participants with depression, AAs and Hispanics have higher GDS-15 scores compared to White participants, suggesting more severe depression (Difference between means: 0.55, 95%CI (0.15, 0.95), 0.86, 95%CI (0.40, 1.33), respectively). Additionally, among AD participants, antidepressant use is significantly lower among AAs, Hispanics and Asians compared to white participants (OR, 95%CI: 0.41, (0.33, 0.50); 0.56, (0.44, 0.72), 0.46, (0.37, 0.85)). CONCLUSIONS: We found significant racial disparities in depression occurrence and severity, as well as antidepressant use among US AD participants. Hispanic participants have higher occurrence of depression compared to white participants and more severe depression. Black and Asian participants have lower depression occurrence but black participants have more severe depression. AAs, Hispanics and Asians all have lower antidepressant use compared to white participants.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/adrd-and-depression-poster20230422127051-pdf.pdf?sfvrsn=ad1a4dc3_0","title":"ADRD and depression poster_20230422127051.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127051","diseases":[{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Annual Disability-State Transition Probabilities Estimated from a Large Sample (-6000) of Australians with Multiple Sclerosis from MS-Base","id":"fa4d923d-ead2-44e4-9c64-97cf2eb255a2","sessionCode":"EE30","topDisplay":"Campbell J1, Henson G1, Fuh Ngwa V1, van der Mei I1, Taylor BV1, MSBase Australian Investigators M2, Palmer AJ1 1University of Tasmania, Hobart, TAS, Australia, 2MS Base, Melbourne, VIC, Australia","locationCode":"230","description":"\r\n\t<div>OBJECTIVES: Multiple sclerosis (MS) is a chronic autoimmune/neurodegenerative disease associated with progressing disability mostly diagnosed between 20-40 years of age in females (approximately 75%). We aimed to estimate transition probabilities from no disability through to severe disability and death. Transition probabilities are a vital input for health economics models that are used to inform healthcare resourcing decisions including for MS-specific disease-modifying therapies (DMT). METHODS: Data were obtained from Australian participants of MSBase, the largest international registry that collects observational data as part of routine clinical care. We used a five-state continuous-time Markov model to describe how people with MS transition between disability milestones defined by the Expanded Disability Status Scale (scale 0-10); no disability (EDSS=0), mild (EDSS=1-3.5), moderate (EDSS=4-6), severe (EDSS=6.5-9.5), and dead (EDSS=10), all recorded by the treating neurologist. Model covariates included sex, DMT usage, MS-phenotype (relapsing-remitting (RR)MS or secondary-progressive (SP)MS), and disease duration. Subgroup analyses were performed. RESULTS: N=6,369 participants (mean age 42.5 years, 75.0% female) entered the study, yielding 38,994 person-years of observation (mean (standard deviation) 6.1 (4.5) years) and 54,699 clinical reviews (mean 8.5 reviews). Holding all covariates at their mean values, one year transition probabilities included: remaining disability-free (54.0% [95%CI: 43.6%, 56.2%]); remaining in mild state (82.0% [60.4%, 82.6%]); from the no to mild state (42.1% [40.1%, 43.9%]); mild to moderate (11.4% [10.9%, 11.9%]; moderate to severe (9.5% [8.8%, 10.3%]); severe to death (0.5% [0.3%, 0.7%]). Hazard ratios showed that SPMS was associated with a 148.2% (95%CI:120.2%, 180.0%) increase and a 66.8% (71.3%, 61.5%) decrease versus RRMS in the hazard of disability progression and recovery, respectively. CONCLUSIONS: MS progresses quickly from the no disability state, particularly with the SPMS phenotype. Estimated transition probabilities will be applied in a health economics simulation model for Australia, intended to support reimbursement of interventions including medications to reduce progression of MS in Australia</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23campbellposter126564-pdf.pdf?sfvrsn=fb829aee_0","title":"ISPOR23_Campbell_POSTER126564.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126564","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Evaluation of Human Papilloma Virus Test in Comparison with Cytology in Uruguay from the Public Health System Perspective","id":"1a0d02eb-56f4-49d0-8d68-991b71301b71","sessionCode":"EE15","topDisplay":"Armijo N1, Abbott T1, Vera F2, Zamorano P3, Balmaceda C4, Espinoza MA5 1Pontificia Universidad Católica de Chile, SANTIAGO, RM, Chile, 2Pontificia Universidad Católica de Chile, Sheffield, YOR, UK, 3Pontificia Universidad Católica de Chile, Santiago, RM, Chile, 4Pontificia Universidad Católica de Chile, Santiago, Chile, 5Pontificia Universidad Catolica, Santiago, Chile","locationCode":"220","description":"\r\n\t<div>OBJECTIVES: To estimate the cost-effectiveness of the screening strategy with the molecular test with genotyping 16/18 compared to conventional cytology for the detection of human papilloma virus infection in Uruguay. METHODS: We performed a model-based cost-effectiveness study to compare molecular tests with genotyping 16/18 at three different intervals, in five, four, and three years, with conventional cytology every three years. A lifetime time horizon and a discount rate of 3% for costs and outcomes were considered from the perspective of the Uruguayan public health system. A microsimulation health-state transition model was used to characterize the natural evolution of the disease. Sensitivity and specificity of both tests were obtained from the literature. Costs were expressed in USD dated June 2022 and outcomes in quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses were performed to explore decision uncertainty. RESULTS: The results of the study showed that the molecular test with genotyping 16/18 was the most cost-effective alternative. In effect, all comparisons were less costly and more effective with ICERs -$152,243; -$35,159; -$6,747 per additional QALY for every five, four, and three years respectively. However, the molecular test with genotyping 16/18 applied every five years showed the highest incremental health net benefits (0.008481817). Probabilistic sensitivity analysis showed that uncertainty is probably associated with the source of parameters used to populate the epidemiological profile of the simulated patients. CONCLUSIONS: Although the three comparisons of the molecular test with genotyping 16/18 were dominant strategies for Uruguay, the screening strategy is most preferred every five years because it shows the highest health net benefit for the public health system</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/poster-ispor-boston-vph-uru127344-pdf.pdf?sfvrsn=9f1091eb_0","title":"Poster ISPOR Boston VPH URU127344.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127344","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Did Gender Healthcare Disparity Against Women Exist in Chile during the First Two Years of the Pandemic?","id":"3e102fe9-cc2c-40c4-86fb-9aafaaa59682","sessionCode":"EPH49","topDisplay":"Arenillas S1, Rada A2, Avila S2, Valdes C2 1Roche, Santiago Chile, RM, Chile, 2Roche, Santiago, RM, Chile","locationCode":"504","description":"\r\n\t<div>OBJECTIVES: Gender disparity has been a priority. In March 2020 the World Health Organization reported that almost 90% of men/women globally are biased against women. In 1997, the Chilean government developed a Women's Health plan. Also, Roche developed a global project to address these disparities. This study aims to know if, in Chile, gender disparity is a factor involved in the pathogenesis, diagnosis, and prognosis. METHODS: Year 2020 and 2021, mortality and hospital discharge databases from the Ministry of Health were used to evaluate the three most important conditions for the Chilean population. Male-to-female mortality and hospital discharge rate ratio were used for the analysis. RESULTS: From this analysis, we obtained that during 2020 and 2021 the three leading causes of mortality were cardiovascular diseases, COVID-19, and cancer. The top three causes were the same in women and men. However, the order of each condition was different, which could be related to the difference in some behavioral factors. For women, cardiovascular diseases were the top 1, then cancer and COVID-19. For men, the top one was COVID-19, then cardiovascular diseases and cancer. Regarding hospital discharge in both years, more women were discharged than men in cancer. However, for cardiovascular diseases and COVID-19, the data was different and it is related that more men experienced these diseases compared to women. CONCLUSIONS: Based on this analysis, we cannot conclude that there are healthcare gender disparities against women in Chile, because the difference in terms of mortality or hospital discharge could be related to other causes (i.e. social behavior, health awareness). However, in cancer, we see some disparities. There are more governmental guarantees for specific women’s cancer than for the general population. Therefore, it is essential to advance regarding general population cancer funds and public health awareness campaigns to reduce the mortality of some preventable diseases.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23arenillasposter127628-pdf.pdf?sfvrsn=85d6144b_0","title":"ISPOR23_Arenillas_POSTER127628.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127628","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Laparoscopic Surgery for Adrenocortical Carcinoma: Estimating the Risk of Margin-Positive Resection","id":"2d0da7bf-2afd-4878-8647-9b221db1f8dc","sessionCode":"RWD16","topDisplay":"Carlisle K1, Blackburn K1, Okoye G2, Japp E3, McArdle P4, Turner D1, Englum B1, Smith P5, Hu Y1 1University of Maryland School of Medicine, Department of Surgery, Baltimore, MD, USA, 2University of Maryland School of Pharmacy, Baltimore, MD, USA, 3University of Maryland School of Medicine, Department of Medicine, Baltimore, MD, USA, 4University of Maryland School of Medicine, Department of Epidemiology & Public Health, Baltimore, MD, USA, 5Univerisity of Virginia School of Medicine, Charlottesville, VA, USA","locationCode":"824","description":"\r\n\t<div>OBJECTIVES: Recent consensus guidelines herald an expanding role for minimally-invasive surgery (MIS) in the treatment of adrenocortical carcinoma (ACC). However, MIS has been associated with non-curative resection and locoregional recurrence. We aimed to identify risk factors for margin-positivity among patients who undergo MIS resection for ACC. We hypothesized that a simple nomogram can accurately identify patients most suitable for oncologically-sound MIS resection. METHODS: Curative-intent resections for ACC were identified through the National Cancer Database spanning 2010-2018. Trends in MIS utilization were reported using Pearson correlation coefficient. Factors associated with margin-positive resection were identified among preoperatively-available variables using multivariable logistic regression, then incorporated into a predictive model. Model quality was cross-validated using an 80% training dataset and 20% test dataset. RESULTS: Among 1260 ACC cases, 38.6% (486) underwent MIS resection. MIS utilization increased over time at non-academic centers (R=0.79, p=0.011), but not at academic centers (R=0.08, p=0.834). Factors associated with margin-positive MIS resection were increasing age, non-academic center (OR 2.0, p=0.008), cT3 (OR 5.2, p<0.001) and cT4 tumors (OR 28.0, p<0.001), and right-sided tumors (OR 2.1, p=0.005). A predictive model incorporating these four factors produced favorable c-statistics of 0.75 in the training dataset and 0.72 in the test dataset. The corresponding predictive nomogram is presented in Figure 1. CONCLUSIONS: An increasing proportion of adrenocortical carcinomas are resected via minimally-invasive operations, particularly at non-academic centers. Patient selection based on a few key factors can minimize the risk of non-curative surgery. Figure 1: Nomogram estimating the risk of margin-positivity for laparoscopic- and robotic-resected adrenocortical carcinoma. For example, a 65-year-old patient (33 pts) with a cT3 (57 pts), right-sided tumor (25 pts) at an academic center (0 pts) would have a 50% risk of margin-positive resection.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporaccposterokoye23125164-pdf.pdf?sfvrsn=8b2fbeef_0","title":"ISPOR_ACC_Poster_OKOYE23125164.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125164","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost Effectiveness of Treating Ivig-Resistant Kawasaki Disease Children with Second Round IVIG Versus Infliximab","id":"d281ad94-fd52-4e1f-b330-9b6099af344b","sessionCode":"EE61","topDisplay":"Johnson J1, Brinton D1, Simpson K1, Burns J2, Simpson A1 1Medical University of South Carolina, Charleston, SC, USA, 2University of California San Diego, San Diego, CA, USA","locationCode":"306","description":"\r\n\t<div>OBJECTIVES: Intravenous immunoglobulin (IVIG) is a known effective treatment to reduce the incidence of coronary artery aneurysms in children with Kawasaki Disease (KD). However, there are IVIG-resistant patients and a lack of clinical trial data to determine the best second round treatment. Using recent effectiveness findings from the KIDCARE study, this research aimed to determine if second round IVIG or infliximab is cost effective in KD patients with persistent or recrudescent fever. METHODS: A decision tree was developed to estimate total costs and outcomes. Cost effectiveness ratios were calculated for both treatment pathways. Cost and resource use were estimated from MarketScan®, US Bureau Labor and Statistics, Redbook and relevant peer-reviewed sources. Outcomes were measured using fever-free days based on KIDCARE study results. RESULTS: Use of infliximab 10 mg/kg in IVIG-resistant patients was found to be the least costly and more effective treatment pathway in children with KD. Infliximab saved one additional fever-free day at a cost of $33,529. The second IVIG treatment pathway had a cost of $1,809 per additional fever-free day and the infliximab treatment pathway had a cost of $1,289 per additional fever-free day. This indicates that infliximab treatment of IVIG-resistant children with KD is dominant. CONCLUSIONS: Infliximab is the economically preferred treatment choice for IVIG-resistant patients with KD compared to a second dose of IVIG under a range of assumptions.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23johnsonposter123496-pdf.pdf?sfvrsn=f44c3339_0","title":"ISPOR23_Johnson_POSTER123496.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123496","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Distributional Cost-Effectiveness Analysis of Cervical Cancer Screening Strategies in England","id":"84d50383-0fef-4d5e-b5ef-9c018ac165cd","sessionCode":"EE48","topDisplay":"van Hest N1, Griffiths M2 1Costello Medical, London, UK, 2Costello Medical, London, LON, UK","locationCode":"245","description":"\r\n\t<div>OBJECTIVES: A distributional cost-effectiveness analysis (DCEA) of cervical cancer screening strategies in England was developed to: 1) evaluate distributional impacts of different strategies on health differences by socioeconomic status and sex; 2) provide an informative case study for implementation of the DCEA method in this indication. METHODS: A cost-effectiveness analysis was developed to estimate incremental costs and health benefits (quality-adjusted life years [QALYs]) by 10 subgroups based on the Index of Multiple Deprivation (IMD) and sex for three actual and hypothetical cervical cancer screening strategies, compared to a baseline of no screening: 1) standard primary human papillomavirus (HPV) screening; 2) addition of a self-sampling HPV kit; 3) a targeted reminder for the two most deprived subgroups. Results were combined with estimates of baseline distribution of health and distribution of opportunity costs. The level-dependent Atkinson social welfare function was used for equity weighting. Sensitivity analysis explored the impact of differing levels of inequality aversion and scenario analysis explored input uncertainty. RESULTS: Compared to no screening, all three strategies had a positive health impact but increased inequality. Self-sampling provided the largest population health gains (24,800 QALYs more than the next best [targeted reminder]) but was associated with the greatest negative impact on equity as assessed by Atkinson index of inequality (A(ɛ)). Targeted reminder had the smallest negative equity impact. The greatest equity-weighted health benefit was provided by self-sampling and targeted reminder at an Atkinson inequality aversion parameter <6 and ≥6, respectively. Results were similar when assuming equally distributed opportunity costs. Main data challenges related to IMD-specific screening compliance, requiring derivation from local authority. CONCLUSIONS: In this analysis, cervical cancer screening strategies were found to be associated with a trade-off between health benefits and increased inequality; a targeted reminder strategy has potential to mitigate equity impacts. DCEA provides an important tool to identify and evaluate this trade-off.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/dcea-for-cervical-cancerispor-2023digital126732-pdf.pdf?sfvrsn=4bf8d7ca_0","title":"DCEA for Cervical Cancer_ISPOR 2023_Digital126732.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126732","diseases":[{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Comparative Effectiveness Using External Controls for Single-Arm Trials of Pembrolizumab in Tumor-Agnostic Indications Leveraging Real-World Data","id":"5fba816a-a341-4508-a068-9de15666e613","sessionCode":"RWD19","topDisplay":"Chen Y1, Martin P2, Ye S3, Inoue L1, Basu A1, Carlson JJ1 1University of Washington, Seattle, WA, USA, 2Kaiser Permanente Washington, Seattle, WA, USA, 3Oregon Health & Science University, Portland, OR, USA","locationCode":"829","description":"\r\n\t<div>OBJECTIVES: Single-arm basket trials represent significant challenges for assessing comparative effectiveness. We compared progression-free survival (PFS) and overall survival (OS) of patients with eight metastatic cancers who received pembrolizumab versus patients receiving NCCN-guideline-based chemotherapies. METHODS: We applied inclusion/exclusion criteria from microsatellite instability–high (MSI-H) trials (Keynote-164 and Keynote-158) to TriNetx electronic health record database to derive chemotherapy control cohorts. Gaussian copulas were fitted to extract the dependence structure from the real-world controls, and trial samples were simulated by combining with marginal distributions of trial baseline covariates. Imbalances of known covariates were adjusted with inverse odds weighting. Median OS and PFS were compared between trial and real-world cohorts for all tumor types. Weighted Cox proportional hazard regressions were also conducted for colorectal cancer (CRC) and endometrial cancer (EC) given available Kaplan-Meier data. RESULTS: Heterogenous median real-world OS (mrwOS, in months) and median real-world PFS (mrwPFS, in months) were observed among 9267 patients with metastatic cancers who progressed on ≥1 line of systemic therapies. Compared to patients receiving pembrolizumab, patients receiving chemotherapy for colorectal (39.3+ vs. 34.3), endometrial (56+ vs. 36.3), cholangiocarcinoma (19.4 vs. 11.7), small intestine (56+ vs. 21.8), and ovarian cancers (33.6 vs. 28.5) experienced shorter mrwOS, whereas patients with gastric (11 vs. 16.5), pancreatic (3.7 vs. 10), and brain cancers (5.6 vs. 10.3) had longer mrwOS. Similar patterns were observed for mrwPFS, which ranged from 2.8 to 4.7 months. Pembrolizumab was associated with more favorable PFS than chemotherapy for treating CRC and EC, respectively (CRC: Hazard Ratio [HR], 0.47; 95%CI, 0.34-0.66; EC: HR, 0.34; 95%CI, 0.26-0.44). However, MSI-H patients with CRC and EC receiving pembrolizumab did not demonstrate significantly better overall survival. CONCLUSIONS: This study provided external comparators for efficacy evidence from single-arm tumor-agnostic trials. Pembrolizumab was associated with significant prolonged PFS but not OS versus chemotherapy in patients with metastatic CRC or EC.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-posteryilin-chenfinal126433-pdf.pdf?sfvrsn=cf308373_0","title":"ISPOR poster_Yilin Chen_Final126433.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126433","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Burden of Disease of Chronic Kidney Disease (CKD) in Type 2 Diabetes (T2D) Using the Standard of Care in Ecuador","id":"09f3f084-f4ac-4428-98fe-9e1918c7b21e","sessionCode":"EE80","topDisplay":"López-Cabra C1, Rodríguez ÁD2, Mayorga Mogollon W2, Chávez MA3, Patiño A1, Herran SE4, Marrugo R5 1Bayer, Bogotá, CUN, Colombia, 2Numeris, Bogotá, Colombia, 3Bayer, San José, CUN, Costa Rica, 4Bayer, Bogota, Colombia, 5Bayer, Bogotá, Colombia","locationCode":"323","description":"\r\n\t<div>OBJECTIVES: To estimate the economic burden of CKD-T2D in Ecuador when the standard of care is used METHODS: A social perspective was used, considering direct costs related to healthcare system and to households; and indirect costs, using Disability Adjusted Life Years (DALY) and a reference of average income per worker. Costs were estimated using a micro-costing method. We developed a Markov´s model with five stages of the disease (Normoalbuminuria, Microalbuminuria, Macroalbuminuria, End-stage renal disease and death). For this model, a cohort of 1.000, 40-year-old people with T2D was used, and a time horizon up to 77 years old (according to life expectancy in Ecuador) RESULTS: The estimated direct annual cost per patient was $2.202,00 USD for microalbuminuria, $2.376,70 USD for macroalbuminuria and $24.959,80 USD for ESRD. Healthcare system costs for microalbuminuria were $874,60 USD, macroalbuminuria were $1.071,40 USD and $15.784 USD for ESRD. Out-of-pocket expenses were $1.327,40 USD, $1.305,30 USD, and $9.175,80 USD for microalbuminuria, macroalbuminuria and ESRD, respectively. Indirect costs per person were found to be $909,31 USD for micro- and macroalbuminuria, $4.992,48 USD for ESRD and $8.743,40 USD for death stage, with a total of 15,16 DALY CONCLUSIONS: The economic burden of the CKD-T2D disease for the group of Ecuador is around $104.239 thousands of dollars for a cohort of 1.000 people</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125101","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Both Dose Frequency and Modality Drive HIV Treatment Preferences Among People Living with HIV in the United States","id":"1a75ce7c-825d-4bd4-a5ba-9e795bb72375","sessionCode":"PCR10","topDisplay":"Russell E1, Zhou M2, Song Y2, Barak N3, Signorovitch J2, Mast TC2 1Merck & Co., Inc, West Point, PA, USA, 2Analysis Group, Inc., Boston, MA, USA, 3CrescentCare, New Orleans, LA, USA","locationCode":"722","description":"\r\n\t<div>OBJECTIVES: To assess stated preference of modality and frequency of HIV treatment among people living with HIV (PLWH) to inform heterogeneity in preference and unmet need for additional treatment options. METHODS: An online discrete choice survey was conducted in the US in 2021-22 among adult PLWH to assess preference for treatment modality (oral pills, injections or implants) and dosing frequency using best-worst scaling and a latent class model to analyze preference heterogeneity. Participants responded to 13 choice cards and questions regarding sociodemographic characteristics and reasons for treatment preference. The treatment options included oral pills 1x a day or week, self-injections every 1-, 3-, or 6-months, injections by a healthcare provider (HCP) every 1-, 3-, or 6-months, and an implant once a year. Participants were recruited from an HIV patient database, an outpatient clinic, and a national online panel. RESULTS: 829 PLWH completed the online survey (mean age was 44 years and 44% were African American). 6-monthly HCP-administered injection was the most preferred modality option, followed by weekly pills. 48% of respondents cited convenience as a driver of medication preference. The latent class model utilized daily pill dosing as the referent for all comparisons. The model demonstrated a strong preference for the longer-acting option within any modality, and among subsets of respondents a strong preference for weekly oral pills, 6-monthly self-injections, 6-monthly HCP-administered injections, and a yearly implant. CONCLUSIONS: Less frequent dosing of HIV treatment was generally preferred, and modality type was a notable driver of preference. PLWH are heterogenous with varied medication preferences; continued preference research should be an important input into HIV treatment research and development to offer new options and improve patient outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23russellposterv2125653-pdf.pdf?sfvrsn=80c9ab9_0","title":"ISPOR23_Russell_POSTERV2125653.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125653","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Opioid-Related Overdose Deaths in the South Region of the U.S. from 2013 to 2020","id":"fca83c3e-5f76-4704-b0cb-9f1829cafe64","sessionCode":"EPH16","topDisplay":"Skiera J, Thigpen J Samford University McWhorter School of Pharmacy, Birmingham, AL, USA","locationCode":"420","description":"\r\n\t<div>OBJECTIVES: The United States is currently suffering an epidemic of rising opioid-related deaths. This alarming trend is worrisome for states in the census-defined South Region of the United States. This research aims to explore the South Region, consisting of the South Atlantic, East South-Central, and West South-Central divisions, in assessing the average annual change and total change in opioid-related overdose deaths from 2013 to 2020. METHODS: Age-adjusted opioid-related death rates per 100,000 population were captured from the Kaiser Family Foundation for each of the 17 states in the South Region. Rates were collected for each year; from 2013 through 2020. Analysis was used to determine differences in opioid-related deaths over time and among divisions. Statistical comparisons were performed using paired T-tests, ANOVA, and post hoc tests. RESULTS: From 2013 to 2020, there was a significant increase in average age-adjusted opioid-related overdose deaths per 100,000 population within the South Region of the United States (mean difference 18.2; 95% CI, 24.7 to 11.8; p<0.001). Although there was no statistical difference in average total opioid-related death rates among the three compared divisions from 2013 to 2020, the average yearly percent change was statistically significantly different (p=0.029). Specifically, the South Atlantic division showed increased yearly rates of opioid-related deaths compared to the West South Central division (mean difference 12.7; 95% CI, 1.36 to 24; p=0.028). CONCLUSIONS: Opioid death rates have increased in the South Region of the United States from 2013 to 2020. Further studies need to be conducted to compare differences among regions and determine what factors are causing an increase in opioid-related deaths.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23skieraposter123699-pdf.pdf?sfvrsn=7ba30fc6_0","title":"ISPOR23_Skiera_Poster123699.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123699","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Long-Acting Modality on Health Technology Assessments and Formulary Decision Making in the EU4 and USA","id":"c9771bae-05f2-4cfa-88a0-9fa353f439f6","sessionCode":"CO40","topDisplay":"Shah S, Nair S, Koka NS, Ahmad M, Patel K, Syed AA, Matangi S, Malempati Y Market Access Solutions LLC / LTD (MKTXS), Raritan, NJ, USA","locationCode":"103","description":"\r\n\t<div>BACKGROUND: Relapse is a substantial risk factor for chronic diseases and is strongly associated with treatment discontinuation, where a major challenge in the management is maintaining treatment adherence. Evidence already in existence indicates that non-compliance increases the clinical and economic burden. Therefore, pharmaceutical companies are entering the market with long-acting modalities to address these compliance issues. The traditional HTA therapeutic benefit assessment, however, is independent of the mode of treatment. OBJECTIVES: To outline the impact of Long-acting modality on inherent HTA and formulary access in the EU4 (Germany, France, Italy, and Spain) and USA. METHODS: Primary research was conducted with twenty Payers across the EU4 and USA to understand the impact of long-acting mechanism of therapies on HTA ratings/ formulary decisions and price. RESULTS: Payers believed that the long-acting modality has little-to-no impact on HTA ratings and formulary decision-making. Innovativeness, clinical outcomes, safety, and cost-effectiveness compared to the existing treatments were found to be key determining factors for higher price, and access. Payers cite Prolia (Densosumab), which is administered once every six months for postmenopausal osteoporosis in women who are at an increased risk of fractures, as an example. Due to its improved efficacy and adherence, Prolia received an ASMR IV and SMR Important rating by the Haute Autorité de Santé (HAS) in France during its initial assessment performed in 2011. However, following a reevaluation in 2018, the HAS rating was demoted to ASMR V and SMR Moderate attributed to safety concerns, and uncertain clinical benefits correlated to lower real-world compliance. CONCLUSIONS: While the long-acting modality is an important benefit at the patient and prescriber level to achieve a relatively higher uptake/adherence, Payers and HTA bodies look beyond the long-acting mechanism to assess the therapeutic benefit, HTA rating, and pricing/reimbursement status of a novel therapy</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/impact-of-long-acting-modality-on-health-technology-assessments-and-formulary-decision-making-in-the-eu4-and-usa127046-pdf.pdf?sfvrsn=1737fbbc_0","title":"Impact of Long-Acting Modality on Health Technology Assessments and Formulary Decision Making in the EU4 and USA127046.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127046","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Increasing Access to Colorectal Cancer Diagnosis in Countries with Limited Colonoscopy Capacities: An Example from Thailand","id":"1017fbd7-cab6-45d2-9b76-a1106737c53e","sessionCode":"EE11","topDisplay":"Wongseree P1, Hasgul Z2, Jalali M2 1Mahidol University, Bangkok, 10, Thailand, 2Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA","locationCode":"215","description":"\r\n\t<div>OBJECTIVES: Low and middle-income countries face constraints in colorectal cancer (CRC) detection, including low access to diagnosis and limited colonoscopy capacity. We aim to conduct an economic evaluation of increasing access to diagnostic approaches, such as Fecal Immunochemical Test (FIT) screening and symptom evaluation, in Thailand which has limited colonoscopy capacities. METHODS: We conducted a population-based cost-effectiveness analysis through healthcare and societal perspectives using Colo-Sim, a system dynamics model of CRC care, calibrated to Thailand national data from 2004-2021. We analyzed improvement in access to FIT screening (strategy-I), symptom evaluation (strategy-II), and both (strategy-III) under current versus sufficient colonoscopy capacity. We estimated sufficient colonoscopy capacity, quality-adjusted life year (QALY) gained, and costs from each strategy over 25 years. We also performed multivariate sensitivity analyses to evaluate the cost-effectiveness results given uncertainties in model inputs, considering $4700 willingness-to-pay threshold of Thailand. RESULTS: With current colonoscopy capacity, strategies I-III result in 0.3M, 1.1M, and 1.3M QALY gained at an incremental cost-effectiveness ratio (ICER) of $7K, $2.4K, and $3.7K per QALY gained, respectively. Sensitivity analysis shows that their probabilities of being cost-effective are 0.12, 1, and 0.82, respectively. Increasing the colonoscopy capacity to a sufficient level does not affect the results of Strategy II; however, strategies I and III result in 1.3M and 2.3M QALY gained at an ICER of $2.4K and $2.1K per QALY gained, respectively. Also, the probabilities of strategies I and III being cost-effective increase to 0.70 and 0.87, respectively. CONCLUSIONS: With the current limited colonoscopy capacity in Thailand, an increase in symptom evaluation access may be the most cost-effective strategy. Improving both screening and symptom evaluation access results in slightly higher QALY gained but has a lower probability of being cost-effective. With sufficient colonoscopy capacity, improving both screening and symptom evaluation access may be the most cost-effective strategy with the most QALY gained.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124531","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact in Health Outcomes of Anti-PD(L)1 Inhibitors to Treat Early-Stage Cancers in Belgium","id":"66bc5336-abc3-4b6f-81d5-a206b53864d5","sessionCode":"CO26","topDisplay":"Aguiar-Ibáñez R1, Neves C2, Mantaian T3, Abreu A4, Sönmez D5, Sillah A6, Aktan G6 1Merck Canada Inc., Toronto, ON, Canada, 2Lumanity, Utrecht, Netherlands, 3Lumanity, Bethesda, MD, USA, 4MSD Belgium, Brussels, Belgium, 5MSD Sweden, Stockholm, Sweden, 6Merck & Co., Inc., Rahway, NJ, USA","locationCode":"130","description":"\r\n\t<div>OBJECTIVES: As the incidence of cancer is increasing and the concern about the sustainability of cancer treatment benefits is rising, recognizing the value of anti-PD(L)-1 inhibitors in neo-adjuvant/adjuvant settings is crucial. Research has shown that anti-PD(L)-1 inhibitors improve recurrence -free survival time in different tumor types for patients diagnosed with an early-stage cancer. We developed a health outcomes projection tool to estimate the health benefits of introducing anti-PD(L)-1 inhibitors to treat patients with an early-stage cancer across different tumor types in Belgium. METHODS: A multi-tumor, multi-indication model was developed to compare the health outcomes at the population level for two scenarios: one where anti-PD(L)1s can be used for patients with early-stage cancers for the approved neoadjuvant/adjuvant indications, versus a second scenario where anti-PD(L)1s are reserved for patients who develop advanced/metastatic cancer. The model assessed patients with early-stage melanoma (stage III), renal cell carcinoma (RCC), and triple-negative breast cancer (TNBC). For each tumor/indication, a 4-health state Markov model was implemented to quantify life years (LYs) without recurrence/event, quality-adjusted life years (QALYs), number of patients treated with metastatic disease, and deaths. Inputs included clinical trial data and Belgian publicly available data (i.e. number of eligible patients, treatment uptake, etc.) RESULTS: In Belgium, the introduction of anti-PD(L)1s to treat early-stage cancers (stage III melanoma, RCC and TNBC) is anticipated to avoid 1,199 recurrences (25%), while increasing in 4,154 the LYs without recurrence (13%), preventing 1,384 active treatments (29%) for metastatic disease, and avoiding 663 post-recurrence deaths (29%) between 2022 and 2031. CONCLUSIONS: Using anti-PD(L)1 inhibitors to treat early-stage cancers can reduce the number of recurrences, extend the time spent by patients free of cancer, and reduce the number of patients requiring metastatic treatment. This model can help inform planning and future discussions around investment in innovative treatments for early-stage cancers.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23aguiar-ibanezposterco26126830-pdf.pdf?sfvrsn=53782648_0","title":"ISPOR23_Aguiar-Ibanez_POSTER_CO26126830.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126830","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Desirability of Implementing an Outcome-Based Delayed Payment Model for Autologous Gene Therapy Atidarsagene Autotemcel (LIBMELDY®)","id":"7ccad7fb-8e10-4cbd-b382-a271150f5e54","sessionCode":"HPR10","topDisplay":"Callenbach MHE1, Vreman RA2, Schoenmakers D3, Mantel-Teeuwisse AK1, Goettsch WG2 1Utrecht University, Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, Netherlands, 2National Health Care Institute (ZIN); Utrecht University, Division of Pharmacoepidemiology and Clinical Pharmacology, Diemen, Netherlands, 3Amsterdam UMC, Department of Child Neurology, Emma’s Children’s Hospital, Amsterdam, Netherlands","locationCode":"513","description":"\r\n\t<div>OBJECTIVES: To illustrate potential consequences for the Dutch healthcare system of implementing different payment models for autologous gene therapy atidarsagene autotemcel (AA, Libmeldy®). METHODS: A calculation tool calculated three payment models: (1) a price discount of 60%, (2) an outcome-based spread payment with a 60% discount, and (3) an outcome-based spread payment linked to the willingness to pay (WTP) model with a 60% discount. Financial consequences were estimated for when patients are full responders (A), patients follow the transition probabilities to all health states provided by the marketing authorization holder (B), and when patients are assumed to be unstable responders (C). The associated costs for an average patient during the timeframe of the payment agreement (five years), the total budget impact (eight patients during the five-year interval), and associated benefits expressed in quality-adjusted-life-years for the total expected lifetime of the patient population were calculated. RESULTS: When patients respond according to the MAHs assumptions (Scenario B) implementing an outcome-based reimbursement model (payment models 2 and 3) has equal or lower associated budget impact while gaining similar benefits compared to a discount (€9,4 million to €5,6 million vs. €9.2 million). In the case of unstable responders (Scenario C) costs for payers are lower in the outcome-based scenarios (€3.4 million and €2.3 million, Scenario 2.C and 3.C, respectively) compared to implementing a discount (€9.2million, Scenario 1.C). Discounts should only be considered if patients are full responders. CONCLUSIONS: Outcome-based models were suitable to mitigate the financial risk and are preferred, from the payer perspective, for AA over simple discounts in situations when clinical performance was similar to or worse than predicted. The framework and calculation tool can aid reimbursement decision-makers to weigh the desirability of each of the different payment scenarios and support them with negotiating and implementing an outcome-based spread payment model.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023poster124480-pdf.pdf?sfvrsn=b0ff1285_0","title":"ISPOR 2023_poster124480.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124480","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Field Testing of a Novel Holistic National Health Outcome Score: An Indicator of Health from Patient-Reported Outcomes","id":"8e5498c3-58c9-4021-9b58-a2b99d2c636e","sessionCode":"MT11","topDisplay":"Yapp FCW1, Tey J1, Mohammad NA2, Hamid B3, Lam JJF1, Kassim N2, Lim HS1 1EVYD Technology, Bandar Seri Begawan, Brunei Darussalam, 2Health Promotion Centre, Bandar Seri Begawan, Brunei Darussalam, 3Health Promotion Centre, BANDAR SERI BEGAWAN, Brunei","locationCode":"639","description":"\r\n\t<div>OBJECTIVES: The field testing of a health score module (health index) via a national mHealth application provides a platform for the population to contribute information on their health status. The tool aims to promote health-seeking behavior and guide policymakers to improve health outcomes through population segmentation for targeted interventions. A preliminary national exercise was conducted to obtain behavioral insights in completing self-reported questionnaires using the tool and yielded an initial indicator of population health status. METHODS: 1,200 active users on a national mHealth application were randomly selected according to age, gender, and history of type 2 diabetes at a 1:1 ratio. Participants were sent periodic nudges to interact with the module. A personalized health score was generated based on patient reported outcomes from 5 sets of questionnaires. User behavior and subsequent health score results were analyzed. RESULTS: Preliminary results showed that 13% of targeted users completed the questionnaires within 1 month. Nudges were most effective on weekends and after 6pm. Uptake in those aged 60 years and above was slow, while users diagnosed with type 2 diabetes mellitus were more likely to participate. 85% of all participants were in the ‘At Risk’ (31-81) category; 94% of participants diagnosed with diabetes were captured here. Analysis of health variables showed that body mass index (BMI) and diet put participants at risk in the physical health and specific domain category respectively. CONCLUSIONS: Preliminary results showed great promise on user adoption. The final roll-out is projected to reach a target audience of approximately 440,000 users. An effective nudging strategy, including optimal nudging windows and customized nudges, may increase public interest to participate. The existing model can capture the holistic health status of participants while taking into consideration existing diagnoses. Further regression analysis will be conducted to identify localized lifestyle factors associated with health risks.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/pro7583-health-indexcompressed125746-pdf.pdf?sfvrsn=f81981a_0","title":"PRO7583-Health Index_compressed125746.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125746","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Implementation Challenges and Real-World Impacts of Switching Pediatric Vaccines: A Global Systematic Literature Review","id":"6438a3da-ea81-4bda-b8ba-a300334ba71f","sessionCode":"HPR21","topDisplay":"Patikorn C1, Kategeaw W2, Perdrizet J3, Li X3, Chaiyakunapruk N4 1College of Pharmacy, University of Utah, Bangkok, 10, Thailand, 2University of Utah College of Pharmacy, Salt Lake City, UT, USA, 3Pfizer Inc, New York, NY, USA, 4University of Utah, Salt Lake City, UT, USA","locationCode":"524","description":"\r\n\t<div>OBJECTIVES: Switching a vaccine for another on a pediatric national immunization program is often done for the betterment of society. Poorly implemented switches may introduce challenges, such as unaccounted for resource use consumed during the transitions or suboptimal transitions, negatively affecting vaccine access or producing unwanted health system impacts. Therefore, this systematic review aimed to evaluate the global evidence indexed in electronic databases on implementation challenges of pediatric vaccine switches and the real-world impact of those challenges. METHODS: Four electronic databases, including PubMed, Embase, CENTRAL, and LILACS, were searched for articles published from database inception to April 30, 2022. We utilized thematic synthesis to classify the identified implementation challenges and impact of a vaccine switch into themes and sub-themes based on the extracted data. RESULTS: Thirty studies were included, vaccine switching implementation challenges and subsequent impact were most frequently found for polio vaccines (n=21) followed by pneumococcal conjugate vaccines (n=6), combination vaccines (n=2), and pertussis vaccines (n=1). Using thematic synthesis, we synthesized three themes: vaccine availability, vaccination program deployment, and vaccine acceptability. Switching pediatric vaccines can pose unforeseen challenges to healthcare systems worldwide and additional resources are often required to overcome those challenges. Yet, the magnitude of the impact, especially economic and societal, was frequently under-researched with variability in reporting. CONCLUSIONS: Our study demonstrated that switching pediatric vaccines has posed unforeseen challenges to healthcare systems regardless of geographic region, and additional resources are often required to overcome challenges. It is essential that all the aspects of a switch are considered prior to decision-making to provide optimum public health benefits under an appropriate timeline. We emphasize that future research should be conducted to comprehensively capture the underrecognized impact, resources consumed, and costs of implementing a vaccine switch.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023vaccination-switchposter-v3123951-pdf.pdf?sfvrsn=796540aa_0","title":"ISPOR 2023_Vaccination switch_Poster v3123951.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123951","diseases":[{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Validity and Accuracy of Weight Status-Related Diagnosis Codes Among Hospitalized Patients in the United States: 2017−2021","id":"566748a6-c702-4010-96f8-a3f6d813eee0","sessionCode":"EPH5","topDisplay":"Moon R1, Rosenthal N2, David J1 1PINC AI™ Applied Sciences, Premier Inc., Charlotte, NC, USA, 2PINC AI™ Applied Sciences, Premier Inc., Oak Park, CA, USA","locationCode":"412","description":"\r\n\t<div>OBJECTIVES: Real-world administrative databases are increasingly used to generate evidence to support clinical and healthcare decision making. Abnormal weight status is associated with many health outcomes and needs to be considered in epidemiological and health outcomes research. Due to the lack of vitals data in administrative databases, assessment of abnormal weight status is often dependent on International Statistical Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis codes. We evaluated the validity and accuracy of weight status-related ICD-10-CM codes against vital measurements. METHODS: A retrospective cross-sectional study was performed using PINC AI™ Healthcare Database (PHD) for adult (aged≥20 years) inpatients with height and weight measurements available and discharged between 1/1/2017−12/31/2021. We compared the presence and accuracy of weight status-related ICD-10-CM codes to weight status determined by body mass index (BMI) calculated using weight and height measured at the visit (BMI=weight[kg]/height[meter]2). RESULTS: Among 2,824,488 patients, 7% were underweight (BMI<20.0kg/m2, n=206,899), 30% were overweight (25kg/m2≤ BMI< 30kg/m2, n=852,999), and 39% were obese (BMI≥30kg/m2, n=1,087,630) at the time of inpatient visit. Among patients with abnormal weight, 65.3% of underweight, 91.0% of overweight, and 50.6% of obese did not have weight status-related ICD-10-CM codes reported. The sensitivity of ICD-10-CM codes for underweight was 32.4%, specificity was 99.7%, positive predictive value (PPV) was 88.3%, and negative predictive value (NPV) was 94.9%. The sensitivity of ICD-10-CM codes for overweight was 3.6%, specificity was 99.7%, PPV was 83.5%, and NPV was 70.5%. The sensitivity of ICD-10-CM codes for obesity was 48.4%, specificity was 98.7%, PPV was 95.9%, and NPV was 75.3%. CONCLUSIONS: Under-reporting of weight status-related diagnosis codes is common in hospital administrative data. Diagnosis codes for obesity showed high specificity/PPV and when present, are a reliable measure for determining patients’ obesity status. However, caution is warranted for using diagnosis codes to assess prevalence of obesity in this population.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023obesityvalidationfinal125610-pdf.pdf?sfvrsn=d5eff0d4_0","title":"ISPOR2023_ObesityValidation_Final125610.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125610","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Use of Work Productivity Instruments for Adult Cancer Patients in Economic Studies: A Systematic Literature Review","id":"beb0f7cb-b096-43bf-a93e-a44517e49ca2","sessionCode":"EE39","topDisplay":"Thakur D1, Zhou M2, Islam S1, Zhang L3, Patel V4, Musat M5 1Cytel Inc., Toronto, ON, Canada, 2Cytel Inc., Toronto Canada, Toronto, ON, Canada, 3Cytel Inc., Toronto, Canada, Mississauga, ON, Canada, 4Cytel Inc., Toronto, Toronto, ON, Canada, 5Cytel, Inc., Waltham, MA, USA","locationCode":"236","description":"\r\n\t<div>OBJECTIVES: Work productivity (WP) is an important metric in economic evaluations, as it allows the estimation of work-related productivity loss and consequential economic impact. The objective of this review was to assess the use of WP measurements in economic analyses of oncology indications. METHODS: The Ovid platform was used to identify records from MEDLINE, Embase, and CENTRAL databases, published in English from 2012 to 2022. Studies assessing the economic impact of productivity loss based on at least one WP scale among adult patients with cancer were included. Data regarding the indication, WP measurement, and its contribution to economic outcomes were collected. RESULTS: Seventeen studies were included from 1571 screened records. The most frequent scales were Work Productivity and Activity Impairment (WPAI), iMTA Productivity Cost Questionnaire, and Productivity and Disease Questionnaire, contributing to outcomes including societal costs, indirect costs, direct costs, productivity loss costs, and cost-utility. Among 17 studies, eight incorporated WP into the estimation of incremental cost or economic burden, seven did not, and two did not specify. Patients with cancer had higher WPAI scores and corresponding indirect costs compared to those without. A significant negative correlation between indirect costs and health-related quality of life was noted. Productivity losses accounted for half of the 3-month mean societal cost per patient with colorectal cancer. High productivity loss and overall costs were noted for both patients with glioma and depression and their caregivers. WP loss due to head and neck cancer-related disabilities had a substantial impact on indirect costs, which were estimated to be 10 times higher than direct costs. CONCLUSIONS: Although many economic evaluations have been conducted in adult oncology patients, very few incorporated WP in the estimations of economic burden. Further research is warranted to understand the reasons for the apparent underutilization of the WP measurements in economic evaluations.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23thakurposteree39126234-pdf.pdf?sfvrsn=95f52346_0","title":"ISPOR23_Thakur_POSTER_EE39126234.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126234","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of the Inflation Reduction Act on Pricing, Reimbursement, and Market Access in the US","id":"fd12c316-d0c6-4c8e-946b-a4e738b0a11b","sessionCode":"HPR34","topDisplay":"Shah S, Kumar Sabbi T, Ahmad M, Patel K Market Access Solutions LLC / LTD (MKTXS), Raritan, NJ, USA","locationCode":"535","description":"\r\n\t<div>BACKGROUND: The Inflation Reduction Act (IRA), passed in late 2022, includes several provisions to lower Medicare prescription drug costs and federal government drug spending. The bill is expected to have significant repercussions in the pharmaceutical industry. OBJECTIVES: To understand the impact of the IRA on market access, pricing, and reimbursement and outline opportunities / methods that biopharmaceutical manufacturers can adapt. METHODS: A secondary literature review was conducted to define the specifics of the IRA and expected implications for innovators. To capture the true impact of IRA from all stakeholder’s perspective, thorough review of pro and con published opinions RESULTS: The IRA gives Medicare the authority to negotiate the amount Medicare pays for certain prescription drugs and to force drugmakers to pay rebate if drug prices rise above inflation rate. The new law effectively cuts the market share and drug price negotiation from at least 75% to 40% depending on market times, eliminates the cost of 5% co-insurance for catastrophic coverage and limited Part D premiums annual increment from 2024 to 2030.Innovators will now focus on generating more value-based data and real-world evidence when justifying their pricing position in negotiations to mitigate the consequences of the new rule. Additionally, manufacturers are looking to conduct portfolio evaluation and adjustments, launching cousin molecules in parallel for multiple indications, pivoting from diseases afflicting the Medicare population, towards biologics and biosimilars to gain market time. Furthermore, manufacturers are, implementing innovative pricing strategies such as optimal launch prices, pre-launch negotiations, and aggressive pricing in pharmacy benefit conditions CONCLUSIONS: The IRA impacts the overall profitability and strategic options of US manufacturers and stakeholders. Based on our findings, we believe IRA will have negative impact on pharmaceutical companies, drug innovation and R&D, significantly decreasing new drug development for indications that mainly focus on Medicare populations</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/impact-of-inflation-reduction-act-on-pricing-reimbursement-and-market-access-in-the-us127072-pdf.pdf?sfvrsn=e7691c0c_0","title":"Impact of Inflation Reduction Act on Pricing, Reimbursement, and Market Access in the US127072.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127072","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Comorbidities in Elderly Patients with Oral Corticosteroid-Dependent Asthma in South Korea","id":"f1e2fa9d-0cc7-4e21-bcea-a588ed3bb9ea","sessionCode":"EPH35","topDisplay":"Pyun D1, Bae EJ2, Kim MKM2, Park S2, Suh HS3 1Department of Regulatory Science, Graduate School, Kyung Hee University, Seoul, Korea, Republic of (South), 2Sanofi Korea, Seoul, Korea, Republic of (South), 3College of Pharmacy, Kyung Hee University, Seoul, Korea, Republic of (South)","locationCode":"435","description":"\r\n\t<div>OBJECTIVES: To examine the adverse effects of oral corticosteroid (OCS) on elderly asthma patients in South Korea, we aimed to estimate the prevalence and odds of potential OCS-related comorbidities in OCS-dependent asthma patients compared with patients who did not use OCS. METHODS: A cross-sectional study was performed using the Health Insurance Review and Assessment Service-National Patient Sample 2020. We included patients aged ≥60 years with OCS-dependent asthma, satisfying all following criteria: (1) ≥1 claim of asthma diagnosis (ICD-10: J45-46) (2) ≥5 mg/day prednisolone equivalents use for ≥90 days in a year. No-OCS asthma patients were also defined for comparison: ≥1 claim of asthma diagnosis and having no prescription record of OCS in 2020. Prevalence rates of potential OCS-related comorbidities were evaluated for each group. We used binary logistic regression to estimate the odds ratio (OR), 95% confidence interval (CI), and p-value for the OCS-dependent patients relative to no-OCS asthma patients. A p-value of <0.05 was considered statistically significant. RESULTS: Overall, 898 OCS-dependent asthma patients and 12,695 no-OCS asthma patients were included. The odds of congestive heart failure comorbidities (OR, 1.63; 95% CI, 1.39-1.90; p<0.0001), peripheral vascular comorbidities (OR, 1.30 95% CI, 1.12-1.50; p=0.0005), rheumatologic comorbidities (OR, 3.60; 95% CI, 2.95-4.38; p<0.0001), peptic ulcer comorbidities (OR, 1.65; 95% CI, 1.43-1.89; p<0.0001), renal comorbidities (OR, 1.62; 95% CI, 1.29-2.04; p<0.0001), type 2 diabetes comorbidities (OR, 1.16; 95% CI, 1.01-1.33; p=0.0328), osteoporosis comorbidities (OR, 1.88; 95% CI, 1.61-2.19; p<0.0001), glaucoma comorbidities (OR, 1.26; 95% CI, 1.08-1.49; p=0.0042) and hypercholesterolemia comorbidities (OR, 1.21; 95% CI, 1.05-1.40; p=0.009) were significantly higher in the OCS-dependent asthma patients in comparison with no-OCS asthma patients. CONCLUSIONS: OCS-dependent asthma was associated with higher odds of comorbidities in the elderly. Alternative treatment strategies are needed to reduce the adverse effects of OCS on elderly asthma patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23pyunposter125017-pdf.pdf?sfvrsn=3aaf5686_0","title":"ISPOR23_Pyun_POSTER125017.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125017","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Hospital Waste and Cost Prevention Potential of Reprocessing Medical Devices","id":"f520619f-1e00-4dab-9fbf-a614a20efeec","sessionCode":"MT7","topDisplay":"Lichtnegger S1, Meissner M2, Paolini F3, Silas U4, Hafermann J3, Saunders R4 1ECOFIDES Consulting GmbH, Vienna, Austria, 2Austrian Institute of Ecology, Vienna, Austria, 3Coreva Scientific GmbH & Co. KG, Königswinter, Germany, 4Coreva Scientific GmbH & Co. KG, Königswinter, NW, Germany","locationCode":"636","description":"\r\n\t<div>OBJECTIVES: Surgery and related postoperative care are resource-intensive, generating large amounts of healthcare waste within a hospital. Single-use medical devices can exacerbate this problem. We assessed the waste and cost prevention potential of switching from a single-use to a multi-use intermittent pneumatic compression (IPC) system from the US hospital payer’s perspective. METHODS: Focusing on Cardinal Health’s Kendall SCD™ Express Sleeves, we compared hospitals´ waste generation and disposal costs when using the single-use (IPC9529) versus the multi-use (IPC9529R) system, which can be reprocessed up to 4 times. The analysis included packaging waste of the IPC devices and pre-components as well as material waste, losses, and reject within the primary production and the reprocessing. Waste generated during the production of the pre-components was not considered. Results are presented for 100-patients treated, assuming that 90% of waste is standard, non-hazardous hospital waste and the remaining 10% is contaminated, hazardous waste (contaminated products are not reprocessed). Waste disposal costs were taken from published literature and are presented in 2021 USD. RESULTS: Multi-use saves 27.7 lbs (30%) of total waste compared to single-use. Of this, 4.6 lbs of waste were reduced in primary production or during reprocessing (no-hospital) and 23.1 lbs of hospital waste were prevented. Three studies were identified reporting on hospital waste disposal costs in the US, with the cost per ton having a median value of $146.13 (range $94.25; $7,843.53) for non-hazardous waste and $31,134.60 ($1,251.06; $61,018.14) for hazardous waste. Hospital costs for waste disposal were $130.69 for single-use and $11.49 for multi-use, a $119.20 (91%) saving. The lower and higher savings estimate were $5.47 and $292.07. CONCLUSIONS: Reprocessing IPC sleeves has clear waste and cost prevention potential for hospitals. The environmental impact of reduced waste is also an important factor to consider in the conservation of finite natural resources.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-us-poster-ipcfinal125518-pdf.pdf?sfvrsn=565ea7c3_0","title":"ISPOR US poster IPC_FINAL125518.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125518","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Is NICE Becoming Less ‘NICE’? a Time-Trend Analysis","id":"715734d4-c01b-44f7-8bc5-a6e08600f76f","sessionCode":"HTA19","topDisplay":"Macaulay R1, Kim KJ1, Leong KW1, Laramie S2 1Precision Advisors, London, UK, 2PRECISIONadvisors (Precision Medicine Group), Sterling, VA, USA","locationCode":"628","description":"\r\n\t<div>OBJECTIVES: The National Institute for Health and Care Excellence (NICE) appraises pharmaceutical products and provides recommendations for reimbursement in England. This research assesses how NICE recommendations have evolved over time. METHODS: Publicly available NICE appraisals of pharmaceutical products were identified from <a href=\"https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/data/appraisal-recommendations\">https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/data/appraisal-recommendations</a> (01-Jan-2001–15-12-2022) and key information extracted. RESULTS: 1077 NICE technology appraisal guidance recommendations for pharmaceutical products were identified (mean: 49/year, range: 2 [2001/02]–108 [2017/18]), being over 50 for the 5 most recently completed years (versus only 4 of the 17 previous years). Overall, 45% of outcomes were ‘recommended’, 27% ‘optimised’, 5% into the Cancer Drugs Fund (CDF), 1% ‘only in research’, 13% ‘not recommended’, and 9% non-submissions. The proportion of ‘recommended’ has consistently declined over time, from 100% (2001/02) to 21% 2022-present), whilst the share of ‘optimised’ has increased from 0% (2001/02) to 62% (2022-present). The proportion of ‘not recommended’ has dropped over time from a high of 35% (2011/12) to 3% (2022-present); this decrease in ‘not recommended’ appears to be notable following the reform of the CDF in 2016 (16% [pre-2016/17] versus 10% [since 2016/17]). However, the proportion of non-submissions has been rising, surpassing that of ‘not recommended’ and exceeding 10% for every year since 2018/19 (versus only 1 of 17 years beforehand). CONCLUSIONS: The proportion of not recommended outcomes has been falling in recent years, seemingly correlated with the introduction of the reformed CDF. The recent introduction of the Innovative Medicines Fund may further drive more favourable outcomes. However, over time there are also increasing proportions of restrictive recommendations and, of particular concern, non-submissions, suggesting a more challenging market access environment for manufacturers. There needs to be a concerted effort to understand this rise in non-submissions to ensure that the UK remains a favourable environment to launch new medicines.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kennedyposter-nice-trends124177-pdf.pdf?sfvrsn=e4e87e5d_0","title":"ISPOR23_Kennedy_POSTER (NICE trends)124177.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124177","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Glucose Levels during the First 24 Hours and Mortality Among Critically Ill Adult Patients","id":"ffb7a219-86a7-4bf3-ae54-a7a97f7ecfff","sessionCode":"CO10","topDisplay":"Liu J1, Li L2 1City University of Hong Kong, N.T., Hong Kong, 2City University of Hong Kong, Chelsea, MA, USA","locationCode":"112","description":"\r\n\t<div>OBJECTIVES: The aim of this study is to investigate the impact of glucose dysregulation ((hyperglycemia and/or hypoglycemia) on ICU and in-hospital mortality. METHODS: Patients from the Medical Information Mart for Intensive Care IV (MIMIC IV) database were used for the analysis. The first 24 hours glucose levels at ICU stays were used to divide patients into hypoglycemia (>180) , hyperglycemia, hypoglycemia & hyperglycemia, and normoglycemia groups. Propensity score matching was based on age, gender, race, Charlson Comorbidity Index (CCI), and Acute Physiology Score III (APSIII). In addition, the same analyses were performed for patients with a diabetes diagnosis and without a diabetes diagnosis respectively. RESULTS: There were 38,290 patients in the analysis: hypoglycemia (n=805), hyperglycemia(23,196), hypoglycemia & hyperglycemia (n=1,636), and normoglycemia (n=12,653). After propensity score matching, compared with normoglycemia, hypoglycemia was not associated with ICU mortality (OR:1.01; p=1) and in-hospital mortality (OR:1.03; p=0.848); hyperglycemia was associated with higher ICU mortality (OR:1.40; p<0.001) and in-hospital mortality (OR:1.25;p<0.001); hypoglycemia & hyperglycemia showed no significant difference in ICU (OR:0.91; p=0.397) and in-hospital mortality (OR:0.89; p=0.254). In diabetic patients, hypoglycemia was not associated with ICU mortality (OR:1.18; p=0.603) and in-hospital mortality (OR:1.16; p=0.625); hypoglycemia & hyperglycemia was not associated with ICU (OR:0.94; p=0.79) and in-hospital mortality (OR:0.83; p=0.264). In nondiabetic patients; the hyperglycemia was highly associated with ICU mortality (OR:1.54; p<0.001) and in-hospital mortality (OR:1.36; p<0.001). CONCLUSIONS: Hyperglycemia is associated with higher mortality in overall and nondiabetic patients in critical care . Hypoglycemia and hypoglycemia & hyperglycemia are not statistically significant with mortality.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/posterv6126056-pdf.pdf?sfvrsn=5b5e5539_0","title":"poster_v6126056.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126056","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Economic Impact of Pencil Point Spinal Needles Versus Conventional Cutting Needles on Postdural Puncture Headache","id":"2e2c1487-8b6a-4aaa-873e-a8826e9bfa70","sessionCode":"EE92","topDisplay":"Telang S1, Pavuluri S2, Shen K2 1Becton Dickinson and Company, Boston, MA, USA, 2Becton Dickinson and Company, Franklin Lakes, NJ, USA","locationCode":"336","description":"\r\n\t<div>OBJECTIVES: Postdural puncture headache (PDPH) is one of the most common complications of diagnostic, therapeutic, or inadvertent lumbar punctures. Compared to conventional cutting or beveled spinal needles, pencil point spinal needles have been conclusively proven to reduce the incidence of PDPH, but their potential economic benefit is not well-known. A customizable cost calculator was created to assess the impact of adopting pencil point spinal (atraumatic) needles over conventional cutting (traumatic) needles. METHODS: A decision-analytic model was developed using MS Excel based on the framework published by Tung et al. to estimate the impact of atraumatic needles versus traumatic needles on the incidence of PDPH as well as associated healthcare resource utilization and costs. The number and cost of PDPH cases, and utilization and costs of traumatic needles, atraumatic needles, and general anesthesia (post needle insertion failure), were considered from a single payer-provider perspective for Mexico. RESULTS: The base-case model assumed 1,000 spinal anesthesia procedures annually, with an increase in utilization of atraumatic needles from 10% to 70%. As per published references of clinical and economic inputs, 16 fewer cases of PDPH and 11 fewer procedures of general anesthesia were estimated. Considering the calculated 502 fewer traumatic needles and 600 additional atraumatic needles, the incremental cost of device mix was 22,134 MXN. Estimated cost savings were 23,592 MXN in general anesthesia and 71,543 MXN in PDPH management. Thus, the overall potential change in utilization was associated with a reduction of 73,001 MXN in total cost. CONCLUSIONS: The higher adoption of pencil point needles may be associated with positive clinical and economic impact by potentially reducing the incidence of PDPH and the burden of its management. The use of the pencil point needle, despite its higher upfront investment, could lead to improved healthcare utilization based on its economic value story.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23telangposter-pencil-point-needlessubmitted127489-pdf.pdf?sfvrsn=c2f12a03_0","title":"ISPOR23_Telang_POSTER-Pencil-point-Needles_SUBMITTED127489.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127489","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Delphi Panel on the Recommended Use of the Cue COVID-19 at Home Diagnostic Test","id":"ad365cb3-5681-4f9f-b0fb-a9c48767411d","sessionCode":"MT3","topDisplay":"Tsay D1, Pastor L2, Whitney S3, Bourque M2, Duggal N4 1Cue Health, San Diego, CA, USA, 2Eversana, Burlington, ON, Canada, 3Eversana, Oakville, ON, Canada, 4Cue Health, Dublin, CA, USA","locationCode":"631","description":"\r\n\t<div>OBJECTIVES: The Cue COVID-19 test is an at-home molecular nucleic acid amplification test (NAAT) that detects the RNA of SARS-CoV-2 using a nasal swab sample, with an accuracy rate of 98.9%. This study aims to understand how clinicians who treat immunocompromised (IC) patients view the Cue COVID-19 test, how the Cue COVID-19 test compares to other COVID-19 tests, and the types of IC patients who would benefit from access to Cue COVID-19 tests. METHODS: Data for the study were collected using a modified Delphi panel methodology. Two sets of electronic surveys were administered in fall 2022 eliciting the opinions of expert panelists on the value of the Cue COVID-19 test, the IC patient population who should be regularly tested for COVID-19, and recommendations on when and how these patients may be tested. Consensus rules were defined a priori; consensus was defined as agreement by ≥ 75% of the panelists. RESULTS: Expert opinions were anonymously collected from eight oncologists/ hematologists/ immunologists with extensive experience treating IC patients in the US. Consensus was achieved that the Cue COVID-19 test would provide value to all IC patients, and that they would benefit from access to this at-home test. Particularly, the panelists agreed that patients would benefit if they were symptomatic, exposed to COVID-19, undergoing chemotherapy, or have HIV with low CD4 count. Panelists recommended that patients should have access to between 1 and 6 Cue COVID-19 tests per month (average of 2.5 tests/month). CONCLUSIONS: The study aims to understand the value of the Cue COVID-19 test for IC patients. Clinicians included on this panel agreed that the Cue COVID-19 test would provide value to IC patients, and that IC patients should have access to between 1 and 6 tests per month (average of 2.5 tests/month), for particular use when symptomatic, exposed to COVID-19, or while undergoing chemotherapy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23duggalposterv2126230-pdf.pdf?sfvrsn=82b7c77d_0","title":"ISPOR23_Duggal_POSTERV2126230.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126230","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Association of Children's Type 1 Diabetes with Parents' Capability Well-Being Assessed By the ICECAP-A Measure","id":"048cfc54-ef9a-4989-ac6b-aa2876f8f6ed","sessionCode":"PCR7","topDisplay":"Hölgyesi Á1, Zrubka Z1, Luczay A2, Tóth-Heyn P2, Muzslay E2, Szabó A2, Világos E2, Gulácsi L1, Kovács L1, Péntek M1 1Óbuda University, Budapest, Hungary, 2Semmelweis University, Budapest, Hungary","locationCode":"717","description":"\r\n\t<div>OBJECTIVES: There is limited data on how managing type 1 diabetes mellitus (T1DM) in children relates to parents’ capability well-being. This interim analysis aimed to assess the diabetic status of children with T1DM and to investigate which factors are associated with parents’ well-being. METHODS: An online cross-sectional study was conducted involving children with T1DM aged 8-15 years and their parents. Parents’ capability well-being was recorded with the ICECAP-A. Children's diabetic status was assessed by glucose control status (6-month mean HbA1C value), and the Pediatric Quality of Life Inventory (PedsQL) Diabetes Module. The type of diabetes therapy was also recorded (options: pen, pen+sensor, pump+sensor). Visual analogue scales (VAS; 0-10) were used to determine the level of parents’ therapeutic cooperation and their knowledge of the disease and the therapeutic tools (based on physician’s assessment), and the self-reported impact of the disease on parents’ life. RESULTS: A total of 121 parent-child dyads were included in the study, with a mean age of 42.5 (±5.8) and 11.8 (±1.8) years. The mean ICECAP-A index, PedsQL Diabetes Module score, and the 6-month mean HbA1C were 0.88 (±0.14), 73.9 (±13.0), and 7.6 (±1.3), respectively. The ANOVA analysis revealed that the ICECAP-A value significantly differed by the type of therapy (F3,117=3.24; p=0.025). Furthermore, ICECAP-A significantly correlated (p<0.05) with 6-month mean HbA1C (r=-0.237), cooperation with therapy (r=0.244), and the knowledge of disease and therapeutic tools (r=0.283 and r=0.284, respectively). However, no significant correlations were found with the impact of the disease on parents’ life and PedsQL Diabetes Module score. CONCLUSIONS: Preliminary results of this study suggest that the well-being of parents might be associated with their knowledge, cooperation, and choice of their children’s therapy, and with children's glucose control. Further studies are needed to explore the role and influencing factors of the capability well-being of parents caring for children with T1DM.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125719","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Budget Impact Analysis of Pneumococcal Vaccines for Older Adults Available in Costa Rica","id":"0bc35d76-0d38-4b31-936b-aa85eb3b3e81","sessionCode":"EE96","topDisplay":"Ordoñez J1, Baldi Castro JJ2 1True Consulting, MEDELLIN, ANT, Colombia, 2Pfizer Central America and Caribbean, Escazu, SJ, Costa Rica","locationCode":"341","description":"\r\n\t<div>OBJECTIVES: In Costa Rica, the 13-valent pneumococcal conjugate vaccine (PCV13) and 23-valent pneumococcal polysaccharide vaccine (PPSV23) are available to prevent invasive pneumococcal disease (IPD) such as meningitis, bacteremia, as well as community-acquired pneumococcal pneumonia (CAP) caused by serotypes contained in these vaccines. We aim to estimate these vaccines' budget impact (BI) on Costa Rica's public health system. METHODS: A BI model was used to estimate the change in expenditure over a three-year time horizon of different vaccination strategies in a population of 500,000 people > 65 years in Costa Rica, assuming that 10 % of the population would be vaccinated annually. The BIs compare PCV13, PCV13+PPSV23, and PPSV23 versus no vaccine. The costs included the direct medical cost of IPD, hospital-treated CAP, outpatient CAP, and complications (hearing loss, neuropsychological deficit, epilepsy, major adverse cardiovascular event) collected from a consultancy with experts (bottom-up method). Vaccine costs were from PAHO tariffs, and vaccine administration cost was $1 per dose. Costs were in USD 2022. RESULTS: Estimated total cost with no vaccine over three years was $35.5million (m), $35.3m, $37.0m, and $36.5m for PCV13 alone, PCV13+PPSV23, and PPSV23, respectively. Compared with no vaccine, the 1st year of BI with PCV13 was $495,717, the 2nd year was $432,869, and the 3rd year was -$188,546. The annual total costs for PCV13+PPSV23 or PPSV23 alone were higher than no vaccine. Overall, PCV13 resulted in the lowest budget impact of all three vaccination strategies over three years. CONCLUSIONS: Vaccinating adults aged >65 years with PCV13 would result in the lowest healthcare budget impact and could be net cost saving over three years compared with no vaccine, though the costs during the first two years might be higher than no vaccine.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ee96poster127749-pdf.pdf?sfvrsn=417fc5b5_0","title":"EE96_POSTER127749.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127749","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"},{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Machine Learning Analysis of Patient Engagement and One-Year Health Care Resource Utilization and Costs in Patients with Opioid Use Disorder Treated with a Prescription Digital Therapeutic","id":"a2e17a87-05bd-40a4-b508-aa9cfb72336c","sessionCode":"CO17","topDisplay":"Mahon R1, Shapiro HM1, Velez F2, Murphy S3, Maricich Y1 1Pear Therapeutics (US), Inc., Boston, MA, USA, 2Pear Therapeutics, Boston, MA, USA, 3Weill Cornell Medicine, New York, NY, USA","locationCode":"101","description":"\r\n\t<div>OBJECTIVES: Opioid Use Disorder (OUD) affects roughly 2.7 million Americans. Prescription digital therapeutics (PDTs) have been associated with reduced health care resource utilization (HCRU). This machine learning analysis assessed HCRU and cost by PDT engagement level, compared to controls. METHODS: Retrospective 12-month claims data analysis of patients who filled a PDT prescription (engagers) vs. those who did not (controls). A machine learning approach identified high engagers (HE) and low engagers (LE), using counts of distinct lessons completed and weeks active. Utilization rate ratios (URR) compared engagement groups to controls across HCRU categories. Facility-related (i.e., emergency department (ED), inpatient, intensive care unit (ICU), partial hospitalization and hospital outpatient department) cost differences were evaluated. RESULTS: 328 individuals were classified as LE, 532 HE, and 978 controls (mean ages: 37.9, 37.9, and 39.2 years, respectively; percent female: 60%, 65%, and 55%, respectively). Engagers showed lower facility utilization vs. controls: inpatient (HE: URR 0.60, 95% CI 0.44 to 0.82; LE: 0.78, 95% CI 0.56 to 1.1), ED (HE: URR 0.96, 95% CI 0.84 to 1.09; LE: 0.91, 95% CI 0.76 to 1.02), and ICU (HE: URR 0.91, 95% CI 0.48 to 1.73, LE: 0.71, 95% CI 0.31 to 1.65) visits. Controls had lower rates of hospital outpatient department visits (HE: URR 1.2, 95% CI 0.63 to 2.63; LE: 1.3, 95% CI 0.56 to 1.1). LE and HE had lower per-patient facility-related costs compared to controls (-$2,270 and -$2,230, respectively). Engagers showed higher utilization of case management (HE: URR 3.53, 95% CI 3.32 to 3.75; LE: 1.27, 1.16 to 1.39), and psychiatry services (HE: URR 1.40, 95% CI 1.34 to 1.46; LE: 1.23, 95% CI 1.17 to 1.3) vs. controls. CONCLUSIONS: Both high- and low-engager patients treated with a PDT had fewer inpatient, ED, and ICU visits, greater use of outpatient services, and lower facility-related costs vs. controls.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127300","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Clinical Characteristics of Patients with Agitation Episodes Associated with Bipolar Disorder or Schizophrenia – Real World Patient Journey","id":"0f08424c-c256-48fb-a621-abe42d0126e7","sessionCode":"RWD8","topDisplay":"Hokett S1, Zoffranieri S2, Hiremath V3, Govindaprasad S3, Kwong M2 1BioXcel Therapeutics, Cedarcreek, MO, USA, 2BioXcel Therapeutics, New Haven, CT, USA, 3Medidata AI, New York, NY, USA","locationCode":"818","description":"\r\n\t<div>OBJECTIVES: Minimal real-world data are available for agitation among patients with bipolar disorder (BPD) or schizophrenia (SCZ). This study identified the settings of care and clinical characteristics of agitation patients. METHODS: Patients with BPD or SCZ with ≥1 acute agitation episode (650,539 patients) were identified by ICD codes using Clarivate Real World Data between 9/3/2015-4/29/2022. Data collected included demographics, clinical characteristics, settings of care and hospital visits. Healthcare resource utilization in the multiple clinical settings were assessed using descriptive statistics and Pearson correlation. RESULTS: Patient management can be complex and involves a multi-disciplinary team across settings of care. There is a broad array of comorbidities (> 2), top comorbidities include depression (61% of patients), drug abuse (36%) and fluid and electrolyte disorders (33%). Patients flow through 10+ different pathways across sites of care pre-, during and post-agitation. Following agitation episodes, 41% of patients have all-cause hospital visits within 30 days. There is a positive correlation between agitation episodes and hospital readmission (0.48) and mortality risk (0.65). Better patient management and treatments are needed to improve healthcare outcomes. CONCLUSIONS: Clarivate Real World Data from >6-years of data from patients with agitation associated with BPD or SCZ revealed that patient management is complex with a high rate of hospital visits. Implementation of treatment protocols and better treatment options may improve patient management, while also potentially reducing risk of mortality and hospital readmission.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/23ispor-pos-agitation-sub127397-pdf.pdf?sfvrsn=e1930c6f_0","title":"23ISPOR POS Agitation SUB127397.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127397","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Post Distant Recurrence (DR) Survival of Muscle-Invasive Urothelial Carcinoma (MIUC) Patients with Prior Radical Cystectomy (RC): Analysis of a Flatiron Real-World Cohort Matched to CheckMate-274","id":"c3c7780d-a298-433a-812d-ac5684981790","sessionCode":"CO29","topDisplay":"Lambton M1, Nickel K2, Patel M3, Kurt M3, Teitsson S4, Kroep S5, Geynisman DM6 1OPEN Health Evidence & Access, York, UK, 2OPEN Health Evidence & Access, Berlin, Germany, 3Bristol Myers Squibb, Princeton, NJ, USA, 4Bristol Myers Squibb, Uxbridge, UK, 5OPEN Health Evidence & Access, Rotterdam, Netherlands, 6Fox Chase Cancer Center, Philadelphia, PA, USA","locationCode":"129","description":"\r\n\t<div>OBJECTIVES: A high percentage of MIUC patients experience DR after undergoing RC despite its curative intent. This study aimed to address the lack of data on the survival of patients after DR, using data from a US-based real-world cohort and CheckMate-274 study. METHODS: De-identified patient-level data from the US Flatiron Health database for patients with history of RC prior to diagnosis of advanced urothelial carcinoma (aUC) were matched to the CheckMate-274 study population experiencing DR via propensity scores. The list of variables used to match the two cohorts was determined based on their clinical influence on survival outcomes and availability in the database. Sex, age at aUC diagnosis, and ECOG performance score were selected for propensity score calculations, and to create matched pairs between the cohorts from the database and the trial. The matched database cohort was described relative to cisplatin eligibility status and first-line (1L) systemic treatment. Post-DR survival was evaluated using standard Kaplan-Meier analysis for the overall matched cohort. RESULTS: Prior to matching, 461 patients from the database met the inclusion criteria. During match-adjustments, 184 matched pairs of patients from the trial and the database created a balanced cohort of patients. In the matched cohort from the database, mean age was 68 years, 63% of patients were male, 24% were cisplatin-eligible, 18% were cisplatin-ineligible, and 58% had unknown cisplatin eligibility status due to missing values in the database. Landmark survival estimates with 95% confidence intervals for the overall matched cohort for the years 1, 2, and 5 were 50% (43-59%), 29% (23-37%), and 15% (10-23%), respectively. Small sample sizes and missing data limited meaningful and robust survival analyses stratified by cisplatin eligibility status. CONCLUSIONS: The study provided real-world survival estimates for aUC patients that underwent RC prior to DR, while indirectly filling an existing gap of data for the adjuvant treatment setting.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ohbmsaucisporfinalversion24apr2023clean126982-pdf.pdf?sfvrsn=76f4c67f_0","title":"OH_BMS_aUC_ISPOR_Final_Version_24APR2023_Clean126982.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126982","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Minimally Invasive Thyroidectomy Implementation for Cancer Care: Do Racial, Ethnic and Insurance Characteristics Play a Role?","id":"e829ddb0-a768-49c2-925c-ad7a3c068386","sessionCode":"HPR5","topDisplay":"Assumpcao L1, Quinn CM2, Rodriguez Franco S2, Leonard LD2, Thomas M2, Albuja-Cruz M2, Gleisner AL2 1Rio de Janeiro State University, Overland Park, KS, USA, 2University of Colorado, 12631 E 17th Ave. C-305 Aurora, CO 80045, CO, USA","locationCode":"509","description":"\r\n\t<div>OBJECTIVES: Racial, ethnic and insurance coverage-related disparities have been documented with regard to traditional thyroid cancer treatment access. Minimally invasive thyroidectomy (MIT) implementation data for those inequalities is yet to be known nationwide. METHODS: Patients with thyroid cancer who underwent MIT from 2010-2019 were selected from the National Cancer Database. Patient characteristics, tumor, and facility factors were compared between patients that underwent MIT and those who did not. A multilevel mixed effects logistic regression model with random intercepts for facilities was used to determine which factors were independently associated with the use of MIT. RESULTS: The majority of all patients (n=300701) were non-Hispanic (88.3%), white race (82.7%) and had private health insurance (66.4%). MIT use was not associated with ethnicity (OR:0.96,95%CI[0.88-1.05]) for Hispanics compared to non-Hispanics or insurance (OR:0.94,95%CI[0.79-1.12]) for uninsured and (OR:0.94,95%CI[0.88-1.01]) for Medicare compared to private one. MIT use was higher in Black (n=693,2.8%) and Asian (n=432,2.6%) patients, compared to white patients (n=5849, 2.32%) (p< 0.001). In the multivariable model adjusting for year, facility type and location, insurance, income, education, Hispanic status, sex, age and tumor size, Asians were more likely to undergo MIT (OR:1.14,95%CI[1.01-1.29]) compared to white patients. While facility factors such as type (OR:0.58,95%CI[0.40-0.84]) for Community Cancer Program, (OR:0.60,95%CI[0.45-0.79]) for Comprehensive Community Cancer Program, (OR:0.69,95%CI[0.50-0.96]) for Integrated Network Cancer Program compared to Academic/Research Program facility and region (OR:0.72,95%CI[0.53-0.97]) for northeast, (OR:0.40,95%CI[0.28-0.58]) for pacific compared to south, were also independently associated with MIT use; tumor size, gender and age were not associated with MIT use. CONCLUSIONS: While MIT use was similar in minority racial and ethnic groups compared to white patients, Asian patients were more likely to undergo MIT. Other patient level factors such as insurance, income and education were also not associated with MIT. MIT use was mainly determined by facility factors rather than individual-level factors. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023assumpcaoposter126288hpr5126288-pdf.pdf?sfvrsn=aff96e66_0","title":"ISPOR2023_Assumpcao_poster126288_HPR5126288.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023assumpcao126288hpr5handout126288-pdf.pdf?sfvrsn=cbe1ce42_0","title":"ISPOR2023_Assumpcao_126288_HPR5HANDOUT126288.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126288","diseases":[{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Alpelisib Plus Fulvestrant in Postmenopausal Women with Hr+/HER2- Advanced Breast Cancer (ABC) in Oman","id":"f4cb6e89-3f9e-49fd-8215-ad7cdb180d96","sessionCode":"EE46","topDisplay":"Soliman D1, Yasar N2, Hawkshaw S3 1Novartis Pharmaceuticals Inc., Montreal, QC, Canada, 2Novartis, Basel, Switzerland, 3Novartis Business Services Center, Limerick, LK, Ireland","locationCode":"237","description":"\r\n\t<div>OBJECTIVES: The aim of this current study is to estimate the cost-effectiveness of Alpelisib plus Fulvestrant in HR+/HER2- advanced Breast Cancer patients with a PIK3CA mutation. METHODS: For the pharmaco-economic evaluation, the selected comparators are Palbociclib plus Fulvestrant and Abemaciclib plus Fulvestrant for post ET setting; Everolimus plus Exemestane for post CDK4/6s plus AI utilization. A partition survival model (PSM) was used to calculate the cost-effectiveness over a 40-year time horizon. The PSM approach includes three health states for progression free survival (PFS), post progression survival (PPS) and dead. Membership in the three states over time is determined by efficacy parameters in the form of survival curves. Probabilities of PFS and OS, utility values, and probabilities of adverse events were based on data from the SOLAR-1 study and literature1. When local cost data was available, these were used. When local cost data were unavailable, UK costs were adapted to reflect 2021 Oman costs. The model was estimated and analyzed for the PIK3CA mutant subgroup in SOLAR-1. RESULTS: In the base case SOLAR-1 analysis the incremental cost-effectiveness ratio (ICER) for Alpelisib plus Fulvestrant is dominant versus Palboiclib plus Fulvestrant and dominant versus Abemaciclib plus Fulvestrant. In the secondary analysis based on BYLieve the ICER for Alpelisib plus Fulvestrant is estimated to be $117,177 per QALY gained versus Everolimus plus Exemestane. Comparing this result to the proposed USA ICER threshold range, this ICER is within the range and would be termed cost-effective3 CONCLUSIONS: Alpelisib plus Fulvestrant is dominant versus Palbociclib plus Fulvestrant and Abemaciclib plus Fulvestrant, this indicates Alpelisib is less costly and more effective than these treatments. Hence, Alpelisib plus Fulvestrant is a cost-effective strategy in HR+/HER2- advanced breast cancer patients in Oman. We can assume by reimbursing Alpelisib plus Fulvestrant this would be an effective use of healthcare resources.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124072","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Reproduction of the Control Group in REMDACTA Trial Using the Millennial Medical Record, an Electric Health Record Database, in Japan","id":"a4e5227f-4222-4d29-ba4b-ad7ddb1b69cb","sessionCode":"RWD7","topDisplay":"Takeshima T1, Hasegawa Y2, Asami K2, Ha C3, Iwasaki K3 1Milliman, Inc., Tokyo, Japan, 2NTT DATA Corporation, Koto-ku, Tokyo, Japan, 3Milliman, Inc., Chiyoda-ku, Tokyo, Japan","locationCode":"817","description":"\r\n\t<div>OBJECTIVES: Developing a control group of a clinical trial using real world data is desirable and ethically sound despite challenges pertaining to internal validity. To examine the internal validity, we reproduced the control group in a Randomized Controlled Trial (RCT) using Electric Health Record (EHR) data and evaluated the difference between the outcome of the original trial and that of the reproduced analysis. METHODS: We selected an RCT, REMDACTA trial, that was performed to evaluate the efficacy of tocilizumab plus remdesivir against placebo plus remdesivir in patients with severe COVID-19 pneumonia. We reproduced its control group (patients with severe COVID-19 pneumonia taking only remdesivir), using Japanese EHR data, Millennial Medical Record provided by Life Data Initiative. Target patients for the main analysis were those prescribed remdesivir within 2 days after admission and diagnosed with COVID-19 (defined by ICD-10 code, U07.1) and/or with COVID-19 pneumonia (defined by diagnosis name). Patients in the sub analysis included only those with COVID-19 pneumonia diagnosis. Among the target patients, those undergoing image inspection, oxygen administration, and not taking any medicines for pneumonia before the first remdesivir prescription were eligible for the analyses. Median length of stay was compared in the reproduced group and in REMDACTA trial. RESULTS: The database included 676 and 110 target patients for the main and sub analyses, respectively. However, only 57 and 14 patients met the eligibility criteria for the main and sub analyses, respectively. The reduction in the number of patients is attributed to the criteria of image inspection and oxygen administration. Median length of stay in the reproduced group were 13 and 11 days in the main and sub analyses, respectively. In REMDACTA trial, 95% CI of median time was 11.0–16.0. CONCLUSIONS: We successfully reproduced the median time of the control group by EHR data.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23takeshimarwd7poster124164-pdf.pdf?sfvrsn=3225ee8f_0","title":"ISPOR23_TAKESHIMA_RWD7_POSTER124164.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124164","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of COVID-19 on the Change in Work Conditions and Career Choices in General Vietnamese Population","id":"9193a393-e8d2-47e5-96cf-af0e1ab1b7c1","sessionCode":"EPH50","topDisplay":"Doan L1, Trong Dam VA1, Nguyen HT1, Nguyen TT2 1Duy Tan University, Danang, Viet Nam, 2Duy Tan University, Hanoi, HN, Vietnam","locationCode":"502","description":"\r\n\t<div>OBJECTIVES: The onset of COVID-19 has resulted in both morbidity and mortality. It also has a consequential impact on the Vietnamese economy. Prior studies examined the COVID-19 impact on healthcare professionals’ career decisions. There remains no study examining the work conditions and career choices in a general Vietnamese population. Our study aims to identify factors associated with change in work conditions and career choices in general Vietnamese population. METHODS: An online cross-sectional study between September 2021 through to November 2021 (during the Omicron COVID-19 pandemic). Snowball sampling method was utilized in recruiting the participants. The questionnaire used in this study included the following questions: (a) Socio-demographic information; (b) impact of COVID-19 on personal habits/daily expenses; (c) Current nature of work & impact of COVID-19 on work; (d) Impact of COVID-19 on career decisions. RESULTS: 650 participants were recruited, of which only 645 completed the survey. The completion rate was 99.2%. This study demonstrated the impact that COVID-19 has on finances, as only 32% of those sampled reported that they were able to pay in full. 46.6% of the respondents have had a decrease in their overall household income. With regards to their employment and work characteristics, 41.0% reported a decrease in their work satisfaction and 39.0% reported having reduced motivation for work. Females were less likely to consider transiting from their current job to another field, as compared to male participants. Respondents who were married, had a higher level of commitment to their current job, and lower inclination to transition to another field. Respondents experiencing financial difficulties were more likely to consider a transition to another field/work. CONCLUSIONS: This is the first study to have examined the characteristics of work/intentions with regards to career choices and transition amongst the general Vietnamese population. It is important that future financial policies take into consideration these factors.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127972","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Risk of Depression before Alzheimer’s Disease Diagnosis and Hyperlipidemia Using Real-World Data","id":"a654624a-97a1-4f29-ac96-b00b6033ba19","sessionCode":"RWD10","topDisplay":"Riepl N TriNetX LLC, Boston, MA, USA","locationCode":"820","description":"\r\n\t<div>OBJECTIVES: Alzheimer’s Disease (AD) is a neurodegenerative disorder resulting in symptoms related to memory and behavior, with symptoms developing up to 20 years pre-diagnosis, one of those pre-diagnosis symptoms being depression onset. A hallmark of AD is beta-amyloid (BA) aggregation, resulting in neuronal death. This aggregation process and symptoms onset can be expedited if patients have hyperlipidemia (HLD). A focus in AD research has been to identify more risk factors in hopes of detecting AD earlier. This study aims to assess if AD patients with HLD have a higher risk of showing depression within 15 years before their AD diagnosis than AD patients without HLD using real-world data. METHODS: This retrospective cohort study identified patients with AD (ICD-10 G30) of two patient populations using the TriNetX federated U.S. Dataworks network of de-identified health data from 56 healthcare organizations. Cohort 1 consisted of AD patients with HLD (ICD-10 E78.5, E78.4, E70.0, E78.2, E78.1). Cohort 2 consisted of AD patients, excluding patients with HLD. Both cohorts had no history of having a depressive episode (MDE) or major depressive disorder (MDD) at least 15 years before their AD diagnosis (ICD-10 F32x-F33x). Instance of MDE or MDD within 15 years before an AD diagnosis were then compared between cohorts. RESULTS: In Cohort 1, the prevalence of MDE or MDD was 24.43% compared with 16.16% in patients in Cohort 2 within 15 years before the AD diagnosis. The risk of MDE or MDD in that time frame was 1.51 times greater for AD patients with HLD than those without (RR=1.51, 95% CI=1.485, 1.539; p<0.0001). CONCLUSIONS: As depression is associated with earlier detection of cognitive impairment in AD, having both HLD and an instance of MDD/MDE could help identify AD at an earlier timeframe.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/2023-isporalzheimersdepression127559-pdf.pdf?sfvrsn=a999f37a_0","title":"2023 ISPOR_Alzheimers_Depression127559.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127559","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"},{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Evidence Usage in Regulatory Approvals from USFDA and EMA","id":"4e9a4877-9b69-4827-aee2-b0313f1b3646","sessionCode":"HPR22","topDisplay":"Shaikh J1, Samnaliev M2 1Axtria India Pvt Ltd, Hyderabad, AP, India, 2Axtria, Inc., Needham, MA, USA","locationCode":"531","description":"\r\n\t<div>OBJECTIVES: Randomized, blinded, and controlled trials are gold standard for establishing medical product effectiveness. However, conducting interventional studies may not always be feasible. In those circumstances, real-world data (RWD) can be used to support regulatory approval. This review identified and compared inclusion of real-world evidence (RWE) as part of an evidence package to support approvals from USFDA & EMA. METHODS: USFDA &EMA submissions between 2017 and 2022 were screened to identify the usage of RWE. Details of name of drug, disease area, approval year, & manufacturer were analyzed and categorized using a pre-specified data extraction form. RESULTS: More than 400 regulatory approvals were screened of which RWE was utilized in >50% of cases. RWE usage increased significantly from year 2017 onwards suggesting the increasing acceptance of RWE by regulatory bodies. RWE was used at a higher rate in EMA (>70% of all submissions) compared to USFDA (>25% of all submissions). RWE was mainly used as clinical evidence to evaluate safety and efficacy, additional supportive evidence, and as a future commitment for post approval studies. RWE serving as an external control arm was observed to be higher in rare diseases and oncology drugs. It was also submitted to inform epidemiological information in EMA approvals other areas of RWE usage included, leveraging RWE to better explain current treatment landscape, or evidence of drug being used off-label. Most common sources of RWE cited included claims data, registry data, medical chart review, medical records, surveys, observational studies, and published literature. CONCLUSIONS: RWE studies are becoming more commonly accepted when ethics, orphan diseases, or enrolment challenges limit the conduct of RCTs. Robust and appropriate RWE have the potential to accelerate patient access to new technologies in diseases with a high level of unmet need.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporrwe-poster-01may-2023125477-pdf.pdf?sfvrsn=3dbdf783_0","title":"ISPOR_RWE POSTER 01May 2023125477.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125477","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Costs Avoided in the Treatment of Acquired Thrombotic Thrombocytopenic Purpura with Caplacizumab in Colombia","id":"f2da45bf-9bcf-4080-9f7d-b1289ee78a87","sessionCode":"EE57","topDisplay":"Londono S1, Gil-Rojas Y2, Lasalvia P2 1Sanofi, Bogota, Colombia, 2NeuroEconomix, Bogota, Colombia","locationCode":"310","description":"\r\n\t<div>OBJECTIVES: Acquired thrombotic thrombocytopenic purpura (aTTP) is an acute life-threatening disease where mortality rates are critical outcomes. Caplacizumab has been included as part of the treatment of aTTP along with plasma exchange and immunosuppression. The objective was to determine health outcomes and costs avoided in the treatment of an aTTP episode with caplacizumab. METHODS: A partitioned survival model with two health states (survival & death) was developed for expected clinical outcomes and costs among patients with an episode of aTTP, treated with the standard of care (SoC) composed of plasma exchange + immunosuppression, versus treatment with caplacizumab as an add-on to the SoC. Outcomes correspond to mortality rates within 30 days, platelet normalization within 10 days, and number of patients without exacerbations or relapses within one year after an aTTP episode. Costs included diagnosis, support measures, SoC treatment, hospitalization, relapses, and exacerbations. The analysis modelled a hypothetical cohort of 100 patients with an aTTP episode. Clinical data for health outcomes was obtained from published literature. Costs were obtained from public local sources. All costs are expressed in USD$ using an exchange rate of COP$4,800 per USD$1. RESULTS: For the comparison between SoC versus caplacizumab + SoC, mortality within 30 days was 3 versus 0 deaths, platelet normalization was achieved within 10 days in 86 vs 95 patients, patients with no exacerbations and no relapses were 85 versus 99, and 73 versus 97, respectively. Costs for the SoC were USD$745,694 compared to USD$399,234 for caplacizumab vs SoC, for a total difference of USD$346,460 (46.5%). Costs avoided were mainly due to reduced relapses (38.1%) and hospitalization (5.2%). CONCLUSIONS: This study demonstrates that caplacizumab + SoC compared to SoC represents better health outcomes including greater survival and reduced number of exacerbations and relapses, as well as a reduction in healthcare resources use associated to these events.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023londonoee57healthcarecostsattp124216-pdf.pdf?sfvrsn=35e4f793_0","title":"ISPOR2023_Londono_EE57_Healthcare_costs_aTTP124216.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124216","diseases":[{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Etodolac and Aceclofenac in Low Back Pain","id":"579a0c89-8c6f-47a7-91a6-b2cd2dbb8566","sessionCode":"EE88","topDisplay":"Satheesan N1, Thomas R2, Sukumaran S3 1National College Of Pharmacy, Kozhikode, Kozhikode, India, 2National College of Pharmacy, CALICUT, KL, India, 3National College Of Pharmacy, Kozhikode, India","locationCode":"330","description":"\r\n\t<div>OBJECTIVES: Over the decades, low back pain (LBP) has emerged as a serious health concern. According to WHO statistics 80% of individuals will experience at least one episode of LBP at some point throughout their lifetime. This present study aims to determine the cost-effectiveness of Etodolac and Aceclofenac in LBP. METHODS: A prospective observational study was conducted on 96 outpatients in Orthopedics department in KMCT Medical College Hospital, Kozhikode. Patients were divided into two groups at random, group one received Etodolac 400mg, and the second group received Aceclofenac 100mg. In order to compare the effectiveness of the two groups, visual analogue scale (VAS) parameter was employed. Cost-effectiveness was evaluated using the incremental cost-effective ratio (ICER). Using the data collected from respondents, the ICER was determined during the initial visit, followed by the first and second reviews. RESULTS: The study population was categorized based on the age(age group 51-60, 15 & 16 patients taken Etodolac and Aceclofenac), gender(from 63 female patients, 25 & 38 patients taken Etodolac and Aceclofenac, in 45 male patients, 29 & 16 patients taken Etodolac and Aceclofenac), educational qualification, occupation, BMI, social habits, socioeconomic status. For the economic evaluation, both clinical and cost data were assessed in patients taken either Etodolac and Aceclofenac. The total cost for treatment with Etodolac and Aceclofenac is 2834.77 and 1918.79 respectively. Mean difference in the effect and cost was found to be -2.46 and Rs 915.98. The calculated ICER was -106.51 and we found that Etodolac was most cost effective drug than Aceclofenac. CONCLUSIONS: Taken together, our results suggests that Etodolac is more cost-effective drug than Aceclofenac for the treatment of low back pain. Etodolac 400 mg OD is more expensive but provides better therapeutic effect, well tolerated relief from low back pain, and has prominent analgesic activity when compared to Aceclofenac 100 mg BD.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123550","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Rasch Calibration of the 18-Item Multidimensional Health Locus of Control - Form B Scale","id":"9bdcee06-6cf9-4d58-8467-b32f512f87b1","sessionCode":"MSR4","topDisplay":"Imeri H1, Nsiah I1, Barnard M1, Holmes E1, Desselle S2, Rosenthal M1, Kang M3 1Department of Pharmacy Administration, School of Pharmacy, University of Mississippi, University, MS, USA, 2Department of Pharmacy, Tuoro University California, Vallejo, CA, USA, 3Department of Health, Exercise Science, and Recreation Management, University of Mississippi, University, MS, USA","locationCode":"645","description":"\r\n\t<div>OBJECTIVES: Health locus of control (HLOC) is among established predictors of health outcomes and patient behaviors in the management of chronic conditions (CC). The Multidimensional Health Locus of Control (MHLC)-Form B has been used for 40+ years to measure HLOC in patients with CC. However, there is no evaluation of MHLC-Form B using advanced measurement theory in a U.S. population with CC. Thus, this research aims to assess the psychometric properties of the MHLC-Form B using Rasch Analysis in an adult population with CC. METHODS: Rasch modeling was used to examine the 18-item MHLC-Form B within 300 adults with CC recruited via MTurk Amazon. Three Rasch models were estimated for each subscale: Internal, Chance, and Powerful Others. Also, three item-person maps were used to evaluate the distribution of item level difficulty in comparison to the individual HLOC level for each subscale. Lastly, three differential item functioning (DIF) analyses were conducted to assess if any item is differently difficult between sex groups, and education levels groups. All analyses were conducted using SAS v9.4 and Winsteps v3.65. RESULTS: No misfit items were identified. Although individual HLOC levels had wide distributions for all subscales (with Internal having the widest, -1.06 ± 1.15, -5.27 – 2.50 logits), the item difficulty levels of MHLC-Form B were concentrated in a narrowly centralized distribution, ranging from -0.43 to 0.43 logits. DIF analyses results for each subscale demonstrated proper functioning of all items across respondents varying in sex or level of education. CONCLUSIONS: The MHLC-Form B was evaluated to have acceptable model-data fit. However, Rasch analyses revealed an overly narrow distribution of item difficulty levels across individual HLOC levels, suggesting a need for additional items to accurately measure a wider range of HLOC levels in adults with CC.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23imeriposter124075-pdf.pdf?sfvrsn=39c086c1_0","title":"ISPOR23_Imeri_POSTER124075.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23msr4imeri124075-pdf.pdf?sfvrsn=828f9021_0","title":"ISPOR23_MSR4_Imeri124075.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124075","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"HBA1C Reduction with Digital Health Devices in Type 2 Diabetes (T2DM): A Meta-Analysis of Randomized Controlled Trials","id":"fbe8209f-f696-4c42-b101-b3723fd80144","sessionCode":"MT2","topDisplay":"Lee F1, Han-Burgess E2, Kennedy A1, Serafini P3, Pourrahmat MM3, Breznen B3 1Sanofi, Bridgewater, NJ, USA, 2Sanofi, Cambridge, MA, USA, 3Evidinno Outcomes Research Inc., Vancouver, BC, Canada","locationCode":"630","description":"\r\n\t<div>OBJECTIVES: To assess the efficacy of digital interventions in promoting HbA1c reduction relative to usual care in T2DM. METHODS: A systematic literature review was conducted by searching MEDLINE®, Embase®, and CENTRAL databases on April 5, 2022 to identify studies which compared usual care to digital interventions consisting of (at minimum) a blood glucose measuring device and coaching from a healthcare professional. Random effects models were used for all meta-analyses. RESULTS: Of 23 eligible trials, 20 measured HbA1c in a laboratory setting and formed the primary analysis set. Average participant age was 56.4 years with a BMI of 31.3 kg/m2 and an HbA1c of 8.4%. Intensity of the digital intervention arm was classified as high (n=5), medium (n=12), or low (n=3), based on frequency of contact and how personalized and comprehensive the coaching was. Two studies employed continuous glucose monitoring (CGM), and the Cochrane risk of bias tool identified four studies as high-risk because they were unblinded or used ambiguous/unreliable glucose measurement. The primary analysis estimated −0.31% greater HbA1c reduction with digital interventions compared to usual care (95%CI: −0.45, −0.16; p<0.0001). Meta-regression estimated significantly greater reduction relative to usual care for high intensity (−0.43, 95%CI: −0.74, −0.11; p = 0.0084) and medium intensity (−0.22, 95%CI: −0.38, −0.06; p = 0.0055) interventions, but not low intensity interventions (−0.25, 95%CI: −0.57, 0.07; p = 0.13). When studies which did not measure HbA1c in a laboratory were added to the primary set, the difference between digital interventions and usual care increased to −0.40% (95%CI: −0.56, −0.24; p < 0.0001). Excluding high-risk and CGM studies did not affect the primary analysis results. CONCLUSIONS: Digital interventions are associated with greater HbA1c reduction in T2DM patients compared to usual care. A non-significant association between intensity and HbA1c reduction was observed, which warrants further investigation to understand optimal intensity for digital interventions.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-poster-mt2hba1c-reduction-with-digital-health-devices-in-t2dm123934-pdf.pdf?sfvrsn=efe2ab6c_0","title":"ISPOR 2023 Poster MT2_HbA1c Reduction with Digital Health Devices in T2DM123934.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123934","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Beyond Conventional Clinical Value: Estimating the Impact of Accelerated Approvals on Therapeutic Bridging between Innovative Therapies","id":"27cceb5e-2beb-49e0-ae0d-b3c08d51ebc7","sessionCode":"HPR6","topDisplay":"Wong W1, Kowal S2, To TM1, Patel A3, Veenstra D4, Garrison L5, Li M6 1Genentech, South San Francisco, CA, USA, 2IQVIA, Alameda, CA, USA, 3Genentech, Inc., Chapel-Hill, NC, USA, 4The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA, 5CHOICE Institute, School of Pharmacy, University of Washington, Seattle, WA, USA, 6University of Texas MD Anderson Cancer Center, Houston, TX, USA","locationCode":"510","description":"\r\n\t<div>OBJECTIVES: Drugs that improve survival may create real option value (ROV) by bridging patients to future innovations. We estimated the ROV attributable to the FDA accelerated approval (AA) pathway for checkpoint inhibitors (CPIs) following ipilimumab’s approval in metastatic melanoma (mMelanoma) and for enfortumab vedotin-ejfv following CPIs’ approvals in advanced bladder cancer (aBladder). METHODS: This study used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database and included patients who received ipilimumab (mMelanoma) or CPIs (aBladder), up to availability of the respective next innovation (CPIs, enfortumab). Overall survival, stratified by type of follow-on therapy (next innovation, no treatment, standard of care), was estimated using inverse probability of treatment weighted Kaplan-Meier curves. Total ROV with/without AA was estimated and then scaled to the U.S. population level based on market shares. Outcomes were calculated using 3 counterfactual dates to simulate traditional FDA approval without AA: 1) conference data presentation for the next innovation, 2) AA conversion to traditional approval, 3) average time from AA to full approval in oncology. RESULTS: Earlier access to next innovations via the AA pathway increased ROV, with an additional 5.3 months survival (range: 0-13.2 months) for ipilimumab (mMelanoma) and 1.3 months (range: 0.3-3.0) for CPIs (aBladder) compared to the counterfactual scenario without AA. Earlier access to next innovations via AA led to 355 to 678 more patients surviving to receive CPIs ( mMelanoma) and 664 to1571 to receive enfortumab (Bladder), resulting in 927 to 1772 LY gained (mMelanoma) and 1411 to 2147 LY gained (aBladder) at the population level. Percent of the ROV attributable to AA ranged from 48% to 91% in mMelanoma and 61% to 92% in aBladder. CONCLUSIONS: A large portion of the additional survival gained by bridging to future innovations may be attributable to the AA pathway. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/gnea046-z-wong-42-x-72-l-postersolid-tumors-rweispor24apr23125560-pdf.pdf?sfvrsn=65929af_0","title":"GNEA046-Z Wong 42 x 72 L Poster_solid tumors RWE_ISPOR_24Apr23125560.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125560","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Prioritization of ADT Notifications Improves Efficiency of New Blue Cross and Blue Shield of Louisiana Care Management Referral Process","id":"29ae5c6b-a805-4d71-9a03-b43354ddfdcf","sessionCode":"OP4","topDisplay":"Kiggans M, Zhang R, Evans T, Bergeron T, Lucas E, Zhang Y, Barfield D, Mills S, Vicidomina B, Nigam S Blue Cross Blue Shield of Louisiana, Baton Rouge, LA, USA","locationCode":"715","description":"\r\n\t<div>OBJECTIVES: Blue Cross and Blue Shield of Louisiana in 2018 began receiving daily admission-discharge-transfer (ADT) notifications to develop a clinical intervention program. To improve management of resources and increase the efficacy of outreach efforts, Blue Cross developed a daily selection algorithm to prioritize members with the highest risk, highest cost, or frequent use of emergency departments, and who are most likely to respond positively to clinical intervention. Prioritized outreach began December 2021 and is ongoing. METHODS: Members considered are high risk, high cost and highly impactable. To verify high risk, Blue Cross predictive models for risk of hospitalization, risk of emergency department event, and risk of high-cost claimant for the most recent month were used. Cost metrics for the most recent rolling year verified high-cost members. In lieu of high cost, more than two emergency room visits in the most recent six-month period may be used. Members with high impact in most recent month, based on impactability score, were included. Prioritized members were in the top 1% of all three categories. Daily reports are sent to Care Management nurses for action. Reports show prioritized members who have an inpatient admission, discharge, or emergency department event on that day. RESULTS: Without ADT notifications, the median Event-to-Referral time is 70 days (86.1 mean). Acting on ADT reports reduces the median time to 1 day (3.3 mean). Referrals stemming from ADT were 4.7 times more likely to engage with care management programs. On average, 416 members appeared on the daily ADT report. The new method prioritizes approximately 10 members each day and directs Care Management nurses to the most effective outreach efforts. CONCLUSIONS: Clinical interventions based on time-sensitive ADT notification referrals are effective. Prioritization of the members in this referral process increases the efficiency of interventions by better managing Care Management resources.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"bb8fd992-de86-4d1a-8bec-f6e2c928db96","parentId":"00000000-0000-0000-0000-000000000000","title":"Organizational Practices","urlName":"organizational-practices"}],"categoryIds":["bb8fd992-de86-4d1a-8bec-f6e2c928db96"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/op4-prioritization-of-adt-notifications127522-pdf.pdf?sfvrsn=cf76d6d0_0","title":"OP4 Prioritization of ADT Notifications127522.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127522","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Multi-Method Approach to an Indirect Treatment Comparison of Eplontersen and Vutrisiran for the Treatment of Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy","id":"bb4c0e09-8e37-4ce5-a7f4-b5ccbc4dbcb1","sessionCode":"MSR11","topDisplay":"Karam C1, Gillmore JD2, Chen G3, Jenkins NC4, Hale MJ4, Taylor GM4, Chen J5, Viney NJ6, Schneider E6 1Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA, 2Centre for Amyloidosis, Division of Medicine, University College London, National Amyloidosis Centre, Royal Free Hospital, London, UK, 3AstraZeneca, Cambridge, CAM, UK, 4Health Economics and Outcomes Research Ltd, Cardiff, UK, 5AstraZeneca, Gaithersburg, MD, USA, 6Ionis Pharmaceuticals Inc., Carlsbad, CA, USA","locationCode":"702","description":"\r\n\t<div>OBJECTIVES: Hereditary transthyretin-mediated amyloidosis with polyneuropathy (ATTRv-PN) is a rare, fatal neuropathy caused by TTR gene mutations leading to accumulation of amyloid deposits composed of TTR protein in multiple tissues, including the peripheral nervous system. Targeted gene silencers include vutrisiran (recently approved by the FDA and EMA) and eplontersen, which is in development. Eplontersen met its co-primary efficacy endpoints and was well tolerated in a planned week 35 interim analysis of the phase III NEURO-TTRansform trial (NCT04136184). In the absence of head-to-head trials, indirect treatment comparisons (ITCs) may help compare efficacy and safety of eplontersen vs vutrisiran. However, challenges include use of different external placebo arms in each pivotal trial, differences in the primary endpoint assessment scale version, endpoint timepoints and missing data handling. There is no established ITC practice in ATTRv-PN to address these challenges, therefore this study evaluated multiple ITC methods. METHODS: Several population-adjustment methods exist for ITCs, each with strengths and limitations. This study used matching-adjusted indirect comparison (MAIC) and simulated treatment comparison (STC), including both anchored and unanchored approaches, alongside Bucher analysis. Efficacy was compared using modified Neuropathy Impairment +7 (mNIS+7) and Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QoL-DN) scores and components/domains. Safety endpoints were also assessed. RESULTS: Data for eplontersen from NEURO-TTRansform (N=144) and external placebo from NEURO-TTR (N=60) were adjusted against data for vutrisiran from HELIOS-A (N=122) and external placebo from APOLLO (N=77). Baseline characteristics were compared and, where possible, population adjustment performed for the outcomes described in the methods, using eight covariables: age, sex, race, prior treatment, V30M mutation, familial amyloid polyneuropathy score, cardiac involvement and baseline value of outcome of interest. Missing data were limited. Additional results will be presented at ISPOR2023. CONCLUSIONS: This research demonstrates the value of applying different ITC approaches to assess the impact of methodological assumptions on decision making in ATTRv-PN.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23chenposter123926-pdf.pdf?sfvrsn=b9738740_0","title":"ISPOR23_Chen_POSTER123926.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123926","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Association between Vaccine Hesitancy and Pertussis: A Systematic Review and Meta-Analysis","id":"b2c359f6-696d-4e52-99cd-b65d64a16c74","sessionCode":"EPH46","topDisplay":"Wang Y, Shi N, Wang Q, Jin H Southeast University, Nanjing, China","locationCode":"447","description":"\r\n\t<div>OBJECTIVES: Robust routine immunization schedules of pertussis-containing vaccines have been applied for years, but the pertussis outbreak is still a worldwide problem. This study aimed to explore the association between vaccine hesitancy and pertussis in infants and children. METHODS: We searched PubMed, Cochrane, Web of Science, Embase, and China National Knowledge Internet from January 2012 to June 2022 and included primary studies that assessed the association between childhood/maternal vaccine hesitancy and the pertussis odds ratios (ORs), risk ratios (RRs), or vaccine effectiveness (VE) in infants and children ≤9 years old. Random-effects meta-analysis, cumulative meta-analysis, and subgroup analysis were used to generate estimated OR/VEs with 95% confidence intervals (CIs), where heterogeneity was assessed using I2. RESULTS: Twenty-two studies were included in this analysis, with a mean quality score of 7.0 (range 6.0-9.0). Infants and children with pertussis were associated with higher vaccine hesitancy at all doses (OR = 4.12; 95% CI, 3.09-5.50). The highest OR was between children unvaccinated over 4 doses and children fully vaccinated (OR = 14.26; 95%CI, 7.62-26.70); childhood vaccine delay was not statistically significant associated with pertussis risk (OR = 1.18; 95% CI, 0.74-1.89). Maternal vaccine hesitancy was associated with significantly higher pertussis risk in infants at both 2 months and 3 months old, with higher OR in infants ≤2 months old (OR = 6.02 [95%CI: 4.31-8.50], OR = 5.14 [95%CI: 1.95-13.52] for infants ≤2 and 3 months old, respectively). Maternal and childhood pertussis-containing vaccination had significantly high VE both in preventing pertussis infection in infants and in reducing the severity of disease in infants with pertussis. The administration time of maternal vaccination had little effect on VE. CONCLUSIONS: Vaccine hesitancy increased pertussis risks in infants and children. Ensuring children receive pertussis vaccines up-to-date is essential; short delays in childhood vaccine receipt may be unimportant. Maternal pertussis-containing vaccination should be encouraged.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/the-association-between-vaccine-hesitancy-and-pertussis-a-systematic-review-and-meta-analysis124971-pdf.pdf?sfvrsn=dd281693_0","title":"The Association between Vaccine Hesitancy and Pertussis A Systematic Review and Meta-analysis124971.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124971","diseases":[{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Association between Prescribing Specialty and Treatment-Related Complications in Patients Using Novel Hormonal Agents for Metastatic Castration-Resistant Prostate Cancer: Population-Based Study","id":"87b92cef-95e5-4a21-b383-b6779b706104","sessionCode":"EPH27","topDisplay":"Hu J1, Aprikian A2, Dragomir A1 1McGill University, Montreal, QC, Canada, 2McGill University Health Centre, Montreal, QC, Canada","locationCode":"424","description":"\r\n\t<div>OBJECTIVES: Novel hormonal agents (NHAs) such as abiraterone acetate (ABI) and enzalutamide (ENZ) are frequently used in metastatic castration-resistant prostate cancer (mCRPC). While mCRPC treatment has been traditionally administered by medical oncologists, urologists have also adopted the use of NHAs. The objective was to assess the association between the incidence of NHA-related complications and prescribing specialty in mCRPC patients treated with NHAs. METHODS: A retrospective population-based cohort was extracted from Quebec public healthcare administrative databases. First-time NHA users between 2011 and 2016 were selected and grouped by the prescribing specialty (medical oncology (MO) vs urology (URO) vs other (OTH)). Outcomes of interest were overall NHA-related complications and its subtypes: cardiovascular, metabolic, infectious and general/non-specific. Secondary outcomes included all-cause mortality and all-cause hospitalization. The overlap weighting (OLW) method was used to adjust for measured baseline characteristics. RESULTS: The cohort comprised 2,183 patients, with 1,157 (53.0%) in the MO group, 740 (33.9%) in the URO group, and 286 (13.1%) in the OTH group. For overall NHA-related complications, the URO group (OLW-hazard ratio (HR): 0.97, 95%CI 0.72-1.31) and OTH group (OLW-HR 1.05, 95%CI 0.70-1.54) were not different compared to the MO group. While the URO group was associated with a greater incidence of cardiovascular complications compared to the MO group (OLW-HR 1.85, 95%CI 1.04-3.28), it was also at lower risk of infectious complications (OLW-HR 0.66, 95%CI 0.43-0.98). Neither all-cause mortality (OLW-HRURO 1.08, 95%CI 0.93-1.24; OLW-HROTH 1.12, 95%CI 0.94-1.33) nor all-cause hospitalization (OLW-HRURO 1.11, 95%CI 0.90-1.34; OLW-HROTH 1.10, 95%CI 0.94-1.28) were associated with prescribing specialty. CONCLUSIONS: We found no differences across prescribing specialties for overall NHA-related complications, all-cause mortality and all-cause hospitalization but subtype-specific associations were identified. These results highlight the complexity of the management of mCRPC with NHA treatment and further studies are required to corroborate these findings.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127339","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Increased Risk of Adverse Events Following Burn Injury in Patients with Hypothyroidism","id":"03d49dce-1867-4109-a585-b6e3a8bb3c20","sessionCode":"EPH15","topDisplay":"Thomas D1, Garate D1, Flores I2, Morgan B1, Fu S3, Golovko G4, El ayadi A4, Song J4, Wolf SE4 1University of Texas Medical Branch John Sealy School of Medicine, Galveston, TX, USA, 2Sam Houston State University College of Osteopathic Medicine, Conroe, TX, USA, 3Baylor College of Medicine, Houston, TX, USA, 4University of Texas Medical Branch, Galveston, TX, USA","locationCode":"419","description":"\r\n\t<div>OBJECTIVES: Thyroid hormone is essential in the healing of soft tissue wounds, as it has shown to promote the proliferation of keratinocytes, dermal thickening, and deposition of mature type 1 collagen. Hypothyroidism has been associated with delayed wound healing and systemic manifestations that may worsen surgical outcomes. However, the impact of this condition following burn injury has not been described in the literature. This study evaluated the role of hypothyroidism on acute outcomes after burn injury. METHODS: A retrospective cohort study using a multicentre research network, TriNetX, was used to stratify population cohorts to compare burn patients with and without a prior diagnosis of hypothyroidism. A 1:1 matched propensity score analysis (PSM) was conducted adjusting for demographics and percent total body surface area burned. Adjusted Risk Ratios (aRR) with 95% CI (p<0.05) were utilized to assess 30-day post-operative burn outcomes. RESULTS: After PSM, we identified a set of balanced patient cohorts with 33,532 patients per cohort. Patients with a history of hypothyroidism were found to experience a significantly greater risk of infection of the skin and subcutaneous tissue 1.28 [1.22-1.34]), hyperglycemia (1.69 [1.50-1.89]), volume depletion (1.45 [1.33-1.59]), kidney failure (1.83 [1.70-1.97]), pulmonary edema (1.27 [1.11-1.45]), pneumonia (1.51 [1.40-1.64]), pulmonary collapse (1.27 [1.15-1.39]), respiratory failure (1.29 [1.18-1.40]), acute myocardial infarction (1.48 [1.35-1.63]), acute embolism and thrombosis of the lower extremity (1.51 [1.38-1.65]), and sepsis (1.76 [1.59-1.96]). There was a significantly lower risk of ICU admission (0.51 [0.355-0.739]). The following outcomes showed no significant differences: skin graft complications, ARDS, and mortality. CONCLUSIONS: These results postulate that burned patients with a history of hypothyroidism are significantly more likely to experience severe acute adverse events. Additionally, they highlight the need for more research to elucidate the mechanism for this relationship and allow physicians to be more aware of the unique risks of this population.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/burnhypothyroidismposter124732-pdf.pdf?sfvrsn=a10235f9_0","title":"BurnHypothyroidismPoster124732.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124732","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"3f994852-a0d4-4706-9665-e4d867006d9a","parentId":"00000000-0000-0000-0000-000000000000","title":"Injury & Trauma","urlName":"injury-trauma"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Characteristics of Patients Treated with CAR-T Therapies across Multiple Indications Utilizing the TriNetX Network","id":"508d1f69-883e-4719-afda-b74e2fb3485c","sessionCode":"SA3","topDisplay":"Menon J1, Madaj K2, Brauneis J3, Seshadri V4, De Cock E3, Vossen C5 1Syneos Health, Aarhus, Denmark, 2Syneos Health, UNIONTOWN, OH, USA, 3Syneos Health, Barcelona, B, Spain, 4Syneos Health, Morrisville, NC, USA, 5Syneos Health, Amsterdam, NH, Netherlands","locationCode":"907","description":"\r\n\t<div>OBJECTIVES: Six Chimeric Antigen Receptor-T (CAR-T) therapies have been approved as treatments in relapsed/refractory (R/R) B-cell malignancies since 2017. This study aims to examine patient counts and characteristics of patients on CAR-T therapies in healthcare organizations in the United States covered by the TriNetX network, an electronic medical records (EMR) database. METHODS: Patients using CAR-T therapies were identified using RxNorm, ICD-10-PCS, and HCPCS codes between Aug 31,2017 (day after approval of first CAR-T therapy, Kymriah® by the FDA) to Jan 13, 2023. Patient counts, demographics, and co-medications were analyzed. RESULTS: Since August 31, 2017, 1,462 patients have been administered CAR-T therapies (Kymriah®, n=385; Yescarta®, n=729; Tecartus®, n=119; Abecma®, n=132; Breyanzi®, n=84; Carvykti®, n=13 patients). Mean age of the cohort was 55 years, 63% were males, and 79% were white. In line with CAR-T indications, 98% of the cohort were diagnosed with ‘malignant neoplasms of lymphoid, hematopoietic and related tissue’ (ICD-10-CM: C81 through C96). At any time prior to their CAR-T therapy, 68% of the cohort was administered cyclophosphamide, 62% fludarabine, 40% rituximab, and 28% doxorubicin. Use of Kymriah® and Yescarta® as the earliest CAR-T therapies has steadily increased over the years (Kymriah®: n=36 in 2017-2018 to n=76 in 2021-Jan 13, 2023; Yescarta®: n=40 in 2017-2018 to n=261 in 2021-Jan 13, 2023). Specifically for Yescarta®, almost all patients (93% of the cohort) were diagnosed with ‘Diffuse Large B-cell Lymphoma’ (ICD-10-CM: C83.3). Patients administered with Kymriah® were diagnosed with different indications (54% with ‘Acute Lymphoblastic Leukemia (ICD-10-CM: C91.0), 38% with ‘Diffuse Large B-cell Lymphoma (ICD-10-CM: C83.3)). CONCLUSIONS: With the use of CAR-T therapies steadily increasing over time, increasing availability of real-world EMR data will allow more robust understanding of patient characteristics, and real-world use and treatment patterns of CAR-Ts.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23menonpostersa3127733-pdf.pdf?sfvrsn=d2b7e688_0","title":"ISPOR23_Menon_Poster_SA3127733.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127733","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Imputation of Line-Level Medical Costs Using a Gradient Descent Boosting Regressor Model","id":"3d83d7fd-bd22-4359-8777-b7c3a7ff7908","sessionCode":"MSR17","topDisplay":"Woywod B1, Katriel R2 1Komodo Health, Minneapolis, MN, USA, 2Komodo Health, San Francisco, CA, USA","locationCode":"706","description":"\r\n\t<div>OBJECTIVES: Accurately impute missing service-level medical claim allowed amounts. METHODS: Line-level allowed amounts were predicted using a Gradient Descent Boosting Regressor machine learning model, trained on a set of independent variables representing provider practice costs, local market payer/provider bargaining dynamics, local market demographics, service type, and billed charge amount. The Gradient Descent Boosting Regressor is a decision tree ensemble algorithm, first developed by <a href=\"https://jerryfriedman.su.domains/ftp/stobst.pdf\" target=\"_blank\" rel=\"noopener\">Friedman in 1999</a>, that combines the potential for high predictive accuracy with a high degree of flexibility (e.g., it can optimize different cost functions and be extensively tuned). The training data set included 26 million claim-line records, representing insurance segments where reimbursement is subject to rate negotiation: commercial, Medicare Advantage, and managed Medicaid. Rather than predicting the cost of a service directly as a dollar amount, the model takes a novel approach to structuring the dependent variable that predicts whether a claim line is reimbursed at above or below the national median. This dependent variable approach has two principal benefits: 1) It improves the model’s generalizability, making it capable of pricing claims with any procedure code, and 2) It improves the model’s performance. The model was validated on an unseen sample of 2.7 million records of withheld data to guard against model overfitting and target leakage. RESULTS: The model exhibited strong performance upon validation, with an R2 value of .87 and a Mean Absolute Error (MAE) of $13.83. Due to the generalizable, code-agnostic design the model was able to estimate allowed amounts for 99.5% of records in the validation sample. CONCLUSIONS: The Gradient Descent Boosting Regressor, coupled with a robust and carefully-designed independent and dependent variable table structure, is capable of producing accurate estimates of service-line level medical allowed amounts across procedure codes and three payer types.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23woywodposter123018-pdf.pdf?sfvrsn=db86416c_0","title":"ISPOR23_Woywod_POSTER123018.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123018","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Methodological Considerations Related to Patient-Reported Outcomes Data (PRO) within HTA Appraisals Reviewed By Institut Für Qualität Und Wirtschaftlichkeit Im Gesundheitswesen (IQWIG) – Example of Triple-Negative Breast Cancer","id":"661bfd53-6888-4ffa-a11f-b8285bd3393e","sessionCode":"PCR23","topDisplay":"Antonova J Compass Strategy and Research Inc., San Francisco, CA, USA","locationCode":"732","description":"\r\n\t<div>OBJECTIVES: Within among assessments, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) reviews patient-relevant outcomes that include mortality, morbidity (symptoms and complications), and health-related quality of life (HRQoL). The latter two require patient-reported outcomes (PRO’s) data. There is a dearth of systematic evidence on the methodological approaches to reporting PRO data within IQWiG appraisals. This study aimed to review the IQWiG decisions regarding patient-relevant outcomes supporting oncology treatments based on an example of triple-negative breast cancer (TNBC). METHODS: A search for TNBC appraisals was performed on the IQWiG website. From the dossier assessment documents, information was obtained on PRO endpoints, evaluation methods, the reported outcomes, the criticism of the methods (if any), and subsequent conclusions about PRO data. RESULTS: For TNBC, IQWiG performed 6 appraisals (all during 2021-2022, including 3 addendums) for: atezolizumab, pembrolizumab (2 indications), and sacituzumab govitecan. Morbidity was reported via EORTC QLQ-C30 and QLQ-BR23 symptom scales and HRQoL—via EORTC QLQ-C30 and QLQ-BR23 functional and GHS/QoL scales and EQ-5D VAS data. IQWiG rejected the EQ-5D VAS time-to-first-worsening analyses with ≥7mm and ≥10mm cutoffs (favoring ≥15mm). The reviews accepted time-to-first worsening for QLQ-C30 and QLQ-BR23 symptoms and functional scales with ≥10-point cut off. However, they rejected mean scale scores at a single timepoint (favoring estimates at all timepoints—the same for EQ-5D VAS). The reviews also rejected PRO data if: data completion was low and misbalanced between arms (62% and 73%), evaluation periods were selected incorrectly (adjuvant and neoadjuvant instead of the full study period). IQWiG highly rated PRO data (e.g., “exclusively positive effects”) given acceptable methods and sizable statistically-significant effect size. CONCLUSIONS: IQWiG demonstrated consistency in the review of PRO data within appraisals of therapies for TNBC. Understanding IQWiG practices in reviewing PRO endpoints can help ensure submitted data meet expectations thereby increasing likelihood of a positive review.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126217","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Are We Ready for Reimbursement of Software As a Medical Device in Asia-Pacific (APAC) Region?","id":"610924bf-dd43-43a8-9480-b86b83b313a8","sessionCode":"HPR20","topDisplay":"Hsu JY1, Wang LYJ2, Lee CY2 1Chang Gung University, Taoyuan, Taiwan, 2Edwards Lifesciences, Taipei, Taiwan","locationCode":"523","description":"\r\n\t<div>OBJECTIVES: Software as a medical device (SaMD) is one type of digital health technologies, which refers to a program designed for use as a medical device. In recent years, clearer regulatory guidelines regarding SaMD have been released in many Asian countries. Moreover, assessments of the value of SaMD and reimbursement pathways have also been a hot topic for discussions. Therefore, we aim to compare the policy readiness and potential reimbursement pathways, trying to understand the policy landscapes in APAC region. METHODS: We did a desktop literature review in APAC region, including Japan, Korea, China, Taiwan, Thailand, Singapore, India, Australia and New Zealand. We searched the government documents from official websites, including Food and Drug Administration (FDA), Health Technology Assessment (HTA) bodies and National Health Insurance (NHI) to understand current policy readiness of SaMD in regulatory, HTA and reimbursement. We further summarized and did a comprehensive comparison regarding SaMD in each aspect. RESULTS: In most countries, the regulatory guidelines were ready for SaMD. So far, Korea was the only country with a clear HTA guideline and reimbursement pathway for AI-based SaMD in radiology and pathology. However, none of SaMDs were reimbursed in Korea yet. The acceleration of review process of SaMD in Japan made it become a big potential market. However, only a few categories of SaMD are reimbursed, and all through the traditional technical fee pathway. CONCLUSIONS: Currently, there is still a big reimbursement policy gap for SaMD in APAC region. The fee-for-service may not apply to all SaMD categories. Therefore, new reimbursement pathways should be proposed for certain categories of SaMD to provide incentives for healthcare providers, reward for innovations and finally benefit to patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/poster2023125751-pdf.pdf?sfvrsn=26789d3c_0","title":"Poster_2023125751.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125751","diseases":[{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Pain-Free Injections for Growth Hormone Deficiency (GHD) Improve Quality of Life: A Time Trade-Off (TTO) Study in the UK and Canada","id":"5f3f553f-47a3-490b-aab9-b8a38b29cfd7","sessionCode":"PCR3","topDisplay":"Kirsch S1, Butler G2, de Fries Jensen L3, Boegelund M4, Håkan-Bloch J3 1Department of Pediatric Endocrinology, Hospital for Sick Children, Toronto and Markham Stouffville Hospital, Markham, ON, Canada, 2Department of Paediatric Endocrinology, University College London Hospitals, London, UK, 3Novo Nordisk, Copenhagen, Denmark, 4Incentive, Holte, Denmark","locationCode":"4A","description":"\r\n\t<div>OBJECTIVES: Growth hormone deficiency (GHD) in children causes decreased growth and markedly reduced adult height. The treatment for GHD has been given as daily subcutaneous injections. However, new GH formulations can be given weekly. Injections are a burden for children and caregivers, but to our knowledge, the impact on quality of life (QoL) has not been investigated using time trade-off (TTO) methodology. This study evaluates the impact of type of injections on QoL using a TTO survey. METHODS: TTO methodology was used to estimate utilities through two online surveys (S1 and S2) completed by the general population, as required by NICE and CADTH, in the UK and Canada. In S1, adults (18+ years) evaluated health states as if they took injections themselves, and in S2, adults evaluated health states as if they gave injections to a child with GHD. To increase relatability, only adults with a child under the age of 15 years were included in S2. The following treatment aspects were evaluated: device complexity, injection frequency, injection pain, needle visibility and storage possibilities. RESULTS: 2,029 and 2,028 respondents completed S1 and S2, respectively. The results suggest that injection pain is important. Avoiding injection pain at weekly injections was associated with a significant utility gain of 0.030 (CI 95% 0.026–0.035, p<0.001) in S1 and 0.044 (CI 95% 0.038–0.051, p<0.001) in S2. Furthermore, less complex injection devices and lower injection frequency also had a significant impact on QoL in both S1 (0.020, CI 95% 0.016-0.025, p<0.001; 0.009, CI 95% 0.005-0.014, p<0.001) and S2 (0.008, CI 95% 0.002-0.014, p=0.006; 0.009, CI 95% 0.003-0.014, p=0.003). CONCLUSIONS: Several aspects of GHD treatment have a significant impact on QoL. Less time-consuming and complex treatment options with reduced injection pain and frequency are expected to result in higher QoL which could lead to higher treatment compliance.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23jensenposter125214-pdf.pdf?sfvrsn=cec97a0d_0","title":"ISPOR23_Jensen_POSTER125214.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125214","diseases":[{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Review of Predictive Modelling in Hypertension Based on Using Risk Factors to Predict Cardiovascular Consequences: A Targeted Literature Review (TLR)","id":"9b9a1d5d-7034-4250-b0a4-b9088705d93e","sessionCode":"MSR3","topDisplay":"Xuan D, Shi L Tulane University School of Public Health and Tropical Medicine, New Orleans, LA, USA","locationCode":"642","description":"\r\n\t<div>OBJECTIVES: Hypertension is a chronic condition that if left unmanaged, will result in significant clinical, humanistic, social, and economic burdens for patients. These outcomes are closely associated with various socio-demographic variables, risk factors, comorbidities, and disease management/intervention strategies. Predicting these outcomes via predictive modelling can provide a critical support for hypertension management and downstream event prevention but requires a deep understanding of the progression pathway as well as the association of risk factors with outcomes. A targeted literature review (TLR) was thus conducted to study potential predictive variables and outcomes of interests as well as existing models to support the development of such a model based on patient characteristics. METHODS: Literature published between January 2017 to July 2022 was identified by searching PubMed. The search strategy combined terms for hypertension with terms for cardiovascular disease, obesity, machine learning, risk analysis, and predictive modelling. RESULTS: Out of an initial 4,494 articles, 42 publications were included in the analysis. Generally, the predictive models followed a cohort population and applied regression analysis onto patient characteristics and risk factors in determining the outcome of interest. The cohorts analyzed followed patients in both general and diseased populations, but no model specifically focused on hypertension. Risk factors presented in the models assessed included age, sex, body mass index, cigarette smoking, physical inactivity, parental history, ethnicity, diabetes, dyslipidemia, and poor diet. If left unmanaged, these risk factors led to outcomes including but not limited to stroke, heart failure, kidney disease, and death. CONCLUSIONS: Hypertension and its downstream outcomes have major global implications towards population health and economics. Literature suggests that there is a capability gap in predicting the hypertension progression from patient characteristics and risk factors. The development of comprehensive and robust models to accomplish this task would be invaluable towards shaping hypertension prevention, care, and management.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/tulanesphtm-scientificpostertlr-126164-pdf.pdf?sfvrsn=53c24285_0","title":"Tulane_SPHTM_-_Scientific_poster_TLR 126164.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126164","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Veno-Occlusive Disease (VOD) Incidence and Treatment Trends Insights from Latest Systematic Review of Case Reports (2018-2023)","id":"e43f6c94-9d50-4ad7-8e91-b944c3f5a7dd","sessionCode":"RWD24","topDisplay":"Aggarwal S1, Topaloglu O1, Kumar S2 1NOVEL Health Strategies, Bethesda, MD, USA, 2NOVEL HEALTH STRATEGIES, COLUMBIA, MD, USA","locationCode":"832","description":"\r\n\t<div>OBJECTIVES: For ultra rare diseases independent case reports provide useful real-world evidence on disease burden and treatment trends. The objective of this review was to understand incidence and treatment trends for Veno-Occlusive Disease (VOD) using latest published case reports. METHODS: PubMed, Medline and NOVEL-VOD databases were searched for English language publications dated January 1, 2018 to December 31, 2022. Case reports were selected for inclusion if publications reported incidence or treatment for VOD (also called SOS-Sinusoidal Obstruction Syndrome). Selected publications were tagged as epidemiology, treatment trends, defibortide treated, pulmonary or hepatic VOD. Each category of case reports were reviewed to develop trends, insights and learnings for latest trends in VOD. RESULTS: A total of 347 full text records on VOD/SOS were identified, of which 46 included case reports. The individual case reports and case services cumulatively reported on VOD incidence or treatment in 99 patients. In 30 patients, the incidence of VOD was induced due to chemotherapies such as pyrrolizidine alkaloids, thioguanine and oxaliplatin. Defibrotide was used in 12 patients. Pulmonary VOD was reported in 14 case reports with most mentioning challenges in diagnosis; hepatic VOD was reported in 13 publications. In 11 case reports, severe or very severe forms of VOD were reported due to chemotherapy and/or conditioning regimens for transplant. Treatment related case reports mention early diagnosis and timely treatment of VOD led to improved outcomes. CONCLUSIONS: Latest case reports provide potentially useful real-world evidence on incidence and treatment trends for rare disease such as VOD. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124846","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identification of Longitudinal Trajectories of Medication Non-Adherence and Their Time-Varying Predictors in Aging Patients in the United States","id":"62c154aa-1333-47e4-9ea3-b96b6f825c3c","sessionCode":"MSR13","topDisplay":"Pontinha V1, Farris K2, Patterson J3, Holdford DA1 1Virginia Commonwealth University School of Pharmacy, Richmond, VA, USA, 2University of Michigan, Ann Arbor, MI, USA, 3Virginia Commonwealth University, Richmond, VA, USA","locationCode":"704","description":"\r\n\t<div>BACKGROUND: Medication adherence is a major obstacle to improving health outcomes in chronic diseases. This study aimed to identify trajectories of adherence to oral medications and investigate the association with predisposing, enabling, and need predictors, according to Andersen’s Behavior Model of health services use (ABM) theoretical framework. OBJECTIVES: N/A METHODS: This study used administrative claims data linked to participants from the Health Retirement Study between 2008-2016. GBTM elicited the number and shape of adherence trajectories, (n=11,068). Medication adherence was estimated using monthly PDC.Time-fixed and time-varying predictors were examined using logistic regression and multi-GBTM, respectively. RESULTS: GBTM were estimated for the sample population taking hypertension medications (n=7,272), statins (n=8,221), and diabetes medications (n=3,214). The hypertension model found three trajectories: near-perfect adherence (47.5%), slow (33%), and rapid decline (19.5%) trajectories. The statins model found 5 trajectories: near-perfect adherence (35.5%), slow decline (17.1%), low then increase adherence (23.6%), moderate decline (12.6%), and rapid decline (11.2%). The diabetes medications model displayed 6 trajectories: near-perfect adherence (24.2%), slow decline (16.9%), high then increase adherence (25.1%), low then increase (13.8%), moderate decline (10.7%), and rapid decline (9.3%). Multi-GBTM identified time-varying predictors of medication adherence trajectories, with disparate trends by drug class. Those pertaining to need characteristics were generally found to occur in parallel with decreases in adherence, or the opposite. CONCLUSIONS: This study showed how changes in the context of the patient can be associated with inflexions of individual medication adherence trajectories. This study implemented a method to identify the context in which patients pursue non-adherent behaviors, but further research should be able to use richer and more contextual data pertaining to the enabling and need dimensions of the ABM to inform initiatives to improve medication adherence and associated outcomes</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/128010","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Treatment Patterns and Survival with First-Line (1L) Pembrolizumab + Platinum + Taxane Therapy for Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) in the United States","id":"e1240924-19f9-436c-8ba9-bca40947b546","sessionCode":"CO23","topDisplay":"Black C1, Hanna GJ2, Wang L1, Ramakrishnan K1, Hair G1, Zheng D1, Goto D1 1Merck & Co., Inc., Rahway, NJ, USA, 2Dana-Farber Cancer Institute, Boston, MA, USA","locationCode":"124","description":"\r\n\t<div>OBJECTIVES: We assessed the real-world treatment patterns and overall survival (rwOS) of patients receiving pembrolizumab + platinum + taxane in 1L R/M HNSCC, a national guideline supported treatment option. This study provides real-world evidence to complement the ongoing phase IV KEYNOTE-B10 trial evaluating pembrolizumab + carboplatin + paclitaxel in 1L R/M HNSCC. METHODS: A retrospective cohort study was conducted using the Flatiron Health Advanced Head and Neck database. The study cohort included adult R/M HNSCC patients who initiated 1L pembrolizumab + platinum + taxane between 07/01/19 and 12/31/21 with follow-up until 06/30/22. Patients were excluded if they received prior platinum treatment ≤6 months of 1L pembrolizumab therapy, had other primary cancers before R/M HNSCC diagnosis, or were treated with protocol therapy. Real-world time on treatment (rwToT), time-to-next treatment (rwTTNT), and rwOS were assessed using the Kaplan-Meier method. RESULTS: A total of 63 patients initiated 1L pembrolizumab + platinum + taxane, mostly with carboplatin (93.7%) and paclitaxel (92.1%). Median age was 64 years (range: 39 - 84). Most were male (77.8%) and had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (66.6%). The most common tumor site was oropharynx (50.8%), followed by larynx (28.6%), oral cavity (15.9%), and hypopharynx (4.8%). P16-positivity was documented in 78.1% (25/32) of oropharyngeal cancers. The median rwTOT was 6.3 months (95% CI: 3.9 - 10.3) with a median rwTTNT of 6.6 months (95% CI: 5.8 - 8.3). The median rwOS was 14.9 months (95% CI: 6.2 - not reached [NR]) with 35.9% (95% CI: 18.7 - 53.5%) of patients alive at 24 months. These rwOS results were consistent with the KEYNOTE-B10 interim analysis (12.1 months, 95% CI: 10 - NR). CONCLUSIONS: Treatment patterns and overall survival among patients treated with pembrolizumab + platinum + taxane in the real-world were consistent with data reported in clinical trials.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124683","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Early Hemoglobin and Quality-of-Life Trends from OPERA: A Real-World Study of Pegcetacoplan Treatment in US Adults with Paroxysmal Nocturnal Hemoglobinuria","id":"abec5f9c-6e23-4b68-8795-bccf7a2d201a","sessionCode":"CO33","topDisplay":"Fishman J1, Min J1, Arnett L2, Shenoy A2 1Apellis Pharmaceuticals, Inc., Waltham, MA, USA, 2Boston Strategic Partners, Inc., Boston, MA, USA","locationCode":"133","description":"\r\n\t<div>OBJECTIVES: Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare (1-1.5 per-million), life-threatening disease characterized by complement-mediated hemolysis. Chronic hemolysis-driven anemia can result in persistent fatigue, negatively impacting patients’ quality-of-life (QOL). We report preliminary trends in hemoglobin (Hb) levels and QOL for patients in OPERA, an observational study, presenting the first real-world data on pegcetacoplan (PEG) treatment for US adults with PNH post-approval. METHODS: The study recruited US patients ≥18 years of age, diagnosed with PNH and prescribed PEG (by a licensed medical professional). OPERA collected information from routine care and did not direct medical interventions. Hemoglobin was reported by site (healthcare provider verified) at baseline (BL), and by patients over 1 year, during monthly follow-up (when available). Hemoglobin analysis only included patients who did not receive a transfusion in the treatment period and reported both a BL and ≥1 follow-up value. Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (0–52 score) and Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Cognitive Abilities (23.27–67.09 t-score) were completed online (low score=negative outcome). Given disease rarity, a small sample size was expected. RESULTS: Of 44 patients enrolled, 28 qualified (mean age 44 years, 60.7% female, mean [SD] BL Hb of 8.8 [1.7] g/dL). The mean (SD) latest Hb was 11.8 (1.4) g/dL with a median (IQR) follow-up period of 4.0 (2.3) months. Among them, 85.7% reported a Hb change from baseline by ≥1.0 g/dL, 71.4% by ≥2.0 g/dL, and 64.3% achieved Hb normalization (≥12.0 g/dL). For 8 patients with valid QOL data, mean (SD) FACIT-fatigue at BL was 29.4 (12.4) and 37.9 (12.6) at 3 months; mean (SD) PROMIS t-score at BL was 46.1 (9.5) and 50.6 (12.1) at 3 months. CONCLUSIONS: Thus far, this first real-world study of PEG in US adults with PNH indicates a positive trend in Hb, fatigue, and cognition after treatment.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23fishmanopera-poster126369-pdf.pdf?sfvrsn=f5b7d217_0","title":"ISPOR23_Fishman_OPERA POSTER126369.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126369","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Prevalence of Perinatal Depression Among Rural Women in Yunnan Province, China: A Population-Based Screening Programme","id":"fb3e9bfa-cf8b-4794-b5a0-bd4d9656a5d5","sessionCode":"EPH17","topDisplay":"Yang ZT, Huang Y Kunming Medical University, Kunming, China","locationCode":"406","description":"\r\n\t<div>OBJECTIVES: To estimate the prevalence of depression from pregnancy to one year after childbirth among rural women in China, and to provide evidence for perinatal depression prevention and control. METHODS: A population-based screening programme for perinatal depression was conducted in a rural county of Yunnan Province in May, 2022 using the Edinburgh Postpartum Depression Scale (EPDS). The cutoff point suggesting depression was EPDS≥9. RESULTS: A total of 1191 women, who were between 14 and 45 years old, received perinatal depression screening. The prevalence of perinatal depression was 13.69% (95%CI: 11.74%-15.64%), with antenatal depression 15.03% (95%CI: 13.00%-17.06%) and postnatal depression 11.55% (95%CI: 9.73%-13.37%). During the pregnancy period, the highest prevalence of depression occurred in the third trimester (16.59%) followed by the first trimester (13.94%) and the second trimester (10.81%). For the postpartum period, the highest prevalence of depression happened during 42 days after childbirth (13.91%). There were 9.28%, 12/20% and 10.53% of women who were detected with depression during 43-100 days, 101-180 days (6 months), and 181-365 days (1 year) after childbirth respectively. Anxiety, young age (<20 years), sleeping problem, adverse events experience within one year, financial concerns of having children, history of negative emotions, and baby gender expectation were major risk factors while higher level of social support and old age (≥35 years) were protective factors. CONCLUSIONS: The prevalence of perinatal depression among rural women was high and similar to those among urban women in China. Urgent attention is needed to address this public health priority. Perinatal depression screening with the EPDS from pregnancy to one year after childbirth could facilitate improving the wellbeing of mother and infant.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/eph17-prevalence-of-perinatal-depression-among-rural-women-in-yunnan-province-china-a-population-based-screening-programme124931-pdf.pdf?sfvrsn=db644872_0","title":"EPH17-Prevalence of Perinatal Depression Among Rural Women in Yunnan Province, China A Population-Based Screening Programme124931.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124931","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The First Validated Innovation in Scale Design Since the Migration to Screens: Results of an Equivalence Study, Testing a New Graphical Version of the Widely Used Verbal Rating Scale","id":"17819336-f3df-4ef4-91ae-bd8ed079b0ce","sessionCode":"PCR49","topDisplay":"Muehlhausen W1, Doll HA2, Hellman B3, James B3, Nagrani G4, O'Neill B5, Ward T5 1SAFIRA Clinical Research Ltd, Cloughjordan, TA, Ireland, 2Clinical Outcomes Solutions, Folkestone, UK, 3uMotif, London, UK, 4SAFIRA Clinical Research Ltd, Cloughjordan, ON, Ireland, 5Dublin City University, Dublin, Ireland","locationCode":"809","description":"\r\n\t<div>OBJECTIVES: While the use of PROMs in clinical research continues to grow and user interface design evolves steadily, newly developed PROMs use mostly standard scale types such as Numeric Rating Scale(NRS), Verbal Response Scale(VRS), Visual Analog Scale(VAS) in a paper-based original design. This research validated a modern design for the VRS and tested it against the standard VRS-design of the EQ-5D-5L to encourage instrument developers to utilise modern design approaches supported by new technology. METHODS: A randomised equivalence study with 55 participants in two groups (Group A=28, Group B=27) and a cross-over design using the standard EQ-5D-5L VRS vs. the new VRS design was conducted. A short training of the two VRS versions was provided to the participants. A period with an active distraction task between the applications was observed and the Intraclass Correlation Coefficient (ICC) for the EQ-5D-5L were calculated to show measurement equivalence between the two VRS versions. Participants of both groups also completed the identical EQ-5D-5L vertical scale. RESULTS: Participants in both groups reported no difficulty with the new petal-like (motif) VRS widget and all participants successfully completed both versions of the VRS. The ICC of 0.875 and the lower bound 95%-confidence interval of 0.796 are strong indications that these two representations of the VRS are equivalent. CONCLUSIONS: Existing and newly developed PROMs utilise only a limited number of well established scale types. These were developed for use on paper and then, almost unchanged, migrated to electronic platforms. This project shows that it is possible to develop modern graphical user interfaces of existing standard scale types (i.e. VRS) without changing psychometric properties of the PROM. The motif VRS can be used to replace the standard VRS design in existing and in the development of new PROMs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123480","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Abiraterone, Enzalutamide, and Apalutamide in Metastatic Castration-Sensitive Prostate Cancer (MCSPC): A Partitioned-Survival Model","id":"ad3f1919-a2a9-4da8-a36b-be0e33021994","sessionCode":"EE47","topDisplay":"Katta A1, Hansen RN2 1University of Washington, Seattle, WA, USA, 2The Comparative Health Outcomes, Policy, and Economics (CHOICE) Institute, University of Washington, Seattle, WA, USA","locationCode":"234","description":"\r\n\t<div>OBJECTIVES: Prostate cancer is the second leading cause of death and second most common cancer among American men. Metastatic castration-sensitive prostate cancer (mCSPC) has largely been treated with androgen deprivation therapy (ADT) alone or ADT plus docetaxel for the past few decades. The emergence of antiandrogen therapies like abiraterone acetate, apalutamide, and enzalutamide in the last decade has transformed the treatment landscape of mCSPC. We aimed to compare the cost-effectiveness of abiraterone, enzalutamide, and apalutamide in addition to ADT in treating mCSPC from the US payer perspective. METHODS: A partitioned-survival model was developed to compare the lifetime costs and outcomes of these three treatment options for mCSPC using data from phase 3 trials and their extensions for each. Drug costs were obtained from the Redbook database and Medicaid. Health outcomes were measured in life-years and quality adjusted life years (QALYs). Survival data was extrapolated from progression-free and overall survival curves from trials. Utility values were derived from published data, including the pivotal trials. One-way and probabilistic sensitivity analyses were conducted to test the uncertainty of our model results. RESULTS: Compared to abiraterone, apalutamide provided a 0.88 QALY and $867,785 gain with an ICER of US$990,307 per QALY. Enzalutamide provided a 0.41 QALY and $55,363 gain against apalutamide with an ICER of $135,983 per QALY. Apalutamide was dominated by abiraterone when using the low input value of pre-progression utility for abiraterone in our one-way sensitivity analyses. When comparing enzalutamide to apalutamide, apalutamide was dominated when using the low and high input values of cost for enzalutamide and apalutamide, respectively. Enzalutamide was dominated when using the low and high input values of pre-progression utility for enzalutamide and apalutamide, respectively. CONCLUSIONS: Abiraterone plus ADT is the preferred treatment compared to either enzalutamide or apalutamide plus ADT at a willingness to pay threshold of US$100,000 per QALY.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kattaposter124710-pdf.pdf?sfvrsn=916f806f_0","title":"ISPOR23_Katta_POSTER124710.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124710","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Economic Evaluation of Donafenib Versus Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma in Japan","id":"4c295e22-38e8-471c-8d08-be136074d21d","sessionCode":"EE42","topDisplay":"Tsuyuki T1, Morimoto K2, Maeda T2, Chen W2, Moriwaki K1, Shimozuma K2 1Ritsumeikan University, Kyoto, 26, Japan, 2Ritsumeikan University, Kyoto-shi, 26, Japan","locationCode":"239","description":"\r\n\t<div>OBJECTIVES: According to the Japanese clinical guidelines, sorafenib is used as first-line therapy for patients with advanced hepatocellular carcinoma (HCC) when not applicable to atezolizumab plus bevacizumab. Although donafenib showed superiority over sorafenib in improving overall survival, it is not approved in Japan and its cost-effectiveness is not necessarily clear. This study aimed to evaluate the cost-effectiveness of donafenib from the payer’s perspective in Japan. METHODS: A partitioned survival analysis model was developed to predict costs and quality-adjusted life years (QALYs) in both groups. Survival data were derived from the phase II/III trial. Drug prices for donafenib were estimated based on foreign prices. Other cost parameters were estimated by using the JMDC calims database. Lifetime horizon and discount rate of 2% was applied. Utility weights were estimated based on previous studies. The incremental cost-effectiveness ratio (ICER) of donafemnib compared with sorafenib was estimated. Sensitivity analysis (SA) was performed to assess parameter uncertainty. RESULTS: Compared with sorafenib, donafenib incurred an additional cost of JPY5,253,716 and conferred an additional 0.211 QALY. This resulted in the ICER of JPY24,864,390/QALY gained. SA showed that the parameter with the largest fluctuation range was utility of donafenib group in progression state, and the minimum value of ICER was JPY22,585,521/QALY and the maximum value was JPY27,654,741/QALY. CONCLUSIONS: Applying the willingness to pay threshold of JPY15 million/QALY and foreign drug price, donafenib was not cost-effective compared to sorafenib. In the future, it would be necessary to incorporate a cost-effectiveness perspective in the pricing of cancer treatment in Japan.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124875","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost Analysis of Antihypertensive Drugs Prescribed in a Tertiary Care Hospital in South Indian City","id":"e8010a33-80cb-49db-862d-bf2fa3bd9348","sessionCode":"EE5","topDisplay":"Gadwal M1, C. C1, H. S. S2, S. V2 1Sree Siddaganga College of Pharmacy, Tumkur, KA, India, 2Sree Siddaganga College of Pharmacy, Tumkur, India","locationCode":"206","description":"\r\n\t<div>OBJECTIVES: The aim of a Cost analysis of antihypertensive agents is to identify, measure, and compare the costs. To analyse the prescription practices of the antihypertensive agents in a tertiary care hospital. METHODS: A prospective cross-sectional study was conducted for 6 months among patients who have been prescribed antihypertensive agents in a tertiary care hospital, in Karnataka, India; from February 2022 to August 2022. A total of 211 patients were involved in this study. Consent was taken from all the patients and data has been collected by using data collection forms, assessed, and analysed for our objectives and results. RESULTS: The most prescribed antihypertensive drugs are Beta-blockers, Diuretics > ARBs > CCBs > Vasodilators > ACE inhibitors, Alpha blockers > Neprilysin inhibitors, 3-KAT inhibitors > Alpha agonists. This study shows in the oral dosage form telmisartan drug shows a huge percentage cost variation of 306.19% and the diltiazem drug shows less variation of 3.85% among branded drugs. ANOVA between the cost of drug therapy and hospital stay results as F-statistic greater than F-critical and Kruskal Wallis test shows our P-value is less than the significant P-value that is 0.05 which indicates that our study is statistically significant. CONCLUSIONS: This study reveals that physicians are prescribing a variety of branded drugs of the same pharmaceutical product. Hence, a pharmacist can suggest prescribing the generic name of the drug when it is clinically appropriate. The patient can choose their affordable drug.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125096","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"},{"id":"3f994852-a0d4-4706-9665-e4d867006d9a","parentId":"00000000-0000-0000-0000-000000000000","title":"Injury & Trauma","urlName":"injury-trauma"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Carbapenem-Resistant Gram-Negative Pathogens in Brazil: Analysis from Patients in a Laboratory Network","id":"f3ec3de8-22b6-41a3-83d3-bf813b350172","sessionCode":"EPH10","topDisplay":"Bittencourt A1, Mizuno G2, Paula MDND2, Fahham L3, de Mendonça Batista P4, Faustino V5, Polis TJ4 1Global Medical Affairs, MSD in Brazil, Sao Paulo, SP, Brazil, 2Global Medical Affairs, MSD in Brazil, São Paulo, SP, Brazil, 3ORIGIN Health, São Paulo, Brazil, 4Global Medical Affairs, MSD in LATAM, São Paulo, Brazil, 5Global Medical Affairs, MSD in LATAM, São Paulo, SP, Brazil","locationCode":"417","description":"\r\n\t<div>OBJECTIVES: Treatment of gram-negative infections has become increasingly complicated by the emergence of carbapenem-resistant (CR) Enterobacterales, Pseudomonas aeruginosa (Pa) and Acinetobacter baumannii. Despite their clinical and economic impact, there is a lack of robust national data in Brazil. Our objective was to determine the frequency of Enterobacterales and Pa in Brazil from 2018-2020. METHODS: Cross-sectional study using a database composed of national private laboratory information. Enterobacterales and Pa were collected from patient samples aged ≥18 years during hospitalization from January 01, 2018 to June 30, 2020. Antimicrobial susceptibility for samples from intensive care unit was determined by broth microdilution, and by disk diffusion for other samples. Susceptibility was interpreted using BRCAST/EUCAST. Carbapenem resistance was defined as resistance to imipenem or meropenem for Pa, and resistance to ertapenem for Enterobacterales. RESULTS: A total of 18,753 samples were included in the analysis, 5,975 (31.9%) Pa, 11,169 (59.5%) non-Morganellaceae Enterobacterales (NME), and 1,609 (8.6%) a combination of Morganella, Proteus and Providencia spp. Almost 50% of the Pa samples were CR, while only 6% of the NME showed the same trait. Nonetheless, 54% of K. pneumoniae samples were CR. CR was most frequently observed among Pa samples from the northeast and southeast (52% and 47%, respectively), when compared to the south and midwest regions (39% and 35%, respectively). Regarding NME, CR was more prevalent in the midwest and northeast regions (22% and 15%, respectively). Finally, 55% and 14% of CR Pa and NME came from samples from the lower respiratory tract. CONCLUSIONS: We observed a high prevalence of CR gram-negative pathogens among hospitalized patients in Brazil. These data should reinforce the urgency of having strategies to fight against antimicrobial resistance.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bittencourtposterv2124124-pdf.pdf?sfvrsn=d0dd263_0","title":"ISPOR23_Bittencourt_POSTERV2124124.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124124","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Innovative Mechanisms of Pre-Market Authorization Access for Rare Diseases in Brazil. a Case Study of Pabinafusp-Alfa for Mucopolysaccharidosis Type II","id":"d349a862-5f32-47a6-bcb0-c0267665db0c","sessionCode":"EE574","topDisplay":"Tanaka E1, Falavigna M2, Romcy MH3, Priszkulnik G4, Santos M5, Daher A6, Maia E7 1TNK, CURITIBA, PR, Brazil, 2\"Inova Medical, Porto Alegre, RS, Brazil, 3ABEA, Fortaleza, Brazil, 4SBAM BRAZIL, SÃO PAULO ,SP, Brazil, 5Sociedade Brasileira de Auditoria Médica, São Paulo, Brazil, 6CASA HUNTER & FEBRARARAS, SÃO PAULO , SP, Brazil, 7SAS - ADVANCED HEALTH SOLUTIONS, RIO DE JANEIRO, RJ , BRAZIL, Brazil","locationCode":"147","description":"\r\n\t<div>OBJECTIVES: Hunter syndrome (HS) is a rare, genetic X-linked recessive lysosomal storage disease. Clinical manifestations vary widely in severity and involve multiple organs and tissues; central nervous system (CNS) symptoms are present in approximately two thirds of patients, being associated with poor prognosis and high burden. So we prompt decide to analyze an innovative mechanisms of pre-market authorization access for rare diseases in our country . METHODS: In Brazil, although guidelines cover diagnosis, supportive and enzyme replacement treatment (ERT) for HS without CNS manifestations, no specific treatment is available for patients with CNS symptoms. Due to patient organizations engagement, it was possible to provide access for an orphan drug before regulatory approval. Pabinafusp-alfa crosses the blood-brain barrier, overcoming current challenges to treat the neuropathic manifestations of HS and help maintain or improve cognitive function in patients. Currently pabinafusp-alfa is available only in Japan and Brazil; in the latter, it is only available nested to research protocols. RESULTS: Studies with pabinafusp-alfa started in Brazil in 2018 (Phase II) as result of direct and organized demand from rare diseases patient associations to drug manufacturer. Despite lack of healthcare authorities’ involvement, up to 2022, 20 patients were treated in Brazil, resulting on estimate savings of USD 13 million for public healthcare system with ERT and providing better patient outcomes . CONCLUSIONS: Innovative access alternatives can provide faster access to treatments for patients with unmet needs, especially with orphan diseases. Other alternatives include a) access through clinical studies, with execution/development aligned with healthcare managers and linked with potential future access strategies; b) risk sharing at regulatory level, considering the uncertainties in effectiveness and possibly market withdrawal and/or reimbursement to the system in case of negative results; c) pre-delivery, with subsequent payment only if the results of the clinical study are positive.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/innovative-mechanisms-of-pre-market-authorization-access-for-rare-diseases-in-brazil--a-case-study-of-pabinafusp-alfa-for-mucopolysaccharidosis-type-ii125347-pdf.pdf?sfvrsn=cd891b12_0","title":"Innovative Mechanisms of Pre-Market Authorization Access for Rare Diseases in Brazil __ A case study of Pabinafusp-alfa for Mucopolysaccharidosis Type II125347.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/hunter-disease-poster125347-pdf.pdf?sfvrsn=eb44d6f4_0","title":"HUNTER DISEASE POSTER125347.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125347","diseases":[{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Axicabtagene Ciloleucel, Lisocabtagene Maraleucel, and Tisagenlecleucel CAR T-Cell Therapies for Treatment of Relapsed or Refractory Large B-Cell Lymphoma (LBCL)","id":"5e256bca-aab7-4b5e-ad93-c05efd98fcb9","sessionCode":"EE86","topDisplay":"Ghanem B1, Seoane-Vazquez E2, Fleming M3, Brown LM2, Rodriguez-Monguio R2 1Chapman University School of Pharmacy, Costa Mesa, CA, USA, 2Chapman University School of Pharmacy, Irvine, CA, USA, 3Chapman University, Irvine, CA, USA","locationCode":"328","description":"\r\n\t<div>BACKGROUND: Axicabtagene ciloleucel (axi-cel), lisocabtagene Maraleucel (liso-cel), and tisagenlecleucel (tisa-cel) are chimeric antigen receptor (CAR) T-cell therapies used to treat adult patients with large B-cell lymphoma (LBCL) who relapsed within 12 months of first line therapy. However, no head-to-head clinical trials have been conducted to compare them. OBJECTIVES: To estimate the cost-effectiveness of axi-cel versus liso-cel versus tisa-cel in patients with relapsed/refractory LBCL (rrLBCL) from a US healthcare payer perspective. METHODS: The primary outcomes included quality of life (QoL) and quality-adjusted life years (QALYs). Gained outcomes and adverse events were derived from the pivotal trials (ZUMA-7, TRANSFORM, and BELINDA) and literature reviews. Costs were extracted from the IBM-Micromedex Red Book, Centers for Medicare and Medicaid Services, and existing literature. Probabilistic sensitivity analyses were performed. RESULTS: The total costs of drug acquisition, administration, and adverse event management per patient were $541,026, $491,759, and $463,368, for axi-cel, liso-cel, and tisa-cel, respectively. Total QALYs for axi-cel exceeded liso-cel (7.24 versus 5.52) and tisa-cel (6.85 versus 4.86) with incremental costs per QALY gained of $28,644 versus liso-cel and $39,024 versus tisa-cel. The probability that the gene therapy is cost-effective was 99% at a willingness to pay $150,000 per QALY. CONCLUSIONS: Axi-cel is a cost-effective CAR T cell therapy for patients with rrLBCL compared to liso-cel and tisa-cel. More studies based on head-to-head clinical trials are necessary to confirm these findings.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23ghanemposter1126426-pdf.pdf?sfvrsn=6886a_0","title":"ISPOR23_Ghanem_POSTER1126426.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126426","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Treatment Patterns and Overall Survival Among Follicular Lymphoma Patients: A SEER-Medicare Analysis","id":"f899a86a-c8ad-4ad5-9946-c0ca08fe807a","sessionCode":"RWD17","topDisplay":"Yang S1, Bains Chawla S2, Zhang G2, Wang A3, Yu J3, Arnette D3, Navarro FR2, Blaedel J2, Mutebi A2 1Genmab US, Inc., Collegeville, PA, USA, 2Genmab US, Inc., Plainsboro, NJ, USA, 3AbbVie, North Chicago, IL, USA","locationCode":"827","description":"\r\n\t<div>OBJECTIVES: To describe clinical characteristics, treatment patterns, and overall survival (OS) in patients with follicular lymphoma (FL). METHODS: This retrospective analysis identified incident FL patients from the Surveillance, Epidemiology, and End Results (SEER) database based on ICD-O-3 codes (9695/3, 9691/3, 9698/3) in the time period 1/1/2000 to 12/31/2017. The first recorded FL diagnosis date was set as the index date. Patients were required to be continuously enrolled in Medicare Parts A and B for ≥12 months prior to index date. From the Medicare database linked with SEER, NCCN-recommended treatment regimens (version 5.2022) were identified and lines of therapy (LOTs) were derived. OS was estimated from initiation of each LOT until death, end of eligible insurance enrollment, or study end (12/31/2019). RESULTS: Overall, 9164 incident FL patients were identified. Median age at diagnosis was 75 years; most were female (56%), had FL grade 1/2 (74.7%), and Ann Arbor stage III/IV (51.9%). During the mean [median(maximum)] follow-up period of 73.1 [61.1(240)] months from index date, 6006 (65.5%), 1976 (21.6%), 693 (7.6%), and 261 (2.9%) patients were treated with 1L+, 2L+, 3L+, and 4L+, respectively. Across different LOTs, the most used regimens were rituximab or obinutuzumab (R/O) + chemotherapy (61.3% in 1L, 52.4% in 2L, 52.7% in 3L) and R/O monotherapy (30.7% in 1L, 30.1% in 2L, 21.8% in 3L). As patients progressed to later LOTs, median OS declined (87.0 months for 1L+, 43.5 months for 2L+, 28.6 months for 3L+, 22.3 months for 4L+). Accordingly, the estimated 2-year OS was 80%, 65%, 56%, and 47% for 1L+, 2L+, 3L+, and 4L+, respectively. Sensitivity analyses exploring different LOT definitions showed consistent results. CONCLUSIONS: This retrospective analysis showed that FL patients experience worsening survival outcomes as they progress through later LOTs, demonstrating the high unmet need of FL patients with relapsed/refractory disease.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23yangposter127246-pdf.pdf?sfvrsn=82a90b1d_0","title":"ISPOR23_Yang_POSTER127246.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127246","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessing the Public Health Impact of the Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine Among Older Adults in the United States (US)","id":"73e513f1-36db-4b42-a0d5-c0d484ef291a","sessionCode":"EPH45","topDisplay":"Molnar D1, La E2, Verelst F1, Curran D1, Poston S3, Van Bellinghen LA4, Graham J5 1GSK, Wavre, WBR, Belgium, 2GSK, Raleigh, NC, USA, 3GSK, Philadelphia, PA, USA, 4CHESS in Health, Bonheiden, Belgium, 5RTI Health Solutions, Durham, NC, USA","locationCode":"445","description":"\r\n\t<div>OBJECTIVES: The burden of respiratory syncytial virus (RSV) is substantial among older adults (OA), with previous research estimating 177,525 RSV-related hospitalizations and 14,000 RSV-related deaths each year in the US. This study estimates the public health impact of vaccinating US adults aged ≥60 years with a single dose of adjuvanted RSV prefusion F protein vaccine (RSVPreF3 OA). METHODS: A Markov-cohort model with a 1-year time horizon was developed to compare health outcomes for scenarios with and without RSV vaccination, assuming the same vaccination coverage rates as for the influenza vaccines in the 2021-2022 season (52.4% among 60–64-year-olds, 73.9% among ≥65-year-olds). Population estimates, RSV epidemiology, and health care resource use inputs were obtained from standard US sources and published literature. Vaccine efficacy and waning rates were estimated from the AReSVi-006 phase 3 clinical trial. Sensitivity analyses were performed to test parameter uncertainty. RESULTS: Without vaccination, RSV results in an estimated 3,031,750 symptomatic infections, 171,415 hospitalizations, and 13,919 deaths each year among US adults aged ≥60 years (n=81,001,651), with considerable burden observed across all age groups. Vaccinating 55,282,554 of these older adults is estimated to prevent 1,277,725 symptomatic RSV infections, including 673,835 cases of RSV lower respiratory tract disease each year. Vaccination is also expected to avoid 496,076 medically attended RSV cases, 94,984 hospitalizations, 23,278 emergency department visits, 87,293 pneumonia complications, 414,668 antibiotic prescriptions, and 7,743 deaths annually. Numbers needed to vaccinate to avoid one symptomatic RSV infection, RSV-related hospitalization, and RSV-related death are 43, 582 and 7,139, respectively. Results were consistent across sensitivity analyses. CONCLUSIONS: Vaccinating adults aged ≥60 years in the US with the adjuvanted RSVPreF3 OA vaccine is expected to have a significant public health impact by reducing RSV morbidity and mortality. Patient and health care provider education on RSV disease and vaccines will be important to support older adult RSV vaccination.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23molnarposter---phi125521-pdf.pdf?sfvrsn=fbbeee74_0","title":"ISPOR23_Molnar_Poster - PHI125521.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23molnarhandout---phi125521-pdf.pdf?sfvrsn=180e5123_0","title":"ISPOR23_Molnar_Handout - PHI125521.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125521","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Disparities in Incidence, Real World Treatment Patterns, and Medication Adherence Among Patients with Systemic Lupus Erythematosus (SLE) in the US: A Retrospective Claims and Electronic Health Records Analysis","id":"ba380c77-ef1b-44d4-8bc6-c177e312de0e","sessionCode":"RWD27","topDisplay":"Verma V1, Brooks L2, Field S3, Daral S4, Markan R4, Aswal D4, Anand S4, Nayyar A4, Dawar V4, Bhargava S5 1Optum, Gurgaon, HR, India, 2Optum, Basking Ridge, NJ, USA, 3Optum, Dallas, TX, USA, 4Optum, Gurugram, HR, India, 5Optum Tech, Eden Prarie, MN, USA","locationCode":"812","description":"\r\n\t<div>OBJECTIVES: To gain insights into gender and racial/ ethnic disparities in incidence, real world treatment patterns, and medication adherence among SLE patients in the US. METHODS: A retrospective study using Optum® de-identified Market Clarity Dataset (linked claims and electronic health records or EHR of patients) was done among adult (>=18 years) patients with 2 or more claims and/ or EHR with SLE diagnosis (ICD-10 code M32) at least 30 days apart during 1st Jan 2018 to 30th Jun 2021. Index date was defined as the first claim or EHR with SLE diagnosis. Only patients with no SLE diagnosis in claims or EHR during preceding 6 months from index date were included. All patients were followed-up for 12 months from index date to determine their SLE-specific treatment patterns and medication adherence. Total 6 SLE-specific treatments were considered: biologics, hydroxychloroquine, immunosuppressants and immunomodulators, NSAIDs, systemic steroids, and topical steroids. The study explores gender and racial/ ethnic disparities in incidence, treatment patterns (overall and biologics treatment rates), and medication adherence (primary and secondary adherence) of SLE. RESULTS: Total 24,469 SLE patients were included in the study. Incidence of SLE was significantly higher in females (8 per 10,000) than males (1 per 10,000), and in African Americans (9 per 10,000) than Caucasians (4.5 per 10,000). SLE-specific treatment rates were significantly lower in males (83% vs 86% in females) and African Americans (83% vs 86% in Caucasians). Also, proportion of patients treated with biologics was significantly lower among males (1.6% vs 2.4% in females) and African Americans (1.4% vs 2.5% in Caucasians). Further analysis of gender and racial/ ethnic disparities in time from diagnosis to treatment initiation, inpatient hospitalization, specialist consultation, primary and secondary medication adherence is currently underway. CONCLUSIONS: There are gender and racial/ ethnic disparities in incidence and treatment patterns of SLE.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/sle-posterispor2023126894-pdf.pdf?sfvrsn=333f39e4_0","title":"SLE poster_ISPOR2023126894.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126894","diseases":[{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Budget Impact Analysis of Proactive Therapeutic Drug Monitoring for Inflammatory Bowel Disease Patients in the United States on Infliximab Therapy","id":"6eb5951a-d48d-4ab0-8930-c387dbbbf085","sessionCode":"EE78","topDisplay":"Dervieux T1, Vasquez P1, Shim A1, Simbaqueba E2 1Prometheus Laboratories, San Diego, CA, USA, 2El Bosque University, East boston, MA, USA","locationCode":"321","description":"\r\n\t<div>OBJECTIVES: Therapeutic Drug Monitoring (TDM), to measure drug and anti-drug antibodies and guide therapeutic adjustments, has been associated with positive clinical outcomes when using biologics such as infliximab (IFX) to treat inflammatory bowel disease (IBD). TDM may be ordered reactively or proactively as the preferred standard of care versus empiric dosing. This study aims to estimate the 2021 incremental budgetary change in per member per year (PMPY) in the US when a proactive TDM approach is implemented for IBD patients treated with IFX. METHODS: Through a probabilistic simulation model over a 2-year period, we compared proactive TDM, reactive TDM, and empiric scenarios in a simulated cohort of 161,781 US patients on IFX treatment for 2021 (Clarivate/DRG, 2021). With proactive TDM, testing occurred as part of a routine monitoring strategy (2x per year). In reactive scenarios, testing was prompted by a clinical recurrence of disease. No TDM occurred in the empiric scenario. We based this study on published literature and clinician interviews. Costs of health care resource utilization (HCRU), TDM, and drugs were obtained from literature and adjusted to 2021 values. RESULTS: Results suggest proactive TDM strategies in the US may be associated with one-year savings average of $5,520 and $9,229 PMPY when compared to reactive and empiric, respectively. Proactive TDM had higher IFX and testing costs compared to reactive, but lower HCRU (IBD-related hospitalizations, procedures, visits). Compared to empiric, proactive TDM had higher testing costs, lower IFX costs, and significantly lower HCRU. CONCLUSIONS: A proactive TDM strategy is associated with total cost-of-care savings resulting from lower IBD-related HCRUs, which are expected from suboptimal dosing and subsequent disease complications. This budget impact analysis highlights the cost value of efficiently maintaining optimal IFX dosing and avoiding drug waste by prescribing the right dose for the right patient.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-dervieux-t-et-al-poster126890-pdf.pdf?sfvrsn=a2662b2b_0","title":"ISPOR 2023 [Dervieux T et al] POSTER126890.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126890","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"},{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluating the Adherence to ISPOR Guidelines in US Published Budget Impact Analyses of New Drugs: A Targeted Literature Review","id":"960db5f8-33c4-4a93-99ec-c48607cfe5c2","sessionCode":"SA11","topDisplay":"Amaefule A1, Thakkar K2, Erb RS3, Rascati KL3 1Thomas Jefferson University, Philadelphia, PA, USA, 2Baylor Scott & White Health/The University of Texas at Austin, Temple, TX, USA, 3The University of Texas at Austin, Austin, TX, USA","locationCode":"913","description":"\r\n\t<div>OBJECTIVES: A budget impact analyses (BIA) is an economic tool used to predict economic changes of introducing new drugs or indications to the market, it is conducted by reimbursement authorities and health systems to assist in the determination of formulary status. This research aimed to assess the quality of US published budget impact analyses based on the ISPOR Budget Impact Analyses: Principles of Good Practice Report. METHODS: A targeted literature search from 2015 through 2022 was conducted using SCOPUS, Health Business Elite, EconLit, Pubmed, and Cochrane databases. US budget impact analyses of new FDA approved drugs and drugs with new indications approved in 2015 or later were included. Publication characteristics such as perspective, target population, validation, and uncertainty analyses were extracted and recorded. RESULTS: A total of 62 articles were identified and evaluated based on the inclusion and exclusion parameters. Overall, the majority (n=59) of BIA’s considered a commercial or a public health plan as the primary perspective, with few (n=3) considering a hospital/health system perspective. The time horizons of all BIAs were specified and ranged from 1 to 5 years. Model validation using face validity or verification of calculations within studies was only seen in a few studies. Although not recommended by the ISPOR guidelines, a six studies conducted discounting. A rebate analysis was conducted in one study, to explore different discounts that could be used to break-even with comparators. CONCLUSIONS: In this review, the majority of articles included several key elements from the ISPOR BIA guidelines. However, the published budget impact analyses frequently failed to provide a clear description of their model validation process, and the extent of sensitivity analyses varied widely among products and indications.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23amaefuleposter125466-pdf.pdf?sfvrsn=5276197a_0","title":"ISPOR23_Amaefule_Poster125466.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125466","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Comparative Analysis of Performance Indicators for Elite Women's Handball Teams Under Lab Conditions","id":"66cb93e1-0bcd-4870-adcf-c4ef8fd12da2","sessionCode":"CO3","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"105","description":"\r\n\t<div>OBJECTIVES: The purpose of our research is to examine whether the cardiorespiratory performance indicators of the Women's Champions League winner Hungarian handball team players are different from those of the Hungarian second division ladies. We assume the first-class team players (Győri Audi ETO) cardiorespiratory performance indicators are higher than the lower-class players indicators. METHODS: During the examination we measured the women’s handball players cardiorespiratory features (respiratory exchange ratio, maximum oxygen uptake, load duration) in a performance diagnostic laboratory. In our study was 25 handball players (n=25). First division was Győri Audi ETO, second division was Kozármisleny SE. During the statistical data processing, we used a descriptive and inference statistical methods (correlation analysis, two-sample T-test). RESULTS: The mean height and age of the team Kozármisleny SE’s (second division) women handball players were lower (173.00±5.37 cm; 24.00±3.65 years) than the Champions League winner team Győri Audi ETO’s players mean height and age (175.50±5.32 cm; 24.00±3.65 years). The results of the two-sample T-test show that the younger team has significantly higher value for respiratory exchange ratio (RER=1.15±0.08) than the older team’s players from Győr (RER=1.05±0.03). Significant difference between maximum oxygen uptake (VO2max) data could not be detected (p=0.407) however, the duration of the load for the Győri Audi ETO’s (T=662.50±119.73) was significantly higher (p=0.003) than the team Kozármisleny SE’s results (T=476.35±54.44 sec). CONCLUSIONS: There was no significant difference in aerobic capacity between the players of the two teams, but the higher-class women players were able to be charged for a longer period of time. This result shows that higher class players can maintain their performance under lab conditions for longer than players in the first division.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127666","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluating the Impact of Random Forest (RF) on Matching Adjusted Indirect Comparisons (MAICS) of Treatments between Trials: A Simulation Study","id":"c09022e7-ee25-4a38-b487-c51831365483","sessionCode":"MSR18","topDisplay":"Moradian H, Heeg B, Tremblay G Cytel, Waltham, MA, USA","locationCode":"707","description":"\r\n\t<div>OBJECTIVES: MAIC is a popular method of population-adjusted indirect treatment comparison. It uses a propensity score approach, which re-weights patient characteristics in the index trial to match the baseline characteristics of a target population. The primary challenge with MAICs is that reweighting may produce significantly smaller effective sample sizes. RF is a non-parametric ensemble technique that averages outcomes from multiple decision trees and can be used to weight patient characteristics based on the number of times any pair of subjects end up in the same terminal nodes. Our hypothesis was that the RF approach estimates the weights more accurately versus the propensity score approach, thus improving the results of MAICs. METHODS: Data was simulated for a two-study comparison (AB and AC) involving three treatment levels. The MAIC included five covariates, an effect modifier (age), and three prognostic variables (time since diagnosis, smoking status, race, and gender). Weights were estimated to match the effect-modifier distributions between the two trials. MAICs using the RF and propensity score approach were applied over 1,000 iterations. RESULTS: With a sample size of 300 patients, MAICs using the RF approach resulted in significantly higher accuracy/lower mean absolute error (MAE) i.e., the absolute difference between the point estimates of the log odds ratio of treatment C vs. B and their true value averaged over 1,000 iterations (MAE=1.29 vs. 1.72, p<0.001). RF also resulted in a smaller reduction in the effective sample size (73.4% vs. 86.8%, p <0.001). CONCLUSIONS: For MAICs, using simulation studies, RF MAIC appears to improve some outcomes of the matching process, including higher accuracy and loss of sample size. Further studies, including actual patient-level data and simulation studies, should be conducted to explore results with varied sample sizes, sparse data, and varied number of covariates.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23moradianposter127280-pdf.pdf?sfvrsn=1da04395_0","title":"ISPOR23_Moradian_POSTER127280.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127280","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Minority Stressors, HIV/AIDS Acquisition Stress, Prep Stigma, and Willingness to Use Prep Among Men Who Have Sex with Men: A Latent Profile Analysis","id":"0d28d3fe-d936-4e97-86d6-c5b8c9d5ed01","sessionCode":"PCR11","topDisplay":"Goswami S1, Barnard M2, Kang M3, Bhattacharya K4, Bentley J4 1Department of Pharmacy Administration, University of Mississippi School of Pharmacy, University, MS, USA, 2Department of Pharmacy Administration, School of Pharmacy, University of Mississippi, University, MS, USA, 3Department of Health, Exercise Science, and Recreation Management, University of Mississippi, University, MS, USA, 4Department of Pharmacy Administration, University of Mississippi School of Pharmacy, Center for Pharmaceutical Marketing and Management, University of Mississippi School of Pharmacy, University, MS, USA","locationCode":"724","description":"\r\n\t<div>OBJECTIVES: This study identified latent classes of men who have sex with men (MSM) based on stressors unique to their minority status. Additionally, this study assessed the association of class membership with participants’ willingness to use (WTUP) HIV pre-exposure prophylaxis (PrEP). METHODS: Data were collected via a cross-sectional anonymous online survey, fielded May-August, 2022, among US-based MSM. Inclusion criteria were: 1)≥18 years, 2)not transgender, 3)HIV status negative/unknown, 4)had sex with men in the past five years, and 5)PrEP eligible. Latent profile analysis was conducted to identify classes of MSM. Nine types of stressors were used as indicators: harassment and discrimination, victimization, internalized homophobia, isolation, concealment, HIV/AIDS acquisition stress, internalized, experienced, and anticipated PrEP stigma. The R3STEP command in Mplus was implemented to assess predictors of class membership (sociodemographic characteristics, HIV risk characteristics, and past PrEP status). Finally, the manual Bolck, Croon, & Hagenaars (BCH) method was implemented to estimate the association of latent class membership with WTUP, adjusting for covariates. Mplus v8.8 was used for analysis. RESULTS: Of the 390 MSM in the study sample, 79.23% were willing to use PrEP. Two distinct latent classes were identified based on fit indices and other criteria: “Lower Stress” class (81.79%) and “Higher Stress” class. Those aged 18-34 years [OR:6.92, 95% CI:2.85-16.84, p<0.001] versus those aged 35-64 years, shared injection equipment [OR:6.17, 95% CI:2.52-15.14, p<0.001], or had STD diagnosis [OR:2.69, 95% CI:1.23-5.91, p=0.014] within the past six months, and experienced depressive symptoms in the past two weeks [OR:3.54, 95% CI:1.37-9.19, p=0.009] had higher odds, and those residing in rural areas [OR: 0.17, 95% CI: 0.05-0.53, p=0.002], had lower odds of belonging in the “Higher Stress” class. Adjusting for covariates, there was no difference in WTUP between the two classes. CONCLUSIONS: Future PrEP programs should incorporate counseling and peer support to empower MSM to cope with such stressors.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/minority-stressors-lca-ispor-poster-2023124431-pdf.pdf?sfvrsn=915d47c2_0","title":"Minority Stressors LCA ISPOR Poster 2023124431.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124431","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"},{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"TAVR Reimbursement and Cost Analysis in Chile: Input Data for Improving the DRG System in Chile","id":"80b9cf52-55b3-4654-940b-c5ef1e8196c4","sessionCode":"EE93","topDisplay":"Paredes D1, Valencia J2 1Medtronic, Santiago, RM, Chile, 2Medtronic, Miami, FL, USA","locationCode":"335","description":"\r\n\t<div>OBJECTIVES: In 2020, Chile implemented a DRG payment reform. However, the system imported internationally sources DRG weights instead of using local costs. Thus, there is a need to understand if the current DRG weights accurately represent the local costs of Chilean public providers. This is particularly evident in procedures requiring high-cost medical devices. The Transcatheter Aortic Valve Replacement (TARV) for Aortic Stenosis (AS) has been described as a critical case. We aim to estimate the gap between the current TAVR reimbursement rate and the local provider costs from the public providers' perspective. METHODS: The reimbursement rate was estimated using open-access DRG databases from public providers. Data on: DRG coding, DRG weights, basal reimbursement, and add-on payment amounts were collected. To estimate local provider costs, an activity-based costing approach and bottom-up strategy was used. Costs were categorized in order to explore principal cost drivers. Estimations were made a per-patient (PP) without complications basis and expressed in 2022 Chilean pesos (CLP). RESULTS: The average DRG TAVR payment (irrespective of AE severity and severity distribution) was CLP$23,138,514 (a baseline of CLP$4,602,504 + an additional add-on payment of CLP$18,536,010 when code 35.05 was approved). The average local cost to providers PP without complications were estimated at CLP$20,353,312. Costs were sorted by lab work and scans (0.30%), bed-days (0.86%), drugs and post-procedure care (0.97%), medical team costs (1.54%), OR supplies (9.22%), and the TAVR device (87.12%). When complications are not considered, the gap between full reimbursement and costs for the intraoperative period was CLP$2,785,202 (12.04%) (positive margin for providers). CONCLUSIONS: With the inclusion of an add-on payment for TAVR in AE, the gap between DRG average reimbursement and procedure costs diminished in non-complicated patients. However, the reimbursement rate versus true costs balance is delicate as it relies on best-case scenarios.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/poster-tavr-1-v2127349-pdf.pdf?sfvrsn=e062b009_0","title":"Poster TAVR 1 V2127349.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127349","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Persistent Opioid Use after Hospital Admissions for Trauma in New Zealand","id":"4f0abbc4-22f4-454f-a2f0-c8c9630285c4","sessionCode":"CO16","topDisplay":"Gong J1, Chan A2, Merry A2, Jones P2 1University of Auckland, Auckland, AUK, New Zealand, 2University of Auckland, Auckland, New Zealand","locationCode":"117","description":"\r\n\t<div>OBJECTIVES: We aimed to determine the rate of new persistent opioid use in New Zealand (NZ) after trauma 1st January 2007 to 31st December 2019. METHODS: This was a retrospective population-based study. We included patients of any age who were admitted with trauma to any NZ hospital. Patients were excluded if they were not dispensed opioids after discharge, had prior history of opioid use, or diagnosed with opioid misuse. Patients who died or had recurrent trauma during follow up were also excluded. All patients were followed for 365 days. The primary outcome was the rate and predictors of persistent opioid use, defined as dispensing of any opioids after discharge within seven days and an additional dispensing of opioids between 91-365 days. Predictors were assessed using multivariable regression analysis. RESULTS: 177,200 individuals were dispensed opioids on discharge; of these the rate of persistent opioid use was 15.3% (n=27,060). Significant predictors included switching of opioid type (adjusted odds ratio (aOR)=2.62; 95% confidence interval (CI) 2.51-2.73), higher comorbidity burden, pre-trauma non-opioid analgesics use (aOR=1.59; 95% CI 1.55-1.64), smoking (1.42; 95% CI 1.33-1.51), pre-trauma hypnotic use (aOR=1.33; 95% CI 1.27-1.39), dispensed slow-release opioid preparation post-trauma (aOR=1.32; 95% CI 1.26-1.39), older age, female sex (aOR=1.12; 95% CI 1.09-1.15), length of stay >1 day (aOR=1.10; 95% CI 1.06-1.14), site of trauma, and opioid type. Conversely, patients who underwent surgery was negatively associated with persistent opioid use (aOR=0.88; 95% CI 0.85-0.91). CONCLUSIONS: One in seven opioid naïve patients who were acutely exposed to opioids after trauma became persistent users. Our findings suggest irrespective of site of trauma there are factors that may minimize risk of persistent opioid use. We recommend avoiding the use of slow-release opioid preparations on discharge from hospital after trauma if an opioid is deemed necessary and avoid unnecessary switching of opioids thereafter.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gongpostertrauma123974-pdf.pdf?sfvrsn=f89156df_0","title":"ISPOR23_Gong_PosterTrauma123974.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/2021persistent-opioid-and-opioid-related-harm-research-protocol123974-pdf.pdf?sfvrsn=6ca26fa_0","title":"2021_Persistent opioid and opioid related harm-Research Protocol123974.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123974","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Race and Social Determinants of Health Data Inform Blue Cross and Blue Shield of Louisiana’s Understanding of Its Medicare Advantage Members","id":"f7cd2a48-422a-4ac4-ae88-ca33cf3ffc47","sessionCode":"OP2","topDisplay":"Kippers J1, Mousavian M2, Palanki S2, Zhang H2, Lanata N2, Zhang Y2, Vicidomina B2, Nigam S2 1Blue Cross Blue Shield of Louisiana, BATON ROUGE, LA, USA, 2Blue Cross Blue Shield of Louisiana, Baton Rouge, LA, USA","locationCode":"714","description":"\r\n\t<div>OBJECTIVES: Blue Cross and Blue Shield of Louisiana (BCBSLA) is using race and Social Determinants of Health (SDOH) data for the first time to help understand its members and potential inequities. For BCBSLA Medicare Advantage (MA) members, 98% of the population has self-identified with one or more race categories, as the U.S. Centers for Medicare & Medicaid Services (CMS) sets. This information will help BCBSLA enhance intervention programs and address potential health disparities to improve members’ health and wellness. METHODS: For this analysis, MA members were eligible if enrolled in calendar year 2021. Race data were collected from CMS enrollment files. SDOH variables were collected from claims data and publicly available data sources. Descriptive analyses focused on the intersection between race and SDOH variables, race groups’ interactions with healthcare systems, race groups’ engagement with Case Management and Disease Management (CM/DM) programs and outcomes for select conditions. RESULTS: For eligible members, the population distribution was White (81%), Black/African American (17%), and Others (2%). Black/African American members tend to live in areas with economic, transportation and food access challenges. White members had a higher rate of specialist visits. Black/African American members had more emergency department visits and more preventive services. Black/African American members had a higher prevalence of diabetes and hypertension. Among members with diabetes and hypertension, Black/African American members were referred to and engaged with CM/DM programs at a higher rate than White members. Black/African American members had higher A1C testing rates but lower hypertension medication adherence rates compared to White members. CONCLUSIONS: Early descriptive analysis using race and SDOH data clearly indicates disparities in health conditions and CM/DM programs. This analysis will help BCBSLA improve outcomes for MA members in different race groups and with various socioeconomic challenges.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"bb8fd992-de86-4d1a-8bec-f6e2c928db96","parentId":"00000000-0000-0000-0000-000000000000","title":"Organizational Practices","urlName":"organizational-practices"}],"categoryIds":["bb8fd992-de86-4d1a-8bec-f6e2c928db96"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-poster-ma-sdohbcbslafinal-1127457-pdf.pdf?sfvrsn=f377572c_0","title":"ISPOR Poster MA SDOH_BCBSLA_Final (1)127457.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127457","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Minimally Invasive Surfactant Treatment Versus Standard Therapy in Preterm Infants at Birth (OPTIMIST-A TRIAL): An Analysis of Initial Hospitalisation Costs and Resource Consumption","id":"dcf25efa-eb1c-4355-ba22-ca4fef50e1dc","sessionCode":"EE56","topDisplay":"Cox I1, de Graaff B1, Otahal P1, Kamlin O2, Orsini F3, De Paoli A4, Clark H5, Soll R6, Carlin J7, Davis P7, Dargaville P4, Palmer AJ1 1Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia, 2Royal Women’s Hospital, Melbourne, VIC, Australia, 3Murdoch Childrens Research Institute, Parkville, VIC, Australia, 4Royal Hobart Hospital, Hobart, TAS, Australia, 5Princess Anne Hospital, Southampton, UK, 6University of Vermont, Burlington, VT, USA, 7University of Melbourne, Melbourne, VIC, Australia","locationCode":"303","description":"\r\n\t<div>OBJECTIVES: To compare the per capita costs of initial hospitalisation in infants receiving minimally invasive surfactant therapy (MIST) or standard treatment (ST) using data from a multicentre blinded parallel group RCT (OPTIMIST-A trial, JAMA 2021, 326:2478). METHODS: Preterm infants 25-28 weeks’ gestation requiring continuous positive air pressure (CPAP) were randomised at less than 6 hrs to MIST (200 mg/kg poractant alfa delivered with a thin catheter) or ST (continuation of CPAP, intubation, and surfactant as necessary). For this analysis, site specific cost attributes were combined with patient-level data but given the variations in costs and annual inflation across sites, these were standardised to Australian tariffs. Generalised linear models (GLM) with gamma and log link functions were used to estimate per capita costs, incremental costs (IC) and cost ratios (CR) between MIST and ST groups, and to assess infant-associated factors that influence costs. All costs were converted to 2021 United States dollars (USD). RESULTS: 417 infants from 9 countries contributed data to this analysis. For infants alive at 36 weeks (MIST=185, ST=191, total=376), mean total per capita costs (95% confidence interval) were $78,858 ($70,828; $86,889) and $88,003 ($80,209; $95,797) for the MIST and ST groups respectively with IC and CR of 9,536 (1,580;17,210) and 1.12 (1.01, 1.28) respectively, favouring MIST. ICs and CRs favoured MIST for all cost categories, except for surfactant costs which favoured the ST group, and hotel costs which did not differ. Similar trends were observed for resource utilisation. Nursing and physician costs represented the highest cost categories. Multivariable GLM regression analysis demonstrated an increased cost ratio (ST/MIST) for infants <27 weeks’ gestation and those with BW <10th centile. CONCLUSIONS: In preterm infants with RDS supported with CPAP, selective application of MIST in the first 6 hours was associated with a considerable reduction in costs of initial hospitalisation and resource consumption.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/optimist-conference-poster-final124433-pdf.pdf?sfvrsn=26d5d238_0","title":"OPTIMIST conference poster final124433.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124433","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Societal Cost of Racial Disparities in Pneumococcal Disease in U.S. Adults Aged 50 Years or Older","id":"f45ff651-8c80-458e-9ddc-cb348bc7ffa8","sessionCode":"EE17","topDisplay":"Altawalbeh S1, Wateska A1, Nowalk M1, Lin C2, Zimmerman R1, Smith K1 1University of Pittsburgh, Pittsburgh, PA, USA, 2The Ohio State University, Columbus, OH, USA","locationCode":"221","description":"\r\n\t<div>OBJECTIVES: Racial health disparities in pneumococcal disease (PD) exist, with greater disease risk and lower vaccination rates in U.S. Black adults. Disparities affect both PD direct costs and longer-term costs of disability and premature mortality. Estimating societal costs of pneumococcal disease disparities in Black adults could inform mitigation of those disparities. METHODS: The societal cost of PD disparities in U.S. Black adults aged ≥50 years was estimated using 1) direct medical costs plus indirect costs from acute illness due to invasive pneumococcal disease (IPD) and hospitalized nonbacteremic pneumococcal pneumonia (NBP), 2) direct and indirect costs due to PD-related disability, and 3) indirect costs due to PD-related mortality. The societal cost of racial disparities was calculated using differences in average per person PD costs between Black and non-Black adults aged ≥50 years multiplied by the Black population aged ≥50 years. Cost year was 2019, with future costs discounted 3%/year. One-way sensitivity analyses were conducted. RESULTS: Total direct and indirect costs per IPD case were $186,791 in Black populations and $182,689 in non-Blacks; total hospitalized NBP costs per case were $100,632 (Black) and $96,781 (non-Black). The difference in population average per person costs between Black and non-Black adults (product of total costs and population-specific disease risk) was $24.20 for IPD and $23.65 for hospitalized NBP. Societal cost of racial disparities for IPD was $340.5 million and for NBP was $332.7 million, totaling $673.2 million for Black adults aged ≥50 years. Disability rates, disease rates, life expectancy and case-fatality rates were influential in one-way sensitivity analyses. However, the lowest disparities cost across all sensitivity analyses was $472.3 million. CONCLUSIONS: US societal costs of racial pneumococcal disease disparities in persons aged ≥50 years are substantial. Pneumococcal vaccination policy and programmatic interventions to mitigate these disparities should be considered.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23altawalbehposter127088-pdf.pdf?sfvrsn=58743ef4_0","title":"ISPOR23_Altawalbeh_POSTER127088.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127088","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Identifying Factors Underlying Variation in the Cost of Acetabular Labral Repair or Debridement during Hip Arthroscopy: A Time-Driven Activity-Based Costing Analysis","id":"47b8b547-2455-4e60-99e0-cd09a0010d70","sessionCode":"EE28","topDisplay":"Dean M1, Etges AP2, Cherian NJ3, Dowley K4, LaPorte ZL3, Torabian K3, Eberlin C5, Best MJ6, Martin SD3 1Massachusetts General Hospital, Cambridge, MA, USA, 2Avant-garde Health, Boston, MA, USA, 3Massachusetts General Hospital, Boston, MA, USA, 4Massachusetts General Hospital, South Boston, MA, USA, 5Massachusetts General Hospital, PEORIA, IL, USA, 6Johns Hopkins University School of Medicine, Baltimore, MD, USA","locationCode":"","description":"\r\n\t<div>OBJECTIVES: Leveraging time-driven activity-based costing (TDABC), this study aims to (1) quantify the cost of arthroscopic acetabular labral repair or debridement and (2) explore variation in costs based on patient-specific characteristics, operative techniques employed, and surgical settings. METHODS: Using TDABC, we calculated the cost of care for 890 patients undergoing hip arthroscopy by five surgeons at four surgery centers within a single institution from 2015-2022. Costs were normalized to protect confidentiality. Multivariable linear mixed-effects models were utilized to identify factors underlying variation in costs. RESULTS: The normalized total cost of arthroscopic acetabular labral repair or debridement ranged from 43.4 to 203.7 (mean ± standard deviation: 100 ± 24.2), with a 1.8-fold variation in costs between patients in the 10th and 90th percentile. On average, supply costs accounted for 48.8% of total costs, while labor costs comprised the remaining 51.2%. Higher costs were significantly associated with male gender (3.9-point increase, p<0.001), labral repair relative to debridement (22.4-point increase, p<0.001), and operative year (0.62-point increase per year, p=0.023). Additionally, significant variations in cost were found in relation to osteoplasty type, treatment of cartilage lesions, provider team, and capsular management (p<0.001 for all). Age, body mass index, and American Society of Anesthesiologists score were not independently associated with costs. A mixed-effects model incorporating these factors as fixed effects and the surgeon and surgery center as random effects explained 88.7% of the observed cost variation; 81.7% of this explanatory power was derived from the surgeon and surgery center. CONCLUSIONS: Variation in the cost of outpatient hip arthroscopy was primarily explained by surgeon and surgery center. Case-specific characteristics were also significantly associated with costs, while patient demographics contributed minimal variability. These insights may support physicians, payers, and other stakeholders to contain costs, implement bundled reimbursement structures, and deliver higher-value care.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126828","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Medicare Part B Spending on Biologics Due to Inadequate Biosimilar Uptake","id":"cab8a170-f665-477c-bea7-cea5a1b1cc62","sessionCode":"HPR13","topDisplay":"Raymakers A1, Feldman WB1, Kesselheim AS2, Rome B1 1Harvard Medical School, Boston, MA, USA, 2Harvard University, Boston, MA, USA","locationCode":"516","description":"\r\n\t<div>OBJECTIVES: Biologics represent a rapidly growing portion of Medicare drug spending. To lower prices, the United States (US) Congress created a Food and Drug Administration (FDA) approval pathway for biosimilars, which are versions of biologics that are made by competing manufacturers. However, biosimilar uptake has been slow after expiration of the market exclusivity on the original biologic. We sought to estimate Medicare Part B savings in 2020 had biologics with available biosimilars been reimbursed at comparable prices. METHODS: In this cross-sectional study, we used public Medicare Part B drug prescribing data from 2020 to extract claims, spending, and spending per claim (price) for all FDA-approved biosimilars and their reference products. We estimated the savings to Medicare if each originator biologic would have been reimbursed at the lower price of its available biosimilar versions. RESULTS: Eighteen biosimilars associated with 7 originator biologics were reimbursed by Medicare Part B in 2020. Claims were 3.8 times higher for biologics (2,402,270 claims) than biosimilars (685,063 claims). Total expenditure on biologics ($5.2 billion) was higher than for biosimilars ($1.3 billion). Spending per claim was lower for the biosimilar in all cases except one (bevacizumab). Excluding bevacizumab, the average reduction in spending per claim was 18% if the lowest-priced biosimilar had been prescribed. If all claims were reimbursed at the lowest biosimilar prices, Medicare would have saved $596 million in 2020. Substituting 25% of biologics for their associated biosimilar would result in savings of $150 million. CONCLUSIONS: Even with less expensive biosimilars available, Medicare use and spending on originator biologics remains high. Medicare could achieve substantial savings by reimbursing a single price for biologics and their biosimilars, similar to how Part B reimburses generic small molecule drugs. Increasing biosimilar uptake, for example, by better educating patients and providers about their safety and effectiveness, could also reduce overspending on expensive biologics.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127593","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Nonpharmaceutical Interventions Combined with Inactivated Vaccination and Oral Medicine in China","id":"0649f877-3685-47de-97bf-cec0172e0be0","sessionCode":"EE19","topDisplay":"Fu Y1, Zhao J1, Wei X2, Han P1, Yang L3, Ren T1, Zhan S1, Li L1 1Peking University, BEIJING, China, 2London School of Hygiene & Tropical Medicine, London, UK, 3Peking University, Beijing, 11, China","locationCode":"222","description":"\r\n\t<div>OBJECTIVES: Various interventions were used to control the COVID-19 pandemic and protect population health, including vaccination, medication and nonpharmaceutical interventions (NPIs). This study aims to examine the cost-effectiveness of different combinations of NPIs (including social distancing, mask wearing, tracing-testing-isolation, mass testing, and lockdown), oral medicine (Paxlovid), and vaccination (including two-dose and three-dose vaccination) under the Delta and Omicron pandemic in China. METHODS: We constructed a Markov model using a SIRI structure with a one-week cycle length over one-year time horizon to estimate the cost-effectiveness of different combinations in China from societal perspective. Effectiveness of interventions, disease transition probabilities and costs were from published data, quality-adjusted life years (QALYs) gained and incremental cost-effectiveness ratios (ICER) and net monetary benefits were calculated for one-year time horizon. One-way and probabilistic sensitivity analyses were performed to test the robustness of the model. Scenario analysis was developed to examine different situations under the Omicron pandemic. RESULTS: Under the Delta pandemic, implementing the combination of social distancing, mask wearing, mass testing and three-dose vaccination was the optimal strategy, with cost at $11165635.33 and utility of 94309.94 QALYs, and had 60% probability of being cost-effective compared with other strategies. Three-dose vaccination combinations were better than two-dose combinations. Under the Omicron pandemic, antigen testing was better than nucleic testing by avoiding cross infections; second, adding Paxlovid or lockdown to the combined intervention strategies could increase limited health outcomes at huge cost and thus were not cost-effective; last, encouraging patients to stay at home can save societal costs compared with concentrated quarantine at hospitals. CONCLUSIONS: Three-dose vaccination and self-quarantine of asymptomatic and mild cases can save total costs. Under the Omicron pandemic outbreak, antigen testing is a better way to control the pandemic, and adding Paxlovid or lockdown to intervention combinations is not cost-effective.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23fuposteree19124301-pdf.pdf?sfvrsn=82006da0_0","title":"ISPOR23_Fu_POSTER_EE19124301.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124301","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Changes of Prescription Patterns after Providing Therapeutic Duplication Dur(DRUG UTILIZATION REVIEW) Information in Outpatient Veterans at Vhs Medical Center","id":"6515d745-f2e6-4c49-8de4-cf0361460e28","sessionCode":"HSD20","topDisplay":"Kim J1, Lim J2, Kim N2, Baek S2, Jeong H2 1VHS medical center, Seoul, South Korea, 2VHS medical center, Seoul, Korea, Republic of (South)","locationCode":"604","description":"\r\n\t<div>OBJECTIVES: Therapeutic duplication (TD) information is one of the drug utilization review (DUR) system provided by Health Insurance Review and Assessment Service (HIRA). TD provides information about duplicated agents in same therapeutic group used together in one patient over the same period. It cannot expect any additional medical effect and the risk of adverse effects could be increased. We figure out the changes in TD prescribing pattern through DUR in VHS medical center. METHODS: We used electronic medical record(EMR) database from March to August 2020 and 2021. Study subjects were the veterans who were prescribed at the outpatient pharmacy in the hospital. Study drugs were selected 20 analgesic drugs, 8 dyslipidemia drugs, 39 anti-hypertension drugs, 4 sedative hypnotic drugs, 4 opioid drugs, 39 psychiatric drugs, 26 respiratory drugs of TD information by referring reimbursement drugs list of HIRA. We calculated frequency of TD prescription by variable such as specialty and efficacy. By utilizing evaluation indexes, we checked change patterns during study period and conducted paired t-test. RESULTS: The TD rate in 2020 is 0.92% and the TD rate in 2021 is 1.05%. The absolute rate of change is 0.12, indicating that the TD rate in 2021 increased compared to 2020. But the p-value was 0.25, which was not statistically significant. The specialties with decrease in TD rate in 2021 were neuropsychiatry, hemato-oncology, cardiothoracic surgery, otolaryngology, endocrinology, gastroenterology, urology, neurology, dental clinic. However, the p-value was greater than 0.05. Also, the efficacy group with the decrease in TD rate in 2021 was sedative hypnotic drugs and psychiatric drugs. Among them, the p-value of the psychiatric drugs was 0.01 and it decreased statistically significantly. CONCLUSIONS: To enhance the influence of TD information effectively, it is necessary to strengthen prescription monitoring for frequent TD drugs and to simplify the conditions for providing alert on DUR system.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kimposterv2123310-pdf.pdf?sfvrsn=8a94cd72_0","title":"ISPOR23_Kim_POSTERV2123310.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123310","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evolution of Polypharmacy and Prescribed Drug Expenditure: The Case of an Insured Poor Population in the Colombian Caribbean during 2018-2021","id":"16432a84-881f-4760-b53f-d02dfd2034c2","sessionCode":"EPH48","topDisplay":"Gamero K1, Alvis J2, Fernandez Mercado JC3, Paz Wilches J4, Alvis Guzman N5 1Distribuciones Pharmaser, Cali, VAC, Colombia, 2Distribuciones Pharmaser, Cartagena, BOL, Colombia, 3MUTUALSER EPS - University of Cartagena - Clínica Crecer, Cali, VAC, Colombia, 4Mutual SER EPS, Cartagena, Colombia, 5ALZAK Foundation- Universidad De La Costa, Barranquilla, Colombia","locationCode":"501","description":"\r\n\t<div>OBJECTIVES: The aim of this study is to estimate the impact of the variation in the prevalence of polypharmacy rate in the prescribed drug expenditure (PDE). during 2018-2021. METHODS: Cross sectional descriptive study of polymedicated patients (PP) during 2018-2021 was developed. Data was extracted from the individual outpatient dispense records from a health insurance company in Colombia. Polypharmacy and hypermedication were defined when patients consumed ≥5 and ≥10 medications in at least a continuous period. The number of patients attended, the number of medications per patient, defined daily doses (DDD) per patient (TI) and cost per DDD are calculated. Finally, a simulation of PDE of 2021 is developed in which the prevalence of polypharmacy is neutralized between 2018 and 2021 and keep the other variables constant. RESULTS: Polypharmacy rate was 26,82% in 2018 and 31,17% in 2021. The PDE in 2015 constant US$ dollars for PP increased from $653,240 to $1,605,527. Neutralizing the prevalence of polypharmacy, the PDE of 2021 was $1,372,664, 110% higher than the PDE of 2018 due to the cost per DDD increased from $0.028 to $0.048, despite TI decreased from 333 to 286 but, lower than 2021 PDE because 2018 polypharmacy is lower. CONCLUSIONS: Polypharmacy has had a significant impact on the increase in PDE of the insurance company because in 2021 the cost per DDD increased as a consequence of the prescription of more expensive health technologies. The design of interventions and strict protocols need to be developed to mitigate the risk of non rational prescriptions in polymedicated patients and controlling the evolution of PDE.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23gameroposter126556-pdf.pdf?sfvrsn=fec74fc3_0","title":"ISPOR23_GAMERO_POSTER126556.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126556","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Prescribing Behavior Among Community Oncologists for Generics/Biosimilars While Considering Costs or Financial Toxicity When Treating Cancer","id":"8dc346f9-982b-4544-8429-d09062163b52","sessionCode":"HSD7","topDisplay":"Miller T1, Savill K2, Brown M1, Jeune-Smith Y1, Feinberg B3 1Cardinal Health Specialty Solutions, Dublin, OH, USA, 2Cardinal Health Specialty Solutions, EL DORADO HILLS, CA, CA, USA, 3Cardinal Health, Dublin, OH, USA","locationCode":"545","description":"\r\n\t<div>OBJECTIVES: Patient out-of-pocket cancer treatment costs can be considerable in the United States (U.S.) resulting in the recently described adverse event, financial toxicity (FT). FT is the adverse impact of a cancer diagnosis or treatment on a patient’s financial well-being due to the treatment cost, travel time, and/or employment status. In the recent PRO-TECT trial, which assessed FT screening in oncology practice, found that routine screening along with communication of concerns to the clinical team resulted in patient benefits (e.g., prevented increased FT). Biosimilar drugs may reduce total cost of care and FT. In October 2022, the Inflation Reduction Act increased Medicare payment to physicians for qualifying biosimilar infusions, thus incentivizing consideration where appropriate. We conducted research to understand physician perceptions around FT and the role biosimilars may play in its reduction. METHODS: Survey questions were administered to U.S. community oncologists at an in-person summit in November 2022. Results are analyzed with descriptive statistics. Not all summit attendees responded to every survey question. RESULTS: Respondents (N=56) reported their primary specialty as hematology oncology (61%) or medical oncology (39%) and had an average of 20 years in practice. Less than half of respondents (40%, 21/53) stated they measure FT in their practice. Predominate barriers (N=51) to financial/cost-related conversations with patients were lack of time (59%) and lack of resources (37%). However, patient out-of-pocket cost (61%, 33/54)) was one of the top non-clinical factors in treatment decisions, with a majority of respondents (75%, 39/52) “very likely” to prescribe a generic/biosimilar over brand drug/biologic. CONCLUSIONS: While increased screening and communication around FT may benefit patients, it is evident that treating physicians have continued barriers to implementation. Oncologists are aware of costs and patient FT when creating treatment plans, specifically when considering prescribing biosimilars.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporfintoxhsd7final127442-pdf.pdf?sfvrsn=462df236_0","title":"ISPOR_FinTox_HSD7_FINAL127442.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127442","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Trends in Mortality Related to Hepatitis C in Colombia 1997 – 2020","id":"6dd09ab6-8864-4d7f-8ec8-d1aa0955e031","sessionCode":"EPH13","topDisplay":"Alvis-Guzman N1, Alvis Zakzuk J2, Salcedo Mejía F3, Paternina-Caicedo A2, Navas MC4, Yepes Barreto IDJ5, De La Hoz F6 1Universidad de Cartagena - Universidad de la Costa, Cartagena, Colombia, 2Universidad de Cartagena - ALZAK Foundation, Cartagena, Colombia, 3ALZAK Foundation, Grupo de Investigación ALZAK, Cartagena, BOL, Colombia, 4Universidad de Antioquia, Medellin, Colombia, 5Gastropack, University of Cartagena, CARTAGENA DE INDIAS, Colombia, 6Universidad Nacional de Colombia, Bogota, Colombia","locationCode":"416","description":"\r\n\t<div>OBJECTIVES: To describe mortality trends related to hepatitis C virus (HCV) infection in Colombia 1997–2000 METHODS: Descriptive study using vital registration. 24 ICD-10 codes related to HCV were used. The distribution of causes by age, sex and year was estimated. Proportional mortality, rates (x100,000) and years of life lost were estimated during the period. Data was obtained from the national agency for population statistics – known as DANE for its initials in Spanish RESULTS: In 1997-2020 there were 79,193 (1.6% of the total) related to HCV. 53.8% in men and 80.7% in those over 54 years of age (78.2% men and 83.4% women). The mean age of death was 65.7 years (SD: 8.3) [67.1 (SD: 8.4) in women and 64.6 (SD: 8.3) in men]. 67.2% of deaths from HCV-related causes were born before 1947, 26.3% between 1947 and 1966, and 6.5% after 1966. In other causes, these proportions were 58.6%, 18.9%, and 22 ,5%. The mean age of death from other causes in women was 64.1 years (SD: 23.3) and in men 56.2 years (SD: 24.9). The 79,193 deaths produced 1,543,154 YLL, 52.9% in women. The YLL rates (x100,000) between 1997 and 2000 were 698.3 (men) and 576.0 (women) and rose to 735.7 (men) and 662.8 (women) between 2016 and 2020. Mortality from cirrhosis and liver carcinoma was 1.25 and 1.10 times higher in men in the last decade, respectively. CONCLUSIONS: Mortality rates were relatively stable during the period and like those estimated by The Institute for Health Metrics and Evaluation (IHME) </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124253","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness Analysis of Nivolumab Plus Ipilimumab (NIVO+IPI) Versus Pembrolizumab Plus Axitinib (PEM+AXI) for the First-Line Treatment of Intermediate- and Poor (I/P)-Risk Advanced Renal Cell Carcinoma Patients in Colombia","id":"81583d74-6a3b-4c4a-b9af-d1c9eb194bdc","sessionCode":"EE81","topDisplay":"Dhanji N1, Van De Wetering G2, Guiot V3, Barco V4, Mejia A5, May JR6, Garcia J7, Dyer M6 1OPEN Health, Oxford, UK, 2OPEN Health, Rotterdam, Netherlands, 3Bristol Myers Squibb, Bogota, CUN, Colombia, 4Bristol Myers Squibb, Cali-Valle, Colombia, 5Bristol Myers Squibb, Bogota, Colombia, 6Bristol Myers Squibb, Uxbridge, UK, 7Bristol Myers Squibb, Princeton, NJ, USA","locationCode":"325","description":"\r\n\t<div>OBJECTIVES: Immuno-oncology (IO) combination NIVO+IPI and IO+tyrosine kinase inhibitor combination (PEM+AXI) therapies have demonstrated significant clinical benefits over sunitinib in the first-line (1L) treatment of I/P-risk advanced renal cell carcinoma (aRCC). We examined the cost-effectiveness of NIVO+IPI versus PEM+AXI for this from a Colombian payer perspective, utilizing a novel approach to estimate comparative efficacy between the treatments. METHODS: A three-state partitioned survival model (progression-free, progressed, and death) was developed to estimate costs, life-years (LYs), quality-adjusted LYs (QALYs), and the incremental cost-utility ratio (ICUR) over a 40-year time horizon. Due to the lack of head-to-head clinical evidence between NIVO+IPI and PEM+AXI, a matching-adjusted indirect comparison that accounted for any imbalance in observed treatment effect modifiers was performed. To extrapolate outcomes over a lifetime horizon, a range of parametric survival curves were fitted to the adjusted Kaplan-Meier survival data, which accounted for non-proportional hazards over time. The model used baseline patient characteristics (age, sex, background mortality) from Colombian literature. In the absence of Colombian EQ-5D-3L tariffs, utilities (EQ-5D-3L) were taken from CheckMate 214 and calculated using the Argentinian value set. All costs (2022 COL$) were Colombian-specific where available. Costs and health outcomes were both discounted by 5% annually in line with IETS guidelines. Robustness of the results was evaluated through extensive sensitivity analysis and scenario analyses. RESULTS: NIVO+IPI was associated with cost savings (COL$ 294,303,933), higher LYs (4.70 vs 4.25) and QALYs (4.08 vs 3.54) versus PEM+AXI, resulting in NIVO+IPI dominating PEM+AXI. Key model drivers were the treatment duration for PEM, NIVO and AXI. NIVO+IPI remained dominant in all scenario analyses, which indicated that model results were robust to alternative modelling inputs or assumptions. CONCLUSIONS: This analysis shows that NIVO+IPI is estimated to be a life-extending and potentially cost-saving 1L treatment option when compared with PEM+AXI for I/P risk aRCC patients in Colombia.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/finalbmscolombiarccispor24042023oh125061-pdf.pdf?sfvrsn=12db1334_0","title":"FINAL_BMS_Colombia_RCC_ISPOR_24_04_2023_OH125061.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125061","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient Characteristics and Social Determinants of Health in a Large Real-World Cohort of Vitiligo Patients in the U.S.","id":"07054ae7-5ed8-49ad-888b-d29aa22b4a99","sessionCode":"RWD28","topDisplay":"Weiss S1, Elyze M2, Starzyk K2 1OM1, Inc., Boston, MA, USA, 2OM1, Inc, Boston, MA, USA","locationCode":"836","description":"\r\n\t<div>OBJECTIVES: Vitiligo, an autoimmune dermatologic condition characterized by the selective loss of melanocytes and pigment dilution, typically in the face and acral regions, can have a substantial impact on quality of life. With the introduction of novel therapies to treat vitiligo, a better understanding of patients and their management is needed. METHODS: Data were derived from the OM1 Dermatology Network (OM1, Inc; Boston, MA), a multi-source, real-world data (RWD) network with linked healthcare claims, social determinants of health (SDoH), and electronic medical records data for U.S. patients managed by dermatologists. Index date was set by the first encounter with a vitiligo diagnosis code during the study period (01/2013 - 12/2022). Patient demographics, insurance type, education, and household income were assessed at index. Major depressive disorder (MDD) and generalized anxiety disorder (GAD) were defined by the presence of at least 2 outpatient diagnosis codes ≥30 days apart or one inpatient diagnosis code. Medications were identified by prescriptions, administrations and/or fills and procedures by procedure codes. RESULTS: The study included 26,016 patients (57% female, mean age at index 45 years), 12,859 (49%) of whom had linked SDoH. Of the 77% with race available, the breakdown was 78% white, 11% black, 6% asian and 5% other. MDD and GAD were diagnosed in 5.1% and 9.1% of patients, respectively. Most common treatments were corticosteroids (48%), topical tacrolimus (29%), topical pimecrolimus (21%), UVB phototherapy (17%), excimer laser (10%), minocycline (4%) and topical ruxolitinib (2%). Trends in management over time and in patient subsets were also explored. CONCLUSIONS: Vitiligo is a serious, chronic condition for which novel, targeted therapies are just beginning to emerge. RWD can help illuminate the unmet clinical need and track effective patient management.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/om1-vitiligo-ispor2023-final127263-pdf.pdf?sfvrsn=96453a9_0","title":"OM1 Vitiligo ISPOR2023 final127263.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127263","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"HIT Where It Hurts: Healthcare Access and Intimatepartner Violence","id":"7a53838e-ebee-4cde-b519-d2a399a0733f","sessionCode":"HPR11","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"514","description":"\r\n\t<div>OBJECTIVES: This paper investigates the causal link between healthcare access and the help-seeking behavior of intimate partner violence (IPV) victims. Healthcare access can be an important entry point for screening or detecting IPV. Doctors are required by law to report any injuries to a judge if they suspect they are the result of a crime and can inform and direct victims to IPV services. METHODS: We exploit the 2012 reform in Spain that removed access to the public healthcare system for undocumented immigrants. We use court reports and protection order requests from the Judicial Branch of the Spanish government to perform a difference-in-differences approach, comparing the help-seeking behavior of foreign and Spanish women before and after the reform. RESULTS: We find that the impact of the reform was immediate; foreign women’s IPV reporting and application for protection orders decreased by 12%. This effect is entirely driven by regions with stronger enforcement of the reform. We show suggestive evidence that the reform left the underlying levels of IPV incidence unaffected. Instead, the results are driven by a reduction in injury reports by medical centers. CONCLUSIONS: Our findings are important given the increase in migration flows globally as well as for current debates on granting/limiting access to healthcare for marginalized groups.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124924","diseases":[{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Fast-Tracking Literature Search for HTAs Using Open Source Tools: Experiences from a Multidimensional Systematic Review on Telemedicine in Secondary Healthcare","id":"2b00e2fb-45b3-4546-bce5-d342fefe4a26","sessionCode":"HTA21","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"620","description":"\r\n\t<div>One of the crucial steps of a health technology assessment (HTA) is conducting a thorough literature review. OBJECTIVES: To use reproducible methods in examining the existing literature on the health benefits, non-health benefits and, patient satisfaction for those seeking specialist care through telemedicine compared to the routine care pathway. To fast track and semi automate the process of literature reviews for HTAs METHODS: The protocol was registered with PROSPERO (CRD42021282042). Four databases were explored to conduct a naïve search using tailored keywords and MeSH terms identified within each PICO component. The naïve search results (*.bib, *.txt) were then imported into R (version 4.1) for merging, identification and review of duplicates using systhesisr package. A keyword co-occurrence network was created and Boolean search strings were generated. This was done using the litsearchr package. Functions from the metagear package were used distribute the efforts among three independent reviewers and screen the abstracts using a graphical user interface. Full papers of the selected abstracts were downloaded using the metagear::PDFs_collect() function. Subsequently, zoteror package was used to skim read the full text and organise the reference database. RESULTS: Out of 5032 articles, total of 19 articles were included in the review. The majority of the articles explored the benefits of telemedicine in secondary care through economic analyses or disease outcomes but only a few studies explored the use of telemedicine for secondary care in LMICs, and the majority were from HICs. CONCLUSIONS: This study demonstrates the utility of reproducible methods in conducting a literature review which is an essential step in conducting an HTA. This has the potential in reducing the time and manual effort required for conducting a traditional systematic review. The results show the effectiveness of specialist or secondary care through telemedicine services, this potential could be explored to bridge the healthcare equity gaps further.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123554","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Emerging Role of Real-World Evidence in Health Technology Assessments in Canada","id":"4f0056f0-d4ad-4786-990f-d4b4abb86f45","sessionCode":"HTA14","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"625","description":"\r\n\t<div>OBJECTIVES: Health technology assessment (HTA) bodies across Canada (provincial HTA authorities and/or the Canadian Agency for Drugs and Technologies in Health [CADTH]) have been considering real-world evidence (RWE) in their appraisal processes; however, there is a scarcity of information on the extent to which it is used. We aimed to evaluate the use of RWE by Canadian HTAs over the past 10 years in reimbursement decision-making. METHODS: Reports published by various HTA bodies in Canada from January 2013 to December 2022 (both inclusive) were extracted using IQVIATM’s proprietary platform database, “HTA Accelerator.” Data from these HTA reports comprising single or multiple drugs, medical devices, and procedural/interventional assessments were quantified to evaluate RWE usage, RWE data source type, outcomes supported, and the acceptability of RWE by HTA bodies. RESULTS: We identified 2,813 published HTA reports, of which 252 (9.0%) comprised RWE. There has been an almost 15-fold increase in RWE usage in HTA reports from 2013 (1.9%) to 2022 (27.8%), and RWE has been most often included for therapeutic indications such as oncology (36.7%), mental/behavioral and cardiovascular disorders (10.2% each). In terms of data sources, RWE was primarily derived from retrospective cohort studies (33.3%), followed by administrative data (17.3%) and prospective cohort studies (10.7%). The major outcomes supported by RWE were effectiveness (63.5%) and safety (32.4%). Of note, in 46.2% of instances, HTA bodies accepted (fully/partially) RWE as supporting evidence for outcomes. CONCLUSIONS: In Canada, there has been an increasing trend in RWE usage, and with ongoing initiatives by Health Canada and CADTH, overall RWE usage is foreseen to increase. To further facilitate and enhance clinical decision-making, augmenting RWE is necessary. Real-world studies complementing traditional randomized clinical trials are thus warranted.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126555","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Determining Patient-Reported Outcomes Fit-for-Purpose By Cross-Linking Regulatory Perspective and Descriptive Information in Interconnected Databases","id":"da60e8eb-4d36-40ae-849b-d5394c1f56f9","sessionCode":"CO46","topDisplay":"Kraft NG, Manus MC, Desvignes-Gleizes C, Bothorel S, Sherafat R Mapi Research Trust, Lyon, 69, France","locationCode":"145","description":"\r\n\t<div>OBJECTIVES: Patient-Reported Outcomes (PROs) are one out of four types of Clinical Outcome Assessments (COAs) – along with observer, clinician and performance outcomes – that can be used alone or as composite measures to reflect patients’ subjective symptoms and the impact of a disease and/or treatment on their quality of life. For several years, health authorities have been advocating for the use of PROs to strengthen the value demonstration of new treatments on efficacy and cost-effectiveness. However, selecting PROs that are fit-for-purpose remains challenging. We aim at facilitating the identification of appropriate PROs to design a suitable endpoint strategy. METHODS: Selection of PROs for clinical trials depends on multiple parameters, including health authorities’ requirements, trial design, population of interest, targeted disease concepts and psychometric performance of PROs. We will demonstrate how a sequential analysis, though interlinked databases, could support identifying the most appropriate PROs. RESULTS: Our team has integrated information on PROs in three databases for a streamlined selection process. The first database describes 250+ guidelines, released by health technology assessment authorities and regulatory agencies, on properties that endpoint measurement tools should meet. The second database refines the search to 1,950+ drugs or devices with COA labelling claims granted by FDA and EMA. This reflects competitors’ claims landscape and PRO success stories in the drug approval process. Finally, the third database reports descriptive information on more than 4200+ PROs including the type of COA, domains, number of items, patient population, development, and validation data, time for completion, conditions of use, and available languages. CONCLUSIONS: Navigating from the guidelines to label claims and PRO properties, in the three interconnected databases, facilitates the selection of fit-for-purpose PROs and the determination of a successful endpoint strategy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023postermapidetermining-pros-fit-for-purposedatabases-1126178-pdf.pdf?sfvrsn=a6640ea1_0","title":"ISPOR-2023_Poster_MAPI_Determining-PROs-Fit-For-Purpose_Databases (1)126178.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126178","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Racialized Economic Segregation and Inequities in Survival Among Patients with Multiple Myeloma","id":"08169ac3-47cc-45c2-9854-d6020b975660","sessionCode":"HPR7","topDisplay":"Pittell H1, Guadamuz J2, Kaur M3, Pierre A2, Ryals C2, Calip G4 1Flatiron Health, Great Neck, NY, USA, 2Flatiron Health, New York, NY, USA, 3Flatiron Health, Port Jefferson, NY, USA, 4Flatiron Health, Chicago, IL, USA","locationCode":"507","description":"\r\n\t<div>OBJECTIVES: Structural racism – including racial and economic segregation – may drive persistent inequities in multiple myeloma (MM) treatment and survival. Here we examined the association of the Index of Concentration at the Extremes (ICE) for area-level racialized economic segregation, and real-world overall survival (rwOS) among patients with MM. METHODS: This retrospective study used the nationwide (US-based) Flatiron Health electronic health record-derived de-identified database, focusing on patients diagnosed with MM from January 2011 to October 2022. The ICE for racialized economic segregation is a measure quantifying differences between the most and least privileged groups in an area (high-income White vs low-income Black households). Using data from the American Community Survey, we constructed a census tract-level measure of ICE categorized as US population-weighted quintiles (ranging from most to least privileged areas). We estimated median rwOS using Kaplan-Meier methods and examined associations using Cox proportional hazard models adjusted for clinical factors (age, sex, ECOG performance status, ISS stage). RESULTS: The cohort included 10,321 patients (median age:70; male:53%). Compared to patients from the most privileged areas (Q1), patients from the least privileged areas (Q5) were older (median age:71 vs. 68), disproportionately Black (55% vs 6.6%) or Latinx (16% vs 3.8%), and had worse performance status (ECOG ≥2: 21% vs 16%). Patients from the least privileged areas had shorter median rwOS (63.4 vs. 69.4 months) and greater risk of death (adjusted HR:1.15 [95% CI:1.04-1.26]) than patients from the most privileged areas. CONCLUSIONS: Racialized economic segregation was associated with survival among patients with MM, where those in the least privileged areas are at increased risk of death. Given inequities in the burden of MM – where Black adults are twice as likely to develop MM than their White counterparts – efforts to reduce persistent cancer inequities should assess and address racialized economic segregation and other forms of structural racism.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23pittellposter126400-pdf.pdf?sfvrsn=34ed4a23_0","title":"ISPOR23_Pittell_POSTER126400.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126400","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Usage and Costs Profile of Long-Term Contraception Users at a Health Plan Operator in the Brazil","id":"2b8512b3-824c-4ab8-b70a-d6b5122358e1","sessionCode":"RWD25","topDisplay":"Budib M1, Ayache R1, Ribeiro N1, Appel R1, Pereira L1, Ramires Y2, Bueno RL3, Lemos E1 1CASSEMS, Campo Grande, MS, Brazil, 2Federal University of Paraná, Fazenda Rio Grande, PR, Brazil, 3University 9 of July, São Paulo, SP, Brazil","locationCode":"834","description":"\r\n\t<div>OBJECTIVES: To evaluate the profile of health resource utilization and costs linked to contraception in users of Etonogestrel Contraceptive Implant (ETN-IMP) and Levonorgestrel Intrauterine System (LNG-IUS). METHODS: The study was designed as a retrospective cross-sectional study of women using ETN or LNG-IUS (2021-2022). The costs and use of resources related to contraception were evaluated using secondary data extracted from the computerized system of a health insurance (Midwest, Mato Grosso do Sul, Brazil), in three time cuts: 90 days before the procedure (90B), moment of insertion (M0) and 90 days after (90A). Descriptive statistical analyzes with categorical variables reported as frequencies and non-normal continuous variables as median with interquartile range (IQR). The comparison between the two means was analyzed by t-test and medians was analyzed using the Mann-Whitney test. All statistical tests were performed with SSS. RESULTS: Were included 100 patients using ETN-IMP and other 100 using LNG-IUS. The mean ages were 29 (± 7,4) and 33 (± 8,3) years, respectively. The cost of method (29.20%; p=0.01) and the total cost of using resources (27.53%; p>0.001) were lower in the ETN-IMP group compared to the LGN-IUS. Significant differences were observed in relation to costs in the three time periods analyzed (90B: p=0.01; M0: p<0.001; 90A: p<0.001), influenced by different frequencies in the use of medical and diagnostic or therapeutic services. CONCLUSIONS: Expanding unrestricted access to modern LARC methods leads to reduced use of health resources and the costs associated with contraception. This first real-world study from the perspective of the brazilian private healthcare system demonstrates that the incorporation of cost-effective technologies can allow for a more efficient budget allocation.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporbudiblemos2023124823-pdf.pdf?sfvrsn=ed4d336_0","title":"ISPOR_BUDIB_LEMOS_2023124823.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124823","diseases":[{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Resource Utilization in Patients with Hidradenitis Suppurativa in Five European Countries and the USA Using Real World Evidence","id":"6f6a86a7-ed88-4fdc-b9fd-d6c202ed2836","sessionCode":"RWD36","topDisplay":"Voorham J1, Tran T2, Ploug U3, Keal A4, Beaty S5, Shang A6 1Data to Insights Research Solutions, Lisbon, Portugal, 2UCB Pharma, Brussels, Belgium, 3UCB Pharma, Copenhagen, Denmark, 4Adelphi Real World, Bollington, UK, 5UCB Pharma, Smyrna, GA, USA, 6UCB Pharma, Basel, Switzerland","locationCode":"902","description":"\r\n\t<div>OBJECTIVES: Hidradenitis suppurativa (HS) is a chronic inflammatory skin disease with a high symptom burden, requiring frequent healthcare encounters. This study describes healthcare resource utilization (HCRU) by disease severity in the EU5 (France, Germany, Italy, Spain, UK) and the USA. METHODS: Data were drawn from the Adelphi HS Disease-Specific Programme™, a cross-sectional survey conducted in the EU5 and USA between November 2020 and April 2021, including HS severity (indicated by Hurley Stage) and HS-related HCRU. Rates of biologic use, hospitalization per person-year (PPY), outpatient visits, and surgery in the previous 12 months are reported by Hurley Stage and country. RESULTS: 1,787 patients were included (mean age: 34.4 years; 57.6% female). 54.7% were at Hurley Stage 1, while 37.0% and 8.3% were at Stages 2 and 3. Stage 3 ranged from 2.5% in Italy to 11.9% in France (USA: 7.5%). 27.6% of patients had used a biologic medication (EU5: 15.9%–40.7%; USA: 30.5%), of which 84.0% had used adalimumab. Hospitalization rate increased with increasing disease severity (Stage 1: 0.05 PPY; Stages 2 and 3: 0.21 and 0.59 PPY); it ranged from 0.03 PPY in Italy to 0.53 PPY in France (USA: 0.05 PPY). Dermatologist visits also increased with increasing disease severity (Stage 1: 3.28 PPY; Stages 2 and 3: 3.95 and 6.09 PPY), ranged from 2.70–4.93 PPY in EU5, and were 2.95 PPY in the USA. Psychologist/psychotherapist visits increased with HS severity (Stage 1: 0.20 PPY; Stages 2 and 3: 0.38 and 0.69 PPY). 6.9% of patients with Stage 1, and 13.8% and 26.4% of patients with Stages 2 and 3, had undergone a surgical procedure. CONCLUSIONS: HCRU increased in patients with more severe HS, a finding that was consistent across the EU5 and USA. Differences in HCRU between countries may be explained in part by HS severity. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23voorhamposter125282-pdf.pdf?sfvrsn=437f8b6a_0","title":"ISPOR23_Voorham_POSTER125282.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125282","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Emergency Department Hyperkalemia Outcomes Are Improved with Newer Potassium Binders","id":"23012bee-56df-4334-8e21-d84a05f5a542","sessionCode":"HSD13","topDisplay":"Rosenthal N1, Gayle J2, Kammerer J3, Brown H2, Budden J3, Neuenschwander J4, Rafique Z5, Peacock WF5 1PINC AI™ Applied Sciences, Premier Inc., Oak Park, CA, USA, 2PINC AI™ Applied Sciences, Premier Inc., Charlotte, NC, USA, 3CSL Vifor, Redwood City, CA, USA, 4Ohio State University School of Medicine, Columbus, OH, USA, 5Baylor College of Medicine, Houston, TX, USA","locationCode":"600","description":"\r\n\t<div>OBJECTIVES: Hyperkalemia is an expensive and potentially fatal Emergency Department (ED) presentation. This study aimed to compare outcomes in ED patients with hyperkalemia who received potassium binders, including patiromer, sodium zirconium cyclosilicate (SZC), binder sodium polystyrene sulfonate (SPS), or no binder. METHODS: Using chargemaster data from the PINC AI™ Healthcare Database, adults (≥18 years) with an ED visit between January 1, 2019, through December 31, 2021, diagnosed with hyperkalemia or had potassium-binder use were analyzed. Patients were excluded if they received multiple binders, were pregnant, or were from hospitals without continuous data submission during 180-day look-back or 30-day follow-up periods. Data were stratified by receipt of patiromer, SZC, SPS, or no binder. Descriptive statistics were used to assess the patient characteristics and outcomes. Unadjusted results are presented here. RESULTS: Overall, 883,001 patients were analyzed, of which 28,893 (3.3%), 217,742 (24.7%), 101,098 (11.4%), and 535,268 (60.6%) were in patiromer, SPS, SZC, and no-binder groups, respectively. Of the total, 54.2% were male, median (Q1-Q3) age was 69 (58-79), 66.4% were white, 20.9% African American, and 10.7% Hispanic. Most common comorbidities were renal disease (50.3%), diabetes (41.8%), and congestive heart failure (40.0%). Median Charlson Comorbidity Index was 4.0 overall and for each subset [Q1-Q3: 3.0-6.0 for patiromer; 2.0-6.0 all other subsets]. The percentage of patients discharged home were similar between patiromer (6.5%) and SZC patients (6.4%), but lower than SPS (8.9%, p<0.01) or no-binder (11.7%, p<0.01) groups. Patiromer and SZC were associated with lower 30-day all-cause hospitalization (2.0% patiromer; 1.5% SZC; 3.1% SPS; and 2.7% no binder, all p-values<0.01) and lower 30-day hyperkalemia-related hospitalization (0.7% patiromer; 0.6% SZC; 1.1% SPS; and 0.8% no binder, all p-values<0.01). CONCLUSIONS: Patients with SPS or no-binder use had higher risk of 30-day all-cause and hyperkalemia-specific hospitalization than patients given patiromer or SZC. Patiromer and SZC had similar discharge dispositions.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23rosenthalposterv2124375-pdf.pdf?sfvrsn=b61ae516_0","title":"ISPOR23_Rosenthal_POSTERV2124375.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124375","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Preferences for Attributes of Oral Antipsychotic Treatments: Survey Results of Patients Living with Schizophrenia or Bipolar I Disorder","id":"a0922430-3472-417a-9ea7-d861e6496fbd","sessionCode":"PCR46","topDisplay":"Doane M1, Boeri M2, Panchmatia H1, Citrome L3, Sajatovic M4 1Alkermes, Inc, Waltham, MA, USA, 2RTI Health Solutions, Belfast, UK, 3New York Medical College, Valhalla, NY, USA, 4University Hospitals Cleveland Medical Center, Cleveland, OH, USA","locationCode":"6B","description":"\r\n\t<div>OBJECTIVES: This study assessed preferences for attributes of oral antipsychotics among adults with schizophrenia (SZ) or bipolar I disorder (BD-I) and explored potential tradeoffs patients may make between efficacy and tolerability. METHODS: A cross-sectional web-based discrete choice experiment (DCE) survey collected preference data from US adults with a self-reported diagnosis of SZ or BD-I across 5 attributes associated with oral antipsychotic treatment: efficacy (ie, symptom improvement), weight gain over 6 months, sexual dysfunction, sedation, and akathisia. RESULTS: A total of 144 respondents with SZ (mean age 41 years, 50% female, 69% White) and 152 respondents with BD-I (mean age 40 years, 70% female, 78% White) completed the survey. Symptom improvement was the most important treatment attribute for respondents with SZ or BD-I. Weight gain and sexual dysfunction were 2 side effects that respondents most wanted to avoid. Respondents preferred treatments associated with 0, 4, or 7 lb of weight gain over 6 months significantly more than those associated with 11 lb of weight gain. Respondents were willing to accept 7 to 9 lb of weight gain over 6 months for the smallest improvement in symptom control (1 incremental step of improvement of disease severity). In addition, respondents were willing to accept >25% risk of sedation for any level of symptom improvement. CONCLUSIONS: In this survey, treatment efficacy was the most important attribute of oral antipsychotics among respondents with SZ or BD-I; weight gain and sexual dysfunction were 2 side effects patients most wanted to avoid. Respondents with SZ or BD-I were willing to accept a limited amount of weight gain as a side effect for better efficacy. As oral antipsychotics have different efficacy and tolerability profiles, it is important to understand the features that patients value in a treatment and how they balance benefits and risks when choosing among treatments.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/-e-ispor-2023pt-pref-within-oral-sgas-in-szbd-pofinal127143-pdf.pdf?sfvrsn=9aba0093_0","title":"[E]ISPOR 2023_Pt Pref Within Oral SGAs in SZBD PO_FINAL127143.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127143","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Perceived Attitudes Toward Vaccines, Trust and Vaccination Behaviors","id":"d1c93a7c-b69e-49ff-9341-d8f580131572","sessionCode":"PCR43","topDisplay":"Guo H UCLA, Los Angeles, CA, USA","locationCode":"802","description":"\r\n\t<div>OBJECTIVES: The decision-making process for taking vaccination is influenced by a multitude of factors such as individual beliefs concerning vaccinations, trust in contextual forces, and sociodemographic. This study established a model to understand the relationship between people’s beliefs in the safety, importance and effectiveness of vaccines, their trust in the medical advice from the government and doctors and their behaviors of having their children vaccinated from infectious diseases in low-and-middle-income countries (LMIC). METHODS: We structured a structural equation model with two latent variables, Motivation and Trust, and their relationships with the vaccination taking behavior. Motivation is constructed by people’s beliefs in the safety, importance and effectiveness of vaccines and trust is constructed by people’s trust in government, medical providers and scientists. This study used the 2018 Wellcome Global Monitor dataset and focused on people in 80 LMIC. The countries were divided into eight geographic regions: Eastern Africa, Central & Southern Africa, Norther Africa & Middle East, Western Africa, Central Asia, Southeast Asia, South Asia and Southern& Eastern Europe. RESULTS: The latent variable Motivation is significantly positively associated with parental vaccination behaviors in all geographic areas except for South Asia and Western Africa. South Asia is the only area where the trust in government and medical system, providers had a significant association with vaccination behavior and such association is positive. CONCLUSIONS: In most LMIC, positive attitudes about vaccines are associated with an improved vaccine rate. Increasing people’s belief in vaccines’ importance, safety and effectiveness will be essential both for boosting vaccination rates and scaling up a vaccine for COVID-19. In South Asia, trust in the government and the public health system are important in deciding taking vaccines. In these countries, policymakers need to think of ways to improve people’s trust in the public health system and further effectively communicate important health messages.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23guoposterv2124315-pdf.pdf?sfvrsn=5cdc0171_0","title":"ISPOR23_Guo_POSTERV2124315.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124315","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Bring out Your Dead: A Review of the Cost Minimization Approach in Health Technology Assessment Submissions to the Australian Pharmaceutical Benefits Advisory Committee","id":"338c770f-5cab-478b-a012-d97c7d60aef1","sessionCode":"HTA10","topDisplay":"Tirrell Z1, Norman A2, Hoyle M1, Lybrand S3, Parkinson B1 1Centre for the Health Economy, Macquarie University, Sydney, Australia, 2Centre for the Health Economy, Macquarie University, North Ryde, NSW, Australia, 3Amgen Australia, North Ryde, Australia","locationCode":"617","description":"\r\n\t<div>OBJECTIVES: Published literature has levied a barrage of criticism against the cost-minimization approach to economic evaluation for new medicines. The prevailing papers on the topic has declared its 'death'. However, the approach is the primary means by which new medicines are listed for public subsidy in Australia. The Pharmaceutical Benefits Advisory Committee (PBAC), which assesses new medicines for public subsidy, maintain Methodology Guidelines that indicate when the approach would be acceptable. While these Methods Guidelines establish requirements for cost-minimization that is theoretically robust and avoid the issues identified in the literature, adherence to these Methods Guidelines has not been assessed. This research aims to explore the factors that influence the PBAC recommendation for subsidy of new medicines that use a cost-minimization approach to economic evaluation, including adherence to the Methodology Guidelines. METHODS: Relevant information was extracted from public summaries of cost-minimization submissions assessed between 2005 and 2022. A generalized linear model was fitted, with control variables selected through an iterative feature selection process using the Bolasso Method. RESULTS: Preliminary results suggest that aspects relevant to adherence to the Methodology Guidelines reduce the likelihood of recommendations and the preponderance of evidence indicate that the PBAC was willing to recommend submissions despite nonadherence to the Methodology Guidelines. CONCLUSIONS: Key stakeholders should consider whether the approach accepted for cost-minimization is appropriate or whether the Methodology Guidelines require revision. Nonadherence reduces the clarity and increases the uncertainty of how a submission process will eventuate for the pharmaceutical company. For the health system and patients, nonadherence could introduce inferior medicines at equivalent costs, resulting in patients having suboptimal outcomes and potentially increased healthcare and other costs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23tirrellposter124447-pdf.pdf?sfvrsn=233d6749_0","title":"ISPOR23_Tirrell_POSTER124447.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124447","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"7caf4c95-ccab-4b02-bf10-d6baabcc6f2b","parentId":"00000000-0000-0000-0000-000000000000","title":"Personalized & Precision Medicine","urlName":"personalized-precision-medicine"},{"id":"5b196821-963c-48d3-9e67-cc2da312735d","parentId":"00000000-0000-0000-0000-000000000000","title":"Vaccines","urlName":"Vaccines"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Bacteremia, Sepsis, and Endocarditis Outcomes in Patients with Opioid Use Disorder Treated with a Prescription Digital Therapeutic","id":"6d5fe784-bd76-4d85-b253-da11577298c8","sessionCode":"CO15","topDisplay":"Velez F1, Anastassopoulos K2, Colman S2, Kauffman L2, Shah N3, Murphy S4, Maricich Y3 1Pear Therapeutics, Boston, MA, USA, 2Labcorp Drug Development, Gaithersburg, MD, USA, 3Pear Therapeutics (US), Inc., Boston, MA, USA, 4Weill Cornell Medicine, New York, NY, USA","locationCode":"100","description":"\r\n\t<div>OBJECTIVES: According to the Centers for Disease Control and Prevention, a deadly consequence of the opioid crisis is the increased incidence of blood-borne infections, including those related to bacteria/fungi causing endocarditis, a life-threatening infection of the heart's inner lining that disproportionally affects patients with all forms of opioid use disorder (OUD). Its significant morbidity and mortality burdens the healthcare system through prolonged, high-complexity episodes of acute hospitalization. This study compared bacteremia/sepsis/endocarditis rates between patients prescribed an FDA-authorized prescription digital therapeutic (PDT) and controls. METHODS: Analysis of closed-claims data from OUD-diagnosed adults one year before (pre-index) and after (post-index) PDT prescription/fill (index). Cases filled the PDT prescription, while controls did not. Outcomes assessed were claims for bacteremia/sepsis, endocarditis, or the composite endpoint (any bacteremia/sepsis/endocarditis). Incidence rate ratios (IRRs) were compared pre- and post-index, and between cases and controls (post-index only) using a repeated-measures negative binomial model of patient counts, adjusting for duration of each period (pre-post analysis), and for baseline demographic and clinical characteristics (cases vs. control analysis). RESULTS: Among 901 cases and 978 controls, cases showed a decrease in bacteremia/sepsis, endocarditis, and the composite endpoint [IRR 0.85, 0.92, and 0.93, respectively; all P>0.6] in the pre- vs. post-index period; controls showed a decrease in bacteremia/sepsis, and an increase of endocarditis and the composite endpoint [IRR 0.96, 1.41, and 1.06, respectively; all P>0.4]. Cases showed a 12% lower incidence of bacteremia/sepsis and a 2% lower incidence of the composite endpoint vs. controls [IRR 0.88 and 0.98 respectively, both P>0.7; model could not be fit for endocarditis]. Rate of acute and subacute infective endocarditis decreased 41% pre-post in cases (P=0.4), and increased 34% in controls (P=0.6). CONCLUSIONS: Treatment with an FDA-authorized PDT for OUD was associated with reduced rates of bacteremia, sepsis, and endocarditis, findings that merit further investigation.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123634","diseases":[{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Shifting Practices in Hospitals: A Systematic Review","id":"57435b96-8d3f-4587-9670-db0b405b8095","sessionCode":"OP5","topDisplay":"Sirur A1, Pillai K R2 1Department of Commerce, Manipal Academy of Higher Education, Manipal, India, 2Manipal Institute of Management, Manipal Academy of Higher Education, Manipal, India","locationCode":"713","description":"\r\n\t<div>OBJECTIVES: The long-standing debate on hospitals charging private payers higher than their public counterparts continues to prevail till date. We perform a systematic review of published evidence on cost-shifting practices in hospitals. METHODS: We follow the procedures of a systematic review by adhering to the scholarly suggestions in this regard. The relevant documents were obtained from Scopus, Web of Science, and Google Scholar databases using keyword search and screened them using the PRISMA framework. Both theoretical and empirical works were included in this review. The findings are organized and presented thematically. RESULTS: This systematic review identified geographical representation of research on cost-shifting in hospitals. The study also helped identify theories relevant to the practice and the factors that led hospitals to engage in cost-shifting. CONCLUSIONS: The present research is the first of its kind to offer a systematic review of cost-shifting practices in hospitals. The study helped identify unexplored areas for future investigations, an intrinsic component of the knowledge management process. Keywords: Cost-shifting, Pricing, Hospitals</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"bb8fd992-de86-4d1a-8bec-f6e2c928db96","parentId":"00000000-0000-0000-0000-000000000000","title":"Organizational Practices","urlName":"organizational-practices"}],"categoryIds":["bb8fd992-de86-4d1a-8bec-f6e2c928db96"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126548","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Risk of Bleeding When Concomitantly Exposed to Non-Vitamin K Anticoagulants and Other Medications","id":"802b2523-cc59-4787-8376-db510d660c21","sessionCode":"RWD1","topDisplay":"Brendle M, Gómez-Lumbreras A, Moorman-Bishir K, Malone DC University of Utah, Salt Lake City, UT, USA","locationCode":"5A","description":"\r\n\t<div>OBJECTIVES: Non-vitamin K anticoagulants (NVKA) are replacing vitamin K anticoagulants due to simplified dosing and monitoring. However, patients on NVKAs are not exempt from bleeding risk. Potential NVKA drug interactions have been scarcely studied. The purpose of this study was to estimate the risk of bleeding in patients on NVKA and potentially interacting drugs. METHODS: This was an observational cohort study using Medicare data. Participants receiving an NVKA from 2017—2020 were studied. The outcome was a clinical encounter associated with bleeding. A concomitant overlapping period while on NVKA was assessed for: non-steroidal anti-inflammatory drugs (NSAIDS); selective serotonin reuptake inhibitors (SSRI); proton pump inhibitors (PPI); platelet aggregation inhibitors; and glucocorticosteroids. Logistic regressions predicting either all bleeding or GI bleeding were conducted. RESULTS: The study cohort of 102,531 had a mean age 77 years (SD=9.8) and 55% was female (N=56,671). There were 2,908 (2.8%) participants with a history of GI bleeding and 3,602 (3.5%) with a history of other bleeding. Risk for any bleeding was shown for clopidogrel (OR: 1.42, 95% CI: 1.34, 1.48), PPIs (OR: 1.60, 95% CI: 1.53, 1.67), prasugrel/ticagrelor (OR: 1.35, 95% CI: 1.16, 1.56), glucocorticosteroids (OR: 1.25, 95% CI: 1.18, 1.33), and SSRIs (OR: 1.10, 95% CI: 1.04, 1.16). GI bleeding risk was shown for clopidogrel (OR: 1.49, 95% CI: 1.39, 1.60), PPIs (OR: 2.53, 95% CI: 2.39, 2.60), prasugrel/ticagrelor (OR: 1.39, 95% CI: 1.14, 1.69), and glucocorticosteroids (OR: 1.31, 95% CI: 1.21, 1.43). PPI use was correlated with both NSAID (r=0.07, p-value<0.0001) and SSRI use (r=0.09, p-value<0.0001). CONCLUSIONS: Persons on NVKA are at increased risk for overall bleeding and GI bleeding when taking anti-platelets, glucocorticosteroids, and SSRIs. Use of PPIs may be a confounding medication because it does not increase risk of bleeding but may be prescribed to patients with increased bleeding risk.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23brendleposter126194-pdf.pdf?sfvrsn=76340aa_0","title":"ISPOR23_Brendle_POSTER126194.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126194","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Vision-Related Quality of Life and Mental Health Outcomes of Children and Young People with Visual Impairment and Their Carers","id":"b39829fb-b8c9-459d-9362-db6f59363590","sessionCode":"PCR36","topDisplay":"Semrov A1, Tadic V2, Rahi JS1 1UCL Great Ormond Street Institute of Child Health, London, UK, 2University of Greenwich, London, UK","locationCode":"4B","description":"\r\n\t<div>OBJECTIVES: To investigate the associations between vision-related quality of life (VQoL) and mental health outcomes of children and young people with visual impairment (CYP-VI) and their parents/carers, as a first step towards development of family-centred intervention. METHODS: Cross-sectional study included 68 CYP-VI aged 8-18 years (visual acuity of logMAR 0.50 or worse, comprising moderate and severe visual impairment and blindness in ICD-11) and their carers. Families were recruited through two paediatric ophthalmology departments and relevant vision loss charities in the United Kingdom. Children’s outcomes included the overall scores on Vision-Related Quality of Life Questionnaire for Children and Young People (VQoL_CYP) as reported by the CYP-VI themselves, and Strengths and Difficulties Questionnaire (SDQ) as reported by their carers. Carers’ outcomes were overall scores on Satisfaction With Life Scale (SWLS), Patient Health Questionnaire (PHQ-9), General Anxiety Disorder Assessment (GAD-7), and Parental Stress Scale (PSS). Associations between children’s and carers’ outcomes were analysed using Spearman’s correlation coefficient. RESULTS: Lower VQoL was associated with more overall behavioural and emotional difficulties on SDQ (r=–0.485, p<0.001), lower carer’s satisfaction with life (r=0.395, p=0.002), worse carer’s depression (r=–0.390, p=0.002) and anxiety symptoms (r=–0.315, p=0.015). VQoL was not significantly associated with parental stress levels (r=–0.196, p=0.140). More overall child’s behavioural and emotional difficulties significantly correlated with higher parental stress (r=0.363, p=0.004), worse carer’s depression (r=0.436, p<0.001) and anxiety symptoms (r=0.422, p<0.001), but not with their satisfaction with life (r=–0.159, p=0.224). Visual acuity and gender were not related with any of the measured outcomes. Older age was associated with lower VQoL (r=–0.320, p=0.010). CONCLUSIONS: Our findings show moderate correlations between mental health of CYP-VI and their carers, and indicate both should be considered when assessing VQoL outcomes of CYP-VI. Interventions targeting mental health of these families may promote better VQoL of CYP-VI.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23semrovposter127282-pdf.pdf?sfvrsn=ef7b2e7f_0","title":"ISPOR23_Semrov_POSTER127282.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127282","diseases":[{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"},{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluation of Clinical Decision Support to Improve Care for Patients with Atrial Fibrillation at Increased Stroke Risk: 2-Year Results","id":"95215b38-7a47-48a8-9484-dc4c9d414ace","sessionCode":"CO2","topDisplay":"Yu A, Godley P, Widmer RJ Baylor Scott & White Health, Temple, TX, USA","locationCode":"104","description":"\r\n\t<div>OBJECTIVES: Effective stroke prevention with oral anticoagulation is the cornerstone of management in patients with atrial fibrillation (AF). However, previous literature has shown that guideline-concordant anticoagulation in patients with high stroke risk is often below 70% in the U.S. The purpose of this study is to evaluate the impact of clinical decision support (CDS) tools on anticoagulation rates. METHODS: This retrospective, longitudinal study used EHR data from an integrated delivery network in Texas. An electronic alert containing an anticoagulation order set was displayed to providers in outpatient settings caring for non-anticoagulated AF patients at increased stroke risk according to their CHA2DS2VASc score. Patients were age ≥18 years with an AF diagnosis and ≥1 outpatient encounter. An interrupted time series design was used to evaluate the effect of this decision support tool on anticoagulant prescribing rates. The pre-intervention period was April 2020-September 2020, and the post-intervention period was September 2020-November 2022. Anticoagulant prescribing rates were assessed weekly for 18 weeks before, and 117 weeks after implementation of the alert. RESULTS: 123,764 unique AF patients had outpatient encounters with mean (SD) age 72.7 (12.6) years, 56.6% male, and mean (SD) CHA2DS2VASc of 3.4 (1.8). The mean (SD) number of weekly eligible patients was 10,514 (1,360) and the median (IQR) was 10,763 (10,325–11,115). Mean (SD) weekly anticoagulant prescribing rates were 60.1% (0.5%) before implementation compared to 65.6% (2.7%) after implementation of CDS. Before the intervention, rates increased at a weekly trend of 0.06%, (SE=0.03%, P=0.0502). Immediately after BPA implementation, rates increased by 0.38%, (SE=0.30%, P=0.2167) and by 0.02%, (SE=0.03%, P=0.4266) over the 117-week period following implementation. None of these increases were statistically significant. CONCLUSIONS: Anticoagulant prescribing rates following implementation of clinical decision support were slightly higher than baseline anticoagulation rates, but the trends were not statistically significant.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23yuposter127825-pdf.pdf?sfvrsn=6ea16358_0","title":"ISPOR23_Yu_POSTER127825.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127825","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"dc752772-538c-4933-b6a5-3b5b6d079673","parentId":"00000000-0000-0000-0000-000000000000","title":"Geriatrics","urlName":"Geriatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Predictors of Sustainability of Response with Cenobamate: Post-Hoc Subset Analysis of a Phase 3, Open-Label Study","id":"b20d18bc-232f-4487-acc2-dced873a08a9","sessionCode":"CO20","topDisplay":"Stern S1, Wechsler R2, Kerr W3, Wade C4, Vossler DG5, Rosenfeld WE6 1SK Life Science Inc., Paramus, NJ, USA, 2Consultants in Epilepsy & Neurology and Idaho Comprehensive Epilepsy Center, Boise, ID, USA, 3University of Michigan, Ann Arbor, MI, USA, 4SK Life Science Inc., Sewickley, PA, USA, 5University of Washington School of Medicine, Seattle, WA, USA, 6Comprehensive Epilepsy Care Center for Children and Adults, St. Louis, MO, USA","locationCode":"123","description":"\r\n\t<div>OBJECTIVES: Cenobamate is an antiseizure medication (ASM) approved in the US and EU for the treatment of focal seizures. We evaluated seizure reduction achieved with adjunctive cenobamate and clinical characteristics associated with maintaining response in a post-hoc analysis from a phase 3, open-label, safety study. METHODS: Patients 18-70 years old with uncontrolled focal seizures taking stable doses of 1-3 ASMs were enrolled. We assessed 100% seizure reduction from baseline achieved over any 3-month interval in the maintenance phase. Among patients who achieved 100% seizure reduction, the time between onset of response to a study visit with <100% seizure reduction was assessed using time-to-event methodology. Logistic regression models were used to evaluate associations with maintenance of clinical response. Characteristics assessed included sex, race, age, baseline seizure frequency (<3 vs ≥3 seizures/28 days), number of ASMs, use of branded ASMs, presence of secondary generalized tonic-clonic seizures, prior epilepsy-related surgery, and baseline concomitant drug load using defined daily dose (ratios of a patient’s prescribed concomitant ASM doses divided by a standardized daily maintenance dose were summed). RESULTS: Of the 214 patients who received ≥1 dose of cenobamate during the maintenance phase (mean age, 41.9 years; median maintenance treatment duration, 29.5 months), 145 (67.8%) had 100% seizure reduction over any 3-month interval. Among patients who initially achieved 100% seizure reduction, the median time to breakthrough seizures was 7 months; 22% maintained 100% seizure reduction for >30 months and 63% had ≤3 study visits with seizures. Patients with lower baseline concomitant drug load and lower baseline seizure frequency were more likely to maintain 100% seizure reduction. CONCLUSIONS: In this post-hoc analysis, adjunctive cenobamate led to sustained seizure freedom in patients, including those with characteristics associated with treatment-refractory epilepsy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23sternposter125277-pdf.pdf?sfvrsn=f150620e_0","title":"ISPOR23_Stern_POSTER125277.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125277","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Characterization of OCS Use in Patients Starting Biologics for Asthma in the United States","id":"c825454f-dd18-4e78-8ca2-dd9d61b0e6aa","sessionCode":"CO34","topDisplay":"Harvey J, Zhang S, Mu G, Valliant S, Alfonso-Cristancho R GSK, Collegeville, PA, USA","locationCode":"134","description":"\r\n\t<div>OBJECTIVES: To describe the burden of oral corticosteroid (OCS) use in patients with asthma initiating treatment with biologics. METHODS: A retrospective cohort study was conducted with patients with asthma who initiated biologics between January 2017 and March 2022, using Optum’s de-identified Clinformatics® Data Mart Database. Differences in OCS use, measured OCS prescription (Rx) count, average daily dose, average prescription count, and average days supplied during the 12 month baseline period were described. Maintenance OCS (mOCS) was defined as Rx with >28 days. Patients with an index biologic prescription from a “dermatology” provider were excluded. RESULTS: Out of 9,273 patients with asthma who initiated biologics, 21.22% (n= 1,968) were on mOCS. Most mOCS patients were 45 to 64 years old (50.98%; non-mOCS: 37.67%). Users of mOCS were more likely to have Medicare coverage (52.95% vs. 38.84%), higher Charlson Commorbidity Index (2.0 vs. 1.7), higher proportion of respiratory infections (64.8% vs. 55.7%) and COPD (50.0% vs. 28.56%). Conversely, non-mOCS users had higher frequency of allergic rhinitis (70.49% vs. 60.06%), atopic dermatitis (27.23% vs. 14.18%), chronic idiopatic urticaria (11.75% vs. 6.71%), and nasal polyps (16.13% vs. 13.26%). The average prescription count for any OCS during baseline was 7.04 (SD: 4.28) for mOCS and 2.80 (SD: 2.95) for non-mOCS. The average OCS daily dose for mOCS was 7.80 mg (SD: 5.93). Across all prescription counts, mOCS group had an average of 24.07 (SD: 21.11) OCS days supplied per prescription compared to 8.76 (SD: 4.79) days for non-mOCS. CONCLUSIONS: Overall, mOCS use prior to biologic initiation in patients with asthma was high, indictive of substantial patient and health system burden. Funding: GSK-Funded: Study ID: 219356</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-ocs-burden90x42-inhr2126857-pdf.pdf?sfvrsn=70f29166_0","title":"ISPOR 2023 OCS Burden_90x42 in_HR2126857.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126857","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Effect of Treatment Discontinuation Definitions on Estimates of Treatment Persistence – A Multi-Indication Study with Health Insurance Claims Data","id":"13166db4-53de-486a-b4c1-df6d121d7511","sessionCode":"SA13","topDisplay":"Kósa F1, He J1, Nair S1, Lehne M2, Ghiani M3, Maywald U4, Wilke T3, Lin X5, Di Scala L1 1Janssen Global Services LLC, Raritan, NJ, USA, 2Cytel, Berlin, Germany, 3IPAM - Institut für Pharmakoökonomie und Arzneimittellogistik e.V., Wismar, Germany, 4AOK PLUS, Dresden, Germany, 5Janssen Global Services LLC, Spring House, PA, USA","locationCode":"917","description":"\r\n\t<div>OBJECTIVES: Treatment duration is a time-to-event variable best characterized by its median, while financial models need mean values for building forecasts. This study investigates the effect of different definitions on treatment discontinuation in four agents and indications. METHODS: Using data from the German AOK PLUS sickness fund (3.4mn patients), we investigated treatment duration of macitentan in pulmonary arterial hypertension (PAH), abiraterone acetate plus prednisone (AAP) in metastatic castration-resistant prostate cancer (mCRPC), darunavir in HIV, and paliperidone in schizophrenia (SCH). We measured treatment duration from first prescription between 1/1/2011-6/30/2020 until discontinuation, using various gap definitions (30, 60, 90, 120 and 180 days) between the runout date of the last prescription and the next prescription. We assumed that patients consumed all accumulated medications (stockpiling). Hospitalizations were considered part of the treatment periods. Median time to treatment discontinuation was described by Kaplan-Meier analysis, mean duration of treatment was estimated with parametric fitting (exponential and Weibull distributions). RESULTS: 103 PAH, 1134 mCRPC, 147 HIV and 1538 SCH patients were identified in the database. Differences in median time to discontinuation across gap definitions were largest for darunavir in HIV (range: 5.8 months [30-day gap] – 26.2 months [90-day gap]) followed by paliperidone in SCH (46.6 months [90-day gap] – 57.9 months [180-day gap]), macitentan in PAH (26.7 months [30-day gap] – 35.8 months [180-day gap]), and AAP in mCRPC (7.4 months [30-day gap] – 9.5 months [90-day gap]). Mean estimates showed 3-fold differences across various gap-length assumptions (darunavir) and statistically significantly different estimates depending on the choice of distribution (paliperidone). CONCLUSIONS: Estimates of treatment duration in real-world data vary substantially depending on the applied statistical methods and rules of gap filling and discontinuation. We recommend conducting sensitivity analyses of underlying assumptions and methods, and the consideration of scenario planning to ensure that medication consumption forecasts are robust and consistent.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d6301e91-40d4-4f22-8c55-9247675547c3","parentId":"00000000-0000-0000-0000-000000000000","title":"Study Approaches","urlName":"study-approaches"}],"categoryIds":["d6301e91-40d4-4f22-8c55-9247675547c3"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporus2023kosa20230421126846-pdf.pdf?sfvrsn=a998a5c9_0","title":"ISPOR_US_2023_Kosa_20230421126846.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126846","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"},{"id":"0dfdbf68-3434-4368-ac15-13526254832f","parentId":"00000000-0000-0000-0000-000000000000","title":"Mental Health (including addition)","urlName":"mental-health-including-addition"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient and Caregiver Spinal Muscular Atrophy (SMA) Treatment Attribute Preferences in Latin America","id":"9698999b-c21c-4c5a-9761-dfbd19727dca","sessionCode":"HSD5","topDisplay":"Saenz V1, Chlistalla M2, Carlos N3, Castiglioni Toledo C4, Soledad Monges M5, Servais L6, Zanoteli E7 1F. Hoffmann-La Roche Ltd, Tigre, B, Argentina, 2F. Hoffmann-La Roche Ltd, Basel, Switzerland, 3F. Hoffmann-La Roche Ltd, São Paulo, Brazil, 4Clinica Las Condes, Santiago, Chile, 5Hospital Pediatria J.P. Garrahan, Buenos Aires, Argentina, 6Muscular Dystrophy UK Oxford Neuromuscular Centre, Department of Paediatrics, University of Oxford, Oxford, UK, 7University of São Paulo, São Paulo, Brazil","locationCode":"541","description":"\r\n\t<div>OBJECTIVES: As access to spinal muscular atrophy (SMA) disease-modifying therapies widens, it is important to understand patient and caregiver treatment preferences. This study aims to identify which treatment attributes drive treatment choices in adult patients and caregivers of patients with SMA across Latin America. METHODS: Part 1 of the study consisted of 45-minute individual telephone interviews with adults with Types 2/3 SMA and caregivers of patients with Types 1/2 SMA which collected data on SMA diagnosis, key symptoms, perception of SMA, quality of life (QoL), treatment experience, unmet needs and treatment attribute preferences. Part 2 was a 30-minute online survey of adults with Types 2/3 SMA and caregivers of patients with Types 1–3 SMA who were treatment naïve or non-treatment naïve (excluding risdiplam), and included a discrete-choice exercise in which respondents were asked to choose between hypothetical treatment profiles. In partnership with an international group of experts, results from Part 1 informed the selection of treatment attributes and the three levels to describe each attribute. The attributes assessed were motor function, breathing, mode of administration, treatment reactions, activities of daily living and fatigue (patient survey only). Patient QoL was also assessed via the EQ-5D-5L questionnaire. RESULTS: To date, 36 adult patients and 62 caregivers have completed the study across Argentina (51.0%), Chile (20.4%), Peru (15.3%), Dominican Republic (5.1%), Brazil (4.1%), Costa Rica (2.0%) and Panama (2.0%). Most caregivers reported caring for a child aged 2–6 years (51.6%). Adult patients were aged 18–53 years, with the majority aged 18–30 years (52.8%). Most adult patients were treatment naïve (75.0%), whereas approximately half of the children with SMA were non-treatment naïve (56.5%). The full results of the study will be reported. CONCLUSIONS: Understanding patient and caregiver SMA treatment preferences, particularly at a regional level, is important for medical decision-making.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23saenzposter125427-pdf.pdf?sfvrsn=b78bfb78_0","title":"ISPOR23_Saenz_POSTER125427.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23saenzhandout125427-pdf.pdf?sfvrsn=bbeb096a_0","title":"ISPOR23_Saenz_HANDOUT125427.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125427","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Socioeconomic Impact of Retinitis Pigmentosa (RP) in Japan","id":"59af4ca8-111c-4a25-ae3a-e02cf39a415d","sessionCode":"EE60","topDisplay":"Yamanaka Y1, Reddy B2, Kawasaki R3, Watanabe K1, Mori K1, O'Brien P2 1Novartis Pharma K.K., Tokyo, Japan, 2Novartis Ireland Ltd., Dublin, Ireland, 3Osaka University, Osaka, Japan","locationCode":"311","description":"\r\n\t<div>OBJECTIVES: Retinitis pigmentosa (RP) is a rare inherited retinal dystrophy (IRD) that can cause blindness. Data on the burden of visual impairment (VI) due to RP were scarce. This study attempts to determine the socioeconomic impact of RP in Japanese patients. METHODS: We performed a post-hoc analysis based on the original data collection reported in an online survey to identify the socioeconomic burden of VI and blindness in patients with RP, their caregivers, and other health system stakeholders. 37 caregivers and 118 patients with RP were included. The analysis accounted for a wide variety of costs and included net stakeholder fund transfers and excluded any costs that were duplicative. Results were presented by perspective (e.g., patient-level, government-level, society-level) and by different levels of VI severity and age groups. RESULTS: It was determined that a patient with RP would have a total average annual societal cost of ¥1,579,864. This was a combination of ¥500,986 in direct costs (healthcare treatment and social welfare payments) and ¥1,078,878 in indirect costs (reductions in patient productivity and caregiver's opportunity costs). Assuming age of onset of 11.2 years and a life expectancy of 84.77 years, the overall lifetime average cost before discounting was calculated at ¥116,230,564 for each RP patient, of which the direct cost was ¥36,857,546. Patients received an average of ¥1,066,013 annually from social welfare payments. The costs to society rose along with the increase in severity of VI. An average burden of ¥1,087,046 was attributed to annual productivity loss. Average productivity (and total) societal costs were higher for working-age populations. CONCLUSIONS: RP is associated with a significant financial burden from a societal perspective in Japan. Indirect expenditures related to impacts on productivity and opportunity costs were about twice as high as direct costs.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23yamanakaposter124023-pdf.pdf?sfvrsn=bc0bfab8_0","title":"ISPOR23_Yamanaka_POSTER124023.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124023","diseases":[{"id":"e29b1bc3-a98e-49c1-8bc2-2975bb5fac5e","parentId":"00000000-0000-0000-0000-000000000000","title":"Sensory System Disorders (Ear, Eye, Dental, Skin)","urlName":"sensory-system-disorders-ear-eye-dental-skin"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"$20.9 Billion Annually Wasted on “Defects in Value” for Total Knee and Hip Replacements in the United States","id":"6c5cbfbf-d018-411a-8bb6-e0f4e0a96163","sessionCode":"HPR4","topDisplay":"Cohen B1, Chen J2, Zheng H2, Pronovost PJ3, Padula W4 1Stage Analytics, Duluth, GA, USA, 2University of Southern California, Los Angeles, CA, USA, 3University Hospitals, Cleveland, OH, USA, 4Department of Pharmaceutical and Health Economics, USC School of Pharmacy, Los Angeles, CA, USA","locationCode":"506","description":"\r\n\t<div>OBJECTIVES: The United States does not get what it pays for in healthcare, spending more money for worse outcomes. One explanation is “Defects in Value” – the components of healthcare delivery systems that hinder the patient experience and increase costs while providing little or negative clinical value. This study described and estimated the costs of defects in value for the roughly 1.5 million annual total knee and hip arthroplasties in the United States. METHODS: We utilized published literature to determine the rate and cost of defects in value for these total joint replacements. Particularly relevant value defects included inappropriate surgeries, avoidable complications, unnecessary post-acute care, procedures at low-volume facilities, and preventable readmissions. Each defect led to value erosion through poor patient outcomes and higher costs. RESULTS: We estimated that defects in value for total hip and knee arthroplasties led to $20.9 billion (2023 USD) in annual wasted spending. Over $14.6 billion of waste was due to spending on surgeries that did not match the appropriateness criteria. Nearly one-third of total knee replacements and one-tenth of total hip replacements were deemed unnecessary. Avoidable complications account for the remaining $6.3 billion in waste. The 3% of patients with 30-day readmissions and 14% of patients discharged to a post-acute care facility led to over $3 billion of combined waste. CONCLUSIONS: Given the prevalence of musculoskeletal conditions and the aging population in the United States, the rate of total knee and hip arthroplasties is expected to increase in the coming years. Thus, it is of increasing importance to address the defects in value associated with these surgeries. Centers of excellence, with explicit standards and protocols, can curb the nearly $21 billion dollars in cost associated with inappropriate care, avoidable complications, readmissions, and unnecessary use of post-acute care services.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127602","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Real-World Treatment Response and Persistence Among Black and Non-Black Patients with Metastatic Castration-Sensitive Prostate Cancer Treated with Apalutamide in a Urology Setting","id":"283aece6-5a57-4eb0-986b-e11488730307","sessionCode":"CO27","topDisplay":"Lowentritt B1, Du S2, Rossi C3, Kinkead F4, Moore B4, Lefebvre P4, Pilon D4, Muser E2, Khilfeh I5 1Chesapeake Urology, Towson, MD, USA, 2Janssen Scientific Affairs, LLC, Horhsam, PA, USA, 3Analysis Group, Inc., Montreal, Canada, 4Analysis Group, Inc., Montreal, QC, Canada, 5Janssen Scientific Affairs, LLC, Jersey City, NJ, USA","locationCode":"125","description":"\r\n\t<div>OBJECTIVES: In the United States, real-world evidence on apalutamide (APA) for treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) is limited. This study describes prostate-specific antigen (PSA) response and treatment persistence among patients with mCSPC initiated on APA, with stratifications for Black/non-Black patients. METHODS: Clinical data from 77 community-based urology practices were used to evaluate patients with mCSPC who received ≥1 APA dispensation (index date = first dispensation). Patients who previously used another next-generation antiandrogen or had <12 months of pre-index clinical activity were excluded. Patients were followed from index date to end of clinical activity or data availability (4/1/2022). On-treatment PSA response (≥90% decline from baseline PSA [PSA90]) 12-months post-index was assessed among patients with reported baseline PSA <13 weeks prior to or on the index date. Persistence was defined as the percentage of patients with no gap in treatment >60 or >90 days of supply at 6- and 12-months post-index. Outcomes were described overall and stratified for Black/non-Black patients. RESULTS: Overall, 589 patients with mCSPC initiated APA (mean age 75.9 years; 98 Black [16.6%], 424 non-Black [72.0%], and 67 of unknown race [11.4%]). By 12-months, PSA90 response was achieved by 72.3% overall, and 73.1% and 70.8% for Black and non-Black patients, respectively. Persistence at 6 months using >60- and >90-day gaps were 92.7% and 96.8% overall, 95.4% and 98.5% for Black patients, and 93.4% and 96.9% for non-Black patients, respectively. Persistence at 12 months using >60- and >90-day gaps were 89.1% and 94.9% overall, 93.3% and 97.8% for Black patients, and 89.3% and 94.4% for non-Black patients, respectively. CONCLUSIONS: Patients with mCSPC initiated on APA exhibited high real-world PSA response rates, and few patients had gaps in therapy. Robust real-world PSA response rates and treatment persistence were also demonstrated for both Black and non-Black patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23lowentrittposter124686-pdf.pdf?sfvrsn=77792de1_0","title":"ISPOR23_Lowentritt_POSTER124686.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124686","diseases":[{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Trends in Prescription Contraceptive Use Among US Commercially Insured Women, 2017 – 2021","id":"6c635f0b-33ec-40df-95e5-e142d2748175","sessionCode":"EPH34","topDisplay":"Lee T1, Do D2, Eatherly M2, Patel U2 1Evernorth, Tampa, FL, USA, 2Evernorth, St. Louis, MO, USA","locationCode":"434","description":"\r\n\t<div>OBJECTIVES: This study examined trends in prescription contraceptives in 2017-2021 among US women of childbearing ages (16 to 49) before and during the Covid-19 pandemic. METHODS: Continuously eligible and commercially insured members who filled any prescription contraceptive were included. Analyses included orals, non-orals, and intra-uterine devices (IUDs). Non-orals included prescription gels, patches, rings, injections, and implants. Interrupted time series (ITS) models were used to assess changes in the prevalence of use (per 100,000 women) pre- pandemic (January 2017 to March 2020) and during the pandemic (April 2020 to December 2021). Secondary models adjusted for member characteristics (age and race/ethnicity) and the Evernorth’s social determinant of health index. RESULTS: There was a significant and immediate decline during the pandemic (vs. pre-pandemic) in the prevalence of women using orals (Coefficient: -199.0, Pvalue: 0.0057), non-orals (Coefficient: -41.1, Pvalue: 0.0331) and IUDs (Coefficient: -66.15, Pvalue: 0.0038). During the pandemic, there was a declining trend in the prevalence of women using orals (Coefficient: -45.60, Pvalue: <0.0001) and non-orals (Coefficient: -3.26, Pvalue: 0.0167). In contrast, there was an increasing trend in the prevalence of women using IUDs (Coefficient: 2.29, Pvalue: 0.142). In secondary models, the immediate level change of IUDs (Coefficient: -78.99, Pvalue: 0.0022) and the declining trend for oral contraceptives (Coefficient: -41.36, Pvalue: 0.0079) remained statistically significant. CONCLUSIONS: A decline in oral and non-oral contraceptive use could be partly due to women shifting to over-the-counter methods, IUDs, or sterilization. A decline in IUD use could be attributed to office closures and patients avoiding potential exposure to Covid-19 at doctor offices. Furthermore, a decline in use across all contraceptive methods could signal an increase in intended pregnancy; as birth rate increased significantly in 2021. Nonetheless, contraceptive use may provide benefits besides pregnancy prevention, including a reduction in the risk of certain reproductive cancers.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/postercontraceptiveisporeph34updated123474-pdf.pdf?sfvrsn=aca858db_0","title":"Poster_Contraceptive_ISPOR_EPH34_Updated123474.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123474","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Using a Novel Machine Learning Algorithm to Diagnose Idiopathic Pulmonary Fibrosis","id":"e98de193-ea09-4cb0-89eb-e15bc5cf6a81","sessionCode":"EE68","topDisplay":"Cadham C1, Reicher J2, Muelly M2, Hutton DW1 1University of Michigan School of Public Health, Ann Arbor, MI, USA, 2Imvaria, Inc, Berkeley, CA, USA","locationCode":"314","description":"\r\n\t<div>BACKGROUND: Idiopathic Pulmonary Fibrosis (IPF) is challenging to diagnose. Patients are diagnosed through a combination of multidisciplinary discussion (MDD), high-resolution computed tomography, and surgical lung biopsy. Surgical lung biopsy is considered a core part of the gold standard. The costly invasive procedure carries a significant risk in both morbidity and mortality. Novel non-invasive classifier algorithms may improve the accuracy of IPF diagnosis and reduce the need for biopsy. OBJECTIVES: We conducted a cost-effectiveness analysis of a machine learning algorithm for the diagnosis of IPF. METHODS: We developed a decision-analytic model to determine the cost-effectiveness of a machine learning algorithm for diagnosing IPF in patients with chronic interstitial lung disease following an initial inconclusive assessment from an MDD. From the health system perspective using a lifetime horizon, we compare (1) the algorithm, (2) biopsy all patients, and (3) treating all patients. Input parameters were from the published literature and retrospective analyses of IPF patients. The primary outcome measures were costs, quality-adjusted life-years (QALYs), and biopsies averted. RESULTS: The algorithm reduced the number of biopsies by 41%. Treat all had an ICER of $3,190,788 per QALY compared to the algorithm. Compared to biopsy all, the algorithm had an ICER of $382,991 per QALY. The cost-effectiveness of the algorithm was driven primarily by treatment costs. In addition, results were sensitive to the risk of mortality from surgical lung biopsy and assumptions regarding follow-up diagnostics. CONCLUSIONS: We found that a novel classifier algorithm may provide additional benefits for diagnosing IPF as a clinical middle-ground. While at a high cost-effectiveness ratio, this is driven by high drug costs. The first generic treatments with reduced costs of ~20% greatly improve the ICER. As additional generic IPF treatments enter the market, cost-effectiveness will likely improve further. Sensitivity analyses illustrate screening technologies' complicated role in identifying diseases with limited, high-cost treatment options.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126091","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Value-Based Purchasing Arrangements in Medicaid Programs: Targeted Review","id":"3d89da08-c5b6-4dbb-9491-e18122cce678","sessionCode":"HPR31","topDisplay":"Necas K, Carlson JJ University of Washington, Seattle, WA, USA","locationCode":"530","description":"\r\n\t<div>OBJECTIVES: Recent guidance from the Centers for Medicare and Medicaid Services (CMS) has changed the “best price” reporting rules to ease the development of value-based purchasing arrangements (VPAs) between health technology developers and payers both within and outside Medicaid programs. VPAs are also known as outcomes-, value-, or performance-based contracts or arrangements. Limited documentation on the current use of these arrangements is available. This research aims to identify and characterize previously implemented Medicaid VPAs. METHODS: A targeted review was conducted from 2017 to 2022 in Embase, Google, PubMed, JMCP, and grey literature to identify publicly disclosed Medicaid VPAs. Search terms were a combination of: Medicaid plus value-, outcomes-, or performance-based contracts, agreements or arrangements. Publications that discussed Medicaid, FDA-approved pharmaceutical or FDA-cleared digital therapies, and search terms were included. Descriptive statistics were used to evaluate the cases identified and included the following categories: year of arrangement, manufacturer, therapeutic area, and outcome measure. RESULTS: Fourteen VPAs for 6 therapies across 4 states were identified. Oklahoma was the first Medicaid program to develop a pharmacy VPA with a manufacturer in 2018 and has implemented 8 to date. Subsequently, Colorado (2), Massachusetts (3), and Michigan (1) have developed arrangements. All 4 states entered into an arrangement with Novartis for Zolgensma for spinal muscular atrophy. The other drug and digital therapies publicly identified were Aristada, Orbativ, Entresto, reSET and reSET-O. There is limited data on the outcomes of these cases. CONCLUSIONS: This is the first study to review Medicaid VPAs in the United States. Only a small fraction of states have implemented VPAs to date. With the recent changes implemented by CMS, the number of executed VPAs may increase.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23necasposter124965-pdf.pdf?sfvrsn=5cd23b88_0","title":"ISPOR23_Necas_POSTER124965.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124965","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Inherited Retinal Disease and Subsequent Use of Homecare: Findings from the National Registries in Sweden 2001-2021","id":"d80ba4a6-5a0d-45e4-9f83-e1d182d032a0","sessionCode":"EPH36","topDisplay":"Wennberg A1, Häbel H1, Qu Y2, Li N3, Sperling M3, Feldman A1, Löfgren S1 1Karolinska Institutet, Stockholm, Sweden, 2Janssen Global Commercial Strategy Organization, Stockholm, Sweden, 3Janssen Global Commercial Strategy Organization, Raritan, NJ, USA","locationCode":"436","description":"\r\n\t<div>OBJECTIVES: Inherited retinal diseases (IRDs), which affect ~4.5 million people worldwide, are a diverse group of progressive conditions that can lead to significant vision impairment and blindness. IRD patients often need formal homecare, which is associated with high costs for patients and society. Evaluating resource utilization (e.g., homecare) and associated socioeconomic costs is important for understanding the impact of disease. METHODS: In a longitudinal cohort study using Swedish national register data, we investigated homecare use among IRD patients (ICD-10 H355 recorded at least twice). Homecare is part of the Swedish national care system and recorded in registers. We used multivariable logistic and Poisson regression models to compare homecare use among IRD patients. RESULTS: We identified 3557 IRD patients for the period 2001-2021, of whom 970 (27.3%) used homecare during 2013-2021. Patients who used homecare were older at diagnosis (p<0.001), a greater proportion were women (p<0.001), and they had a longer disease duration (p<0.001), compared to those who did not use homecare. In logistic regression models, patients aged ≥61 at diagnosis (OR=12.17, 95% CI 9.09, 16.29) and those diagnosed earlier (2001—2005) (OR=2.87, 95% CI 2.31, 3.56) had higher odds of homecare use. In Poisson regression models, homecare use was associated with mortality, independent of age and sex (IRR=1.39, 95% CI 1.20, 1.61). Compared to the total older Swedish population (≥65), 11% of whom used homecare, 36% of older IRD patients (≥61) used homecare. CONCLUSIONS: Homecare use was common among IRD patients and was associated with mortality, independent of patient’s age and sex. Older IRD patients and those diagnosed earlier, perhaps indicating more severe vision impairment, had greater odds of homecare use. These findings suggest that IRD patients have a significant need for homecare, which may place a burden on the care system and impact individual and societal economy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/posterv1123987-pdf.pdf?sfvrsn=61dd452f_0","title":"poster_v1123987.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123987","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Budget Impact of Anti-Inflammatory Reliever Therapy with Budesonide-Formoterol Combination in the Treatment of Mild Asthma in Honduras","id":"ec53659d-5ffb-4ae3-a8f6-e330162bc8e7","sessionCode":"EE73","topDisplay":"Ordoñez J1, Buitrago R2, Sosa Ferrari S3 1True Consulting, MEDELLIN, ANT, Colombia, 2AstraZeneca CAC, San José, Costa Rica, 3Hospital del Tórax, Tegucigalpa, FM, Honduras","locationCode":"316","description":"\r\n\t<div>OBJECTIVES: Asthma is a heterogeneous disease characterized by airway inflammation. Daily inhaled corticosteroid (ICS) plus short-acting beta-agonist (SABA) as a reliever is the standard of care (SoC) in Honduras for mild asthma. Anti-inflammatory reliever (AIR) therapy with budesonide–formoterol (Bud-Form) as needed is at least as effective as ICS monotherapy plus SABA as a reliever in reducing oral corticosteroid use, emergency room (ER) visits and hospitalizations; however, in Honduras, the information on the budget impact of the efficacy of AIR in patients with mild asthma is unknown. METHODS: We performed a model comparing Bud-Form as needed vs. daily ICS plus SABA as reliever therapy (SoC). Data about treatment-related outcomes are from published clinical trials and exacerbations medicines, ER visits, and hospitalizations from an advisory board with local pulmonologists. The first-year market share for AIR is 2%, 10% in the second year, and 15% in the third year; was assumed. Costs are in USD. Costs per inhaler: Bud-Form 160/4,5µg, $20.50; beclomethasone 100µg, $2.37; fluticasone propionate 250µg, $16.48; budesonide 200µg, $6.55; and salbutamol 100µg, $2.15. All inhalers have 120 inhalations, except beclomethasone and salbutamol, which have 200. All ICS need two inhalations/day; the mean number of inhalations: Bud-Form as needed=0.52 inhalations/day and salbutamol=0.98 inhalations/day. Compliance is 100% for all treatments. A population of 128,326 patients in the first year, 138,218 second year, and 148,325 third year was assumed. Relapsing average costs are $128 for an ER visit and $248 for a hospitalization. RESULTS: Bud-Form, as needed, saves $22,768 the first year (-0.4%), $122,704 a second year (-2.1%), and $197,514 the third year (-3.2%). The savings are directly proportional to the market share of patients using AIR therapy. CONCLUSIONS: In Honduras, the total budget impact over three years due to the introduction of Bud-Form as needed was $342,987, less expensive than SoC in patients with mild asthma.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127908","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Non-Pharmaceutical Interventions (NPI), Vaccines and the Combination of NPI and Vaccines in Managing the COVID Pandemic","id":"7f4b44b5-5343-427b-8353-e3802b62eb3e","sessionCode":"EE14","topDisplay":"Lou J1, Cai CGX1, Clapham H1, Teerawattananon Y2, Wee HL1 1National University of Singapore, Singapore, Singapore, 2Ministry of Public Health, Muang District, Nonthaburi, Thailand","locationCode":"217","description":"\r\n\t<div>OBJECTIVES: We estimated the cost-effectiveness of non-pharmaceutical interventions (NPI), vaccines, and the combination of NPI and vaccines in managing the COVID pandemic. METHODS: A dynamic transmission model was constructed to simulate the incidence of COVID infections and deaths among community-dwelling Singapore residents. Using this model, we compared the cost and outcomes of NPI (border control measures, safe distancing and mask wearing) versus no NPI in an unvaccinated and a vaccinated population. The analysis was conducted from the societal perspective over a one year time horizon, with data based on the COVID situation in Singapore during Jan 2021 to Dec 2021. Costs of vaccination, adverse events, masks, self-testing using rapid antigen tests, test-trace-isolate (TTI), outpatient visits, hospitalization, productivity loss and reduced sales receipt from retail and food and beverages industries were included. Health loss from adverse events, TTI and COVID infection and deaths were also included. RESULTS: Among the scenarios compared, vaccination combined with NPIs yield the lowest cost (S$7.6 billion), while no vaccination with NPIs had the highest costs (S$49.1 billion). The largest loss in QALYs from the population was seen from the scenario without vaccination or NPIs. Using a dominance approach, vaccination combined with NPIs is cost saving with an ICER of -S$213 billion per QALY, compared to no vaccination with lockdown measures. The results show that NPIs alone without vaccination only delays transmission, but does not significantly change the total number of cases observed in the population. Vaccination is both cost saving and health saving as the difference in cases averted from vaccination and their associated costs, is far greater than the additional costs required to vaccinate the public. CONCLUSIONS: Both vaccination and NPI are critical strategies for managing the COVID pandemic. In the presence of vaccine, NPIs continue to offer benefits in terms of reduced number of infections and deaths.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23weeposter126843-pdf.pdf?sfvrsn=de92e668_0","title":"ISPOR23_Wee_POSTER126843.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126843","diseases":[{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Impact of Novel Anti-Tumor Therapies on Mortality in Various Oncology Indications across EU5","id":"86378b4f-2a5c-4069-837c-e510089e553c","sessionCode":"CO25","topDisplay":"Shah S, Matangi S, Malempati Y, Koka NS, Syed AA, Nair S, Ahmad M, Patel K Market Access Solutions LLC / LTD (MKTXS), Raritan, NJ, USA","locationCode":"102","description":"\r\n\t<div>BACKGROUND: The burden of the four common cancers, i.e., lung, breast, colorectal, and prostate, has been gradually increasing globally. In 2020, Lung cancer remained the leading cause of cancer death, with an estimated 1.8 million deaths (18%), followed by colorectal (9.4%), liver (8.3%), stomach (7.7%), and breast (6.9%) cancers. Approximately 34 novel therapies targeting various pathways with different combinations gained EMA approval from the plethora of pipeline therapies in EU5 over the last 10 years. OBJECTIVES: To assess the impact of innovation in anti-cancer therapies on overall mortality in Lung, Breast, Colorectal, and Prostate Cancer in the EU5 (France, Germany, Italy, Spain, and the United Kingdom) from 2010 to 2020 METHODS: Secondary research was conducted to identify the mortality trends from English publications (France, Germany, Italy, Spain, UK) over the last 10 years. RESULTS: The age-standardized mortality rates of Lung, Breast, Colorectal, and Prostate Cancer in the EU5 (2010) are 24.15, 15.4, 11.53, and 10.94, respectively, and in the EU5 (2020), they are 21.64, 13.92, 10.66, and 8.92, respectively. With the introduction of 34 therapies over the last 10 years, there was a significant decrease in the mortality of lung cancer by 10%, breast cancer by 10%, colorectal cancer by 8%, and prostate cancer by 18%. But these novel therapies are highly expensive, and the predicted mean incremental anticancer drug cost increased from $30,447 in 2006 to $161,141 in 2015 (greater than five-fold increase). CONCLUSIONS: : With the innovation in oncology with target-specific therapies, all the EU5 countries reported a significant decrease in mortality over the last 10 years for all four cancers. Although these novel therapies are expensive, they are lifesaving, which increases the survival rates of the affected cancer patients</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/impact-of-novel-anti-tumor-therapies-on-mortality-in-various-oncology-indications-across-eu5126916-pdf.pdf?sfvrsn=2ad77263_0","title":"Impact of Novel Anti-Tumor Therapies on Mortality in Various Oncology Indications across EU5126916.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126916","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Insights and Lessons from Systematic Literature Review of Budget Impact Model Methodologies for United States Payers","id":"486ffb62-f244-4f36-a904-e513ca63240d","sessionCode":"EE87","topDisplay":"Aggarwal S1, Kumar S2, Topaloglu O1 1NOVEL Health Strategies, Bethesda, MD, USA, 2NOVEL HEALTH STRATEGIES, COLUMBIA, MD, USA","locationCode":"331","description":"\r\n\t<div>OBJECTIVES: United States payers have expressed concerns with budget impact models submitted to them for formulary review and/or pricing negotiations. The objective of this study was to review and develop lessons from published budget impact models for United States public and private payers. METHODS: A systematic literature review was conducted using PubMed and Medline for full text budget impact publications for United States public and private payers. The data were extracted for model methods: design, assumptions, time horizon, incorporation of adverse events, resource use, sensitivity analyses and payer perspective. Insights and lessons for new model development were generated from this review. RESULTS: Sixty seven (67) full text budget impact model publications for United States were identified and reviewed. Nearly half of the model publications claimed savings (30 of 67) or low/small budget impact (4 of 67). Adverse events were included in 21 models, and resource use (hospital, emergency room and nursing time) was included in 17 models. Cost-Effectiveness model structure was used in 10 models. Sensitivity analyses were reported in 33 publications (all one-way sensitivity analysis, no probabilistic analyses were reported). Most models focussed on commercial payer or Medicare perspective (37), while only 2 models were developed for Medicaid. The time horizons varied across publications, with an even mix of 3 and 5 years. The hypothetical plan size also varied across models (1, 5, 10 million), though 1 million was the most common plan size (24 models). Overall, models show a wide range of heterogeneity which could make it challenging for payers to accept and compare model results. CONCLUSIONS: US budget impact models show wide range of heterogeneity in methodology and assumptions. There is a need for a consistent modeling approach to improve acceptability by payers.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127146","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Quality Appraisal Checklist for Economic Evaluations: What Are Health Economists Thinking About?","id":"66e9689b-66e2-42d4-a430-e56f3ea7dc7d","sessionCode":"EE103","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"401","description":"\r\n\t<div>OBJECTIVES: This presentation will comprise a quantitative comparison of six most frequently used checklists including BMJ, CHEC, Drummond, QHES, CHEERS and Philip’s checklist , focusing on the issue concerning the methodological quality versus reporting quality and whether the level of experience of the reviewers impact on choosing checklists and assessing quality assessment. METHODS: Reviewers were recruited through publicly available email address invitations or via postings on websites and social media. Three reviewers with different levels of experience will independently assess one study using six identical checklists. Reviewers also ranked selected checklist items according to their perceived importance including ease of use, completeness and applicability. RESULTS: 34 health economists were recruited and have worked in different heath areas. For purpose of using the checklist, the majority of participants acknowledged the existing checklists they used before for both methodological quality and reporting quality even with CHEERs and BMJ checklists that are used for reporting quality only. Regarding ease of use of checklists, CHEC was rate at the highest followed by CHEERs while Phillip’s checklist was rated lowest followed by QHES. Regarding the comprehensiveness of the checklists, CHEERS and Drummond checklist were rated highest compared to QHES and CHEC which were rated lowest. In terms of applicability of the checklists, participant rated similarly across the checklists with the highest for CHEERs and BMJ and the lowest for QHES and Phillip’s checklist. While participants with no prior work experience rated CHEC as the highest ease of use and applicability while participants with over 5 years put CHEERs at first in these criteria. CONCLUSIONS: This is the first empirical evidence that can provide a starting point for future research that either may guide user’s selection of the most appropriate checklist for their particular purpose.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124952","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A New View on Quantification of Disease Modification: Two Case Studies from Parkinson’s Disease","id":"ce5da0bd-f499-48e2-b5af-e58bc594de70","sessionCode":"CO21","topDisplay":"Ivkovic M1, Gustavsson A2, Hahn-Pedersen JH1, Leon T1, Raket LL1 1Novo Nordisk A/S, Copenhagen, Denmark, 2Quantify Research, Stockholm, Sweden","locationCode":"122","description":"\r\n\t<div>OBJECTIVES: Therapies that slow disease progression are a major unmet need in neurodegenerative diseases, such as Parkinson’s disease (PD). Disease-modifying treatment effects are usually reported in terms of differences in outcome measures which can be difficult to interpret, especially by patients. Here we aim to explore an interpretable quantification of time delay of two PD therapies rasagiline (approved symptomatic PD therapy with potential disease-modifying effects) and prasinezumab (investigational anti-α-Synuclein antibody), based on published trial results. METHODS: Rasagiline and prasinezumab explored their potential for disease modification in two delayed-start trials (ADAGIO 36+36 weeks and PASADENA 52+52 weeks). Neither trial met primary endpoints but showed some promise for disease modification. Based on reported trial results, we calculate approximate estimates of the mean time-delay observed in the main and delayed-start parts of both trials. We focus on Unified Parkinson's Disease Rating Scale (UPDRS) total score (ADAGIO) and Movement Disorder Society UPDRS part III (PASADENA). RESULTS: At 36 weeks, both doses of rasagiline demonstrated delays in progression of more than 18 weeks (>50% slowing) compared to placebo representing both the symptomatic and potentially disease-modifying effect. At 72 weeks (36 weeks after delayed start of placebo group), the slowing of progression compared to the delayed-start cohort was maintained for the low dose (appx. 24 weeks), suggesting a potential disease-modifying effect, while the high dose showed no slowing. At 52 weeks, prasinezumab slowed progression by appx. 38% (20 weeks) compared to placebo. At 104 weeks (52 weeks after delayed start of placebo group) the delay in progression was maintained (appx. 28 weeks). CONCLUSIONS: Results from ADAGIO and PASADENA are inconclusive, due to differences in results across doses or outcomes. Regardless, estimation of time delays by methods such as the progression model for repeated measures could be helpful in quantifying disease-modifying aspects of treatments.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23ivkovicposter124826-pdf.pdf?sfvrsn=8da34864_0","title":"ISPOR23_IVKOVIC_POSTER124826.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124826","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Budget Impact of Faricimab in Patients with Diabetic Macular Edema and Neovascular Age Related Degeneration in Canada","id":"2d56581b-6bc7-48ca-a0dc-e680d628a84a","sessionCode":"EE76","topDisplay":"Bührer C1, Diles D2 1F. Hoffmann-La Roche, Basel, BS, Switzerland, 2Hoffmann-La Roche Limited, Mississauga, ON, Canada","locationCode":"318","description":"\r\n\t<div>OBJECTIVES: Faricimab is a bispecific antibody targeting ANG-2 and VEGF for the treatment of DME and nAMD. In the pivotal clinical trials, patients treated with faricimab in a Treat & Extend (T&E) regime required less frequent treatments compared to Aflibercept given every eight weeks (Q8W) with non-inferior vision changes. Clinical practice in Canada is typically characterized by pro re nata regimens as well as T&E. This research aims to assess the budget impact of faricimab vs. anti-VEGF treatments applied in such regimens. METHODS: A budget impact model was developed in Microsoft®Excel® to estimate drug costs related to the treatment of DME and nAMD. The analysis was based on the patient population estimated using province-specific data, Canadian epidemiological data, projected market shares, and list prices. Incremental drug costs were compared for each forecast year and over the entire three-year forecast period (2023 to 2025). We included a pan-Canadian analysis as well as a scenario analysis for two provinces (British Columbia and Ontario) to illustrate the impact of a bevacizumab first vs. no mandated first line use policy. RESULTS: Across Canada and combining both indications, it was estimated that faricimab resulted in cost savings of $10,045,236 for Year 1, $43,743,804 for Year 2, $88,675,700 for Year 3, and $142,464,740 cumulatively. Scenario analyses results showed the base case results were robust. The cumulative three-year costs savings in Ontario were $79,855,003 and $6,344,228 in British Columbia respectively. CONCLUSIONS: Over the three-year time horizon, it was estimated that the introduction of faricimab would lead to substantial cost savings. Albeit the savings were less pronounced in provinces with intensive use of bevacizumab, faricimab still leads to significant cost savings replacing less durable treatments. Given the cost savings and clinical benefit of faricimab, the availability provides an additional option in addressing the current unmet needs in DME and nAMD.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/faricimab-dme-namd-bim-isporus23-30032023126624-pdf.pdf?sfvrsn=6a5be38d_0","title":"Faricimab DME nAMD BIM ISPORUS23 30032023126624.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126624","diseases":[{"id":"e29b1bc3-a98e-49c1-8bc2-2975bb5fac5e","parentId":"00000000-0000-0000-0000-000000000000","title":"Sensory System Disorders (Ear, Eye, Dental, Skin)","urlName":"sensory-system-disorders-ear-eye-dental-skin"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Advantages of Fixed-Dose Combination (FDC) Products over Loose Dose Combination (LDC) Products: A Systematic Literature Review (SLR)","id":"3e1864b7-d75b-4a51-91e7-e6f2f85cac39","sessionCode":"PCR45","topDisplay":"Worden C1, Tran J2, Winberg D1, Grieve S3, Thakur D4, Wyckmans J5, Linder J6, Gurjar K4 1Janssen Scientific Affairs, Inc., Titusville, NJ, USA, 2Cytel Inc., Waltham, MA, USA, 3Cytel Inc., Montreal, QC, Canada, 4Cytel Inc., Toronto, ON, Canada, 5Janssen Pharmaceutical Companies of Johnson & Johnson, Basel, Switzerland, 6Janssen Cilag GmbH, Neuss, Germany","locationCode":"804","description":"\r\n\t<div>OBJECTIVES: FDC products provide benefits for patients such as ease, convenience and a single co-payment. However, for FDC superiority vs LDC products is inconclusive and therefore we sought to evaluate existing published evidence on the benefits of FDC formulations. METHODS: We conducted a SLR on data published (Jan 2001–Dec 2021) comparing FDC and LDC products in: 1) clinical trials, 2) real-world evidence (RWE), 3) health-related quality of life (HRQoL) and 4) health economics. Databases and registries were searched following PRISMA guidelines. Search terms included “fixed or single pill” and “free or loose combination” with related terms along with validated study design filters. Studies were included if medication adherence, compliance, persistence, HRQoL or economic outcomes were reported for FDC and LDC products. RESULTS: There were 109 original studies identified. All health economic (25 studies) studies favored FDC over LDC: showing dominance, cost savings, and lower healthcare resource use. In the RWE studies, compared with LDC, there was statistically significant higher persistence with FDC in 16/19 studies, higher adherence in 15/20 studies, and higher compliance in 2/4 studies. Of 14 studies evaluating efficacy and adherence/compliance/persistence, 6 (43%) showed a positive correlation between these parameters. In clinical trials, similar adherence (13 studies) and compliance (4 studies) was observed. In the identified HRQoL studies, pill burden was not assessed. Similar HRQoL was observed with both FDC and LDC formulations (one study showed a statistically significant benefit for FDC vs LDC). CONCLUSIONS: SLRs showed significant benefits of FDC over LDC in terms of cost-effectiveness, cost savings and healthcare resource use. In most (77%) real-world studies, medication adherence, compliance and persistence were significantly improved for FDC vs LDC. RCTs are not appropriate to assess adherence, compliance and persistence as patient behavior differs in trial settings vs the real world.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/janssen-stct-slrposterfinal17apr2023clean125776-pdf.pdf?sfvrsn=b9489fba_0","title":"Janssen STCT SLR_poster_final_17APR2023_clean125776.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125776","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Cost Effectiveness of Telehealth and in-Person Care Versus in-Person Care for Adults with Co-Occurring Mental Health and Substance Use Disorders","id":"3438338b-8f61-40cb-8a2a-e732f27013b6","sessionCode":"HTA2","topDisplay":"Goldwater J Laurel Health Advisors, LLC, Laurel, MD, USA","locationCode":"608","description":"\r\n\t<div>OBJECTIVES: Telehealth has proven effective with many disorders, but there is a paucity of data on the cost-effectiveness of telehealth on individuals 18 and over with co-occurring mental health and substance use disorders. This analysis was designed to build a decision analytic model to evaluate medical interventions using telehealth and in-person care or just in-person care to treat adults 18 and over with these conditions. METHODS: We tracked the progression of depression, substance use disorder, and cumulative death among adults 18 and over using a Markov model with 50 annual cycles through three health states. Deterministic and probabilistic sensitivity analysis addressed uncertainly in estimating the parameters and around the model's assumptions. RESULTS: A medical and behavioral health system that integrates telehealth and in-person care are cost-effective at a willingness to pay $50,000 per Quality Adjusted Life Year (QALY) compared with in-person care only. The incremental cost was $13,685, and the incremental effectiveness was a 27.7 QALY with an incremental cost-effectiveness ratio of $2,341 per QALY. CONCLUSIONS: Appropriate referrals to integrated mental and substance use services using a hybrid approach of telehealth and in-person care is beneficial in reversing losses in quality of life and death.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporsudsmi2023127548-pdf.pdf?sfvrsn=be47e6fd_0","title":"ISPOR_SUD_SMI_2023127548.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127548","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Development and Validation of the Natural History Component of an Economic Model for Primary Sclerosing Cholangitis","id":"ac184a80-65ca-4ddf-8107-ea421590011d","sessionCode":"EE59","topDisplay":"Bowlus C1, Levy C2, Kowdley KV3, Kachru N4, Kaushik A4, Jeyakumar S5, Rodriguez-Guadarrama Y6, Smith N6, Briggs A7, Sculpher M8, Ollendorf D9 1University of California Davis School of Medicine, Sacramento, CA, USA, 2University of Miami School of Medicine, Miami, FL, USA, 3Liver Institute Northwest, Seattle, WA, USA, 4Gilead Sciences Inc., Foster City, CA, USA, 5Maple Health Group, LLC, Jersey City, NJ, USA, 6Maple Health Group, LLC, New York, NY, USA, 7London School of Hygiene & Tropical Medicine, London, LON, UK, 8University of York, York, NYK, UK, 9Tufts Medical Center, Boston, MA, USA","locationCode":"309","description":"\r\n\t<div>OBJECTIVES: Primary sclerosing cholangitis (PSC) is a rare, chronic cholestatic disease that can progress to cirrhosis, liver failure, and secondary cancers. Disease progression is typically non-linear, with no clearly defined milestones or disease stages. Several drugs are under investigation, but no economic model for PSC exists to evaluate the value of new treatments. The objective of this study was to develop an early economic model framework for PSC and validate through discussions with clinical and health economic experts. METHODS: A Markov-cohort model was developed to simulate PSC progression over a lifetime time horizon. The framework for disease progression, as well as inputs for disease progression, mortality, and adverse events were determined by literature review. The preliminary model structure and input values were validated with 3 US clinical experts and 3 health economic experts. An alternative structure accounting for the complications of cancers secondary to PSC was also explored. Fibrosis staging was used to model disease progression for PSC-related liver complications. Model outcomes included overall and transplant-free survival, incidence of liver transplants (LTs), the rate of recurrent PSC (rPSC) and LTs after rPSC. RESULTS: The conceptual model aligned upon with the experts estimated the overall survival for PSC patients to be 23.1 years and transplant-free survival to be 21.5 years, in line with values from the literature of 21.9 and 18.3 years, respectively. The estimated rate of LT in the lifetime of PSC patient was 14%. The rate of rPSC was estimated to be 3.39%. Within rPSC patients, the rate of second LT was estimated at 3%. CONCLUSIONS: An early economic model framework was developed to replicate the progression of PSC. Model results validated the accuracy of the disease progression component of the model framework. This may serve as the foundation of models to evaluate the benefits of future treatments.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23bowlusposter126987-pdf.pdf?sfvrsn=a83661af_0","title":"ISPOR23_Bowlus_POSTER126987.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126987","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Developing a Risk Prediction Model for Heart Failure (HF) Incidence in Patients with Diabetes Mellitus Using AI &AMP; Ml Techniques","id":"e1a81640-577c-4eb8-95c7-ea7a373e062d","sessionCode":"RWD4","topDisplay":"Verma V1, Sharma S2, Markan R2, Dawar V2, Bhargava S3, Brooks L4, Musle A2, Kumar S2, Nayyar A2 1Optum, Gurgaon, HR, India, 2Optum, Gurugram, HR, India, 3Optum Tech, Eden Prarie, MN, USA, 4Optum, Basking Ridge, NJ, USA","locationCode":"810","description":"\r\n\t<div>OBJECTIVES: This model aims at predicting incidence of HF in patients with Diabetes, based on multiple risk factors. Early identification will enable healthcare providers in early intervention and delaying disease progression. METHODS: Based on ICD-9 and ICD-10 codes, 165,963 diabetics, aged 18 years and above were identified using Optum’s Market Clarity Database. Patients with continuous eligibility for 5 years (2015 to 2019), having at least one yearly claim for Diabetes were included in the analysis. Of the overall cohort, 53,534 diabetic patients were found to have at least one inpatient OR 2 outpatient claims (>=60 days apart) for HF between January 2019 to December 2019. Patients having claim for HF in the pre index period (5 years) were excluded from the analysis. A multivariate analysis was conducted to develop a prediction model by incorporating 36 variables like demographics, comorbidities and Sign and Symptoms during pre-index period using feature selection techniques. Training and evaluation of Logistic Regression, XGBoost and Random Forest Classifier were executed. The models were trained and tested using 80:20 ratio of total subjects. RESULTS: The AUROC is 0.828 for Logistic Regression. The model identified HF and non-HF patients with 68% and 78% precision respectively. Odds ratio (OR) indicates higher probability of having HF in Diabetics with risk factors like Atrial fibrillation (OR: 2.55), Renal failure (OR: 2.77), Ventricular hypertrophy (OR: 2.06), COPD (1.86), Myocardial infraction (2.51), Respiratory (1.31) and Musculoskeletal symptoms (1.24). Further analysis would be performed by including more features and multiple iterations on various ML models to enhance HF prediction. CONCLUSIONS: The predictive model worked effectively in identifying risk factors for HF in patients with diabetes. It would improve outcomes by providing physicians with tools and data to identify patients risk factors. Payers can utilize this model in optimizing their pricing strategy for patients at risk of developing HF.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/heart-failure-posterispor2023126876-pdf.pdf?sfvrsn=75fa333a_0","title":"Heart Failure Poster_ISPOR2023126876.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126876","diseases":[{"id":"3597f8d1-60cd-4a60-b852-9d842ea4edf9","parentId":"00000000-0000-0000-0000-000000000000","title":"Cardiovascular Disorders (including MI, Stroke, Circulatory)","urlName":"cardiovascular-disorders-including-mi-stroke-circulatory"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Analysis of the Dispensing and Calculation of the per Capita Value of Feeding Formulas Nutritional Consumption in Colombia 2022","id":"4a5cb5e2-7928-49f9-9de7-eb08b14841cc","sessionCode":"HSD15","topDisplay":"ABSTRACT WITHDRAWN","locationCode":"601","description":"\r\n\t<div>OBJECTIVES: The dispensing of nutritional formulas for the management of clinical pathologies has increased remarkably during the last 2 years, showing an increase in the cost of health dispensations, this increase is justified in part by the inclusion in the health benefits plan. For this reason, this study analyzes the dispensing of these nutritional formulas and calculates the per capita cost for Colombia METHODS: A descriptive analysis of the dispensing of the year 2022 was carried out with the databases of a pharmaceutical manager, the amounts of oral administration liquid and powder formulas were included, it was classified by pathology of use, and it was valued with the prices adjusted to the drug system of the Colombian Ministry of Health. The per capita value was obtained with the population reported by the national planning department for 2022 RESULTS: There is an increase in the frequency of use, for 2021 of 5.2/100,000 users compared to 7.2/100,000 users in 2022. The classification by indication of use of nutritional showed a higher frequency of use for patients in critical care with 33.0%, followed by malnutrition with 29.7%, diabetes 12.1%. The national per capita cost would be around COP 1,063 per year (USD 0.22). CONCLUSIONS: The per capita cost of feeding formulas nutritional dispensing for 2022 corresponds to 0.11% of the UPC for the same year.</div>\r\n\r\n","withdrawn":true,"categories":[{"id":"14023d0b-776e-43fa-8552-0cd263b29305","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Service Delivery & Process of Care","urlName":"health-service-delivery-process-of-care"}],"categoryIds":["14023d0b-776e-43fa-8552-0cd263b29305"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127564","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient‑Reported Outcomes to Support Regulation, Reimbursement and Health Policy Among Patients with Head and Neck Cancers: A Systematic Review","id":"c3cc234e-ca14-4d1d-afdc-ebd132f1b2a8","sessionCode":"PCR21","topDisplay":"Joshi M1, Iquebal S1, G KY2, Johri S2 1Hamdard University, Delhi, DL, India, 2BITS Pilani, Pilani, India","locationCode":"733","description":"\r\n\t<div>OBJECTIVES: Head and Neck cancers (HNCs) account for 4% of all cancers, causing 15,000 deaths annually in the US. Patient-reported outcomes (PROs) may regulate global reimbursement processes for HNCs. This review aims to encapsulate utilization of PROs in HNCs in real-world (RW) setting for supporting reimbursement, and framing health policies. METHODS: The review was conducted as per PRISMA. PubMed and Embase database were searched and supplemented by searches on google scholar and HTA websites to include RW studies. RESULTS: Ten records fulfilled the eligibility criteria. The most recommended and validated PROs were: University of Washington Quality of Life Scale (UW-QoL); European Organization for Research and Treatment of Cancer (EORTC-QLQ-HNC); Functional Assessment of Cancer Therapy-Head and Neck (FACT-HNC). PROs were assessed at various stages of HNC: diagnosis (Satisfaction with Cancer Information profile); treatment (Symptom Severity Scale); drug toxicity (Oral Mucositis Weekly Questionnaire-Head and Neck Cancer); recovery (FACT-HNC); recurrence (Vanderbilt Head and Neck Symptom Survey) and palliation (EORTC QLQ-C15-PAL). Voice, speech and swallowing were perceived to be troublesome and required appropriate PROs (Voice Handicap Index, Speech Handicap Index and Swallowing Questionnaire on QoL) to evaluate their impact on the patients’ QoL. The use of ePROs with patient education was advocated allowing remote and out-of-hospital reporting. PRO measurement during surgical timeline was considered a critical component, necessary to increase the understanding and impact of pre-habilitation interventions. PRO evaluation in a surgical timeline could be improved by effective communication and using activity tracker, substantiating accurate PRO recordings. Other barriers for using PROs were: lack of awareness and resources; unproven or unvalidated PROs. CONCLUSIONS: Limited RWE is available for the utilization of PROs in HNCs. Combining PRO outcome measures at different stages may allow for the development of targeted interventions. The use of PROs may tailor rehabilitation and refine future strategies for better patient care.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/20230425hnc-poster-ispor-usa-2023123680-pdf.pdf?sfvrsn=b0201830_0","title":"20230425_HNC Poster_ ISPOR USA 2023123680.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123680","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Outcomes of Non–Vitamin K Antagonist Oral Anticoagulants Versus Warfarin in Patients with Atrial Fibrillation and Diabetes Mellitus: A Systematic Review of Randomized Controlled Trials and Observational Studies","id":"8a5d0ef3-0c55-47bb-8882-ebed70eb9beb","sessionCode":"CO4","topDisplay":"Wang R1, Lien PW2, Borrow A1, Fleishman D1 1Daiichi Sankyo Inc, Basking Ridge, NJ, USA, 2University of Illinois Chicago, Chicago, IL, USA","locationCode":"108","description":"\r\n\t<div>OBJECTIVES: Concomitant diabetes mellitus (DM) increases risk of unfavorable outcomes among patients with atrial fibrillation (AF). The beneficial effect of non–vitamin K antagonist oral anticoagulants (NOACs) vs warfarin on both stroke and bleeding prevention within this population was established in meta-analyses. Comparisons between NOACs via meta-analyses may not be appropriate, considering the heterogeneity between studies. This study aimed to identify differences between original studies of NOACs vs warfarin to support interpretation of results across studies. METHODS: A systematic search of PubMed was performed to identify relevant outcome studies. RESULTS: Four randomized controlled trials (RCTs) and 5 observational studies comparing NOAC(s) vs warfarin in patients with AF and DM were identified. Among the 4 pivotal RCTs for each NOAC, patients from the edoxaban trial had the highest baseline stroke risk score; a baseline bleeding risk score or a common proxy was not available across studies. Dabigatran and edoxaban were the only NOACs to significantly reduce stroke (hazard ratio [HR]: 0.61, 95% confidence interval [CI]: 0.41–0.91) and major bleeding risk (HR: 0.79, 95% CI: 0.65–0.96) compared to warfarin. Among the 5 observational studies, either matching/weighting using propensity score or regression analyses were applied to adjust for covariates and balance between groups. However, baseline bleeding risk and diabetic-related factors were not assessed in every study. Definition of effectiveness and safety endpoints also differed across studies. Overall, NOACs were better than or comparable with warfarin with regards to stroke and bleeding prevention. CONCLUSIONS: NOACs are more effective and safer than warfarin in patients with AF and DM in both clinical-trial and real-world settings. Appropriate covariate adjustment and standardized outcome measures will be required in future studies to make a comparison between NOACs across different studies possible.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23dongposter126336-pdf.pdf?sfvrsn=861ce50c_0","title":"ISPOR23_Dong_POSTER126336.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126336","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Variation in Demographic Characteristics, Socioeconomic Status, Clinical Presentation and Selected Treatments in Mortality Among Patients with a Diagnosis of COVID-19 in the United States","id":"e4095e24-ac8f-498b-8949-ec702caaf3cb","sessionCode":"RWD26","topDisplay":"Wade R1, Doshi R2, Tian D3 1IQVIA, Crozet, VA, USA, 2IQVIA, Falls Church, VA, USA, 3IQVIA, Wayne, PA, USA","locationCode":"835","description":"\r\n\t<div>OBJECTIVES: COVID-19 infected over 150 million people and caused over 1 million deaths in the US. This study evaluates several variables thought to be associated with mortality risk in the COVID-19 population. METHODS: The IQVIA longitudinal medical and pharmacy claims databases identified 17,682,111 patients with a COVID-19 diagnosis between 4/1/2020-4/30/2022 from a population of >277 million patients in the US. Patients were linked to Veritas Data Research fact-of-death records (90% complete compared to CDC reporting) and confirmed deaths were flagged. Confirmed mortality rates (CMR) were evaluated by age group, socioeconomic status (SES) using the Area Deprivation Index (v2.0, University of Wisconsin, 2015), co-morbidities and COVID-specific (approved and unapproved) treatments. RESULTS: Of the 563,744 patients (3.2%) identified as dead (3.67% in men, 2.85% in women overall), CMR was lowest in patients aged 0-17 (0.08%), highest in age 65-75 (5.92%) and >75 (16.40%). Patients in the lowest 40% of SES had CMR of 4.43% while in the highest 20% was 1.56%. Respiratory failure, pneumonia and sepsis were the most common acute diagnoses accompanying COVID-19 deaths in all SES. In patients with comorbid dementia or Alzheimer’s disease, CMR were 21.62% and 23.40% respectively. Additionally, congestive heart failure (15.79%), atrial fibrillation (15.50%), chronic kidney disease (15.30%) and COPD (12.19%) were associated with high CMR. Among patients receiving approved therapies, casirivimab/imdevimab and remdesivir had CMR of 1.41% and 12.63% respectively, while for those receiving unapproved therapies, ivermectin and hydroxychloroquine had CMR of 2.54% and 2.45%. CONCLUSIONS: Compared to the 1.1% case-mortality rate (Johns Hopkins 2023) among US COVID-19 patients, we found CMR exceeded 3% among those with a medical claim for COVID-19. Advanced age, dementia, and cardio-renal disease were associated with mortality. Patients with the lowest SES had approximately 3 times the confirmed mortality rate compared to those in the highest SES group.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23wadeposterrwd26125273-pdf.pdf?sfvrsn=537f5179_0","title":"ISPOR23_Wade_POSTER_RWD26125273.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125273","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Systematic Literature Review to Evaluate Randomized Clinical Trials of Advanced Therapies for Moderate to Severe Crohn's Disease","id":"a3a32fa4-dff7-43c9-83c8-ec93d7c7db76","sessionCode":"CO11","topDisplay":"Yousif Z1, Schultz BG1, Candela N1, Harold S2, Bell J2, Turpin R1, Hartley L2 1Takeda Pharmaceuticals U.S.A., Inc., Lexington, MA, USA, 2RTI Health Solutions, Didsbury, Manchester, UK","locationCode":"113","description":"\r\n\t<div>OBJECTIVES: We conducted a systematic literature review to identify randomized controlled trials (RCTs) investigating the efficacy and safety of advanced therapies for Crohn’s disease (CD). METHODS: Literature searches were conducted in six databases (including MEDLINE, Embase, and Cochrane databases) on August 25, 2022, without geographic, language, or date restrictions. Additional searches were conducted in conference proceedings, regulatory websites, trial registries, and bibliographies. Records were screened by two independent reviewers to identify phase 2–4 RCTs of prespecified advanced therapies in adults with moderate to severe CD. Data were extracted from eligible studies reporting at least one prespecified outcome of interest. Study quality was assessed using the Cochrane Risk of Bias tool. RESULTS: Data for 51 RCTs were extracted from 240 records. Half of the studies (N = 26) were double-blind, multinational, phase 3 RCTs. Mean patient age (28–47 years), disease duration (1–16 years), and CD activity index (CDAI) score (88–364) varied across studies, as well as the proportion of men (0–87%), and patients with a history of fistulizing disease (0–100%). Clinical remission was the most reported efficacy outcome, defined as a CDAI score ≤ 150, although six studies used additional definitions based on stool frequency and abdominal pain scores. The Inflammatory Bowel Disease Questionnaire was the most reported health-related quality of life outcome. Overall, study quality was good, despite uncertainty in some quality domains. CONCLUSIONS: The use of CDAI to measure efficacy was common among the studies; however, variability in baseline characteristics and timing of outcome measurements presents challenges in generating strong comparative evidence. Further analyses are needed to determine whether these differences can be addressed quantitatively and provide insight into the comparative efficacy of advanced therapies for CD. An emerging trend was observed for the inclusion of patient-reported outcomes in the clinical remission definition.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23schultzposter124625-pdf.pdf?sfvrsn=68d5c997_0","title":"ISPOR23_Schultz_POSTER124625.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23schultzhandout124625-pdf.pdf?sfvrsn=b0f37e8f_0","title":"ISPOR23_Schultz_HANDOUT124625.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124625","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Economic Evaluation of Multi-Sectoral Public Health Programmes: A Scoping Review","id":"c0a5ee85-ecd3-4082-8211-ee436f2123b5","sessionCode":"EE104","topDisplay":"Seninde I, Booysen F University of the Witwatersrand, Johannesburg, South Africa","locationCode":"400","description":"\r\n\t<div>OBJECTIVES: Economic evaluation aims to compare costs and consequences of alternative programmes. The conventional approaches tend to capture health related outcomes, and are not well suited to evaluate public health programmes with multiple outcomes across various sectors. While there is a growing body of research that seeks to address such existing methodological challenges, an overview of these developments is still lacking.This scoping review aims to map methodological literature, appraise the quality of applied case-studies and identify priorities for further research of economic evaluation of multi-sectoral public health programmes. METHODS: We systematically searched for relevant English literature across five electronic databases: PubMed, PROQUEST Central, EBSCOhost, SCOPUS and the National Health Service-Economic Evaluation Database (NHS-EED), from their date of inception to 24 May 2022. We included applied case-studies, methodological- and theoretical papers that applied a multi-sectoral approach to economic evaluation for public health programmes. We presented a narrative summary of the existing conceptual or methodological approaches, as well as a qualitative appraisal of the methodological quality of included case-studies based on a standardized checklist. We further conducted thematic coding to identify dominant themes for further research. RESULTS: Eight methodological approaches, ten applied case-studies and thirteen priority-or agenda setting records were included. Approaches that aggregate outcomes in monetary units (e.g., cross-sectoral cost–benefit analysis) emerged as the most frequently applied. Our review identified significant variations in methodological quality, which undermines conclusions on the cost effectiveness of multi-sectoral public health programmes. CONCLUSIONS: This scoping review provides a far-reaching, yet narrative overview of methodological research. Further research should prioritize development of instruments that enable valuation and aggregation of cross-sectoral outcomes using a more comprehensive economic evaluation framework that can address the existing methodological uncertainty related to economic evaluation of multi-sectoral public health programmes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23senindeposter125899-pdf.pdf?sfvrsn=b89e4e56_0","title":"ISPOR23_Seninde_POSTER125899.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125899","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"International Generic Availability Improvements between 2010 and 2021","id":"7886d75f-721b-4202-a61a-ee8ef493a8ce","sessionCode":"HPR18","topDisplay":"Gaudette E, Pothier K PMPRB, Ottawa, ON, Canada","locationCode":"521","description":"\r\n\t<div>OBJECTIVES: Although expensive new medicines occupy much policy attention, older and less expensive generic drugs make up the majority of drugs used internationally and are vital to population health. This research aims to rank a group of countries with similar pharmaceutical environments on their generic drug market’s vitality. METHODS: We use oral solid drug sales data from IQVIA’s MIDAS database and population data from the OECD for the period 2010-2021. We investigate trends in the distribution of medicines sold by number of available generics, the number of companies selling generics, generic sales per capita, and bilateral price ratios. We compare the generic markets of the United States, Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Norway, Spain, Sweden, and the United Kingdom. RESULTS: While the countries investigated showed important variance in all metrics, international generic availability and competition indicators considerably improved since 2010. In 2021, the median country sold generics for 73% of the oral solids on its market, a 12-pp increase from 2010. Similarly, the median country saw a rise of 10 pp in the proportion of oral solids with competing generics between 2010 and 2021, which increased from 44% to 54%. The US led other countries in most metrics, including the number of competing manufacturers selling generics (N=251 in 2021), the number of generic medicines sold (N=12,851), and the proportion of medicines with competing generics (78%), while Canada had the highest generic spending per capita (US$ 109). Smaller countries tended to rank lower in most metrics. CONCLUSIONS: Availability and competition in international generic markets have markedly improved between 2010 and 2021. For most metrics, the US ranks favorably relative to other countries, showing greater than median generic availability, competition, and sales.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126133","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Fluctuation in Treatment Initiation: Increasing the Accuracy of Modeling Patient Entry in Budget Impact Analyses","id":"0c578cf4-4c25-434d-b456-ef8888ca2fb5","sessionCode":"EE102","topDisplay":"Neves C1, Bappoo Y2, Bjerke A3, Bruette R4, Meng Y5 1Lumanity, Utrecht, Netherlands, 2Lumanity, London, LON, UK, 3Lumanity, Bethesda, MD, USA, 4Lumanity, Independence, MO, USA, 5Lumanity, Inc., Las Vegas, NV, USA","locationCode":"404","description":"\r\n\t<div>OBJECTIVES: Seasonal variation in disease incidence, screening, and diagnosis has been extensively reported and impacts treatment initiation. However, budget impact analyses typically assume that patients initiate treatment at the start of each year. We explored whether accounting for fluctuations in patient entry timing affects budget impact projections. METHODS: We developed a budget impact model in Microsoft Excel® using dummy data to test different patient entry patterns: yearly intervals (Scenario 1); weekly intervals assuming even distribution throughout the year (Scenario 2); and weekly intervals assuming 70% of entries in winter, spring, summer, and fall months (Scenario 3–Scenario 6, respectively). 150–250 patients initiate treatment each year and are followed up in weekly cycles. The post-launch uptake of the hypothetical intervention is 10% in Year 1, 30% in Year 2, and 50% in Year 3. The intervention is administered every 2 weeks ($150/administration; 1.15% weekly discontinuation probability), and the comparator is administered every 3 weeks ($250/administration; 1.72% weekly discontinuation probability). Following discontinuation of the intervention or comparator, patients receive subsequent treatment. RESULTS: The direction of the budget impact (negative/cost saving or positive/cost increase) varies between years and scenarios. The 3-year cumulative budget impact for all weekly entry scenarios (Scenario 2–Scenario 6) is less than half of that in the standard yearly entry scenario (Scenario 1): $28,045, $8,615, $14,018, $13,129, $5,627, and $2,148 for Scenario 1 through Scenario 6, respectively. CONCLUSIONS: The pattern of patient entry affects budget impact estimates, with the potential to distort reimbursement decisions and price negotiations. With increased access to real-world data, clinical and diagnostic treatment patterns can be reviewed and modelled based on electronic health records and claims data – including, for example, the number of patients diagnosed, the time from diagnosis to treatment, and the treatments provided in a population.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23nevesposter126247-pdf.pdf?sfvrsn=9d33a790_0","title":"ISPOR23_Neves_POSTER126247.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126247","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Minimization Analysis to Two Surgical Treatments of Benign Prostatic Hyperplasia in the Brazilian Private Health Sector","id":"fdd50895-80c1-4c49-af17-f0a29fefed6f","sessionCode":"MT5","topDisplay":"Rodrigues S1, Tortele H2, Contó M3 1Boston Scientific, São Paulo, SP, Brazil, 2Boston Scientific, Santo André, SP, Brazil, 3Boston Scientific, São Paulo, Brazil","locationCode":"637","description":"\r\n\t<div>OBJECTIVES: Benign prostatic hyperplasia (BPH) can be defined as an enlargement of the prostrate and it is a very prevalent condition affecting almost 90% of the men older than 80 years old. An enlarged prostate gland can cause uncomfortable urinary symptoms, such as blocking the flow of urine out of the bladder. Technologies using laser have emerged as an alternative to meet the challenges in treating BPH patients with efficacy and safety superior to the Transurethral Resection of the Prostrate (TURP), the current gold standard. This analysis aims to evaluate the economic impact of Laser Photovaporization of the Prostrate (PVP) in the treatment of BPH within the Brazilian health private sector. METHODS: This study carried out a cost-minimization analysis using a decision tree model to compare PVP to TURP. This economic evaluation also included a subgroup analysis of patients with higher surgical risk (higher risk of bleeding due to the use of anticoagulant/antiplatelet therapies). RESULTS: The incorporation of PVP for the surgical treatment of BPH both in patients with higher medical risk and patients with no risk restriction is cost-saving, resulting in savings higher than US$ 4 thousand and near US$ 1 thousand respectively per treated patient. In the sensitivity analysis, the variable with higher influence in the results was the length of stay that is greatly correlated to the intercurrences caused by bleeding and other adverse events. Further, the budgetary impact analysis showed savings of over US$ 13 million for the 5-year time horizon considering that high-risk patients and US$ 8 million for patients with no risk restriction. CONCLUSIONS: This analysis demonstrated PVP é a cost saving alternative to the current gold-standard in the treatment of low urinary tract symptoms related to BPH in the Brazilian private health sector.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/mt5127073-pdf.pdf?sfvrsn=23d5b5e5_0","title":"MT5127073.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127073","diseases":[{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"},{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"A Novel Patient-Centered Real-World Evidence Study Designed to Better Understand Chronic Inflammatory Demyelinating Polyneuropathy Using Longitudinal Data in the United States","id":"4d16adf5-3bf9-4e5e-8af4-f0b835e78c32","sessionCode":"RWD22","topDisplay":"Kuk D1, Chen BPH1, Kudesia V1, Tsai R1, Hoke A2 1Inspire, Arlington, VA, USA, 2Johns Hopkins University, Baltimore, MD, USA","locationCode":"830","description":"\r\n\t<div>OBJECTIVES: Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare autoimmune inflammatory disorder of the peripheral nervous system. Evidence is limited with the real-world patient population. The aim of the study is to better understand patient demographics, diagnostic journey, healthcare resource utilization (HCRU) and treatment patterns of patients in the Inspire CIDP cohort using primarily medical claims and user-generated contents. METHODS: A retrospective study using data from the Inspire Integrated Analytical Database, which links Inspire member data with medical and pharmacy claims through HIPAA-compliant tokenization. Inspire members with ≥ 1 diagnosis of CIDP (ICD-10 G61.81) from 01/01/2015 to 11/30/2021 were included. Index date was defined as the date of first claim with a CIDP diagnosis. Baseline patient characteristics and all-cause and CIDP-related HCRU were evaluated. Descriptive statistics were reported. RESULTS: A total of 438 CIDP patients were identified, with median followup time of 48 months from index date. The median age at diagnosis is 55 and 60% of patients were female. Patients were geographically represented across the US. About 90% of the cohort had ≥100 claims from a median of 28 care sites across 36 providers. The median number of hospitalizations was 2. 37% of patients received OT/PT and 20% have a claim for electromyography or nerve conduction studies prior to their CIDP diagnosis. 32% of patients had a previous diagnosis of unspecified polyneuropathy. Median time from the first diagnostic procedure to index diagnosis was 8.5 months. Top 5 most common topics viewed on Inspire among the cohort include: Skin, Side effect, Muscle, Drug and Nerve. CONCLUSIONS: CIDP patients in this ongoing retrospective analysis had a median of 4+ years of healthcare visit data since diagnosis. Majority of patients had 100+ claims, which indicate substantial healthcare resource utilization. CIDP patients endure a long diagnostic journey to undergo appropriate treatment.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kukposter124247-pdf.pdf?sfvrsn=2283b1c1_0","title":"ISPOR23_Kuk_Poster124247.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124247","diseases":[{"id":"e7063f12-1b6c-43a7-bc6e-23a7adf361a4","parentId":"00000000-0000-0000-0000-000000000000","title":"Neurological Disorders","urlName":"Neurological-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Measuring the Prevalence of Fatigue in Children with Cancer: Evidence from Egypt","id":"f19ec09d-b16e-42f8-88ac-f2bb98046563","sessionCode":"PCR24","topDisplay":"Abdalkader N1, Zawara A1, Lasheen S2, Osman A3 1Newgiza University, Cairo, Egypt, 2Cairo University, Cairo, Egypt, 3Newgiza University, Cairo, GZ, Egypt","locationCode":"729","description":"\r\n\t<div>OBJECTIVES: Cancer related fatigue (CRF) is a common side effect of cancer and cancer treatment that impacts quality of life. To our knowledge these statistics for pediatrics are lacking in Egypt. The aim of this study is to record the prevalence of fatigue and its significant predicting factors in pediatric oncology patients. METHODS: Children aged 8-18 years with cancer, prescribed chemotherapy and not in severe distress were interviewed. After the consent of the guardian is taken, the children personally filled 2 fatigue-related questionnaires (PROMIS Pediatric Short Forms of Fatigue (PROMIS fatigue), pedsQL multidimensional fatigue (PedsQL fatigue)) and 3 symptoms related questionnaires. RESULTS: 42 children (47.6% female) (mean age 12.1 years (SD 3.3 years)) participated. Half of the children were in primary school (n=21, 50%) and most of them had their parents accompanying them (n=35, 83.3%). Most children suffered from a hematological tumor (n=35, 83.3%) and didn’t suffer from other chronic health conditions (n=39, 92.8%). Reported moderate to severe fatigue in children is between half to third of the children depending on the measurement tool used. The mean T-score for PROMIS fatigue was 53.76 (SD 12.5), the mean score for PedsQL fatigue was 74.27 (SD 21.79). Stepwise standardized multivariant linear regression showed that fatigue following PROMIS fatigue could be predicted by depressive symptoms (𝜷= 0.47, p <0.001) and mobility (𝜷= -0.39, p =0.002) while following PedsQL fatigue it could be predicted by higher upper extremity function (𝜷= 0.34, p= 0.005), depressive symptoms (𝜷=-0.49, p <0.001) and treatment status (𝜷=-0.25, p= 0.013). CONCLUSIONS: CRF is multifactorial and prevalent among children and adolescents with cancer. Moreover, predicting factors differed between different tools as they measure fatigue from different dimensions. PedsQL fatigue was predicted by more factors. There is a need to include fatigue screening for pediatric oncology patients and incorporate its management in the medical care plan.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23nourhanposter127262-pdf.pdf?sfvrsn=83e45d54_0","title":"ISPOR23_Nourhan_POSTER127262.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23nouranhandout127262-pdf.pdf?sfvrsn=122108c_0","title":"ISPOR23_Nouran_HANDOUT127262.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127262","diseases":[{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"ac8e5c06-82a1-4ece-9b58-c1a36a72a607","parentId":"00000000-0000-0000-0000-000000000000","title":"Pediatrics","urlName":"Pediatrics"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Disparities in COVID-19 Related Outcomes in the United States By Race and Ethnicity: An Umbrella Review of Meta-Analyses","id":"ecc285e6-1053-4509-921c-f2c01f30249f","sessionCode":"CO14","topDisplay":"Duong K1, Le L1, Veettil SK2, Saidoung P1, Wannaadisai W3, Nelson RE4, Friedrichs M5, Jones B6, Visnovsky L4, Pavia A7, Jones M4, Samore M4, Chaiyakunapruk N1 1Department of Pharmacotherapy, College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 2College of Pharmacy, University of Utah, Salt Lake City, UT, USA, 3Faculty of Pharmacy, Mahidol University, Bangkok, Thailand, 4Division of Epidemiology, School of Medicine, University of Utah, Salt Lake City, UT, USA, 5Utah Department of Health, salt lake city, UT, USA, 6Division of Pulmonary & Critical Care, University of Utah, salt lake city, UT, USA, 7Division of Pediatric Infectious Diseases, University of Utah, Salt Lake City, UT, USA","locationCode":"115","description":"\r\n\t<div>OBJECTIVES: Meta-analyses have investigated associations between race and ethnicity and COVID-19 outcomes. However, there is uncertainty about these associations' existence, magnitude, and level of evidence. We, therefore, aimed to synthesize, quantify, and grade the strength of evidence of race and ethnicity and COVID-19 outcomes in the US. METHODS: In this umbrella review, we searched four databases (Pubmed, Embase, the Cochrane Database of Systematic Reviews, and Epistemonikos) from database inception to April 2022. The methodological quality of each meta-analysis was assessed using the Assessment of Multiple Systematic Reviews, version 2 (AMSTAR-2). The strength of evidence of the associations between race and ethnicity with outcomes was ranked according to established criteria as convincing, highly suggestive, suggestive, weak, or non-significant. The study protocol was registered with PROSPERO, CRD42022336805 RESULTS: Of 880 records screened, we selected seven meta-analyses for evidence synthesis, with 42 associations examined. Overall, 10 of 42 associations were statistically significant (p ≤ 0·05). Two associations were highly suggestive, two were suggestive, and two were weak, whereas the remaining 32 associations were non-significant. The risk of COVID-19 infection was higher in Black individuals compared to White individuals (risk ratio, 2·08, 95% Confidence Interval (CI), 1·60–2·71), which was supported by highly suggestive evidence; with the conservative estimates from the sensitivity analyses, this association remained suggestive. Among those infected with COVID-19, Hispanic individuals had a higher risk of COVID-19 hospitalization than non-Hispanic White individuals (odds ratio, 2·08, 95% CI, 1·60–2·70) with highly suggestive evidence which remained after sensitivity analyses. CONCLUSIONS: Individuals of Black and Hispanic groups had a higher risk of COVID-19 infection and hospitalization. These associations of race and ethnicity and COVID-19 outcomes existed more obviously in the pre-hospitalization stage. More consideration should be given in this stage for addressing health inequity.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23duongposter124701-pdf.pdf?sfvrsn=db0d8676_0","title":"ISPOR23_Duong_POSTER124701.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124701","diseases":[{"id":"51dd65bf-b41e-4681-b7ab-844cd26e5fe6","parentId":"00000000-0000-0000-0000-000000000000","title":"Infectious Disease (non-vaccine)","urlName":"Infectious-Disease--non-vaccine-"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Burden of Surgery in Desmoid Tumors","id":"b815c0b1-b68a-4d11-9cc6-f3c1d8a7892a","sessionCode":"CO43","topDisplay":"Fernandez M1, Bell T2, Tumminello B2, Khan S3, Zhou S4, Oton AB2 1RTI-Health Solutions, Research Triangle, NC, USA, 2SpringWorks Therapeutics, Stamford, CT, USA, 3RTI Health Solutions, Research Triangle Park, NC, USA, 4SpringWorks Therapeutics, Cary, NC, USA","locationCode":"143","description":"\r\n\t<div>OBJECTIVES: Desmoid tumors (DTs) infiltrate into surrounding structures with ill-defined margins. The aim of this research was to assess the burden of surgery in patients with DTs, focusing on rates of recurrences after surgery and functional deficits resulting from surgery, including limb amputation. METHODS: We searched the literature from the past 10 years to identify publications describing recurrence rates and functional outcomes post-surgery in patients with DTs. Given the lack of economic data related to DT surgeries, reviews of soft tissue sarcoma surgery costs and amputation general costs were also conducted. RESULTS: Key risk factors identified for recurrence after surgery are young age (< 30 years), tumor location (extremity), tumor size (> 5 cm in greatest diameter), positive resection margins, and history of trauma near the primary tumor site. DTs in the extremities have the highest risk of recurrence after surgery (29.6%-45.5%). Some studies have reported an increase in major functional limitations in patients with DTs in the limbs after surgical resections of their tumors, with > 40% suffering functional loss or amputation of the involved limb. Lifetime all-cause (including any condition being treated) direct costs for lower-extremity amputation is about one million 2022 USD. Patients undergoing more aggressive local treatments reported the lowest functioning scores. As a result of adverse outcomes reported after surgery for DT and emerging systemic treatments or active surveillance as acceptable control of the tumor, the use of surgery as initial treatment has decreased during the last 10 years (from 90.9% to 35.7% in the case of abdominal wall tumors). CONCLUSIONS: Although surgery may be effective in some cases, it can be associated with poor long-term functional outcomes and high economic costs. Alternative treatments with significant efficacy and acceptable safety profiles that preserve limb function and improve quality of life are needed for DT patients.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23zhouposter124188-pdf.pdf?sfvrsn=d464fd22_0","title":"ISPOR23_Zhou_POSTER124188.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124188","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Preferences and Willingness to Pay of Medication for Patients with Renal Cell Carcinoma in China: A Discrete-Choice Experiment","id":"b211be81-5993-4b85-9424-f3c63eaa963b","sessionCode":"PCR39","topDisplay":"Ding R, Shao R, Yan J China Pharmaceutical University, Nanjing, China","locationCode":"5B","description":"\r\n\t<div>OBJECTIVES: To evaluate the relative importance (RI) of attributes and willingness to pay (WTP) of pharmacological therapies for patients with metastatic renal cell carcinoma(RCC) in China. METHODS: Patients with RCC completed a D-efficient designed discrete-choice experiment survey that presented a series of 11 trade-off questions online. Each question included a pair of hypothetical RCC medication profiles defined by eight attributes and their levels, which were selected through literature review and consultation with RCC patients and doctors: progression-free survival (PFS), objective response rate (ORR), medication regimen, fatigue, gastrointestinal reaction, hand-foot syndrome and monthly out-of-pocket cost. RI and WTP were calculated with the coefficients estimated by conditional-logit and mixed-logit regression analysis. In addition to a main analysis, some subgroup analyses were also carried out to consider the heterogeneity of the respondents. RESULTS: The questionnaires of 100 respondents were included in the analysis. Overall, all attributes were statistically significant except the medication regimen. Monthly out-of-pocket cost was the most important attribute (RI:22.06%), followed by ORR (20.94%), PFS (18.82%), fatigue (18.58%), gastrointestinal reaction (10.81%) and hand-foot syndrome (7.42%). Patients were willing to pay ￥1929.25(95% CI: 1389.80, 2466.71), ￥454.51(95% CI: 313.28, 595.74) for 1 unit improvement of PFS, ORR and￥9680.40 (95% CI: 5360.90, 14000.00),￥7238.06(95% CI: 4285.77, 10190.34) for avoiding fatigue and gastrointestinal reaction respectively. Differences in preferences and WTP were found according to patients’ gender, income and education level. For male, highly educated and high-income subgroup, ORR was more important than PFS and monthly out-of-pocket cost was less important. CONCLUSIONS: RCC patients’ preferences of medication are mainly determined by out-of-pocket cost and efficacy (ORR and PFS) in China. Heterogeneity can be found in patients' preferences for monthly out-of-pocket cost, PFS, ORR and Fatigue.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-v2124928-pdf.pdf?sfvrsn=ca4d1b7b_0","title":"ISPOR 2023 v2124928.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124928","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Characteristics, Healthcare Resource Utilization, Cost, and Quality Outcomes of Medicare Beneficiaries While Commercially Insured and after Transition to Medicare Advantage Versus Traditional Fee-for-Service","id":"fdb06809-0f67-4138-8c01-f564606c6a35","sessionCode":"HPR24","topDisplay":"Teigland C1, Pulungan Z1, Mohammadi I1, Jones BT1, Bilder S1, Brot-Goldberg Z2, Su Y2, Vabson B2 1Inovalon, Bowie, MD, USA, 2Harvard Medical School, Boston, MA, USA","locationCode":"526","description":"\r\n\t<div>OBJECTIVES: For decades the US Medicare system has provided two options: public traditional fee-for-service (FFS) and private managed Medicare Advantage (MA); however, little is known about who is selecting FFS versus MA and differences in outcomes before and after enrollment. This study provides a first look at demographic, clinical, and social risk characteristics of individuals who select MA versus FFS while covered by commercial insurance prior to turning age 65 and compares healthcare outcomes before and after enrolling. METHODS: Beneficiaries were continuously enrolled in a commercial plan for one-year prior to joining Medicare (baseline) within 3-months of reaching age 65 (index date) 2015-2018 and in MA or FFS one-year post-index. Patient characteristics were evaluated during baseline; healthcare resource utilization Per-100-Members-Per-Year (P100MPY), costs, and quality outcomes were compared during baseline and the one-year after enrollment. RESULTS: Of 205,557 beneficiaries, 87.6% enrolled in FFS; 12.4% MA. FFS had fewer males (39.7% vs 41.5%) and more Whites (95.6% vs 90.6%). More selecting MA were in a commercial Healthcare Maintenance Organization (HMO) (45.8% vs. 27.8%) while more selecting FFS were in a Preferred Provider Organization (PPO) (56.6% vs 43.4%). MA enrollees had higher social risk (e.g., low income, high-school education, low English proficiency). MA and FFS enrollees had similar prevalence of chronic conditions but those selecting FFS had 26.5% higher costs during baseline and 27.1% higher costs post-index. Beneficiaries selecting FFS had 15.2% higher hospitalization rates during baseline (6.08 vs. 5.28), increasing to 54.4% higher hospitalization rates after joining Medicare (9.88 vs 6.40). CONCLUSIONS: This study is the first to profile who is selecting FFS versus MA and compare outcomes under commercial coverage to outcomes after enrolling in Medicare. With the rapid growth of Medicare and move toward value-based care, it is essential stakeholders understand who is enrolling in MA versus FFS and expected differences in outcomes.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"b3576717-528d-445f-95f1-dcd93dce9460","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Policy & Regulatory","urlName":"health-policy-regulatory"}],"categoryIds":["b3576717-528d-445f-95f1-dcd93dce9460"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23teiglandposterv2123475-pdf.pdf?sfvrsn=cec5287d_0","title":"ISPOR23__Teigland_POSTERV2123475.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123475","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Clinical, Operational, and Economic Impacts of Automated Medication Dispensing Cabinets in Perioperative and Ambulatory Surgical Center Settings: A Systematic Literature Review","id":"8abac7ec-2270-4342-8d67-f5bb518bfb7b","sessionCode":"MT10","topDisplay":"Borrelli E1, Telinoiu M2, Fitzgibbons S2, Park M2, Dumitru D2, Lucaci J2 1Becton, Dickinson and Company, Escondido, CA, USA, 2Becton, Dickinson and Company, Franklin Lakes, NJ, USA","locationCode":"638","description":"\r\n\t<div>OBJECTIVES: Implementation of automated dispensing cabinet (ADC) technology in hospitals has shown to improve clinical, operational, and economic outcomes. Safety and professional organizations recommend the adoption of ADCs in outpatient care areas, such as Ambulatory Surgical Centers (ASCs) and perioperative settings outside of the hospital. However, implementation of this technology in these settings has lagged significantly. The objective of this study was to assess the documented impact of ADCs in ASCs and perioperative care areas. METHODS: A systematic literature review (SLR) was conducted in PubMed and Google Scholar in November 2022. The SLR was performed according to the PRISMA guidelines. Original research studies were included if they reported empirical data on ADCs in ASCs and perioperative areas. The search criteria consisted of site locations in North America or Europe, with articles written in English and published in the last thirty years. Outcomes were categorized as medication errors, drug diversion, inventory management, workforce satisfaction, and economic impact. RESULTS: A total of eleven studies met the inclusion criteria. Six studies assessed ADC impact on drug diversion and controlled substance inventory management, with all studies finding reductions in missing controlled substances. Three studies showed a reduction in medication errors up to 100% after ADC implementation. Three studies revealed a positive impact on workforce satisfaction, with a range varying from 81%-100% of nurses across these settings being satisfied with ADC usage. Two studies showed post-ADC implementation labor cost savings. CONCLUSIONS: ADC implementation in ASCs and perioperative care was found to decrease medication errors, reduce drug diversion/missing controlled substances, improve inventory management, increase workforce satisfaction, and reduce labor hours. Despite the current evidence, the literature assessed did not indicate conclusive evidence for the lag in adoption. Larger-scale studies are needed to support these findings, which would allow a stronger understanding of the multifactorial impact of ADCs in these settings.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-poster-asc-slr-final123360-pdf.pdf?sfvrsn=b55dd1ee_0","title":"ISPOR Poster ASC SLR FINAL123360.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123360","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"9f4dd7f6-8042-4f9a-bc9c-675cf1739ab4","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Devices","urlName":"Medical-Devices"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"The Financial Impact of a Newly Introduced Thermosetting, Bioadhesive, Antibacterial Hydrogel to U.S. Commercial and Medicaid Insurers in Treating Bacterial Vaginosis","id":"8f620fe9-923e-4ef8-b1c1-f6e64888c1de","sessionCode":"EE67","topDisplay":"Goto D1, Amico J2, Chow C3, Tangirala K1, Watkins E4 1Organon, Jersey City, NJ, USA, 2Rutgers - Robert Wood Johnson Medical School, Rutgers, NJ, USA, 3Actu-Real, Roswell, GA, USA, 4Organon, Johns Creek, USA","locationCode":"312","description":"\r\n\t<div>OBJECTIVES: We analyzed the financial impact of a recently approved thermosetting, bioadhesive, antibacterial clindamycin phosphate vaginal hydrogel, XACIATOTM, to U.S. commercial and Medicaid insurers in treating Bacterial Vaginosis (BV). The U.S. FDA granted XACIATOTM’s regulatory approval in 2021. BV is most prevalent among reproductive-aged women and has a high rate of recurrence among those with symptomatic infection. An important factor affecting patient access to new therapies is the financial burden to insurers. METHODS: We retrieved retrospective real-world data from MerativeTM MarketScan® Database containing claims from commercial and Medicaid patients with ≥2 years of continuous enrollment between January 1, 2016 and September 30, 2021. BV patients were identified as women aged 12 – 49 years with diagnosed BV and ≥1 course of treatment. Using the same database, we calculated the shares of existing medications. Medication costs were calculated using wholesale acquisition costs (WAC) obtained from a proprietary third-party database. We then summarized the potential financial impact of XACIATOTM. RESULTS: We found 25,324,730 commercially insured patients, of whom 0.56% were BV patients with ≥1 course of treatment, and 0.20% with ≥2 courses (36% of BV patients with ≥1 course). There were 12,488,141 Medicaid patients, of whom 0.92% were BV patients with ≥1 course, and 0.40% with ≥2 courses (43% of BV patients with ≥1 course). Metronidazole oral was most frequently prescribed in commercial and Medicaid populations for both first and second courses (Commercial: 68%, 59%; Medicaid: 84%, 70%, respectively). The median WAC of a single course of metronidazole oral treatment was 8 U.S. Dollars. CONCLUSIONS: BV patients typically receive one course of inexpensive oral treatment while many (36% of commercial and 43% of Medicaid) advanced to ≥2 courses. U.S. insurers will continue to be able to manage the financial impact of BV by utilizing inexpensive oral treatment while gaining access to XACIATOTM’s new bioadhesive hydrogel technology.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023-bim-poster-approved126364-pdf.pdf?sfvrsn=e2077db8_0","title":"ISPOR 2023 BIM Poster Approved126364.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126364","diseases":[{"id":"bd923eb7-0eba-48be-86a0-7e4a636bf00a","parentId":"00000000-0000-0000-0000-000000000000","title":"Reproductive & Sexual Health","urlName":"Reproductive---Sexual-Health"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Association of Social Determinants of Health and HIV Pre-Exposure Prophylaxis (PREP) to Need Ratio on the County Level in the United States","id":"bf6badec-d24a-4326-8fbf-f7dafc465350","sessionCode":"MSR14","topDisplay":"Zaki S1, Goswami S2, Vivek V2, Aparasu R3 1Complete HEOR Solutions (CHEORS), North Wales, PA, USA, 2Complete HEOR Solutions (CHEORS), Chalfont, PA, USA, 3University of Houston, Houston, TX, USA","locationCode":"705","description":"\r\n\t<div>OBJECTIVES: Pre-exposure Prophylaxis (PrEP) can greatly help to prevent Human Immunodeficiency Virus (HIV) infections. However, the uptake of PrEP is low among at-risk individuals due to several factors, including the Social Determinants of Health (SDOH). This study assessed county-level SDOH associated with county-level PrEP use to need ratio (PnR) in the United States (US). METHODS: A cross-sectional study was conducted using the AIDSVu dataset merged with County Health Rankings (CHR) dataset for the year 2021. AIDSVu includes data from state and local health departments. The outcome variable was county-level PnR (i.e., the ratio of PrEP users to new HIV cases in a county with a higher PnR indicating better PrEP utilization in the county). Descriptive statistics were used to examine the county-level PnR across thirty-four SDOH variables, and regression analyses were conducted to assess the association of SDOH-related factors with county-level PnR. RESULTS: The study included 691 counties with valid PnR; the mean county-level PnR was 8.9 [standard error, (SE)=7.5]. The regression model found that the percentage of people with poor/fair health (bz=0.501, p=0.003), number of mental health providers (bz=0.383, p<0.01), and number of social associations (bz=0.563, p<0.01) were associated with higher PnR. In contrast, the percentage of the following: births with low birthweight (bz=-0.146, p=0.024), smokers (bz=-0.251, p=0.004), chlamydia cases (bz=-0.448, p<0.01), physically inactive individuals (bz=-0.243, p=0.001), and uninsured individuals (bz=-0.131, p=0.009) were associated with lower PnR. Lastly, the poor physical environment of a county indicated by days with poor air quality (bz=-0.067, p=0.040) and a percentage of people having severe housing problems (bz=-0.155, p=0.006) were associated with lower PnR. CONCLUSIONS: Understanding the variability of county-level PrEP across various SDOH can help to focus on county-level priorities for improving PrEP- uptake in the US.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"9a8a8cd2-8374-445e-898f-1c074569c9bd","parentId":"00000000-0000-0000-0000-000000000000","title":"Methodological & Statistical Research","urlName":"methodological-statistical-research"}],"categoryIds":["9a8a8cd2-8374-445e-898f-1c074569c9bd"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-2023sdoh-of-prep-use20april2023-updated125849-pdf.pdf?sfvrsn=ffe8f023_0","title":"ISPOR 2023_SDoH of PrEP use_20April2023 Updated125849.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125849","diseases":[{"id":"33800909-66da-424f-8548-418f4333d28f","parentId":"00000000-0000-0000-0000-000000000000","title":"Systemic Disorders/Conditions (Anesthesia, Auto-Immune Disorders (n.e.c.), Hematological Disorders (non-oncologic), Pain)","urlName":"systemic-disorders-conditions-anesthesia-auto-immune-disorders-n-e-c--hematological-disorders-non-oncologic-pain"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Effectiveness of Long-Term Medication Therapy for Obesity Management","id":"28b6df12-51da-4d2a-a56f-f7e82875a540","sessionCode":"EE8","topDisplay":"Shah K1, Kim K1, Lien PW1, Atlas SJ2, Moradi A3, Beaudoin F3, Touchette D1 1University of Illinois Chicago College of Pharmacy, Chicago, IL, USA, 2Division of General Internal Medicine, Massachusetts General Hospital, Boston, MA, USA, 3Institute for Clinical and Economic Review, Boston, MA, USA","locationCode":"211","description":"\r\n\t<div>OBJECTIVES: Obesity is one of the most prevalent chronic conditions in the United States. The availability of medications, including semaglutide, liraglutide, phentermine/topiramate, and bupropion/naltrexone, provide more options for chronic obesity management. We assessed and compared the cost-effectiveness of these medications for long-term obesity management. METHODS: The four medications, along with standard lifestyle modification (LSM), were compared to LSM alone. We developed a decision model followed by Markov model to project lifetime healthcare cost, in 2022 US dollars, and quality adjusted life years (QALYs) from the healthcare sector perspective. The modeled population included adult patients with an average BMI of 38 kg/m2 and average age of 45 years. Patients initially without diabetes could transition to states with diabetes, myocardial infarction (MI), stroke, other cardiovascular comorbidity (i.e., angina, transient ischemic attack, or peripheral vascular disease), and heart failure. Weight-lowering effects were identified from a review and network meta-analysis of clinical trial results. All other model inputs were sourced from peer-reviewed literature and publicly available data. We conducted sensitivity analyses to evaluate model uncertainty. RESULTS: Respective lifetime cost and QALY estimates were $392K/17.83 for semaglutide, $377K/17.34 for liraglutide, $183K/ 17.38 for phentermine/topiramate, $207K/17.16 bupropion/naltrexone, all added to LSM, and $237K/16.93 for LSM alone. The incremental cost-effectiveness ratios (ICERs) for semaglutide, liraglutide, phentermine/topiramate, and bupropion/naltrexone compared to LSM were $238K, $483K, $8K and $123K per QALY gained, respectively. The model was sensitive to utility gained per unit reduction in BMI, effectiveness of each drug in achieving weight loss, baseline HbA1C, and cost of diabetes care. Estimated life expectancy and cumulative incidence of cardiovascular conditions were comparable to real-world data. CONCLUSIONS: Long-term medication therapy to manage obesity may provide individuals with opportunities for sustained weight loss; however, semaglutide and liraglutide would generally require discounted prices to become a cost-effective life-long obesity management strategy.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23shahposter125296-pdf.pdf?sfvrsn=ae3751a3_0","title":"ISPOR23_Shah_POSTER125296.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125296","diseases":[{"id":"8da22847-bf2c-4e2d-9e3e-8f42192004ef","parentId":"00000000-0000-0000-0000-000000000000","title":"Diabetes/Endocrine/Metabolic Disorders (including obesity)","urlName":"diabetes-endocrine-metabolic-disorders-including-obesity"},{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Reuse of Tumor Necrosis Factor Inhibitors for Treatment of Rheumatoid Arthritis Despite Discordance with Patient-Important Outcomes and Standard Disease Assessments","id":"8f4ed64e-e7ff-4bc3-b903-f80fa93ed1a4","sessionCode":"CO18","topDisplay":"Frick A1, Broestl J1, Cox K2, Milligan K2, Persons D1, Milligan S1 1Trio Health Analytics, Louisville, CO, USA, 2Trio Health Advisory, Louisville, CO, USA","locationCode":"118","description":"\r\n\t<div>OBJECTIVES: TNFi are heavily relied upon treatments for RA yet are associated with increased infection and cancer risks, and repeated TNFi treatment post-TNFi failure is negatively associated with disease response. Here we assess treatment choices following initial TNFi treatment relative to patient-important outcomes and/or disease assessment measures (DAM). METHODS: Data: PIONEER-Rheumatology, an open text-enhanced EMR database specific to care given by American Rheumatology Network (ARN). Study population: Adult (18+y) patients with RA, first TNFi in 2016-2019 (index), >180d history, >36m follow-up. Baseline measures closest to but within -180 to +30d of index. Patient reasons for index-TNFi discontinuation were extracted from chart notes into non-overlapping groups: lack/loss of efficacy (LoE)->clinical conditions->non-clinical reasons. Analyses: One-way ANOVA with post-hoc Games-Howell and Pearson chi-square with proportions comparisons by z-test with Bonferroni correction. RESULTS: Index-TNFi for 3494 patients: 31% adalimumab, 23% etanercept, 21% golimumab, 15% infliximab, 10% certolizumab. During observation, 47% patients did not initiate a subsequent b/tsDMARD, 20% switched to non-TNFi b/tsDMARD (non-TNFi), 23% switched to a different TNFi, and 9% were retreated with the index-TNFi following a >90d gap. Of 1844 patients initiating b/tsDMARD after index-TNFi, 95% (1755) had patient reasons for index-TNFi discontinuation; LoE was indicated by 53% (931/1755) overall, 62% (425/686) of patients switching to (A) non-TNFi, 62% (488/785) of patients switching to (B) new TNFi, and 6% (18/284) of (C) index-TNFi retreated patients (p<0.001; A or B v. C). DAM (CDAI, DAS28, RAPID3) at discontinuation of index-TNFi were observed for 77% (1413/1844) patients; the proportions with moderate-high disease activity were 70%, 61%, and 55% for (A) switch to non-TNFi, (B) switch to new TNFi, and (C) index-TNFi retreated groups, respectively (p<0.001; A v. B or C). CONCLUSIONS: By both patient-defined efficacy and standard DAM, reuse of TNFi is substantial following initial TNFi failure.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"87546aa9-e592-49a6-ba7f-a9e9daa90133","parentId":"00000000-0000-0000-0000-000000000000","title":"Clinical Outcomes","urlName":"clinical-outcomes"}],"categoryIds":["87546aa9-e592-49a6-ba7f-a9e9daa90133"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23milliganposterco18p123100-pdf.pdf?sfvrsn=591e32ab_0","title":"ISPOR23_MILLIGAN_POSTER_CO18_p123100.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123100","diseases":[{"id":"bd738b2c-6ed3-4dcb-a254-49809b6311af","parentId":"00000000-0000-0000-0000-000000000000","title":"Biologics & Biosimilars","urlName":"biologics-biosimilars"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"On the Frontline Against COVID-19: Provision of Community Pharmacy Services during a Public Health Crises","id":"6b453d3a-2f71-4a86-958a-f86414e65416","sessionCode":"EPH44","topDisplay":"Nazaryan L1, Barseghyan A2, Simonyan MH3 1Yerevan State Medical University, Erevan, Armenia, 2Yerevan State Medical University, Yerevan, KT, Armenia, 3Yerevan State Medical University, Yerevan, Armenia","locationCode":"444","description":"\r\n\t<div>OBJECTIVES: During the current pandemic, it is recognised that pharmacies will often be the first point of contact with the health system for individuals with COVID-19 related health concerns or who require reliable information and advice. It is also important in the midst of the current public health crisis to reduce general practitioners’ (GP) minor ailment-related workload. The aim of our study is to examine the problems in the midst of public health crisis of the current magnitude with the roles and activities of pharmacists. This information could help to inform future decisions about the restructuring of existing health services by governments, public health bodies and policy makers in response to public health crises such as COVID-19. METHODS: The study was carried out among 384 consumers using pharmacy in the regions of Armenia and Yerevan. Research instrument was questionnaire. Number of questionnaires distribution was determined by The Survey System Version 11.0. Analyses were performed using Statistical Package for the Social Sciences (SPSS) software (version 12.0). RESULTS: During the study it becomes clear that very few percentage of consumers (17%) consulted by a pharmacy employees. Most of them don’t get the necessary information from the pharmacy employee about medicine. Only 29 % of consumers are clearly satisfied with the answers of a pharmacy employee and 26% fully trust them. CONCLUSIONS: Steps should be taken for improving the professional knowledge of pharmacists about medicines and pharmaceutical care, which, in turn, can restore consumer trust in them, will help avoid self-medication errors by providing advice on medicines in response to public health crises such as COVID-19. There is a need to develop pharmaceutical care algorithms for minor ailments, national emergency drug formularies for COVID-19.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126662","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Healthcare Resource Utilization Among Patients with Transfusion-Dependent Beta-Thalassemia in Germany","id":"f648e78e-5d8c-46e7-8bb9-f8af3984dc12","sessionCode":"EE62","topDisplay":"Kunzweiler C1, Udeze C1, Li N1, Baldwin J1, Tuzin P1, Barth SD2, Vetter C2, Dombrowski S2, Georgiadou-Schmidt E3, Meisel R4 1Vertex Pharmaceuticals Incorporated, Boston, MA, USA, 2IQVIA Commercial GmbH & Co. OHG, Frankfurt, Germany, 3Team Gesundheit GmbH, Essen, Germany, 4Heinrich-Heine-University, Duesseldorf, Germany","locationCode":"202","description":"\r\n\t<div>OBJECTIVES: Patients with transfusion-dependent β-thalassemia (TDT) have reduced or absent β-globin production and require regular red blood cell transfusions (RBCTs) for survival, which lead to morbidity and long-term mortality associated with iron overload. This study describes the healthcare resource utilization (HCRU) among patients with TDT in Germany. METHODS: This longitudinal, retrospective cohort study utilized statutory health insurance records (Betriebskrankenkasse data source) in Germany to identify patients with a primary or secondary diagnosis for β-thalassemia between January 1, 2010, and December 31, 2018 (eligibility period). Eligible patients with TDT had ≥8 RBCTs in any 1-year period during the eligibility period and had ≥1 year of follow-up after the first qualifying RBCT claim (index date). Patients with hereditary persistence of fetal hemoglobin, sickle cell disease, or hematopoietic stem cell transplant in their medical records at any time were excluded. Patients were followed from index until the earliest of death, deregistration due to patient leaving the data source, or end of study period (December 31, 2019). Demographics were assessed at index. Rates (per-patient-per-year [PPPY]) of transfusions and HCRU, including outpatient visits, hospitalizations, and pharmacy prescriptions, were descriptively summarized during follow-up. RESULTS: In total, 68 patients with TDT were included; 30 (44.1%) were female, and their mean age at index was 50.6 (standard deviation [SD]=26.0) years. The average length of follow-up was 5.0 years. Patients with TDT averaged 16.4 (SD=11.2) transfusions PPPY during follow-up. The mean rate of outpatient visits for any specialty was 59.4 (SD=40.8) PPPY. During follow-up, patients had an average of 3.8 (SD=3.3) hospitalizations and 62.0 (SD=53.3) pharmacy prescriptions PPPY. CONCLUSIONS: Results from this analysis demonstrate that patients with TDT have substantial HCRU driven by transfusions, outpatient visits, and hospitalizations. Innovative therapies that eliminate transfusions hold promise to reduce the clinical and economic burden associated with TDT.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23kunzweileree62124848-pdf.pdf?sfvrsn=7b1d1deb_0","title":"ISPOR23_Kunzweiler_EE62124848.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124848","diseases":[{"id":"3f8630a8-7f8e-421f-8d3d-0d647b124c8d","parentId":"00000000-0000-0000-0000-000000000000","title":"Genetic, Regenerative & Curative Therapies","urlName":"genetic-regenerative-curative-therapies"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Association of Ustekinumab with Carpal Tunnel Syndrome, Cutaneous Lupus Erythematosus, Basedow's Disease and Melanocytic Naevus: A Disproportionality Analysis in Usfda Adverse Event Reporting System Database","id":"25a220c3-6231-4b6f-bb9f-f992de656bc1","sessionCode":"EPH41","topDisplay":"Vajapu M, Das A Ramaiah University of Applied Sciences, Bangalore, KA, India","locationCode":"441","description":"\r\n\t<div>BACKGROUND: Ustekinumab is a human immunoglobulin G1 kappa monoclonal antibody acting as an antagonist of the p40 subunit of interleukin-12 and interleukin-23, that is approved by USFDA for use in Plaque Psoriasis in 2009 and for Crohn disease in 2016. This study aimed at detecting side effects in early stages that are associated with Ustekinumab by conducting disproportionality analysis of the FDA Adverse Event Reporting System (FAERS). OBJECTIVES: To identify the number of events of Carpal Tunnel Syndrome, Cutaneous Lupus Erythematosus, Basedow’s Disease, and Melanocytic Naevus associated with Ustekinumab using disproportionality analysis of the FDA Adverse Event Reporting System (FAERS) METHODS:Publicly available data from FAERS database was used for this study. Case/non-case method was adopted for the analysis of association between Ustekinumab and the side effects. The data-mining algorithms used for the analysis were Reporting Odds Ratio(ROR) and Proportional Reporting Ratio (PRR). A value of ROR-1.96SE>, PRR≥2 were considered as positive signal. RESULTS: A total of 75 drug related events were identified for Ustekinumab of which 17 events were Cutaneous lupus erythematosus with mean age of 58.6 years and M:F 1:18 although age and sex were not reported in all the reports, PRR for the same was 3.802 and ROR was 3.803. 36 events were Carpal tunnel syndrome with PRR 2.035 and ROR 2.036. 13 events were of Melanocytic Naevus with PRR of 2.101 and ROR 2.102. 9 events were related to Basedow’s disease with PRR of 2.101 and ROR 2.101. These DECs show significant positive signals above the pre-set threshold following the disproportionality analysis of FAERS database. CONCLUSIONS: Potential signals associated with Ustekinumab were generated by data mining in the FAERS database. The result requires an integration of further clinical surveillance for the quantification and validation of possible risks for the AEs reported of Ustekinumab.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"01f1d3ca-3d48-408e-a5d0-c99dbbf48b70","parentId":"00000000-0000-0000-0000-000000000000","title":"Epidemiology & Public Health","urlName":"epidemiology-public-health"}],"categoryIds":["01f1d3ca-3d48-408e-a5d0-c99dbbf48b70"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125852","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"fa5c47a6-1e67-420d-baf4-019c13fc2b50","parentId":"00000000-0000-0000-0000-000000000000","title":"Gastrointestinal Disorders","urlName":"Gastrointestinal-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Patient-Reported Outcomes in Opioid Use Disorder (PR-OUD): Recommendations and Barriers in Clinical Trials and Studies","id":"635d6f2f-3e09-44dc-98cc-fa2770b93ff0","sessionCode":"PCR16","topDisplay":"Ibrahim N, Walker M, Waris H, Litcher-Kelly L Adelphi Values, Boston, MA, USA","locationCode":"725","description":"\r\n\t<div>OBJECTIVES: Based on regulatory interest in utilizing patient-centric outcomes in clinical trials for treatments of opioid use disorder (OUD), a review of the published literature was conducted to understand current use of patient-reported outcomes (PROs) in clinical trials and non-interventional studies. Additionally, patient barriers to providing transparent PRO data were investigated. METHODS: A targeted literature search was conducted to explore (1) current endpoints being utilized to assess buprenorphine and methadone treatment efficacy in both clinical trials and non-interventional clinical research studies, and (2) barriers to reporting transparent data in the target patient population (TPP). Potential articles were identified by title, and abstracts were reviewed before selecting full-text articles for inclusion. Additionally, relevant Food and Drug Administration regulatory documents were reviewed. RESULTS: Eighty-five abstracts and two regulatory documents were reviewed. Seven full-text articles and two regulatory documents were selected for inclusion. One randomized controlled trial utilized a PRO for its primary endpoint and two trials utilized a range of PROs as secondary endpoints. In one longitudinal, non-interventional study, PROs were used at various timepoints. Non-PRO outcomes used in clinical trials and clinical studies largely relied on opioid-related overdose, acute care use, treatment adherence, and opioid-negative urine specimens as efficacy endpoints. After review of OUD-specific regulatory guidance documents, both suggested including patient-centric outcomes to measure how patients feel and function. Barriers to patient reporting identified in the literature included low rates of retention in clinical trials (except in populations that risk significant negative consequence for relapse), stigmatization of receiving medication-assisted therapy, and insufficient information regarding potential consequences of disclosing substance use to healthcare providers. CONCLUSIONS: Patient-centric endpoints, including PROs, should be included at the forefront of OUD-related clinical trials. Full transparency regarding the use of PRO data and ensuring that data is safeguarded whenever possible may mitigate inaccuracies in PRO data reported by the TPP.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23ibrahimposter125533-pdf.pdf?sfvrsn=4f98ac4f_0","title":"ISPOR23_Ibrahim_POSTER125533.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/125533","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Oxidized Zirconium Results in Significantly Reduced Readmissions and Mortality for Patients Undergoing Hip Arthroplasty Due to Hip Fracture","id":"cdbff5e1-edfb-4624-a692-fa80ce6304ba","sessionCode":"RWD32","topDisplay":"Nherera L1, Watson GJ2 1Smith & Nephew, Dallas Fort Worth, TX, USA, 2Watson Policy Analysis Inc., Arlington, VA, USA","locationCode":"841","description":"\r\n\t<div>OBJECTIVES: The Comprehensive Care for Joint Replacement (CJR) Model from the Centers for Medicare and Medicaid Services make hospitals and healthcare systems more responsible for better clinical and economical outcomes of total hip arthroplasty (THA) aimed at slowing Medicare spending growth. Oxidized Zirconium◊ (OxZr) implants have been shown in numerous registry and clinical studies to be clinically effective when used on elective THA. The objective of this study was to evaluate 30, 90 and 180- and one-year outcomes in hip replacement due to hip fracture for patients using OxZr implants compared to non-OxZr. METHODS: We retrospectively reviewed data from the Limited Data Set version of the Medicare Standard Analytic File– 100% sample. The inpatient and denominator files were used, and claims were linked based on the unique beneficiary identifier to track beneficiaries longitudinally. We used 1:1 propensity score matching on demographic characteristics including the Charlson Comorbidity Index. All-cause mortality and readmissions were computed for patients who had at least one year follow up data before 31 December 2021. RESULTS: We matched 1,274 OxZr and non-OxZr 1,274 patients. Patients treated with OxZr were 53% less likely to be readmitted compared to non-OxZr treated patients (odds ratio [OR] 0.47 p=0.0000, 47% OR 0.53 p=0.0000, 42% OR 0.58 p=0.0000 and 32% OR 0.68 p=0.0000 over 30, 90, 180 and 365 days respectively. For mortality, OxZr were 83% less likely die (OR 17 p=0.0000, 78% OR 0.22 p=0.0000, 77% OR 0.33 p=0.0000 and 72% OR 0.28 p=0.0000, over 30, 90, 180 and 365 days respectively compared to non-OxZr treated patients. CONCLUSIONS: Our study demonstrated that using OxZr compared to non-OxZr in THA patients due to hip fracture results in significantly reduced readmissions and mortality. These findings corroborate a growing body of evidence suggesting better clinical performance of OxZr in elective patient population.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127267","diseases":[{"id":"3f994852-a0d4-4706-9665-e4d867006d9a","parentId":"00000000-0000-0000-0000-000000000000","title":"Injury & Trauma","urlName":"injury-trauma"},{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"},{"id":"bde7079b-7db2-4006-9dbf-54d654e04fc7","parentId":"00000000-0000-0000-0000-000000000000","title":"Surgery","urlName":"Surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Evaluating the Adherence of Reporting Patient Reported Outcomes to the Consort PRO Extension, CONSORT-Outcomes Extension and ISOQOL Standards Among Aggressive Large B Cell Lymphoma Patients: Systematic Literature Review of RCTs","id":"6c1203a2-cd37-4c8f-b7fe-fa8859b5e1b9","sessionCode":"PCR218","topDisplay":"Mohamed AF1, Kandikatla R2, Thirugnanam A3, Patel NM3, Patel U4, Yunusa I5, Doucette J4, Kallich J4, Eguale T4 1MCPHS university, Roxbury, MA, USA, 2MCPHS University, Malden, MA, USA, 3MCPHS university, Boston, MA, USA, 4MCPHS University, Boston, MA, USA, 5University of South Carolina, Columbia, SC, USA","locationCode":"840","description":"\r\n\t<div>OBJECTIVES: To evaluate the adherence of reporting Patient Reported Outcomes (PROs) to the 2013 CONSORT PRO extension, CONSORT-Outcomes 2022 extension and ISOQOL standards in Randomized Control Trials (RCTs) among Aggressive Large B Cell Lymphoma (LBCL) patients. METHODS: Literature search was performed on PubMed, Embase, Cochrane library between 2013 and 2022 to identify RCTs in Aggressive LBCL patients with a PRO endpoint for assessing the adherence to the CONSORT PRO extension, CONSORT-2022 Outcomes extension and ISOQOL standards. Trial frequencies and percentage were reported for data items. According to Mercieca-Bebber et al, individual item compliance was rated \"good\", \"moderate\", \"poor\" when ≥80%, 50–79% and ≤49% of RCTs respectively addressed the CONSORT 2013 and 2022 items checklist. RESULTS: In all the ten included studies, PROs were secondary endpoints. Five studies pertained to single-arm trials in patients experiencing relapse/refractory to two or more systemic treatment regimens and seven studies reported PROs in secondary publications. Across all RCTs, the most consistently reported items with good overall compliance to CONSORT-PRO and CONSORT-outcomes extension were P6ai-evidence of PRO instrument (10/10), 13ai-participants reporting PRO data at baseline (9/10; 90%) and at subsequent time-points (13aii; 10/10), P20-PRO-specific limitations (8/10; 80%) and 6a.5-state the time-points used for analysis (10/10). Items P2bi-PRO hypothesis present (1/10; 10%), P2bii-PRO domains specified in the hypothesis (1/10; 10%) and P6aiii-mode of administration specified (3/10; 30%) were least often reported with poor compliance to CONSORT-PRO extension. Items specific to missing data such as P12a-statistical approach for dealing with missing data specified (3/10; 30%) in CONSORT-PRO, 12a.3-describe the methods used to handle missing outcome items or entire assessments (2/10; 20%) in CONSORT- 2022 Outcomes extension and statistical approaches for dealing with missing data (3/10; 30%) in ISOQOL, were poorly reported across all RCTs. CONCLUSIONS: Our research indicated incomplete adherence to the established standards of reporting PROs among RCTs in aggressive LBCL.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor-23syed-mohamedposter127719-pdf.pdf?sfvrsn=fb46086b_0","title":"ISPOR 23_Syed Mohamed_Poster127719.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/127719","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Cost-Utility of Nivolumab Versus Observation for the Adjuvant Treatment of Urothelial Carcinoma (UC) for Patients Who Are at High-Risk of Recurrence: A Canada Public Payer Perspective","id":"f7e2a622-5161-4969-b52d-fa9e7dafd56a","sessionCode":"EE41","topDisplay":"Graham J1, Kassouf W2, Tomaras D3, Kurt M4, Patel M5, Teitsson S6 1RTI Health Solutions, Durham, NC, USA, 2McGill University Health Centre, Montreal, QC, Canada, 3Bristol Myers Squibb, Montreal, QC, Canada, 4Bristol Myers Squibb, Princeton, NJ, USA, 5Bristol Myers Squibb, Summit, NJ, USA, 6Bristol Myers Squibb, Uxbridge, LON, UK","locationCode":"244","description":"\r\n\t<div>OBJECTIVES: To estimate the cost-utility of adjuvant UC treatment with nivolumab versus observation after radical resection from a Canadian public-payer perspective. METHODS: A three health-state Markov model consisting of disease-free (DF), recurred disease (RD), and death states was developed to evaluate discounted total costs and quality-adjusted life-years (QALYs) over a 30-year time horizon. The annual discount rate on costs and outcomes was 1.5%. The model included costs of drug acquisition, administration, monitoring, subsequent treatment, adverse events, routine disease management, and end-of-life care. Transitions from the DF state were estimated using DF survival data and the distribution of first-recurrence events from CheckMate 274 and published data from the control arm of the EORTC 30994 study in adjuvant treatment of UC. Model assumed functional cure for DF patients starting from year 5. Published literature informed subsequent treatment-specific survival estimations from the RD state. Treatment-specific survival estimations were weighted with corresponding usage rates in Canada. Health-state utilities were derived from CheckMate 274 EQ-5D-3L data. Costs [2021 Canadian dollars (CAD)] were obtained from publicly available local sources and published literature. Incremental cost-utility ratio (ICUR) was the primary outcome of the analysis and assessed probabilistically. RESULTS: Nivolumab was associated with an additional 1.37 life-years compared to observation which translated to 1.18 incremental QALYs. An incremental cost of CAD 75,361 over observation produced an ICUR of CAD 64,046/QALY. Nivolumab had almost 100% probability of cost-effectiveness for all willingness-to-pay thresholds ≥ CAD 76,000/QALY. Key drivers of ICURs included annual discount rate and utility values in DF state. Alternative approaches to estimating transition probabilities had only marginal impact on the results, with ICURs ranging from CAD 61,936-97,683. CONCLUSIONS: Nivolumab is estimated to be a life-extending treatment option compared with observation for UC in Canada, which results in a compelling ICUR that is robust to uncertainties in the data.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"63ee603c-f5ab-4644-b76c-0d8299764d84","parentId":"00000000-0000-0000-0000-000000000000","title":"Economic Evaluation","urlName":"economic-evaluation"}],"categoryIds":["63ee603c-f5ab-4644-b76c-0d8299764d84"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23grahamposter124139-pdf.pdf?sfvrsn=40a72372_0","title":"ISPOR23_Graham_POSTER124139.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124139","diseases":[{"id":"7f059074-623e-4c96-8812-8affdc603f10","parentId":"00000000-0000-0000-0000-000000000000","title":"Urinary/Kidney Disorders","urlName":"Urinary-Kidney-Disorders"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Implementation of Minimally Invasive Thyroidectomy for Cancer Care: Conversion Rates Are Associated with Facility Learning Curve but Not Total Volume of Thyroidectomies","id":"475fb1f9-8f5c-45cd-bbc8-fbb85a615f2f","sessionCode":"MT4","topDisplay":"Assumpcao L1, Quinn CM2, Rodriguez Franco S2, Leonard LD2, Thomas M2, Albuja-Cruz M2, Gleisner AL2 1Rio de Janeiro State University, Overland Park, KS, USA, 2University of Colorado, 12631 E 17th Ave. C-305 Aurora, CO 80045, CO, USA","locationCode":"632","description":"\r\n\t<div>OBJECTIVES: Minimally invasive thyroidectomy (MIT), both laparoscopically and robotically, is increasingly being implemented for cancer care in the United States. Rates of conversion to an open procedure and risk factors for conversion at a national level are unknown. METHODS: Patients with thyroid cancer who underwent MIT between 2010 to 2019 were selected from the National Cancer Database, and conversion to open cases was identified. Average annual volume of thyroidectomies (TV), including both open and MIT, and cumulative volume of MIT for each year (MIT-CV) was calculated for all facilities A facility-clustered logistic regression model was used to determine patient, tumor, procedure, and facility level factors independently associated with conversion. RESULTS: A total of 7399 MIT cases were identified, 83.4% of which were laparoscopic. Conversion rates were initially higher with the laparoscopic approach and decreased overtime (from 13.3% in 2010 to 4.8% in 2019, p<0.001), while they remained stable with the robotic approach (from 4.6% in 2010 to 6.1% in 2019, p=0.379). Although converted cases had larger lesions (16mm[IQ:7-30];vs13mm[IQ:6-24];p=0.037), tumor size, surgery extension – total thyroidectomy and nodal dissection were not associated with conversion. Most conversions (54.1%) occurred in facilities with a MIT-CV <6 cases, which corresponded to the lowest quartile. On multivariable analysis, the risk of conversion decreased as the MIT-CV increased (OR:0.49;95%CI[0.31-0.77]) for MIT-CV 7 to 19 cases; (OR:0.17;95%CI[0.09-0.34]) for MIT-CV 20 to 51 cases and (OR:0.20;95%CI[0.07-0.56]) for MIT-CV >51 cases. When adjusted for MIT-CV, neither year or TV were associated with conversion. CONCLUSIONS: As MIT for thyroid cancer is being implemented nationwide, conversion rates are decreasing. Conversion rates decreased as the facility experience with MIT increased, denoting a facility learning curve, while TV was not associated with conversion. Other adverse events such as laryngeal nerve injury need to be evaluated to determine the impact of MIT learning curve. </div>\r\n\r\n","withdrawn":false,"categories":[{"id":"dda9555e-19ab-4405-936c-34532e5825c6","parentId":"00000000-0000-0000-0000-000000000000","title":"Medical Technologies","urlName":"medical-technologies"}],"categoryIds":["dda9555e-19ab-4405-936c-34532e5825c6"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023assumpcaoposter126425mt4126425-pdf.pdf?sfvrsn=280a08a8_0","title":"ISPOR2023_Assumpcao_poster126425_MT4126425.pdf"},{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor2023assumpcao126425mt4handout126425-pdf.pdf?sfvrsn=86c1465_0","title":"ISPOR2023_Assumpcao_126425_MT4HANDOUT126425.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/126425","diseases":[{"id":"211b3238-c597-4b53-9c40-66cc67e46481","parentId":"00000000-0000-0000-0000-000000000000","title":"STA: Surgery","urlName":"sta-surgery"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Assessment of Pain, Stiffness, and Physical Functioning Pre and During Burosumab Among Adults with X-Linked Hypophosphatemia: Results from a Multinational, Long-Term, Prospective Outcomes Disease Monitoring Program","id":"aba16077-a0b7-4f5b-a57e-fc13381e0e54","sessionCode":"PCR31","topDisplay":"Yang E1, Chen Z1, Hetzer J1, Kruger E2, Skrinar A1 1Ultragenyx Pharmaceutical Inc., Novato, CA, USA, 2Ultragenyx Pharmaceutical Inc., San Francisco, CA, USA","locationCode":"737","description":"\r\n\t<div>OBJECTIVES: Excess FGF23 causes hypophosphatemia, leading to chronic debilitating musculoskeletal impairments in patients with X-linked hypophosphatemia (XLH). Treatments include burosumab, a fully-human monoclonal antibody to FGF23, or the combination of oral phosphate and active vitamin D (Pi/D). XLH symptoms in adults include bone/joint pain, stiffness, and fatigue. Previous research validated the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in adults with XLH. This study assesses burosumab impact on WOMAC among adults from an XLH Disease Monitoring Program (XLH-DMP; NCT03651505). METHODS: The DMP is a 10-year study to collect real-world data on the safety and effectiveness of both Pi/D and burosumab for the treatment of XLH in adults and children. WOMAC has 24 items divided into three subscales: pain (5 items), stiffness (2 items), and physical function (PF, 17 items). WOMAC scores collected from adults at enrollment were compared to scores obtained one year later for three cohorts: 1, burosumab-naïve at enrollment with burosumab dosed within 90 days post-enrollment; 2, burosumab-naïve at enrollment with burosumab dosed between 91-180 days post-enrollment; 3, no-burosumab. RESULTS: As of February 2022, 24 and 14 burosumab-naïve and 51 no-burosumab patients from North America were selected into cohort 1, 2 and 3. Average WOMAC scores were 35.6, 51.0, 32.8 for pain, stiffness, and PF for cohort 1, and 43.2, 51.8, 39.0 for cohort 2, and 24.8, 34.1, 19.3 for cohort 3 at enrollment. At year 1, reduction of 12.7, 13.5 and 9.4 scores were observed in pain, stiffness, and PF for cohort 1; and reduction of 16.1, 11.6, and 10.8 were observed for cohort 2. No-burosumab cohort had minimal changes. CONCLUSIONS: Clinically meaningful improvement in pain (>9.7), stiffness (>10) and PF (>9.3) with burosumab were observed one year after enrollment among adults with XLH and were consistent with results from a randomized, double-blind placebo-controlled registration study.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"d72a145a-f216-45d6-a2d2-af65d912c83d","parentId":"00000000-0000-0000-0000-000000000000","title":"Patient-Centered Research","urlName":"patient-centered-research"}],"categoryIds":["d72a145a-f216-45d6-a2d2-af65d912c83d"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/ispor23yangposter124696-pdf.pdf?sfvrsn=96da5612_0","title":"ISPOR23_Yang_POSTER124696.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124696","diseases":[{"id":"e0294922-dcb4-4a59-8433-fea4d71449cc","parentId":"00000000-0000-0000-0000-000000000000","title":"Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal)","urlName":"musculoskeletal-disorders-arthritis-bone-disorders-osteoporosis-other-musculoskeletal"},{"id":"38bbb968-9a07-4d26-983e-234f3e629d4f","parentId":"00000000-0000-0000-0000-000000000000","title":"Rare & Orphan Diseases","urlName":"rare-orphan-diseases"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Analysis of US Real World Evidence Data to Assess and Compare the Effectiveness of Two Chemotherapy Regimens: FOLFIRINOX Vs Gemcitabine/Nab-paclitaxel for First Line Metastatic Pancreatic Cancer","id":"8196296f-5b71-43ec-8e96-fd919fadf806","sessionCode":"RWD20","topDisplay":"Bocheńska K1, Galusza M2, Hodge JP3, Raupp MD2, Zeng S4 1IQVIA, Warsaw, MA, Poland, 2IQVIA, Durham, NC, USA, 3IQVIA, Raleigh, NC, USA, 4IQVIA, Wayne, PA, USA","locationCode":"825","description":"\r\n\t<div>OBJECTIVES: To demonstrate the validity of our analysis techniques utilizing real-world data to assess and compare the effectiveness of two chemotherapy regimens that have not been directly compared in randomized clinical trials: FOLFIRINOX (combined leucovorin calcium, fluorouracil, irinotecan and oxaliplatin) and gemcitabine plus nab-paclitaxel for first line metastatic pancreatic cancer. METHODS: Our proprietary detection algorithm identifies attributes of chemotherapy regimens in a large population of individual patients in US medical claims and pharmacy prescription fill data. Key attributes examined: chemotherapeutic agents, duration, timing, and associations to preceding and following treatments. With a cohort of 17k pancreatic cancer patients treated either with FOLFIRINOX or gemcitabine/nab-paclitaxel as first line therapy in the last 5 years, we identified a subset of 2439 metastatic patients aged 50+ at the time of the first line starting date, who completed first line treatment prior to December 31st, 2021. Using medical claims made through June 30th, 2022, a death surrogate event was estimated as last medical event of any type prior to the observation end date. Overall Survival (OS) analysis was made using the Kaplan-Meier method. The cohort was split by chemotherapy regimen. RESULTS: The analysis demonstrates survival benefit of FOLFIRNOX over gemcitabine/nab-paclitaxel: FOLFIRINOX 12.5 months vs gemcitabine plus nab-paclitaxel 10.25 months. Comparable outcomes can be found in publications based on the results of randomized clinical trials, separately for each chemotherapy regimen, and retrospective analyzes. CONCLUSIONS: Survival benefit was shown in patients with metastatic pancreatic cancer treated with FOLFIRNOX over gemcitabine/nab-paclitaxel. Our proprietary detection algorithm identifies attributes of chemotherapy regimens in claims data and can be used to provide insights into oncology treatment regimens in large populations of oncology patients, which is especially important when comparative analyzes of clinical effectiveness are limited.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"48c6b73a-07ce-409d-95f0-b8ade1a832c8","parentId":"00000000-0000-0000-0000-000000000000","title":"Real-World Data & Information Systems","urlName":"real-world-data-information-systems"}],"categoryIds":["48c6b73a-07ce-409d-95f0-b8ade1a832c8"],"relatedPdfs":[{"url":"https://www.ispor.org/docs/default-source/intl2023/isporlemotte123798-pdf.pdf?sfvrsn=f6132485_0","title":"ISPOR_Lemotte123798.pdf"}],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/123798","diseases":[{"id":"e8a428f2-769e-4a1a-9cd7-c8bf0bdf664d","parentId":"00000000-0000-0000-0000-000000000000","title":"No Additional Disease & Conditions/Specialized Treatment Areas","urlName":"no-additional-disease-conditions-specialized-treatment-areas"}],"viewingMethods":[],"shouldShowPdfs":true},{"title":"Pembrolizumab Vs. Standard of Care Chemotherapy As First-Line Treatment for Advanced Non-Small Cell Lung Cancer with High Pd-L1 Expression Levels: A Cost-Utility Analysis from the Ontario, Canada Public Payer Perspective","id":"bd4c6e10-70a3-406f-85b1-fe8fd1462598","sessionCode":"HTA4","topDisplay":"Chu R1, Tudor R1, Choi D2, Wong O3, Chan KKW4, Leighl NB5, Chan BCF6, Coyte PC1, Rebecca HH1 1University of Toronto, Toronto, ON, Canada, 2University of Toronto, Richmond, BC, Canada, 3York University, Toronto, ON, Canada, 4Sunnybrook Odette Cancer Centre, Toronto, ON, Canada, 5Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 6KITE Research Institute, Toronto, ON, Canada","locationCode":"613","description":"\r\n\t<div>OBJECTIVES: Initial 1-year results from the pivotal KEYNOTE-024 (KN024) trial showed improved efficacy of pembrolizumab over chemotherapy in advanced non-small cell lung cancer (NSCLC). 5-year results from KN024 are now available. The cost-utility of pembrolizumab can be re-analysed, addressing the uncertainty regarding long-term outcomes highlighted in the previous 2017 pan-Canadian Oncology Drug Review assessment. The objective of this study was to assess the cost-utility of pembrolizumab monotherapy vs chemotherapy as first-line treatment in advanced NSCLC patients, with a programmed death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50% from the Ontario, Canada public payer perspective. METHODS: A three state partitioned survival model (progression-free disease, progressed disease, and death) was used. Costs were sourced from public Ontario sources and the literature. Survival estimates and health state utilities were from KN024. Costs and benefits were discounted at 1.5% per year. The model implemented a lifetime horizon of 15 years. The primary outcome was the incremental cost-utility ratio (ICUR), measured as incremental cost ($CAD, $1 CAD = $0.77 USD) per quality adjusted life year (QALY). Base case, scenario analyses, threshold analyses, probabilistic (PSA), and one-way sensitivity analyses were conducted. RESULTS: The base case calculated an incremental cost of $126,553, and an incremental QALY gain of 1.02, resulting in an ICUR of $124,607 per QALY. The PSA average ICUR was $119,113 per QALY, with 0% and 24% probability of meeting the $50,000 and $100,000 per QALY cost-utility thresholds. CONCLUSIONS: At the public list price, first-line pembrolizumab treatment for PD-L1 TPS ≥50% NSCLC does not meet the $100,000 per QALY threshold in Ontario, Canada.</div>\r\n\r\n","withdrawn":false,"categories":[{"id":"6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73","parentId":"00000000-0000-0000-0000-000000000000","title":"Health Technology Assessment","urlName":"health-technology-assessment"}],"categoryIds":["6f5ef72f-8f2d-4f1e-8746-b96cc7c07b73"],"relatedPdfs":[],"detailUrl":"https://www.ispor.org/heor-resources/presentations-database/presentation/intl2023-3665/124343","diseases":[{"id":"8e45721c-577e-4445-ba28-7da762aa0e0f","parentId":"00000000-0000-0000-0000-000000000000","title":"Drugs","urlName":"Drugs"},{"id":"4c3286be-524e-4892-8f01-1b369a24d82e","parentId":"00000000-0000-0000-0000-000000000000","title":"Oncology","urlName":"Oncology"},{"id":"4516d297-cd6a-4f78-8eaa-3ebf6f65ff78","parentId":"00000000-0000-0000-0000-000000000000","title":"Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)","urlName":"respiratory-related-disorders-allergy-asthma-smoking-other-respiratory"}],"viewingMethods":[],"shouldShowPdfs":true}]; </script> <script> window.mgConfexProgramConfig = window.mgConfexProgramConfig || {}; window.mgConfexProgramConfig.programType = "posters"; window.mgConfexProgramConfig.usePosterLinks = true; </script> <div> <div id="confex-sessions-v2"></div> </div> <script src='/ResourcePackages/ISPOR/modules/confex-sessions-v2/dist/assets/index.js?v=2023-09-07-10:08' type='module'></script> </div> </div> </div> </div> </div> </div> <div > <div class="sfContentBlock sf-Long-text" ></div> </div> </main>  <footer class="section__footer py-8"> <div id="footer__links" class="container"> <div class="row"> <div class="col-md-5"> <div > <div class="sfContentBlock sf-Long-text" ><h5>Quick Links</h5><hr /></div> </div> <div> <ul class="footer-nav"> <li class=""> <a href="/about" target="_self">About</a> </li> <li class=""> <a 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