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class="news_sectionContainer__QEy85"><h2>Latest articles</h2><article class="FeaturedStory_story__9p_lI"><div class="FeaturedStory_imageContainer__HlBRh" style="background-image:url(https://a.storyblok.com/f/243782/2120x1414/da6a7688ab/doctor-talking-to-patient-during-mammography.jpg/m/868x0/filters:quality%2880%29)"></div><div class="FeaturedStory_content__D_xaU"><h3 class="FeaturedStory_heading__P_klO"><a href="/news/articles/nice-responds-to-failure-of-talks-to-reach-price-agreement-on-enhertu">NICE responds to failure of talks to reach price agreement on Enhertu</a></h3><p>Talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged.</p><footer><span class="tag tag--outline" data-component="tag">News</span><time class="FeaturedStory_date__N6AXV" dateTime="2024-11-19 00:00">19 November 2024</time></footer></div></article><ol class="NewsGrid_newsGrid__S8v92"><li class="newsItem"><article class="NewsCard_newsCard__kP3m6 "><a class="NewsCard_imageContainer__sjaVO" style="background-image:url(https://a.storyblok.com/f/243782/2121x1414/e1d1103512/support-worker-helping-a-young-man-using-a-laptop.jpg/m/868x0/filters:quality%2880%29)" aria-hidden="true" tabindex="-1" href="/news/articles/two-technologies-recommended-for-people-with-chronic-tic-disorders-and-tourette-syndrome"> </a><div><h3 class="NewsCard_heading__xb27b"><a href="/news/articles/two-technologies-recommended-for-people-with-chronic-tic-disorders-and-tourette-syndrome">Two technologies recommended for people with chronic tic disorders and Tourette syndrome</a></h3><p>Draft guidance issued for consultation recommends two technologies to help people manage their condition. </p><footer><div><span class="tag tag--outline" data-component="tag">News</span><time class="NewsCard_date__X58Ck" dateTime="2024-11-19 00:00">19 November 2024</time></div></footer></div></article></li><li 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Subject to<!-- --> <a href="https://www.nice.org.uk/terms-and-conditions#notice-of-rights">Notice of rights</a>.</p></div></div></footer></div></div><script id="__NEXT_DATA__" type="application/json">{"props":{"pageProps":{"newsArticles":[{"name":"NICE responds to failure of talks to reach price agreement on Enhertu","created_at":"2024-11-19T16:20:59.590Z","published_at":"2024-11-19T16:45:04.410Z","alternates":[],"id":581421880,"uuid":"f384c425-a2fc-413c-ab6b-8ce0a67b3541","content":{"_uid":"afcd9186-1ab1-4731-8ad8-be6ab77cf1d2","date":"2024-11-19 00:00","image":{"id":18588908,"alt":"","name":"","focus":"","title":"","source":"","filename":"https://a.storyblok.com/f/243782/2120x1414/da6a7688ab/doctor-talking-to-patient-during-mammography.jpg","copyright":"","fieldtype":"asset","meta_data":{},"is_external_url":false},"title":"NICE responds to failure of talks to reach price agreement on Enhertu","content":{"type":"doc","content":[{"type":"blok","attrs":{"id":"1970b74b-d731-4541-8e61-d11255498bef","body":[{"_uid":"i-1cbd4eb5-ef9d-436a-ad5d-b8a3c696e668","component":"quote","quoteText":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"We are extremely disappointed that talks to reach a price agreement that would have made advanced breast cancer drug Enhertu available to around 1000 women in England and Wales have not been successful.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]}]},"quoteAuthor":"NICE chief Executive Dr Samantha Roberts "}]}},{"type":"paragraph","content":[{"text":"Dr Samantha Roberts continues, \"","type":"text"},{"text":"As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price. We have done all we can to try and achieve that.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]},{"type":"paragraph","content":[{"text":"“Once again ","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]},{"text":"I would like to thank the breast cancer community for their hard work on this issue and I am sorry the outcome was not what we, nor they and the patients they represent, expected.”","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"We were set to act swiftly on receipt of an agreed new cost-effective price with updated guidance and patient access to the treatment within days.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]},{"type":"paragraph","content":[{"text":"In the talks both ourselves and NHS England continued to offer as much flexibility as possible, but despite the intervention of Secretary of State for Health Wes Streeting, the companies did not put forward a cost-effective price that would have enabled us to recommend Enhertu as value for money for the taxpayer.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]},{"type":"paragraph","content":[{"text":"Enhertu remains the only breast cancer treatment we’ve been unable to recommend for 6 years and breaks a line of 21 positive breast cancer recommendations. This includes the positive recommendation in February for talazoparib (Talzenna) for treating HER2 negative locally advanced or metastatic breast cancer.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Talzenna was approved using the same process as the evaluation of Enhertu for advanced HER2-low breast cancer.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"A recent report showed the new severity weighting is working as intended and expected.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"It has been applied more widely than the end-of-life modifier it replaced.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"It has contributed to an increase in positive decisions for cancer medicines and non-cancer medicines.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"The proportion of positive decisions where the new additional severity weighting was used is higher (84.4%) than with end of life (82.7%)","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"We are saying yes to a greater proportion of new cancer treatments.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"The proportion of positive cancer recommendations overall is higher (79% compared to 78%) and","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"The proportion of positive recommendations for advanced cancer treatments is higher (81% compared to 69%)","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"Our committees can now give greater weight to severe conditions and conditions characterised by a poor quality of life such as hepatitis D and cystic fibrosis – neither would qualify for additional weighting under the narrower end of life criteria.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]}]},"metadata":[],"component":"newsArticle","introText":"Talks with the makers of Enhertu have ended without agreement, meaning guidance that does not recommend Enhertu for advanced breast cancer will remain unchanged.","resources":[],"relatedNews":[]},"slug":"nice-responds-to-failure-of-talks-to-reach-price-agreement-on-enhertu","full_slug":"news/articles/nice-responds-to-failure-of-talks-to-reach-price-agreement-on-enhertu","default_full_slug":null,"sort_by_date":null,"position":-2220,"tag_list":[],"is_startpage":false,"parent_id":420552799,"meta_data":null,"group_id":"32e8cb90-c9d5-4b0d-8ab3-3e866f32f303","first_published_at":"2024-11-19T16:45:04.410Z","release_id":null,"lang":"default","path":null,"translated_slugs":[]},{"name":"Two technologies recommended for people with chronic tic disorders and Tourette syndrome","created_at":"2024-11-18T16:45:54.833Z","published_at":"2024-11-19T13:38:41.062Z","alternates":[],"id":580614705,"uuid":"08785ada-b926-4079-9a91-249fe9fa4a44","content":{"_uid":"59796119-3c67-48d7-a8e9-669035956a53","date":"2024-11-19 00:00","image":{"id":18546566,"alt":"","name":"","focus":"","title":"","source":"","filename":"https://a.storyblok.com/f/243782/2121x1414/e1d1103512/support-worker-helping-a-young-man-using-a-laptop.jpg","copyright":"","fieldtype":"asset","meta_data":{},"is_external_url":false},"title":"Two technologies recommended for people with chronic tic disorders and Tourette syndrome","content":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"Two technologies that could reduce the severity of the symptoms of chronic tic disorders and Tourette syndrome have been recommended for use in draft guidance from NICE.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"It is the first time a NICE committee has recommended digital therapies for these conditions which developers believe could also improve the user’s ability to go about their everyday life.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"We surveyed people with chronic tic disorders and Tourette syndrome, and their parents or carers, about their experiences and received 1,508 responses. In response some said that for most people it can take a long time to get a diagnosis (most people need to wait at least 6 months to 2 years). The acceptance of using digital technologies varied between people who completed the survey but it highlighted present treatment options are limited.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Tics are fast, repetitive muscle movements that result in difficult to control body movements or sounds. Examples of tics might include blinking, grimacing, head jerking, head banging, finger clicking, coughing, grunting, sneezing, repeating a sound or phrase (in approximately 10% of people this can be something offensive, such as swearing). When both motor and vocal tics are present for more than 1 year, this is commonly known as Tourette syndrome.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"We have launched a consultation on the recommendations reached by the independent committee on recommendations to allow the use of Online Remote Behavioural Intervention for Tics (ORBIT) and Neupulse (once appropriately regulated) by NHS patients for the next three years. Further evidence will be generated during this time on the technology’s long-term clinical effectiveness, how they affect the person’s quality of life, and which patients benefit most from using them.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"ORBIT is accessed via a web browser and is an online guided self-help intervention which uses videos, animations and interactive scripts to help children and young people aged 9 to 17 years. It is supported by an online therapist across a 10-week programme to deliver a form of behavioural therapy called an exposure with response-prevention intervention, which involves practicing confronting the thoughts, images, objects, and situations that makes a person anxious and provokes their tic.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Neupulse is a wearable wrist-worn device linked to a mobile phone app, used to treat those over the age of 12. The device delivers low-intensity electrical pulses to the median nerve to reduce tic frequency and severity. Users are supported by written and video-based guidance and a technical support helpline.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Each technology would only be offered after clinical assessment with a GP. The first line treatment option will remain as psychoeducation, which combines the elements of cognitive-behaviour therapy and education, before offering one of the two technologies could be offered.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"It is estimated that Tourette syndrome affects ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"one school child in every hundred","type":"text","marks":[{"type":"link","attrs":{"href":"https://bestpractice.bmj.com/topics/en-gb/1042","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":", with more than 300,000 children and adults in the UK living with the condition. Experts estimate less than 20% of children and young people with tic disorders ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"currently have access","type":"text","marks":[{"type":"link","attrs":{"href":"https://pubmed.ncbi.nlm.nih.gov/37488511/","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":" to behavioural therapies.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"blok","attrs":{"id":"835537de-07fa-4fa6-b279-9e130d1b3e68","body":[{"_uid":"i-5af1bf7b-7d0e-47c9-b870-ebaf5ee1ee75","component":"quote","quoteText":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"Our committee heard that diagnosis, treatment and support for people with chronic tic disorders and Tourette syndrome can be variable depending on which part of the country they live in. For many it can take several months to receive a diagnosis, and our patient survey has highlighted that treatment options can be limited. Our committee’s recommendation of these two technologies could increase treatment options and ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"could allow more convenient treatment for people wherever they live be that urban or rural given the inconsistency in access.","type":"text"}]}]},"quoteAuthor":"Mark Chapman, director of HealthTech at NICE"}]}},{"type":"paragraph","content":[{"text":"Neupulse can be used once it has appropriate regulatory approval – it is currently working towards CE and UKCA marking (expected 2026) – and meets the standards within NHS England’s Digital Technology Assessment Criteria (DTAC).","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"After the consultation, responses will be considered by the committee who may then alter their recommendations before final guidance is published on our website.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"A consultation on the draft recommendations has begun and comments can be submitted until Tuesday 17 December 2024.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},"metadata":[],"component":"newsArticle","introText":"Draft guidance issued for consultation recommends two technologies to help people manage their condition. ","resources":[{"_uid":"73e83abd-41a0-4961-a6bb-56bab6d5f045","link":{"id":"","url":"https://www.nice.org.uk/guidance/indevelopment/gid-hte10056/consultation/html-content-5","linktype":"url","fieldtype":"multilink","cached_url":"https://www.nice.org.uk/guidance/indevelopment/gid-hte10056/consultation/html-content-5"},"title":"Digital therapy for chronic tic disorders and Tourette syndrome: early value assessment","component":"relatedLink"}],"relatedNews":[]},"slug":"two-technologies-recommended-for-people-with-chronic-tic-disorders-and-tourette-syndrome","full_slug":"news/articles/two-technologies-recommended-for-people-with-chronic-tic-disorders-and-tourette-syndrome","default_full_slug":null,"sort_by_date":null,"position":-2210,"tag_list":[],"is_startpage":false,"parent_id":420552799,"meta_data":null,"group_id":"2633806e-d4ac-4892-b483-41adda9aade3","first_published_at":"2024-11-19T00:15:00.263Z","release_id":null,"lang":"default","path":null,"translated_slugs":[]},{"name":"New study shows NICE Advice support can reduce appraisal timelines by 3 months","created_at":"2024-11-14T07:49:45.669Z","published_at":"2024-11-14T09:58:42.160Z","alternates":[],"id":578772127,"uuid":"622fa496-a7dd-4375-94da-e19ccf3f6907","content":{"_uid":"3336a877-c03b-40a1-bfe6-49f75c00e267","date":"2024-11-14 00:00","image":{"id":18425808,"alt":"","name":"","focus":"","title":"","source":"","filename":"https://a.storyblok.com/f/243782/2495x1201/766442ac9a/perscription-being-delivered-to-a-patient-at-home.jpg","copyright":"","fieldtype":"asset","meta_data":{},"is_external_url":false},"title":"New study shows NICE Advice support can reduce appraisal timelines by 3 months","content":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"The research","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-europe-2024/program/program/paper/euro2024-4008/19100/the-value-of-nice-scientific-advice","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":", which will be presented to delegates at the ISPOR conference in Barcelona, Spain, examined NICE technology appraisal and highly specialised technologies guidance published between June 2020 and May 2023. It found that products benefiting from NICE Advice’s scientific advice service had a shorter time from marketing authorisation to the publication of NICE guidance.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"type":"hard_break"},{"type":"hard_break"},{"text":"According to the study, technologies that received scientific advice took a median of 312 days to progress from marketing authorisation to NICE guidance publication. In contrast, those without such advice required a median of 400 days – a difference of nearly 3 months.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"type":"hard_break"},{"type":"hard_break"},{"text":"The analysis included 230 technology appraisal and highly specialised technologies guidance documents, of which 51 technologies had received scientific advice from NICE Advice. While the study acknowledges that various factors can influence the time to guidance publication, the majority of these would be expected to apply to technologies with or without scientific advice.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"blok","attrs":{"id":"8316733d-835e-4a6f-936e-27ac0435434a","body":[{"_uid":"i-be244960-b69b-464e-8969-d4c937ac0ab8","component":"quote","quoteText":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"This study reinforces the value of engaging with NICE Advice’s scientific advice service early in the product development process. Our depth of knowledge and unique insights can help companies effectively prepare for their NICE evaluation, potentially streamlining their path through the process, and helping to get innovative technologies to patients faster.","type":"text"}]}]},"quoteAuthor":"Andrew Walsh, associate director of NICE Advice"}]}},{"type":"paragraph","content":[{"text":"The results support ","type":"text"},{"text":"previous findings","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.valueinhealthjournal.com/article/S1098-3015(20)33008-4/fulltext","uuid":null,"anchor":null,"target":null,"linktype":"url"}}]},{"text":" on the benefits of NICE Advice’s scientific advice service. This earlier study showed that between 2009 and 2019, the median time from marketing authorisation to publication of NICE guidance was 296 days for products that used NICE Advice’s scientific advice service compared to 405 days for products that did not.","type":"text"},{"type":"hard_break"},{"type":"hard_break"},{"text":"As the life sciences sector continues to innovate, our independent and highly confidential support service, ","type":"text"},{"text":"NICE Advice","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service","uuid":null,"anchor":null,"target":null,"linktype":"url"}}]},{"text":", offers a valuable resource to companies aiming to speed up the NICE appraisal process and get their new treatments to NHS patients faster. By partnering with NICE Advice, companies can ensure their technologies meet NHS needs from the early stages of development, guiding them in collecting high-quality evidence that resonates with decision-makers.","type":"text"}]}]},"metadata":[],"component":"newsArticle","introText":"Companies who receive scientific advice from our NICE Advice service may experience a faster path to guidance publication, a study has found. ","resources":[{"_uid":"3f064c04-f11b-4eca-9949-8b0af7de6c04","link":{"id":"","url":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service","linktype":"url","fieldtype":"multilink","cached_url":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service"},"title":"NICE Advice","component":"relatedLink"},{"_uid":"a0444453-7388-496d-92a2-c14ab504974a","link":{"id":"","url":"https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-europe-2024/program/program/paper/euro2024-4008/19100/the-value-of-nice-scientific-advice","linktype":"url","fieldtype":"multilink","cached_url":"https://www.ispor.org/conferences-education/conferences/upcoming-conferences/ispor-europe-2024/program/program/paper/euro2024-4008/19100/the-value-of-nice-scientific-advice"},"title":"The value of NICE scientific advice","component":"relatedLink"}],"relatedNews":[]},"slug":"new-study-shows-nice-advice-support-can-reduce-appraisal-timelines-by-3-months","full_slug":"news/articles/new-study-shows-nice-advice-support-can-reduce-appraisal-timelines-by-3-months","default_full_slug":null,"sort_by_date":null,"position":-2200,"tag_list":[],"is_startpage":false,"parent_id":420552799,"meta_data":null,"group_id":"e04b4626-7880-4a76-a1a4-bcd8cf42397b","first_published_at":"2024-11-14T07:54:04.336Z","release_id":null,"lang":"default","path":null,"translated_slugs":[]},{"name":"Our updated guideline to improve the diagnosis of endometriosis","created_at":"2024-11-11T13:02:43.265Z","published_at":"2024-11-11T13:28:51.318Z","alternates":[],"id":576985436,"uuid":"26e8ba96-d56d-4d84-a0ad-0ddd0fa687d2","content":{"_uid":"45901b6b-42dd-49d6-95f3-4e27becf91bf","date":"2024-11-11 00:00","image":{"id":18369641,"alt":"A woman bent over in pain, clutching her abdomen with her right hand, head resting in her left hand","name":"","focus":"","title":"","source":"","filename":"https://a.storyblok.com/f/243782/2121x1414/662d75faa1/endometirosis.jpg","copyright":"","fieldtype":"asset","meta_data":{"alt":"A woman bent over in pain, clutching her abdomen with her right hand, head resting in her left hand","title":"","source":"","copyright":""},"is_external_url":false},"title":"Our updated guideline to improve the diagnosis of endometriosis","content":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"Recent reports from both the National Confidential Enquiry into Patient Outcome and Death (NCEPOD) and Endometriosis UK have highlighted problems with the diagnosis of endometriosis in the UK. According to Endometriosis UK, the average length of time it takes for a woman to get a diagnosis of endometriosis is 8-10 years, and as NCEPOD has pointed out, a delay in diagnosis is a significant issue as it can lead to prolonged suffering, ill health, and risks to fertility.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Our updated guideline aims to help address these issues by:","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"Recommending specialist ultrasound as an alternative to MRI for investigating suspected endometriosis in secondary care.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"Recommending early transvaginal ultrasound in all people with suspected endometriosis, even if the pelvic or abdominal examination is normal.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"Making firmer and clearer recommendations regarding referral.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"Providing greater clarity about the care available for women with suspected endometriosis.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]},{"type":"blok","attrs":{"id":"4f5c79e9-5175-40c7-8f05-590752bee9de","body":[{"_uid":"i-cd68d0ed-58dd-4d40-9e66-d809252304de","component":"quote","quoteText":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"This guideline will help healthcare professionals detect endometriosis early, to close the symptom to diagnosis gap and ensure more timely treatment.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},"quoteAuthor":"Professor Jonathan Benger, chief medical officer and interim director of the Centre for Guidelines at NICE"}]}},{"type":"paragraph","content":[{"text":"Professor Benger continued: “We recognise that capacity in endometriosis clinics remains an issue, and that waiting times to be seen in secondary care can sometimes be lengthy.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"“However, we also recognise the serious problems which people with suspected endometriosis face in accessing the care they need and the consequences of delayed diagnosis and treatment. This update aims to help tackle these problems by clarifying what high quality care for women with suspected endometriosis should be.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"“It is also sometimes the case that women are not always informed when endometriosis is suspected and do not have the pathway of care explained to them. This guideline should help ensure women with suspected endometriosis are informed about what to expect, and that appropriate information is provided throughout their care journey.”","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"blok","attrs":{"id":"4f5c79e9-5175-40c7-8f05-590752bee9de","body":[{"_uid":"i-c6db31ca-a71b-4a6b-93e9-dc03e178b104","component":"quote","quoteText":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"Endometriosis can be debilitating and women with this condition have been failed for far too long.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"This government is determined to overhaul women's healthcare and these changes will help patients receive an accurate and timely diagnosis, benefitting over a million women affected.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Our 10-Year Health Plan, backed by a £22.6 billion increase in day-to-day health spending, will help cut waiting lists in gynaecology and get women the support they need.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},"quoteAuthor":"Baroness Merron, Women’s Health Minister "}]}},{"type":"paragraph","content":[{"text":"Endometriosis is a chronic long-term condition that develops when cells normally found in the womb are present elsewhere in the body such as the bladder or bowel.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Although some women don’t have any symptoms, endometriosis is usually associated with pelvic pain, painful periods and difficulty getting pregnant. Endometriosis can also have a significant effect on quality of life.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},"metadata":[{"_uid":"aadd66e4-8276-4278-a555-1577632372fb","creator":"","component":"metadata","description":"NICE's updated guideline to improve the diagnosis of endometriosis"}],"component":"newsArticle","introText":"The guideline makes new recommendations and updates existing ones on diagnosing and managing a condition that affects approximately 1.5 million women of reproductive age in the UK. 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scientific adviser in NICE’s Science Policy and Research Programme ","component":"author"},"slug":"jamie-elvidge","full_slug":"news/blogs/authors/jamie-elvidge","default_full_slug":null,"sort_by_date":null,"position":-520,"tag_list":[],"is_startpage":false,"parent_id":416560259,"meta_data":null,"group_id":"10ff16b8-195d-449a-912c-c9f6f2e80f78","first_published_at":"2024-10-31T09:30:19.956Z","release_id":null,"lang":"default","path":null,"translated_slugs":[]}],"content":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"In today's rapidly evolving healthcare landscape, health technology assessment (HTA) agencies face a difficult challenge: keeping up with the fast-paced development of innovative technologies. Traditional assessment methods sometimes struggle to evaluate new treatments. HTA agencies must continue to evolve to avoid potentially delaying patient access to life-changing innovations.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"heading","attrs":{"level":2},"content":[{"text":"The sandbox solution","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"The sandbox concept, originally developed in the financial technology sector, creates a safe and controlled environment where new ideas, products, or processes can be explored and developed without impacting existing systems or users. In the context of HTA, a sandbox allows agencies to experiment with innovative assessment methods and collaborate with stakeholders, isolated from the pressures of live evaluations.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"type":"hard_break"},{"type":"hard_break"},{"text":"As part of the EU-funded ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"Next Generation Health Technology Assessment (HTx) project","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.htx-h2020.eu/","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":", we conducted a literature review to explore the extent of sandbox use in healthcare and assessed its potential for HTA organisations. We followed this up by testing the sandbox approach to address some known HTA challenges. Finally, we developed a series of recommendations to help HTA agencies implement this innovative testing ground.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"heading","attrs":{"level":2},"content":[{"text":"Key findings","type":"text","marks":[{"type":"bold"},{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Through our literature review, ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"The sandbox approach and its potential for use in health technology assessment","type":"text","marks":[{"type":"link","attrs":{"href":"https://link.springer.com/article/10.1007/s40258-021-00665-1","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":", we found that:","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"regulatory sandboxes in healthcare are relatively new and primarily used in high-income countries","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"they mainly support the adoption of new technologies, particularly in digital health","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"despite its potential, this approach was not being used in HTA.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]},{"type":"paragraph","content":[{"text":"We concluded that HTA agencies should consider this approach to facilitate developing policies, methods and processes for innovative and disruptive health technologies.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"heading","attrs":{"level":2},"content":[{"text":"Recommendations for implementation","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Our paper, ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"Implementing a sandbox approach in health technology assessment: benefits and recommendations","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.cambridge.org/core/journals/international-journal-of-technology-assessment-in-health-care/article/implementing-a-sandbox-approach-in-health-technology-assessment-benefits-and-recommendations/91B4A85A24A73CE4CE2C114486663207","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":", provides guidance on effective implementation.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Key recommendations for HTA agencies include:","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"use sandboxes in an anticipatory way: align with horizon-scanning efforts to prepare for upcoming challenges","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"focus on technical solutions: HTA sandboxes are most useful for challenges expected to have objective technical solutions","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":" ","type":"text"},{"text":"(rather than challenges relating to values or ethics, for example)","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"communicate clearly: define the sandbox scope, objectives and safe space concept to manage stakeholder expectations and mitigate potential conflicts.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]},{"type":"heading","attrs":{"level":2},"content":[{"text":"Applying the concept","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"This work has laid the foundations for NICE's own sandbox - our ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"HTA Innovation Laboratory","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/hta-lab","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":". The HTA Lab presents an exciting opportunity for NICE, and our stakeholder community. Through a process of co-creation, it is helping us develop solutions to complex HTA issues. We’ve already used it in the development of:","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"a new approach to appraising medicines which are highly likely to need a managed access agreement","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/hta-lab-projects#rema","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"our guidance on virtual ward platform technologies for people with acute respiratory infections","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/hta-lab-projects#virtualwards","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":".","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]},{"type":"paragraph","content":[{"text":"Current HTA Lab projects include:","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"bullet_list","content":[{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"AI in HTA","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/hta-lab-projects#ai","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"comparing environmental impacts of health technologies","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/hta-lab-projects#environment","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]}]}]},{"type":"list_item","content":[{"type":"paragraph","content":[{"text":"emerging treatments for metabolic dysfunction-associated steatohepatitis","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/hta-lab-projects#mash","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":".","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]}]}]},{"type":"heading","attrs":{"level":2},"content":[{"text":"Shaping the future","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Sandboxes can play an important role in shaping the future of HTA. As healthcare rapidly evolves, particularly in areas like AI and personalised medicine, the flexibility and innovation fostered by sandboxes will be crucial in ensuring organisations like NICE have HTA methods that keep pace with technological advancements. By embracing this concept, HTA agencies can position themselves at the forefront of healthcare innovation, driving improvements in patient care.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"heading","attrs":{"level":2},"content":[{"text":"Find out more","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"NICE participates in ","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]},{"text":"various methodological research projects","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/our-research-work/our-projects-and-partners","uuid":null,"anchor":null,"target":"_blank","linktype":"url"}},{"type":"textStyle","attrs":{"color":"#228096"}}]},{"text":" with partners around the world, such as HTx. These partnerships help us improve our work. They also help us anticipate and adapt to policy developments, including changes in health and social care delivery.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]},{"type":"paragraph","content":[{"text":"You can learn more about one of our other key outputs from the HTx project in our blog post: ","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]},{"text":"Introducing CHEERS-AI: improving health economic evaluation reporting for AI technologies","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/news/blogs/introducing-cheers-ai:-improving-health-economic-evaluation-reporting-for-ai-technologies","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":".","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]},{"type":"paragraph","content":[{"text":"If you'd like to learn more about our ongoing research projects or discuss potential collaborations, please ","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]},{"text":"reach out to our research team","type":"text","marks":[{"type":"link","attrs":{"href":"mailto:research@nice.org.uk","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":". Contact us today to explore how we can work together to advance healthcare methodological research.","type":"text","marks":[{"type":"textStyle","attrs":{"color":"black"}}]}]}]},"metadata":[],"component":"blogPost","introText":"Colleagues in our Science Policy and Research Programme discuss their international research, paving the way for next generation health technology assessment."},"slug":"a-safe-space-for-bold-ideas-implementing-a-sandbox-approach-in-health-technology-assessment","full_slug":"news/blogs/a-safe-space-for-bold-ideas-implementing-a-sandbox-approach-in-health-technology-assessment","default_full_slug":null,"sort_by_date":null,"position":-560,"tag_list":[],"is_startpage":false,"parent_id":420552804,"meta_data":null,"group_id":"0b1dd4a5-6fb6-4ab2-ac30-634e452c8a40","first_published_at":"2024-11-19T16:14:20.519Z","release_id":null,"lang":"default","path":null,"translated_slugs":[]},{"name":"Planning for the International Recognition Procedure ","created_at":"2024-11-15T10:14:42.815Z","published_at":"2024-11-15T13:39:29.469Z","alternates":[],"id":579439816,"uuid":"fedf0a7d-642a-4ddf-ae4e-26017911e0cb","content":{"_uid":"251f7cdf-18a7-43fc-b2ed-c5d7a1ee0248","date":"2024-11-15 00:00","image":{"id":18449674,"alt":"","name":"","focus":"","title":"","source":"","filename":"https://a.storyblok.com/f/243782/1222x823/7b11ed44de/pills.jpg","copyright":"","fieldtype":"asset","meta_data":{},"is_external_url":false},"title":"Planning for the International Recognition Procedure ","author":[{"name":"Richard Chivers","created_at":"2024-01-26T14:05:41.283Z","published_at":"2024-11-15T11:44:09.960Z","alternates":[],"id":433395023,"uuid":"1e99d476-42ce-411f-9835-7086a0ad298b","content":{"_uid":"0b44aa68-e342-4292-9154-b84f6dca664b","name":"Richard Chivers","image":{"id":13876569,"alt":"","name":"","focus":"","title":"","source":"","filename":"https://a.storyblok.com/f/243782/225x300/22d1ba3ee0/richard-chivers.jpg","copyright":"","fieldtype":"asset","meta_data":{},"is_external_url":false},"jobTitle":"operations manager for NICE Advice","component":"author"},"slug":"richard-chivers","full_slug":"news/blogs/authors/richard-chivers","default_full_slug":null,"sort_by_date":null,"position":-300,"tag_list":[],"is_startpage":false,"parent_id":416560259,"meta_data":null,"group_id":"0741302c-bb0f-4a47-8b53-646ab12c784b","first_published_at":"2024-01-26T14:06:34.834Z","release_id":null,"lang":"default","path":null,"translated_slugs":[]}],"content":{"type":"doc","content":[{"type":"paragraph","content":[{"text":"Are you a pharmaceutical company considering the International Recognition Procedure (IRP) for your UK market entry? While the IRP offers opportunities for faster access to the UK market, it also presents new challenges for your NICE technology appraisal submission. Our trusted support service, ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"NICE Advice","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":", is here to help you successfully navigate this new pathway from a health technology assessment perspective.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"1.    Understanding the IRP landscape","type":"text","marks":[{"type":"bold"},{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"The IRP allows you to apply for UK marketing authorisation based on approvals from other international regulators. You can visit the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) website for ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"more detailed information on the IRP","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.gov.uk/government/publications/international-recognition-procedure/international-recognition-procedure","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":". You’ll also find helpful information in NICE’s report ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"Implications of using the IRP for a NICE technology appraisal evidence submission","type":"text","marks":[{"type":"link","attrs":{"href":"https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.nice.org.uk%2FMedia%2FDefault%2FAbout%2Fwhat-we-do%2Four-programmes%2Ftechnology-appraisals%2Fimplications-of-using-international-recognition-procedure-for-a-nice-technology-appraisal-evidence-submission.docx\u0026wdOrigin=BROWSELINK","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":".","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"2.    Aligning with NICE evidence requirements","type":"text","marks":[{"type":"bold"},{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"NICE's evidence requirements remain unchanged, regardless of your regulatory approval route. Are you confident that your evidence package will still meet these standards if you follow the IRP path? ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"NICE Advice","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":" can help you in your preparations for a future technology appraisal by advising on evidence requirements for your product and approaches to addressing any gaps. ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"Learn more about our scientific advice service.","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service#scientificadvice","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"3.    Tackling timeline challenges","type":"text","marks":[{"type":"bold"},{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Using the IRP might mean submitting to NICE before your submission to the MHRA. Sound challenging? ","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]},{"text":"Our experts","type":"text","marks":[{"type":"link","attrs":{"href":"https://www.nice.org.uk/about/what-we-do/life-sciences/nice-advice-service","uuid":null,"anchor":null,"target":null,"linktype":"url"}},{"type":"textStyle","attrs":{"color":""}}]},{"text":" can advise on this process, ensuring you are prepared to meet all crucial deadlines without compromising on the quality of your submission.","type":"text","marks":[{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"4.    Addressing evidence maturity","type":"text","marks":[{"type":"bold"},{"type":"textStyle","attrs":{"color":""}}]}]},{"type":"paragraph","content":[{"text":"Using the IRP can potentially accelerate your UK market access journey. But how do you balance this opportunity against possible increased uncertainty in your evidence base? 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