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Most of our topics are identified by the National Institute for Health Research Innovation Observatory. They aim to notify the Department of Health and Social Care of key, new and emerging healthcare technologies that might need to be referred to NICE against the following timeframes:</p> <ul> <li>New drugs, in development, at 20 months to marketing authorisation.</li> <li>New indications, at 15 months to marketing authorisation.</li> </ul> <p>A single highly specialised technology evaluation can only cover a single technology for a single indication.</p> <h2>Development process</h2> <ol class="alt"> <li class="pb--c"> <h3 class="h4">Provisional evaluation topics chosen</h3> <p>The Department of Health and Social Care produces a list of provisional evaluation topics.</p> </li> <li class="pb--c"> <h3 class="h4">Consultees and commentators identified</h3> </li> <li class="pb--c"> <h3 class="h4">Scope prepared</h3> <p>We work with the Department of Health and Social Care to develop a scope. The scope defines the disease, the patients and the technology covered by the evaluation and the questions it aims to answer. Consultees and commentators are requested to comment on the draft scope.</p> </li> <li class="pb--c"> <h3 class="h4">Evaluation topics referred</h3> <p>The Department of Health and Social Care refers highly specialised technology evaluation topics to NICE.</p> </li> <li class="pb--c"> <h3 class="h4">Evidence submitted</h3> <p>The manufacturer or sponsor of the technology is invited to provide an evidence submission. We also invite all non-manufacturer consultees to submit a statement on the potential clinical effectiveness and value for money of a treatment.</p> </li> <li class="pb--c"> <h3 class="h4">Evidence Review Group (ERG) report prepared</h3> <p>We commission an independent <a href="/About/What-we-do/Our-Programmes/NICE-guidance/NICE-technology-appraisal-guidance#academic">academic centre</a> to technically review the evidence submission and prepare an ERG report.</p> </li> <li class="pb--c"> <h3 class="h4">Evaluation report prepared</h3> <p>This includes all of the evidence that will be looked at by the evaluation committee. This evidence includes:</p> <ul> <li>the ERG report and any comments received on it</li> <li>written submissions</li> <li>personal statements from patient experts and clinical specialists.</li> </ul> </li> <li class="pb--c"> <h3 class="h4">Evaluation committee</h3> <p>An independent advisory committee considers the evaluation report and hears evidence from nominated clinical experts, patients and carers. Evaluation committee discussions are held in public.</p> <p><a href="/Get-Involved/Meetings-in-public/Highly-Specialised-Technologies-Evaluation-Committee">Find out more about the evaluation committee</a>, including how to attend a meeting.</p> </li> <li class="pb--c"> <h3 class="h4">Evaluation consultation document (ECD) produced if needed</h3> <p>The evaluation committee makes its provisional recommendations in the ECD. An ECD will be produced only if the recommendations from the evaluation committee are restrictive. A restrictive recommendation will be one that is more limited than the instructions for use that accompany the technology.</p> <p>Consultees and commentators have 4 weeks to comment on the ECD. It is also made available on our website so health professionals and members of the public can comment on it.</p> </li> <li class="pb--c"> <h3 class="h4">Final evaluation determination (FED) produced</h3> <p>The evaluation committee considers the comments on the ECD if produced, then makes its final recommendations in the FED on how the technology should be used in the NHS in England. Consultees can appeal against the final recommendations in the FED.</p> </li> <li class="pb--c"> <h3 class="h4">Guidance issued</h3> <p>If there are no appeals, or an appeal is not upheld, the final recommendations are issued as NICE guidance.</p> </li> </ol> </div> <div data-g="12 sm:4"> <div class="panel"> <h3><a href="/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/changes-to-health-technology-evaluation">Changes to health technology evaluation</a></h3> <p>We're reviewing and, where necessary, updating the methods and processes that we use to produce guidance around health technologies.</p> </div> <div class="panel"> <h3>Past consultations on our ways of working</h3> <p><a href="/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/consultation-on-changes-to-technology-appraisals-and-highly-specialised-technologies">Changes to technology appraisals and highly specialised technologies</a></p> </div> <div class="panel"> <h3>More information</h3> <p><span class="card__icon icon icon--chevron-right" aria-hidden="true"></span><a href="/about/what-we-do/our-programmes/nice-guidance/technology-appraisal-guidance/eq-5d-5l">Our position on use of the EQ‑5D‑5L valuation set for England</a></p> <p><span class="card__icon icon icon--download" aria-hidden="true"></span><a href="/Media/Default/About/what-we-do/NICE-guidance/NICE-highly-specialised-technologies-guidance/HST-interim-methods-process-guide-may-17.pdf">Highly specialised technologies interim methods and process guides (PDF)</a> This document only applies to appraisals that started with us before 1 February 2022.</p> <p><span class="card__icon icon icon--download" aria-hidden="true"></span><a href="/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/company-decision-problem-form-jan-22.docx">Company initial decision problem form - HST (Word)</a></p> <p><span class="card__icon icon icon--download" aria-hidden="true"></span><a href="/Media/Default/About/what-we-do/NICE-guidance/NICE-highly-specialised-technologies-guidance/company-evidence-submission-template-HST-jan-22.docx">Highly specialised technologies evidence submission template (Word)</a></p> <p><span class="card__icon icon icon--chevron-right" aria-hidden="true"></span><a href="https://www.nice.org.uk/process/pmg24/resources">User guide for company submission template</a></p> <p><span class="card__icon icon icon--download" aria-hidden="true"></span><a href="/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/CMA-interim-process-addendum.pdf">Guide to the processes of technology appraisal April 2018 - commercial and managed access interim addendum (PDF)</a></p> <p><span class="card__icon icon icon--download" aria-hidden="true"></span><a href="/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Guidance%20for%20industry%20when%20completing%20the%20SIP.docx">Guidance for industry when completing the Summary of information for patients (SIP) (Word)</a></p> <p><span class="card__icon icon icon--download" aria-hidden="true"></span><a href="/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/SIP%20template.docx">Summary of information for patients (SIP) template (Word)</a></p> </div> </div> </div> </div></div> </div> </main>  <script async="" src="https://cdn.nice.org.uk/niceorg/js/app.js" type="text/javascript"></script>  <script src="https://cdn.nice.org.uk/V2/Scripts/twitter.bootstrap.min.js" type="text/javascript"></script> <script src="https://cdn.nice.org.uk/V2/Scripts/NICE.bootstrap.min.js" type="text/javascript"></script> <script type="text/javascript"></script> <script src="/Modules/Orchard.Resources/scripts/history.min.js" type="text/javascript"></script> <script src="//cdn.nice.org.uk/V3/Scripts/nice/NICE.EventTracking.js" type="text/javascript"></script> <script src="/Themes/NICE.Bootstrap/scripts/niceorg/NICE.TopScroll.js" type="text/javascript"></script> <script src="/Themes/NICE.Bootstrap/scripts/foot.combined-v1.10.9325.0.js" type="text/javascript"></script> <script> var global_nav_config = { service: "", header: { skipLinkId: "content-start", search: { url: "/search", autocomplete: "/autocomplete?ajax=ajax", query: "", onSearching: window.globalNavSearchingHandler || null }, auth: { environment: "live" }, cookie: false }, footer: true }; </script> <script src="https://cdn.nice.org.uk/global-nav/global-nav.min.js" defer></script> <script src="//cdn.nice.org.uk/cookie-banner/cookie-banner.min.js"></script> <script type="text/javascript"> $(document).ajaxSend(function (event, jqxhr, settings) { if (settings.url.indexOf("?") >= 0) { settings.url = settings.url + "&ajax=ajax"; } else { settings.url = settings.url + "?ajax=ajax"; } }) if ('ontouchstart' in document.documentElement) { $('body').addClass('touch-screen-device'); } else { $('body').addClass('non-touch-screen-device'); } </script> <div id="global-nav-footer"></div> </body> </html>