NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Guide to the single technology appraisal (STA) process
Interim process
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Contents
ForewordThis document is part of a suite of documents about the NICE technology appraisal programme. It should be read in conjunction with the Institute's Guide to the methods of technology appraisal document and, where relevant, with the other related documents on contributing to an individual appraisal that have been prepared for patients and carers, manufacturers and sponsors, professional groups and NHS organisations. When finalised, these documents will be available on the Institute's website ( www.nice.org.uk) and will include the following:
Consultees to the Institute's STA programme should read this guide in conjunction with documents 2 to 6 above. Documents 3 and 4 provide detailed notes for each of the consultee communities on how to contribute effectively to the STA process.
Acknowledgements[These will be added in final document] |
| 1 |
Introduction |
| 1.1 | The purpose of this document |
| 1.1.1 | This document sets out the process, including timescales, that the National Institute for Health and Clinical Excellence (NICE, or the Institute) follows when undertaking a STA. It describes a uniform, open and transparent process designed to achieve robust guidance for the NHS. It provides guidance for organisations that are invited to contribute to these STAs, and has been developed to allow understanding and input from consultees and stakeholders. |
| 1.1.2 | The STA process is specifically designed for the appraisal of single products, with single indications. The process will result in formal NICE guidance. This process will normally be used to ensure that NICE is able to issue guidance to the NHS in England and Wales on new technologies close to their introduction into the UK market. The STA process may be applied to any single appraisal of a new pharmaceutical product, device, or other technology referred by ministers to the Institute. |
| 1.1.3 | See appendix B for a glossary of terms used in this document. |
| 1.2 | General description of the STA process |
| 1.2.1 | NICE is part of the NHS. It is the independent organisation responsible for providing national guidance on treatments and care of people using the NHS in England and Wales. Further details about the Institute and its work programmes are available in the Guide to NICE, which is available on the website ( www.nice.org.uk) or from the NHS Response Line (telephone 0870 1555 455 and quote reference N0189). |
| 1.2.2. | One of the Institute's responsibilities is to provide guidance to the NHS on the use of selected new and established health technologies. The guidance issued about the use of a health technology is based on an appraisal of that technology. |
| 1.2.3 |
It is the Secretary of State for Health that formally refers technologies to the Institute for STA. These include:
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| 1.2.4 | The purpose of all technology appraisals carried out by the Institute, including those undertaken through the STA process, is described in the directions of the Secretary of State for Health. That is, to appraise the health benefits and the costs of those technologies notified by the Secretary of State for Health and to make recommendations for their use to the NHS in England and Wales. |
| 1.2.5 | A STA considers the evidence of the health benefits and costs of a health technology. This includes the impact on quality of life (for example, relief of pain and disability), and the probable effects on mortality. It also considers estimates of the associated costs, concentrating particularly on costs to the NHS and Personal Social Services. |
| 1.2.6 | The principal evidence for a STA is derived from an evidence submission by the manufacturer or sponsor of the technology. The review of this evidence submission is carried out by the Evidence Review Group. Selected clinical specialists and patient experts advise this group (see section 3.3) and submit their personal view to the Committee on the technology and the way it should be used in the NHS in England and Wales. |
| 1.2.7 | The evidence is provided by the manufacturer or sponsor against a clear and detailed specification developed by NICE (see sections 3.1.1.1 and 3.2.9). This specification is based on the decision-analytic approach to the evaluation of the clinical and cost-effectiveness of health technologies, currently used by NICE. This approach is outlined in the Guide to the methods of technology appraisal. |
| 1.2.8 | The evidence is considered by the Institute's Appraisal Committee, which examines the balance of evidence, and decides whether the technology can be recommended as a cost-effective use of NHS resources in general or, if more appropriate, for a specific subgroup of patients. |
| 1.2.9 | The Appraisal Committee evaluates the impact on both costs and benefits of any technology under consideration. This judgment is referred to as the appraisal determination, and once the process is complete, the determination is submitted to the Institute. This is the basis of the guidance that the Institute issues. See the Institute's Guide to the methods of technology appraisal document for further information on the methods used. |
| 1.2.10 |
In reaching the decision, the Institute and the Appraisal Committee take into account the following factors listed in the directions of the Secretary of State for Health:
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| 2 |
Selection of technologies |
| 2.1 | The Institute cannot begin the appraisal of a technology until it is formally referred to it by the Secretary of State for Health. |
| 2.2 | The process for selecting topics for the Institute's technology appraisal programme is currently under review. The Department of Health intends to consult on changes to the current process later in the year. This will include proposals for allocating topics to the STA process. Further information about this process can be obtained in England from the NICE Liaison Unit, Department of Health, Quarry House, Quarry Hill, Leeds, LS2 7UE and in Wales from the Performance, Quality and Regulation Division 2, NHS Quality Division, Welsh Assembly Government, Cathays Park, Cardiff, CF1 3NQ. |
| 3 |
The STA process |
| Figure 1 Sumary of the STA Process {A flow chart to be added in final document] |
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| 3.1 | Overview |
| 3.1.1 | The STA process consists of three phases outlined below, which begin after formal referral of a STA to NICE. |
| 3.1.1.1 | The first phase begins either when NICE is notified that the manufacturer of the selected topic is applying to the regulatory authorities for a particular indication, or at a point determined by NICE when the STA is not tracking a regulatory submission. NICE then contacts the manufacturer to notify them of the STA and request an Evidence Submission. Manufacturers are provided with a detailed template for this submission, called the Submission Template. The formal referral process will ensure that the manufacturers involved will already have been notified that the STA is planned. Manufacturers are given a minimum of 8 weeks to prepare the Evidence Submission, but depending on when a product is selected for STA and when regulatory approval, where relevant, is expected, this may be longer. |
| 3.1.1.2 | The second phase begins with receipt of the Manufacturer Evidence Submission and includes the independent review of the Evidence Submission (a minimum of 8 weeks), appraisal (4 weeks), and preparation of the recommendations (2 weeks). |
| 3.1.1.3 | The final phase consists of either consultation on preliminary recommendations in the form of an Appraisal Consultation Document (ACD), or the release of the Final Appraisal Determination (FAD). This phase takes between 7 and 15 weeks, depending on whether an ACD is issued, or if an FAD is produced and proceeds directly to the appeal stage. Following release of a FAD, consultees have 15 working days to lodge an appeal. The arrangements for making an appeal are set out in the existing Guide for Appellants. |
| 3.1.1.4 | If no appeal is received, the total time from initiation of the appraisal to the publication of the guidance is between 32 weeks (no ACD issued) and 39 weeks (ACD issued), depending on the time needed for consultation. The FAD is put into the public domain at 27 weeks and 35 weeks, respectively, |
| 3.1.1.5 | Where the appraisal is tracking regulatory approval, the elapsed time from regulatory approval to guidance publication is between 11 (no ACD issued) and 18 weeks (ACD issued). The FAD is put into the public domain 6 weeks and 14 weeks after regulatory approval. |
| 3.2 | Phase 1 - Submission preparation |
| 3.2.1 | Topics for STA are formally referred to the Institute in groups, known as ‘waves'. After a wave of STA topics has been referred, the Institute finalises the list of consultees and commentators who will participate in each STA. |
| 3.2.2 | If the STA is tracking a regulatory submission, the manufacturer must notify the Institute of when it has submitted its dossier to the regulatory authorities for the indication being appraised through the STA process. |
| 3.2.3 | The Institute will write to manufacturers and consultees to inform them of the key dates for the STA, a minimum of 8 weeks before the manufacturer has to make the Evidence Submission to NICE. |
| 3.2.4 | The remit, the composition of the Evidence Review Group, and the final matrix of consultees/commentators will be posted on the Institute's website a minimum of 8 weeks before the deadline for the Manufacturer Evidence Submission. Each STA is assigned to a project team at the Institute, the members of which are listed on the website. The roles of key members of the project team are summarised in appendix D. |
| 3.2.5 | The timeline for an individual STA starts when the Institute invites the manufacturer or sponsor of a technology to complete an Evidence Submission using the submission template (week 0). The requirements of the template are consistent with the approach adopted in the Institute's Guide to the methods of technology appraisal. |
| 3.2.6 | If there is no manufacturer or sponsor, an independent review of the evidence is commissioned by NICE. |
| 3.2.7 | The Evidence Review Group is formally commissioned to review the evidence submission received from the manufacturer or sponsor. This is done at the same time as the manufacturer or sponsor is invited to submit an Evidence Submission to NICE. |
| 3.2.8 | All healthcare professional groups and patient/carer groups that are consultees or commentators for the STA are invited to nominate clinical specialists or patient experts to advise the STA. |
| 3.2.9 | The Manufacturer Evidence Submission should be made using the STA submission template, which contains information about the type and length of information that it should contain once completed. |
| 3.2.10 | For model-based economic evaluations, a fully executable electronic copy of the model should be submitted. If the model is not constructed using either Excel or DATA software, the Institute should be informed in advance of submission. The Evidence Review Group should have full access to the programming code, and running of the model should be unhindered. Care should be taken to ensure that the submitted versions of the model program and the content of the submission match. |
| 3.2.11 | Unless the Department of Health indicates otherwise, recommendations will not be made by NICE on indications for which the product being appraised is not licensed. |
| 3.3 | Phase 2 - Evidence Review |
| 3.3.1 | Review of the Manufacturer Evidence submission will normally be undertaken by an external group (the ‘Evidence Review Group'). The group's remit is to critically evaluate the Evidence Submission, identify its strengths and weaknesses and supplement it, at the Institute's request, with their own analysis. Normally, the group is commissioned by the National Coordinating Centre for Health Technology Assessment (NCCHTA). NICE may selectively supplement the assessment made by the group using its Decision Support Unit (DSU). |
| 3.3.2 | The evidence review phase requires liaison with clinical and patient experts. The experts are asked to advise the Institute and Evidence Review Group on the current management of the condition and the potential place of the new technology within current clinical practice. |
| 3.3.3 | The Evidence Review Group prepares an Evidence Report (ERG Report). This is a review of the clinical and cost effectiveness of the technology based on a review of the Manufacturer Evidence Submission. The ERG Report may include additional assessment of cost effectiveness. This is prepared in accordance with the quality criteria of the HTA Programme (www.hta.nhsweb.nhs.uk) and is consistent with the Institute's Guide to the methods of technology appraisal. The content and quality of the EGR Report is the responsibility of its authors. |
| 3.3.4 | If, during the evidence review, there are concerns about the completeness or quality of the Evidence Submission, manufacturers may be asked to undertake further work, where this is necessary to ensure that the Appraisal Committee is properly informed. Exceptionally, manufacturers may be asked to make a full resubmission. Where such requests delay the published timeline, the reasons for the delay will be posted on the Institute's web site. |
| 3.4 | Phase 3 - Appraisal |
| 3.4.1 |
The appraisal stage of the STA process consists of four elements:
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| 3.4.2 | Consideration by the Appraisal Committee |
| 3.4.2.1 | Appraisal Committees are standing advisory committees of the Institute constituted to encompass the full range of perspectives on the use of a technology in the NHS. Members of the appraisal committees are appointed for a 3-year term and are drawn from the NHS, patient/carer organisations, relevant academic disciplines and the pharmaceutical and medical devices industries. Further information about the current composition and membership of the Institute's Appraisal Committees is available on the Institute's website. |
| 3.4.2.2 | The Appraisal Committee undertakes its initial consideration and discussion about the evidence on a STA. This evidence is presented in the Manufacturer Evidence Submission, clinical specialists and patient expert personal views and the Evidence Review Group Report. More information about how the Appraisal Committee considers the evidence and makes its decision is available in the Guide to the methods of technology appraisal. |
| 3.4.2.3 |
At the Appraisal Committee meeting, the Chair and NICE Technical Lead make a brief presentation to the other members to introduce the STA topic. This presentation includes:
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| 3.4.2.4 | Representatives of the Evidence Review Group also attend the meeting. The Appraisal Committee may seek further clarification from the Evidence Review Group representatives on the EGR Report and discuss relevant issues raised. Evidence Review Group representatives may remain present during Committee discussions in order to answer any further questions the Committee have. Exceptionally, the Committee may decide that additional analysis of the evidence is needed. These will usually be commissioned from the Decision Support Unit (DSU). |
| 3.4.2.5 | After careful consideration of the evidence, the Committee agrees the content of the document and sets out its recommendations. This takes the form of either an ACD, which sets out the Appraisal Committee's preliminary recommendations for consultation, or an FAD which sets out the Committee's final recommendation. |
| 3.4.3 | Consultation |
| 3.4.3.1 | Normally, formal consultation (which involves the production of an ACD rather than an FAD) only takes place if the recommendations emerging from the Committee are substantively restrictive. A substantively restrictive recommendation will be one that is more limited than the terms of the licensed indication to an extent judged to be significant in clinical practice. (In the absence of a regulatory approval process, a substantively restrictive recommendation will be one that is more limited than the sponsor's claims for how the technology should be used.) Exceptionally, there may be other aspects of the Committee's recommendations which, at the discretion of the Committee Chair, may also be subject to consultation, and therefore an ACD will be produced. |
| 3.4.3.2 | The ACD contains provisional guidance, a description of clinical need and practice and of the technology, and the considerations taken into account by the Committee's in interpreting the evidence. |
| 3.4.3.3 | If an ACD is produced, the Institute will contact consultees and commentators by email after the Appraisal Committee meeting, to let them know when they can expect to receive it. The Institute usually circulates the ACD to consultees, commentators and experts 10 working days after the Appraisal Committee meeting. In exceptional circumstances, this may take longer. If the Institute expects a delay, consultees and commentators will be informed as soon as possible. |
| 3.4.3.4 | Consultees and commentators are invited to comment on whether the provisional recommendations of the Appraisal Committee are sound and constitute a suitable basis for guidance to the NHS. |
| 3.4.3.5 | Comments from consultees and commentators must be submitted to the Institute in writing, preferably by email. The Institute reserves the right not to consider comments received after the close of consultation. |
| 3.4.3.6 | The Institute sends the Manufacturer Evidence Submission and the EGR Report, with any confidential information removed, to consultees and commentators after the Appraisal Committee meeting. These form part of the committee papers supporting either the ACD or FAD, whichever is produced. All these documents (with any confidential information removed) will be published on the Institute's website 5 working days after consultees and commentators have received them. |
| 3.4.3.7 | If a FAD is produced at the first committee meeting there is no consultation on the guidance. |
| 3.4.4 | Preparation of the Final Appraisal Determination (FAD) |
| 3.4.4.1 | The Appraisal Committee discusses the technology, and agrees the content of the FAD that sets out its final recommendations. The NICE project team then drafts the FAD according to the instructions of the Appraisal Committee. |
| 3.4.4.2 | The FAD contains the Committee's guidance, a description of clinical need and practice and of the technology, and the considerations taken into account by the Committee's in interpreting the evidence. |
| 3.4.4.3 | After the Appraisal Committee meeting, the Institute contacts consultees and commentators by email to let them know when they can expect to receive the FAD. Following approval by the Guidance Executive1, the FAD is issued to consultees so that they can consider whether to appeal (see section 6). Commentators are sent the FAD for information only. |
| 3.4.4.4 | The Guidance Executive, which comprises the Institute's Executive Directors and the Institute's Centre Directors, approve the FAD for publication on behalf of the Board. |
| 3.4.4.5 | The FAD is posted on the Institute's website for information 5 working days later. Any further analysis undertaken by the Institute or the Evidence Review Group during an ACD consultation, which has been considered by the Appraisal Committee during the development of the FAD, is distributed to consultees and commentators and posted on the Institute's website with the FAD. Subject to any appeal by consultees, the FAD forms the NICE guidance on the use of the appraised technology. |
| <sup>1</sup>The Guidance Executive, which comprises the Institute's Executive Directors and the Institute's Centre Directors, approve the FAD for publication on behalf of the Board. |
| 4 |
Evidence and assessment |
| 4.1.1 | The manufacturer or sponsor of a technology is required to prepare an Evidence Submission to the Institute for STA. The selected clinical specialist and patient experts are invited to submit a concise personal view or perspective on the technology and its use in the NHS. The Institute does not accept unsolicited submissions (that is, from parties other than the manufacturer or sponsor of the technology under STA). Details about the structure, content and length of the submission, are available in the submission template |
| 4.1.2 | If information in the Manufacturer Evidence Submission meets the criteria to be considered as ‘commercial in confidence', or ‘academic in confidence', then the relevant information must be highlighted and underlined in the submission. A checklist of confidential information (provided by the Institute) should be completed, giving the reasons for designating the information confidential and the time needed for the information embargo. If a checklist of confidential information is not completed then it will be assumed that there is no confidential information in the Evidence Submission. |
| 4.1.3 | The Institute cannot issue guidance or an ACD on a technology before it receives UK regulatory approval. Where a STA begins before UK regulatory approval has been granted, it will only proceed past the point when the ACD or FAD is released, once UK regulatory approval has been granted, and once the price and the indication(s) for the technology are known. |
| 4.1.4 | Manufacturers or sponsors preparing the Evidence Submission may be contacted by the Evidence Review Group during the process of the STA to clarify any aspects of their Evidence Submission. The Institute's Technical Lead and Project Manager must be copied into all communications between the manufacturer or sponsor and the Evidence Review Group. Under exceptional circumstances, the Institute will organise a face-to-face meeting to discuss any issues that cannot be resolved by other means. |
| 4.1.5 | The Institute wants to ensure that the best possible Evidence Submission is prepared for the Appraisal Committee. Although they cannot validate the Manufacturer Evidence Submission, the technical lead will endeavour to help clarify substantive issues. |
| 4.1.6 | The Evidence Review Group assesses the Manufacturer Evidence Submission and writes a report which forms part of the committee papers. Occasionally, at the Institute's request, the Evidence Review Group may undertake additional analyses which will also be included in that report. This report will later be released to consultees and commentators and put on the NICE website either with the ACD or FAD. |
| 4.1.7 | Submission of late data from the manufacturer or sponsor will not be accepted. |
| 4.1.8 | Participation of clinical specialists and patient experts |
| 4.1.8.1 |
Usually, two clinical specialists and two patient experts are selected from the nominations received from consultees and commentators. Nominated clinical specialists and patient experts can only take part if they agree to the following conditions.
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| 4.1.8.2 |
Additionally, the following criteria are used to inform the selection of clinical specialists.
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| 4.1.8.3 | The evidence review phase will require liaison with experts. The external experts will be asked to advise the Institute and Evidence Review Group on the current management of the condition and the potential place of the new technology in clinical practice. |
| 4.1.8.4 | The chosen clinical specialists and patient experts are asked to complete a short pro-forma on their personal view or perspective on the technology and the way it should be used in the NHS in England and Wales. These personal views are given to the Appraisal Committee and made available during the period of consultation on the ACD as part of the Committee papers. Further advice about the contribution of clinical specialists and patient experts is available in the specific guides for groups participating in a STA. |
| 4.1.8.5 | The Institute will inform consultees and commentators of the names and affiliations of the selected clinical specialists and patient experts invited to take part in a STA. This information will also be posted on the NICE website. |
| 5 |
Process timelines and publication of documents
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| 5.1.1 | The timeline and consultation periods are, other than in exceptional circumstances, fixed. Consultees and commentators are provided with key dates for each STA with their invitation to participate |
| 5.1.2 | Throughout a STA, up-to-date information about timing and progress is available on the Institute's website, and further information and clarification are available from the Project Manager. |
| 5.1.3 | The Institute will advise consultees and commentators at the earliest opportunity of any extension to the timelines for a STA and the reason(s) for that extension. This will only occur in exceptional circumstances. |
| 5.1.4 | After the submission invitation, manufacturers or sponsors have a minimum of 8 weeks to prepare the Evidence Submission. |
| 5.1.5 | After receipt of the Evidence Submission, the Evidence Review Group has a minimum of 8 weeks to review the Manufacturer Evidence Submission and preparation of their Report. |
| 5.1.6 | The agenda for the Appraisal Committee meeting is normally published on the Institute's website 5 working days before the meeting takes place. |
| 5.1.7 | Unconfirmed minutes of the meeting are posted on the Institute's website within 15 working days of the meeting. Confirmed minutes are posted on the website when they have been confirmed by the Appraisal Committee, normally within 8 weeks of the meeting. |
| 5.1.8 | Consultees and commentators have 4 weeks in which to submit comments on the ACD, where one is issued. |
| 5.1.9 | The ACD, with an electronic comment facility, and the Committee papers, with confidential material removed, are posted on the Institute's website 5 working days after they have been circulated to consultees and commentators. A summary of comments received via website consultation is submitted to the Appraisal Committee for consideration. (Note that the website comment facility must not be used by consultees and commentators to submit their comments on the ACD.) |
| 5.1.10 | When consultation leads to a substantial revision of the ACD, the Appraisal Programme Director, the Chair of the Appraisal Committee and the Executive Lead will decide whether it is necessary to prepare another ACD. If so, the consultation process will be repeated. The decision to produce another ACD will extend the timeline for the appraisal. The additional evidence will be circulated with the new ACD. |
| 5.1.11 | The Institute usually circulates the FAD within 5 weeks of the Appraisal Committee meeting. The Institute will notify consultees and commentators if it expects a delay in the circulation of the FAD. |
| 5.1.12 | If an ACD is developed and consulted upon the comments received from consultees, commentators and web responders on the ACD, together with a summary table of these comments and the action taken in response to them, is supplied with the FAD when it is sent to consultees and commentators. This information will also be posted on the Institute's website at the same time as the FAD. |
| 5.1.13 | In exceptional circumstances, for example, if a relevant report is published while the FAD is being developed or as a consequence of comments from consultees or commentators, the Institute or the Evidence Review Group may undertake further analysis before the circulation of the FAD. Any such analysis will be distributed to consultees and commentators and posted on the Institute's website at the same time as the FAD. |
| 5.1.14 | When the FAD is posted on the website, the Institute also posts the summary table of comments on the ACD (if produced) with the Institute's responses. |
| 5.1.15 | If there is no appeal or an appeal is dismissed, the Institute makes arrangements for the FAD, as issued to consultees (subject to correction of any factual errors), to be published as guidance. Normally, the Institute will publish the guidance as part of its monthly schedule (the last Wednesday of each month). In exceptional circumstances, guidance may be published outside this schedule. |
| 6 |
Appeal |
| 6.1.1 | Consultees are given 15 working days in which to lodge an appeal. Any appeal must be in writing and must be lodged with the Institute by the deadline and in the manner indicated. The detail of the Institute's appeal process is set out in a separate document and the following is only a brief summary of the process. Appeals are heard by the Institute's Appeal Panel. |
| 6.1.2 |
It is not possible to appeal against the FAD simply because the appellant does not agree with it. The Appeal Panel will not consider appeals unless the grounds for appeal are appropriate and fall within one or more of the following categories.
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| 6.1.3 | The Board of the Institute will appoint the members of the Appeal Panel. The Panel will comprise five members drawn from the Institute's Appeals Committee, all of whom will have had no prior involvement in the appraisal in question. The Panel will consist of at least one Non-Executive Director of the Institute who will chair the appeal, at least one member from within the NHS, one member with experience of the relevant industry or clinical field, and one member with experience of patient/carer organisations. |
| 6.1.4 | The Institute will inform the appellant(s) of the membership of the Appeal Panel and the confirmed date of the appeal hearing as soon as possible after an appeal has been lodged. |
| 6.1.5 | The Appeal Panel will consider the appellant's representations in private and its findings, along with the appellant's documents for appeal, will be made public. Neither the appellant's documentation nor the identity of the appellant will be made public until the outcome of the appeal(s) has been published. |
| 6.1.6. | The Institute will usually issue the outcome of an appeal within 28 days of the appeal hearing, but there may be circumstances in which a longer interval is necessary. The full text of the appeal decision will be made available to appellants 2 working days before it is made available to the other consultees and posted on the Institute's website. |
| 6.1.7 | If the appeal is upheld, the Institute will consider the appropriate course of action. The Guidance Executive may consider editorial changes made in response to the Appeal Panel's decision before issuing its guidance to the NHS, or the Institute may ask the Appraisal Committee to reconsider the evidence, in which case the process will resume at step 13 (the meeting of the Appraisal Committee to prepare a FAD). |
| 7 |
Updating technology appraisal guidance (reviews) |
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| 7.1 | When the Institute publishes its STA guidance, it will indicate the date on which the guidance will be considered for review. This date is referred to as the ‘review date'. The date refers to the month and year in which the Institute will consult with relevant organisations on proposals for reviewing the guidance. | ||||||||||||||
| 7.2. |
The length of time between the issue of the guidance and the review date will vary depending on the anticipated rate of development in the evidence for the technology, and on prior knowledge of when pivotal ongoing research is to be reported. Experience to date shows that this period varies from 1 to 5 years. The Institute has standardised its arrangements for determining appropriate review dates (see Box F).
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| 7.3 | It is possible that evidence that may make a substantial impact on the current guidance will become available in advance of the official review date for the guidance. The Institute, or consultees or commentators to the original appraisal, can identify such evidence. The Institute's Guidance Executive considers the likely impact of the new evidence on the validity of the guidance. If the Guidance Executive considers that the emerging evidence is of particular significance then the review date for the guidance may be brought forward. The Institute will not review any guidance earlier than 1 year after its publication. | ||||||||||||||
| 7.4 | Planning the most appropriate timing for reviewing technology appraisal guidance is multi-factorial. Furthermore, the expanding work of the Institute presents the opportunity for increased integration between work programmes. Before a review is planned into the work programme, the Institute gathers information and conducts a literature search to inform its proposal on the best approach to updating the guidance. The aim of collecting this information is to identify new indications for the appraised technology(ies), new related technologies, the progress of ongoing trials referred to in the existing guidance or Assessment Reports, information that would satisfy the recommendations for further research in the existing guidance, and new evidence published since the searches undertaken for the Assessment Report were run. The Institute may at this point seek information from consultees involved in the original appraisal. | ||||||||||||||
| 7.5. |
In the light of this information, the Institute's Guidance Executive will decide on one of the following options for reviewing the guidance.
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| 7.6 | The option agreed by the Guidance Executive for reviewing the guidance will be sent to the consultees, commentators and Assessment Group or Evidence Review Group involved in the original appraisal. They will be given 20 working days to submit comments on the proposed option. The proposals will be posted on the Institute's website 5 working days after the consultees, commentators and the Assessment Group or Evidence Review Group have been notified. | ||||||||||||||
| 7.7 | Comments received will be discussed at a second meeting of the Guidance Executive, which will review the proposal in the light of comments received. A final decision on the most appropriate option for updating the guidance will then be made and consultees will be informed in writing of the final decision of the Guidance Executive. The final decision will also be posted on the Institute's website. | ||||||||||||||
| 7.8 | It is anticipated that, eventually, the evidence base for a technology and its diffusion into the NHS will stabilise at a point at which no further update to guidance on its use is required. In this circumstance, the guidance will be transferred to a ‘static list' and no further update of guidance will be planned. Topics on the static list may be transferred back to the active list for further appraisal if new evidence becomes available that is likely to have a material effect on the last guidance issued. | ||||||||||||||
| 7.9 | If a piece of guidance needs updating the review will be timetabled and will follow the standard timelines and process. | ||||||||||||||
| 7.10 | Consultees will be asked to indicate what new evidence they consider should be taken into account and provide any new data they have that is not in the public domain. Further guidance is available in the relevant guides for contributing to a technology appraisal. | ||||||||||||||
| 7.11 | In all cases in which reviews take place, arrangements will be made to assess new information. If it is decided that a piece of guidance does not need a standard update, but instead falls under one of the other categories mentioned above consultees and commentators will be advised accordingly. If appropriate, the associated new timelines and/or scopes and other relevant details will be distributed to consultees and commentators. | ||||||||||||||
Appendices |
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[Appendix B will be created for this document during/after the consultation process.]
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| Appendix C | Disclosure of information | ||||||||||||||||||||
| 1 | The Institute adheres to the principles and requirements of the Data Protection Act and the Freedom of Information Act in dealing with information it receives during an appraisal. | ||||||||||||||||||||
| 2 | The Institute will not put into the public domain, nor circulate amongst consultees, any documents for consultation before the technology concerned has received regulatory approval. | ||||||||||||||||||||
| 3 | The Institute requires manufacturers and sponsors of a technology under STA to sign a statement declaring that all relevant material pertinent to the STA has been disclosed to the Institute. | ||||||||||||||||||||
| 4 | To ensure that the STA process is as transparent as possible, the Institute considers it highly desirable that evidence pivotal to the Committee's decisions should be publicly available. Ideally, all the evidence seen by the Appraisal Committee should be available to all consultees and commentators. Under exceptional circumstances, unpublished evidence is accepted under agreement of confidentiality. Such evidence includes ‘commercial in confidence' information and data that are awaiting publication (‘academic in confidence'). | ||||||||||||||||||||
| 5 |
The Institute expects consultees to keep confidential material within consultation responses to an absolute minimum. When a consultee believes that part of a response needs to be treated as confidential, the rationale for doing so should be clearly stated and should be consistent with the principles set out below.
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| 6 | The Institute asks consultees to reconsider restrictions on release of data when either there appears to be no obvious reason for the restrictions, or such restrictions would make it difficult or impossible for the Institute to show the evidential basis for its guidance. | ||||||||||||||||||||
| 7 | Confidential information submitted by consultees in responses can be made available for review by the Evidence Review Group, the Appraisal Committee and the clinical specialists and patient experts. Confidential information may be distributed to consultees with permission from the data owners. | ||||||||||||||||||||
| 8 | The documents that are released to consultees and commentators during the appraisal process are shown in Box B. The Institute posts these documents on its website at least 5 working days after they have been sent to consultees and commentators. These documents are not considered confidential when they are posted on the website. | ||||||||||||||||||||
| 9 |
The Institutes hopes that consultees will take steps to ensure that their individual responses are made available - for example, by placing it on the consultee's own website.
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| 10 |
The Institute will not comment on the content of a STA until the process has been completed and its guidance has been produced, other than in the circumstances set out below.
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| 11 | Organisations participating in a STA are required to sign a confidentiality agreement before they are recognised as formal consultees and commentators and STA documentation is released to them. | ||||||||||||||||||||
| 12 | It is the responsibility of the consultees and commentators, and any other party that has signed a confidentiality agreement for the STA, to keep documents not otherwise in the public domain confidential and secure at all times. The Institute considers individuals within a consultee or commentator organisation who see STA documentation to be bound by the terms of the confidentiality agreement signed by the consultee or commentator organisation. | ||||||||||||||||||||
| 13 | Consultees and commentators must not disclose confidential STA documents until the time that the Institute makes documents public. | ||||||||||||||||||||
| 14 | Consultees and commentators may discuss confidential STA documentation with other consultees and commentators but, before doing so, each consultee or commentator must be satisfied that the others have signed and returned their confidentiality agreements to the Institute. | ||||||||||||||||||||
| 15 | Consultees and commentators may discuss confidential STA documentation with other consultees and commentators but, before doing so, each consultee or commentator must be satisfied that the others have signed and returned their confidentiality agreements to the Institute. | ||||||||||||||||||||
| 16 | The Institute reserves the right to use in its ACDs and FADs any material received during the course of a STA that is not designated by the consultee as being ‘confidential', or which ceases to be so after the specified embargo (see section 4.1.2). Reference will be made in the Committee Papers to the existence of documents that have been designated as confidential by the originator. | ||||||||||||||||||||
| Appendix D | Key participants in the appraisal process |
| Appraisal Committee | A standing advisory Committee of the Institute. Its members are appointed for a 3-year term and are drawn from the NHS, patient/carer organisations, relevant academic disciples and the pharmaceutical and medical devices industries. Names of Appraisal Committee members are posted on the Institute's website. |
| Consultees | Organisations that accept an invitation to participate in the appraisal: national professional organisations; national patient organisations; the Department of Health and the Welsh Assembly Government; relevant NHS organisations in England. Consultees can participate in the consultation on the Appraisal Consultation Document (if produced) All consultees are given the opportunity to appeal against the Final Appraisal Determination (FAD). |
| Commentators | Organisations that engage in the appraisal process but that receive the FAD for information only, without right of appeal. These organisations are: manufacturers of comparator technologies, NHS Quality Improvement Scotland, the relevant National Collaborating Centre (a group commissioned by the Institute to develop clinical guidelines), other related research groups where appropriate (for example, the Medical Research Council [MRC], National Cancer Research Institute), other groups (for example, the NHS Confederation, NHS Information Authority and NHS Purchasing & Supplies Agency, the British National Formulary, and the British Medical Association). |
| Evidence Review Group | An independent group that reviews the evidence in manufacturer/sponsor evidence submission and may also prepare some additional analysis. This group is normally commissioned by the NHS Research and Development Health Technology Assessment Programme. |
| Institute staff | |
| Director of Centre for Health Technology Evaluation (CHTE) | The Director is responsible for the delivery of the appraisal programme. In addition to, and in conjunction with, the Executive Lead, the Director is responsible for signing off consultation documents at various stages of an individual appraisal. The Director is also responsible for ensuring that appraisals are conducted in accordance with the published appraisal process and methodology. |
| Associate Director - Appraisals | The Associate Director has responsibility for delivery of individual projects within the appraisal programme. |
| Technology Appraisals Project Manager | The Project Manager is responsible for planning individual appraisal timelines, ensuring the timeline and process are followed, and liaising with consultees, commentators and other individuals and organisations contributing to the appraisal. |
| Technical Lead | Each appraisal will be assigned a technical lead. The Technical Lead is responsible for the technical aspects of the STA, including liaising with the Evidence Review Group, working with the Chair of the Appraisal Committee, to prepare the guidance document or drafts for consultation document and advising the Appraisal Committee on technical aspects of the appraisal. |
| Executive Lead | The Executive Lead is responsible for steering the appraisal through the stages of the process, resolving policy issues, and for signing off documents for consultation. |
| Communications Lead | The Communications Lead is responsible for disseminating and communicating the technology appraisal guidance to the appropriate groups within the NHS in England and Wales, and to patients and the public, and for ensuring that the guidance is available on the NICE website when it is released. |
| Editorial Leads | The Editorial Leads edit the ACD and FAD before they are published on the website. They write the quick reference guide and information for the public versions of the guidance. They are responsible for publication of all versions of the final guidance, both electronic and printed. |
This page was last updated: 20 January 2012
