Consultation on the process for Single Technology Appraisals
Please note that consultation on the process for Single Technology Appraisals has ended.
| 1. | Introduction |
| 1.1. | The Institute's reputation rests on the quality of its guidance. Quality, for NICE, has always been synonymous with thoroughness, since the Institute needs to be able to demonstrate not only that it has based its recommendations on the best available evidence, but that the interpretation has been transparent and participative. The current technology appraisal process has developed with experience and in consultation with the Institute's stakeholders. It is regarded as a model of its kind throughout the world. |
| 1.2. | NICE is commissioned, by the Department of Health, to appraise, for their clinical and cost effectiveness, selected new and existing health technologies. For new technologies there is often pressure for guidance to be issued as new innovations are first introduced or when new evidence raises important questions about existing treatments. The existing technology appraisal process, which takes around 14 months to complete, already makes it possible for NICE to issue guidance on new technologies at their point of launch. However, for this to happen, initial referral of the topic to NICE needs to occur early enough in the pre-license phase of product development and the Institute needs to have the capacity to run the standard process in time to complete shortly after product launch. Uncertainties about the licensing and launch date can add to any planned timeline and can contribute to further delays. These challenges, combined with the pool of topics waiting for appraisal, mean that the current process is not always able to produce guidance as soon as the NHS needs it. |
| 1.3. | The Institute is now establishing a new Single Technology Appraisal (STA) process. This consultation document sets out and seeks comments on the arrangements for conducting the new process. The current process for appraising health technologies, which will be referred to, in future, as the Multiple Technology Appraisal (MTA) will be retained but will also be reviewed. The Single Technology Appraisal process is designed to enable comparison of single products, normally with single indications, with one or more standard treatment comparators. Both the STA and MTA processes can be initiated at any point in the life cycle of an intervention, but the assumption would be that the STA process would normally be used to ensure that NICE is able to issue guidance on new technologies, to the NHS, close to their point of introduction into the UK. |
| 2. | Principles of the STA process |
| 2.1. |
NICE guidance production processes are based on key principles that define how the Institute works. The principles are:
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| 2.2. | The application of these principles has been fundamental to the Institute's success and they are valued highly by stakeholders. Therefore, the characteristics of any new process need to adhere to them in order to set the same standard of excellence for which the Institute is recognised world-wide. |
| 2.3. | This approach is explored in more detail, through the Institute's quality assurance principles, which are set out below: |
| 2.4. | Guidance development processes are governed by clear statements of methodology and process, including a standard timeline, which will have been developed in consultation with stakeholders and updated at regular, pre-determined intervals. These development processes will be published. |
| 2.5. | Standard operating procedures are prepared for each principal step in the guidance development processes. These procedures will be developed in consultation with the staff who will operate them and they will be reviewed at regular pre-determined intervals. |
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| 2.6. | Each piece of guidance (or its originating document) is reviewed and signed off by an independent advisory committee. |
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| 2.7. | Guidance publications are authorised for publication, on behalf of the Board, by the Guidance Executive. |
| 2.8. | The Senior Management Team and the Board receive regular reports which identify variations from the planned programme, the reasons for the variations and the remedial action taken. |
| 2.9. | Each member of staff is aware of his or her personal responsibility for applying their best endeavours in assuring the quality of their work, through the application of standard processes and methodologies and through independent thought and action where necessary and appropriate. |
| 2.10. | The risks associated with guidance development programmes are assessed and reported to the Risk Management Committee together with risk minimisation and handling strategies. |
| 2.11. | A set of clear publication standards will be applied to the presentation of our work, including review, in every case, by a trained editor. |
| 2.12. | Dissemination of our publications will be undertaken following an analysis of the extent and needs of the audience for each piece of guidance. |
| 2.13. | Appropriate training will be provided for staff to enable them to apply these principles in their daily practice |
| 3. | Overview of the Single Technology Appraisal process |
| 3.1. | The full process statement is set out in the accompanying document. What follows here is a summary overview. |
| 3.2. | This new process is designed specifically to appraise single technologies, with limited indications. The process is suitable for all single technology appraisals, including new technologies, new indications for existing technologies and reviews of existing guidance. However, the decision as to which technologies use the process will be made at the topic selection stage. Key stages of the existing appraisal process have been adapted to reflect the requirements and reduced complexity of a single technology appraisal. |
| 3.3. | The principle evidence needed for a single technology appraisal will be provided by the manufacturer, against a clear and detailed specification developed by NICE. The specification, which will be referred to as the 'submission template', is one of the accompanying documents. This approach is possible because much of the evidence base for new technologies (and new indications for existing technologies) will be held by the manufacturers and sponsors. The specification for the evidence required will be based on the Institute's current decision-analytic approach to the evaluation of the clinical and cost-effectiveness of health technologies. |
| 3.4. | Review of the evidence submission will usually be undertaken by an external group (the evidence review group). Their remit will be to critically evaluate the submission, identify its strengths and weaknesses and supplement it with their own analysis, at the request of the Institute. Normally, the external group will be commissioned by the National Coordinating Centre for Health Technology Assessment (NCCHTA), as is the case for the current programme. Existing assessment groups will be used, but NCCHTA may commission other groups as required. The Institute will supplement the assessment capacity selectively and will otherwise support the work of the Appraisal Committee with its Decision Support Unit. |
| 3.5. | The evidence review phase will require liaison with clinical experts. The external experts will be expected to advise the Institute on the current management of the condition and the potential place of the new technology in clinical practice. These experts will be recruited in the same way as for the current process. |
| 3.6. | The appraisal and the development of the guidance documents will be undertaken by the existing Appraisal Committees. |
| 3.7. | Consultee and commentator organisations (i.e. patient, professional and commercial organisations that have an interest in the technology, plus the NHS, DH and Welsh Assembly Government) will be identified for each single technology appraisal. The processes for identifying organisations will be the same as for the current process. Unlike the existing programme, these consultee organisations will not be invited to make a submission of evidence, although patient and clinical experts will be asked to contribute their perspective on the intervention and its use in the NHS. |
| 3.8. | The production of an appraisal consultation document (ACD) and its publication for general consultation will only take place if the recommendations emerging from the Committee are substantively restrictive or for some other exceptional reason. A substantively restrictive recommendation will be one that is more limited than the terms of regulatory approval (or, in the absence of a regulatory approval process, the claims of the sponsor for how the technology should be used), to an extent judged, by the Appraisal Committee, to be significant in clinical practice. |
| 3.9. | If required, the consultation phase will be for 4 weeks and the arrangements for publishing and receiving responses to consultation will be those used in the current. At the same time, consultees and commentators will be provided with the Committee papers. This document will comprise all the evidence seen by the appraisal committee except that which is designated commercial-in-confidence by the manufacturer. The ACD and the report of the evidence review group will be published. |
| 3.10. | Responses to consultation will be considered by the Appraisal Committee at a second meeting and a final appraisal determination (FAD) will be prepared. |
| 3.11. | If the recommendations emerging from the first meeting of the Appraisal Committee broadly support use consistent with the approved indications of the technology (see above), a final appraisal determination (FAD) will be prepared, which will be issued for appeal. The FAD and Committee papers will be published, in line with the current process. |
| 3.12. | In all cases, consultees will be allowed to make an appeal, once a FAD has been issued. The arrangements for making an appeal are those set out in the existing Guide for Appellants. The NHS primary care trusts, invited to take part in each appraisal will be designated as a consultee and will be entitled to appeal. |
| 3.13. | 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, |
| 3.14. | 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. |
| 3.15. | For these timelines to be achievable, it will be crucial to develop systems to track the date of regulatory approval - and NICE will need to be in a position to seek a submission from companies at least 20 weeks before regulatory approval. In addition, Appraisal Committee time will need to be guaranteed to avoid timeline slippage. |
| 4. | Consultation |
| 4.1. | Comments are invited on the process described in the accompanying document. They should be submitted in accordance with the following arrangements: |
| Consultation dates: | 11 November 2005 - 6 February 2006 |
| What to comment on: | Any aspect of the process document and submission template. |
National Institute for Health and Clinical Excellence
November 2005
This page was last updated: 04 June 2009
