The main features of the government's proposals are as follows:
   
New interventions
   
10.1 The NHS Executive of the Department of Health will arrange for intelligence to be gathered systematically on all significant new interventions under development, including new medicines, and new indications for existing interventions.
   
10.2 The Department will regularly review the results of this intelligence in consultation with the NHS in order to identify those interventions likely to have significant impact on the NHS, and will decide whether any specific action is required (eg work through the NHS R&D programme to inform further decisions centrally or in the NHS).
   
10.3 The Department will also regularly examine all interventions likely to be marketed to the NHS in the foreseeable future, and will provisionally identify which of these are likely to require appraisal. The companies developing these interventions (the "sponsoring companies") will be notified of this provisional selection and invited to comment. Once the process is fully underway, the Department will aim to give formal notice to the sponsoring companies 12 months before the expected launch date of the products selected for appraisal, and will invite evidence to be submitted to NICE generally no later than 4 months before the launch date. Initially, notice periods may need to be very much shorter.
   
10.4 Sponsoring companies will be invited to discuss at any stage, and in particular when the intervention is first provisionally identified as likely to be selected for appraisal, what research evidence they are likely to be required to submit. The broad areas to be covered will be set out in guidance. Relevant patient groups will also be invited to submit any comments.
   
  In principle, "intervention" for the purpose of this paper includes all new diagnostic and therapeutic products and interventions, and population screening procedures. See para 11 for a further discussion.
   
10.5 For a transitional period from the establishment of NICE, any relevant evidence can be submitted provided that it will be made publicly accessible by the time the intervention is first marketed to the NHS. Where the submitted evidence is incomplete the Department of Health, through the NHS R&D programme, may at its discretion respond to requests from NICE to commission any further primary research, research review or economic evaluation of the available evidence that will be needed for the appraisal process.
   
10.6 The appraisal process will be carried out by a multi-professional appraisal group within NICE and with a dedicated secretariat. The terms of reference of this group will convey any general guidance from the Department of Health and the Welsh Office on the factors to be taken into account or the format of the advice to be issued.
   
10.7 The secretariat will critically review the submitted evidence and will if necessary add further analysis of the likely impact on the NHS as a whole. The sponsoring company will have the opportunity to see this critique and to add any further observations.
   
10.8 The appraisal group will then examine all the evidence and will form a judgement on the advice to be given to NHS commissioners and clinicians, after allowing the sponsoring company, patient groups and the health departments the opportunity to comment on the advice in draft.
   
10.9 The advice will be issued directly to the NHS by NICE. Provided that all deadlines for comments are met, the process will generally be completed within 4 months of the initial company submission, ie by the expected time of launch.
   
10.10 Exceptionally, the NHS Executive and the Welsh Office may wish to issue further management guidance to health authorities and commissioners on how introduction of the new intervention might be managed.
   
10.11

There will be provision for review of the initial advice, either

  • at a time determined by the appraisal group in advance (eg where the evidence on which the initial appraisal is based was inconclusive), or
  • in the light of new evidence, improvements in products or techniques, or price movements which could significantly alter the initial appraisal
 
Existing interventions
   
10.12 As health technology assessments (HTAs) of existing interventions are completed, either within the NHS R&D programme or elsewhere, the Department will consider whether further action is needed in the light of their findings (other than dissemination to the NHS). On occasion this might involve reference to the national appraisal group which would consider guidance in a similar format to that used for new interventions.
   
10.13 In addition, the Department will develop a prioritised "catch up programme" which will, over a period of years, commission appraisals of selected existing interventions. Selection will take account not only of the intrinsic significance to the NHS but also any evidence of inappropriate use or variations in access.
 
The rest of this paper expands on these points, and notes areas on which we would particularly welcome comments. It is stressed that this will be a learning process, both for NICE and for other stakeholders, and the arrangements will need to evolve in the light of experience. The proposed timescale for the initial assessment process for new interventions is summarised at Annex A.