21

Once the process is mature, ie in about 3 years, the various items of evidence required might be provided as follows:

   
(i) Single sponsoring company
   
22 The sponsoring company will provide evidence on (i) to (vi) and, if they wish, on (vii) and (viii).
   
23 The appraisal secretariat will analyse the submission and may need to go back to the sponsoring company to clarify points or to point out apparent errors. The secretariat will then add a commentary which
 
i
 discusses the robustness of the evidence submitted
 
ii
 adds to the analysis as needed, for example supplying an analysis of the impact on NHS resources if the sponsoring company has not included this in their submission.
   
  The commentary will then be sent to the sponsoring company who will have the opportunity to add any further comments of their own.
   
24 Any relevant patient groups will also be invited to submit comments, either on their own initiative or in response to the industry submission and/or secretariat comments. The Department of Health, Welsh Office or NHS bodies such as the NHS Confederation, might also wish on occasion to submit views.
   
25

Once this process is complete, the full set of papers - sponsoring company's submission, any other initial submissions, secretariat commentary, and any further comments from the company and from patient groups - will be passed to the appraisal group. We suggest that the total process, from the first receipt of the industry submission to the passing of the full set of papers to the appraisal group, should normally take no more than 8-12 weeks; additional time might be granted, at the company's request, if the company wished to submit further evidence in the light of the secretariat's critique.
   
(ii) No sponsoring company
   
26 If there is no sponsoring company - as for instance for most surgical procedures - NICE will invite the Department of Health to commission an assessment from a suitable provider. (Providers will typically be University-based groups, including those which already have experience of similar work on behalf of the regional Development Evaluation Committees (DECs).) This will comprise a review of existing research and/or new research as appropriate. Patient groups will also be invited to submit views. The process will then continue as above.
   
(iii) Several sponsors
   
27 A more complicated situation could arise if several companies have an interest in an appraisal. This might occur, for instance,
 
i
 when there are a number of alternative devices for a single procedure; or
 
ii
 when a number of alternative treatments (none of which have been previously appraised) are being compared for the same indication at more or less the same time.
   
28 It may be difficult to lay down detailed procedures in advance, as each instance is likely to show particular features. However, a possible approach might be:
 
i
 the Department would commission research on the clinical effectiveness of the procedure in generic terms, and on the particular variations associated with particular products, drawing as far as possible on research already carried out by individual sponsoring companies;
 
ii
 this would be combined with information on the cost of individual products to produce an assessment of the relative clinical cost-effectiveness of each product;
 
iii
 the final submission to NICE would be made by the group carrying out the research, but each company (and relevant patient groups) would have the opportunity to add its comments either on the overall assessment or on the aspects relating to its particular product.