Memorandum of understanding on appraisal of
health interventions
 
1. This memorandum sets out the ground-rules under which NICE will carry out the appraisal of individual health interventions, in order to promote the appropriate use of those which offer good value to patients and to discourage the use of those which do not. It builds on the proposals set out in the discussion paper Faster access to modern treatment, modified in the light of comments received and further discussion with stakeholders. Further details are available from NICE.
   
Selection of interventions for referral to NICE
2. The responsibility for determining which interventions should be referred to NICE will remain with the Department of Health, in consultation with the National Assembly for Wales, NICE and other interested parties. Once the process is mature, the Department of Health will aim to give final notification of referral of interventions to NICE no later than 9 months before the point at which guidance is to be ready for dissemination. Exceptionally, a shorter notice period may be necessary, for instance when a technology is changing rapidly or when new evidence radically alters the perception of an existing technology.
   
Submission of evidence
3. NICE, in consultation with the Department of Health, will identify the "sponsor(s)" of the technology (if any) and any appropriate NHS, professional and patient groups with an interest and invite them to submit evidence. Where there is no commercial sponsor the Department will on behalf of NICE commission any necessary research from a suitable independent person or organisation.
   
4. The contents of the evidence package to be submitted will be determined by NICE, in consultation with interested parties. NICE should aim to apply equal rigour to its appraisal of all types of intervention
   
5. NICE will need to give careful thought to issues of confidentiality. As a general principle, NICE’s processes should be as transparent as possible and it is highly desirable that the evidence underlying its recommendations should be accessible (see para 16 below). However, to operate effectively it will wish to have access to information from sponsors which is not yet in the public domain at the point of appraisal. In many cases, this information will be commercially confidential and sponsors will be reluctant to make it available unless they can be assured that it will not be disclosed outside NICE.
   
6. NICE will adopt policies which reflect these objectives, subject to current legal requirements (including any future freedom of information legislation) and prevailing understandings between government, industry and the general public on information in regulatory submissions.
   
Appraisal process
7. NICE will follow a transparent and well-structured process for its appraisals, giving appropriate interested parties the opportunity to submit evidence, to comment on draft conclusions, and to appeal to a panel independent of those involved in the original judgement in cases where NICE is alleged to have failed to act fairly, to have exceeded its powers or to have acted perversely in the light of the evidence submitted. The current form of this process is set out in NICE’s "Interim Appraisal Guidelines" which are available on request from NICE. If it becomes necessary to modify this process in the light of experience, NICE will consult on proposed changes and will give due notice of bringing them into effect.
   
Timescale
8. It is intended that the whole process should be completed as expeditiously as is consistent with allowing for all parties a reasonable opportunity to make their input. In particular, for new technologies, the intention is that guidance should be available to the NHS as soon as possible after the launch or general dissemination of the technology. The process described in Appendix C of the interim appraisal guidance would imply an overall timetable of up to 8 months from submission of evidence to issue of guidance.
   
9. In exceptional circumstances, for instance in the case of a review of previous guidance in the light of significant new evidence, this timetable may be abbreviated provided that interested parties still have a realistic opportunity to be consulted.
   

Appraisal methodology and criteria
10. NICE’s function in relation to appraisals, as set out in Secretary of State’s Directions, is "to appraise the clinical benefits and the costs of such healthcare interventions as may be notified by the Secretary of State or the National Assembly for Wales and to make recommendations". In other words, its task is to assess the evidence of all the clinical and other health-related benefits of an intervention – taking this in a wide sense1, to include impact on quality of life, relief of pain or disability etc as well as any impact on likely length of life – to estimate the associated costs, and to reach a judgement on whether on balance this intervention can be recommended as a cost-effective use of NHS and PSS resources (in general or for specific indications, subgroups etc). Where there is already a cost-effective intervention for the condition, the appraisal should appraise the net impact on both benefits and costs of the new intervention relative to this benchmark.
     
11. In reaching this judgement NICE should have regard to those factors listed in Secretary of State’s Directions, namely:
   
 
i the Secretary of State’s and the National Assembly of Wales’ broad clinical priorities (as set out for instance in National Priorities Guidance and in National Service Frameworks, or any specific guidance on individual referrals),
ii the degree of clinical need of the patients with the condition under consideration,
iii the broad balance of benefits and costs,
iv any guidance from the Secretary of State on the resources likely to be available and on such other matters as he may think fit;
v the effective use of available resources.
   
  NICE will also wish to ensure that, in carrying out its statutory functions, it is sympathetic to the longer-term interest of the NHS in encouraging innovation of good value to patients.
   
12. NICE will develop a detailed methodology for its appraisals, consistent with guidance given to it by the Department of Health , and taking as its starting point the proposals in Faster access to modern treatment. NICE should consult with its stakeholders over this methodology and over any future changes. NICE will liaise closely with the Joint Committee on Vaccination and Immunisation and with the National Screening Committee to ensure that their respective methodologies are as far as relevant consistent with one another.
   
Format and contents of NICE's guidance
13. NICE will produce guidance to commissioners and clinicians on the appropriate use of the intervention alongside current best practice. This guidance should among other things cover the following aspects:
   
 
i an assessment of whether or not the intervention can be recommended as clinically effective and as a cost-effective use of NHS resources for NHS use, either in general or in particular circumstances (first or second line treatment, for particular subgroups, for routine use or only in the context of targeted research etc);
ii where appropriate, any priorities for treatment;
iii recommendations on any questions requiring further research to inform clinical practice;
iv an assessment of any wider implications for the NHS;
v a concise summary of the reasoning behind NICE's recommendations and the evidence considered , with a supporting paper available on request.
   
14. NICE will also when appropriate prepare guidance for users and carers, consulting with appropriate patient groups on the best format and means of dissemination. This guidance should inter alia explain the nature of the clinical recommendations, the implications for the standards which patients can expect, and the broad nature of the evidence on which the recommendations are based.
   
15. As far as practicable all evidence sources should be made available for inspection.
   
Legal status of guidance
16. All guidance must be fully reasoned and written in terms which makes clear that it is guidance. Guidance for clinicians does not override their professional responsibility to make the appropriate decision in the circumstances of the individual patient, in consultation with the patient or guardian/carer and in the light of any locally agreed policies. Similarly guidance to NHS trusts and commissioners must make clear that it does not take away their discretion under administrative law to take account of individual circumstances.
   
Implications for guidelines and other information
17. Where appropriate, NICE will ensure that the implications of its recommendations are carried through to
   
 
i related clinical guidelines,
ii PRODIGY guidelines,
iii the National Electronic Library for Health,
iv

the protocols used by NHS Direct and NHS Walk-in Centres, and any material for patients produced by NHS Direct Online.
     
  Department of Health
August 1999
   

1

The wider benefits of treatment (such as a reduction in disability which allows continuation of employment) can be taken into account on the benefit side of the equation but should not simply be treated as an offset on the cost side