Select Committee on Health Appendices to the Minutes of Evidence


Supplementary evidence by Croydon Health Authority (NC 31A)

Copy of a letter dated 13 August from South and West Health Authorities Pharmaceutical Advisors to the Head of MPI Group Department of Health


  The Pharmaceutical Advisers from the South West Health Authorities would like to raise our concerns regarding the NICE with you. As you will be aware there is disquiet about the guidance that NICE has issued such that it is our belief that the laudable aims of the NICE are under threat. We have considerable experience of managing the entry of new medicines through our Area Prescribing Committees and feel that some of the lessons that we learnt could be adopted by the NICE.

  Prior to the NICE, the Wessex Development and Evaluation Committee (DEC) undertook evaluations prioritised by the South West Health Authorities and provided us with clear recommendations. Attached is the whole decision matrix (as updated in March 1998) which led to one of the following five recommendations being made:

    —  Strongly supported—good evidence of excellent or ordinary value for money, or moderate quality of evidence of excellent value for money.

    —  Supported—poor evidence of excellent value for money or good evidence of ordinary value for money.

    —  Limited support—evidence of poor value for money or poor evidence of ordinary value for money.

    —  Not supported—evidence of more harm than good.

    —  Not proven—evidence inadequate or inconclusive.

  This framework was invaluable to Health Authorities in setting our priorities and we strongly believe that adopting a similar approach would increase the credibility of the NICE. As the NICE's workload increases it will be impossible to implement all the guidance immediately. Adopting a mechanism for prioritisation should ensure that interventions supported by strong evidence, which will have the biggest impact on health gain, would be introduced as quickly as possible.

  When implementing NICE guidance we have to contend with all other competing priorities, for example, National Service Frameworks (NSFs) and NHS Plan requirements. Prioritisation of NICE guidance will help to ensure the place of NICE guidance against these other competing demands.

  There have been inconsistencies in the representation of the evidence in NICE guidance. For example,

    —  The zanamivir (Relenza) guidance relied heavily on unpublished data which is not recommended by the exponents of Evidence Based Medicine.

    —  The rosiglitazone guidance appears to ignore the hard outcome data from the UKPDS for insulin in combination with metformin or sulphonylureas by suggesting that rosiglitazone (which only has HbA1c rather than hard outcome data to support its use) should be offered as an alternative to insulin.

  We are also concerned that the NICE does not appear to adopt a consistent approach to evaluating the cost effectiveness of interventions. In particular, the guidance for both riluzole and drugs for Alzheimer's disease discuss the lack of reliable cost effectiveness information but then recommends these treatments. However, we understand that the guidance for the treatments for multiple sclerosis is being held up because of concerns regarding the methodology used to assess cost benefit. We believe that a consistent approach, similar to that developed by DEC, should be adopted.

  As Health Authority Pharmaceutical Advisers we would recommend that the draft technology appraisals are available to all at an early stage and that the NHS has the same right of appeal as invited specialists, patient organisations and the manufacturers. Prior to publication, pharmaceutical company representatives have often seen the draft guidance but we only know the evidence base, which has not proved to be a good predictor of NICE guidance. We feel that adopting the current approach is excluding the wealth of knowledge and experience that the NHS has developed over the years. Pharmaceutical Advisers and our colleagues in Public Health could provide valuable input into the NICE's guidance at an early stage.

  The current system of secrecy also places us in a difficult situation on publication of NICE guidance, as we receive enquiries from within the NHS, the press and public. On one occasion the press had seen the guidance but the NICE website had not posted it so we could not obtain it. We believe that those in the NHS who will be responsible for implementing NICE guidance (usually Public Health, Pharmaceutical Advisers and PCT Prescribing Leads) should be allowed sight of the guidance before it is released to the press.

  Public expectation is immense, fuelled by the media, and it is necessary to recognise the time it takes to bring all the relevant local players together to plan local implementation of the NICE's guidance. Therefore, we would urge you to consider setting realistic timescales for the implementation of NICE guidance within the guidance, and public information, so that public expectation is realistic. Using a prioritisation scheme similar to that used by DEC would provide a strong basis on which to set realistic timescales. For example, a classification of "urgent implementation" might be employed with a time-scale of three to six months, whereas a classification of "recommended use" might require implementation over the following three years, recognising the financial frameworks that Health Authorities and Primary Care Trusts operate within.

  We are also concerned to see that the NICE does not appear to have a robust "Declaration of Interests" procedure. We believe that the NICE should be up front and seek and publish in their guidance any material interests relevant to the guidance from all members of the Appraisal Committee as well as patient organisations and specialists consulted during the development of the guidance. The Department of Health's recently published guidance provides extremely useful advice that we believe must be followed if the NICE is to be perceived as a credible body.

  We hope that our thoughts will be seen as constructive as is our intention. We want the NICE to succeed but believe that fundamental changes along the lines we suggest above are necessary in order for the NICE to be seen as a credible body by the NHS. We would be happy to discuss any issues with you or your representatives further if you think this would be helpful.

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