Select Committee on Health Appendices to the Minutes of Evidence


APPENDIX 18

Memorandum by Dr Stephen Head, Chairman, PACE (NC 72)

EVIDENCE FOR THE NEW INQUIRY INTO THE NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE (NICE)

  1.  Summary. The concept of NICE was widely welcomed by local NHS management but the way it currently functions creates more difficulties than it solves. NICE must provide timely advice, usually at the time of licensing, and if there are delays NHS use should also be delayed. NICE should assess treatments in more global health economic terms, especially considering the current NHS environment (in terms especially of human and financial resources) and explicitly include the Opportunity Cost of their advice. More "ordinary" people should inform NICE advice: NHS clinicians, managers and non-sectionist members of the public. We do not believe these changes would do any harm to the Pharmaceutical Industry's substantial interests in the NHS.

  2.  The authors. This evidence was prepared by the Prescribing and Clinical Effectiveness (PACE) Group. This is a committee of North Derbyshire Health Authority, which provides advice to the local health community. The Authority, Primary Care Trusts, Acute Trusts, the Community Trust and Local Medical Committee are represented. Membership is largely professional with pharmacists, hospital doctors, general practitioners, nurses and public health specialists. One or more members of the Group would be willing to attend to give oral evidence if requested. We feel our evidence reflects the typical problems encountered by local health bodies in coping with NICE as it currently works.

  3.  The duty to identify and meet health needs remains a local function, at least until NICE has reported; and local commissioning bodies are explicitly forbidden to defer decisions on using new treatments "pending NICE guidance". This leaves local managers having to try to "second guess" what NICE will decide. Different local managers may guess differently: hence perpetuating "Postcode Rationing" and be at risk of major problems should they invest heavily in treatments that NICE subsequently rejects or accepts only with rigorous conditions. We believe NICE should report on treatments at or prior to licensing; and where for whatever reason they fail to do so, there should be a moratorium on NHS use pending NICE's assessment.

  4.  The need for such timely advice is not helped by the quasi-judicial processes by which NICE operates. Inevitably the most contentious issues, are the ones on which guidance is most needed quickly, yet precisely those where delays are most likely. This also appears to have affected the ability of the organisation to consider all available evidence in some cases. We believe NICE should report promptly "and regardless". Organizations that wish to dispute NICE guidance may do so AFTER it is issued, and if they make a successful case there is nothing to stop revised guidance being issued later. Almost four years after North Derbyshire Health Authority was taken to Judicial Review for our policy on Beta-Interferon in multiple sclerosis, the NHS is still waiting for a definitive answer to the place of this drug in NHS practice.

  5.  Although committed to consider cost-effectiveness in its deliberations, NICE does not answer the needs of local health managers and clinicians on broader resource issues, nor does it appear to make recommendations that are sensitive to current resourcing problems. The anti-obesity drugs illustrate this, where there is simply not the dietetic and nurse time available to provide the level of support likely to make the drugs beneficial, and indeed without such support it might be questionable if they were being prescribed within their Product Licence.

  6.  The influenza drug Zanamivir was approved by NICE, subject to certain conditions of use, yet fewer than 10 prescriptions were issued for it last Winter in North Derbyshire. It runs totally counter to the current emphasis in Primary Care: scarce resources being targeted at Chronic Disease Management with the prospect of substantial proven health gain. We found the suggestion of using Patient Group Directives a most worrying solution, considering the novelty of the drug, reports of adverse events, and the fact the most patients in the target group would probably be unfit to attend a pharmacy anyway.

  7.  NICE should have a much sharper Health Economic focus, not simply looking at the cost effectiveness of individual therapies but global issues of funding, effects on NHS resources, and the Opportunity Costs associated with adopting new therapies.

  8.  Perhaps this process requires some "grass roots" input. We have often felt advocacy groups: the Pharmaceutical Industry, patient interest groups and clinicians or academics with a special interest have dominated the evidence and hence the conclusions of NICE. It is local clinicians and managers who must implement the decisions; they should at least have a strong say in how those decisions are made. Similarly patients' interests could also be seen in "holistic" terms with the views of patient/tax payers without a strong sectionist advocacy being sought.

  9.  Given finite NHS funding we do not believe these ideas pose a threat to the Pharmaceutical Industry. The only way the Industry can do better from the NHS is through greater global health funding, or a greater proportion of NHS funding being spent on pharmaceuticals. Our proposals would threaten neither of these two options, but would ensure NHS resources were used in a more effective way to promote patient care. Given these realities a NICE which really did address NHS management needs, with front end (ie pre licensing) assessments and a cost sensitive evaluation would do the Industry no harm. At least by correctly identifying NHS impact (and hence sales) it would allow the Industry to plan on a more rational and therefore more efficient basis.

2 January 2002



 
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