The High Court hearing this year over the issue of the NHS funding drugs for treating Alzheimer's disease forced NICE to state its principles with great clarity. Now it has to stick to them, says David Lock

The issue of which drugs the NHS should prescribe for long-term conditions remains highly contentious and political. At a High Court hearing in August over NHS funding for Alzheimer's drugs, the methods of the National Institute for Health and Clinical Excellence were substantially upheld.

At the hearing, pharmaceutical company Eisai questioned - by means of a judicial review - NICE's decision to withdraw approval for NHS drugs for mild and late-onset Alzheimer's disease. Its attack was not on the decision itself but on the procedures NICE had followed to reach it.

In particular, Eisai wanted to examine the institute's methodology to see whether there were flaws in the approach that led NICE to say the modest cost of the drug Aricept for people with mild to moderate Alzheimer's was not justified. Eisai wanted to use its resources to test the assumptions of the NICE model and try to get the quality-adjusted life years scale working for its commercial advantage. It is hardly surprising NICE was anxious to avoid this.

The court refused to allow the drug companies access to the detailed methodology, insisting NICE had published enough material to be consistent with its duties as a public body.

However, Judge Linda Dobbs held that the approach of the NICE appeal panel was flawed in that no proper consideration was given to the institute's duties as a public authority to promote equal opportunities and to have due regard to the need to eliminate discrimination. She held it was unreasonable and unlawful to overlook that responsibility, and the same was true of the guidance. NICE has been obliged to amend its guidance in the light of this observation, but its methods have been left intact.

NICE methodology

Of particular interest is what was not challenged. Professor Andrew Stevens, vice-chair of the NICE appraisal committee, summarised the NICE approach as follows: 'If money is spent on donepezil for patients with mild Alzheimer’s disease, then that money is not available to spend elsewhere on the treatment of other patients. The role of NICE's appraisal committees is therefore to judge whether the clinical and cost-effectiveness of a technology being appraised is such as to justify spending the NHS's money on that technology, rather than on one of the many other technologies competing for the finite resources available.'

Judge Dobbs went on to find: 'NICE cannot simply assume that there will be some benefit. There has to be some evidential basis.' Yet she also decided that it was for NICE to determine the form of the evidence and allowed considerable latitude about how it could be presented.

The result, paradoxically, leaves NICE in both a stronger and weaker position. It is stronger because it can robustly bat back the complaints of the drug companies with the backing of the High Court. But it leaves NICE potentially weaker because it has set its logical analysis standards out so clearly that it opens itself to complaints from the NHS (which has to fund the recommended treatments) if it ever succumbs to lobbying or political pressure to fund something where the cost-effectiveness evidence is weak but the heartstrings arguments are strong.

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