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NICE taken to task

Pharma companies apply for a judicial review over decision-making process used by the Institute to restrict Alzheimer's drugs

The National Institute for Health and Clinical Excellence (NICE) has published its guidance for the use of drugs in the treatment of Alzheimer's disease despite facing a legal challenge from pharma companies over the decision-making process used to reach its conclusions.

For the fist time in its history the UK cost-effectiveness body is facing a judicial review over the methodology used to reach its decision to ban Alzheimer's drugs for patients newly diagnosed with the disease in the UK.

Eisai, the licence holder of Aricept, and its co-promotion partner Pfizer, informed NICE of their intention to apply for a judicial review on November 17, after the cost-containment watchdog repeatedly refused to disclose a fully working version of the cost effectiveness model used to determine the value of treatment in patients with mild Alzheimer's disease and the process leading to the Final Appraisal Determination (FAD).

ìA judicial review is now the only option remaining to us to ensure that NICE reconsiders how it arrived at such flawed conclusions, which will have a devastating impact on the lives of thousands of people affected by this terrible disease,î said Dr Paul Hooper, managing director of Eisai.

Eisai and Pfizer believe that the proposed new treatment guidance is unfair and many of the conclusions drawn in the FAD cannot be supported legally or are irrational. Both companies are calling for NICE to: withdraw the current FAD and postpone issuing new guidance; disclose a fully transparent working version of the calculations used in the cost-effectiveness model, so they can be independently evaluated; and develop a new FAD using both a more accurate cost-effectiveness model and data.

Shire Pharmaceuticals, the maker of Reminyl, another Alzheimer's drug that NICE has recommended not for use in newly diagnosed patients, has lent its support to the judicial review. Danish firm Lundbeck, which has also been affected by NICE's decision to withdraw NHS funding for its late-stage Alzheimer's drug, Ebixa, has not openly given its support to Eisai but has voiced its disappointment over the publication of guidance of Alzheimer's drugs.

The Association of the British Pharmaceutical Industry (ABPI) said it is clear that the health technology assessment methodology used by NICE is ìan emerging science, and impreciseî, saying that as a consequence ìassessments must not be reduced only to a narrow cost-effectiveness calculationî.

ìNICE should be giving the NHS the freedom to use exciting new therapies for life-threatening conditions, and thus gain the very experience needed to assess their long-term value for money,î said ABPI director general, Dr Richard Barker.

While Eisai's proposed action has garnered significant support from pharma and patient groups, some have been critical of the measures. Trustee of the Patient Choice Initiative, Roy Lilley: ìThe decision to try and take NICE to judicial review is an act of madness. The first judicial review can only be sought on the grounds of a failure in process. NICE's processes are as smooth as a Rolls Royce and have the precision of a Swiss watch.

ìThe industry has to realise that it must work with NICE. NICE is not going away and more than likely there will soon be a European NICE,î he added.

30th September 2008

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