The Pharmaceutical Journal
Vol 278 No 7434 p42
13 January 2007

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Eisai seeks judicial review of NICE processes

Pharmaceutical company Eisai has formally applied to the High Court for permission to proceed to a judicial review of the National Institute for Health and Clinical Excellence's appraisal processes.

The move is in response to NICE’s dementia guideline and technology appraisal of medicines for Alzheimer’s disease, in which the use of cholinesterase inhibitor drugs — donepezil, galantamine and rivastigmine — is not recommended for people with mild Alzheimer’s disease (PJ, 25 November 2006, p625). Pfizer, which jointly promotes Eisai’s Alzheimer’s disease drug Aricept (donepezil) in the UK, has backed the company. According to Eisai, its application to the High Court is based on the following:

• That NICE’s repeated refusal 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 is procedurally unfair

• That some of the assumptions made or conclusions drawn in the final appraisal document are irrational or cannot be supported

• That the use of mini mental state examination scores as a rigid diagnostic tool discriminates against certain patient groups

The Alzheimer’s Society has voiced its opposition to NICE’s restriction of the drugs and is in support of the legal challenge.

Andrew Dillon, NICE chief executive, said that the decision would divert energy and funding away from the institute’s work in supporting patients and health professionals and getting the most out of NHS resources.

A spokeswoman for NICE told The Journal that manufacturers do receive a copy of the economic model used in an appraisal and can see the calculations used. However, she said: “Companies are unable to enter their own figures into the model or change calculations that exist within the model.”

The spokeswoman said that Eisai made a freedom of information request for the fully working model, but that the request was refused because the institute considered it to be the property of the University of Southampton team commissioned to put the model together. The information commissioner is reviewing NICE’s decision, she said.