NICE to face judicial review over Alzheimer’s drug decision
pharmafile | November 17, 2006 | News story | |Â Â Â
Legal action is to be taken against NICE over its decision to withdraw approval for NHS drugs for mild and late-onset Alzheimer's disease, the first time a NICE decision has been contested at this level.
Eisai/Pfizer, which jointly markets Aricept, has told NICE that Eisai is to apply for a judicial review of the process by which the institute reached its decision in October. A judicial review looks at the way by which a public body reached a decision but not at the merits of the decision itself, and the grounds for such actions fall into three main categories: procedural fairness, irrationality and abuse of power.
As part of the legal process, Eisai is now required to write to NICE outlining the proposed grounds for requesting a judicial review, after which NICE has 14 days to formally respond. Eisai can then apply to the High Court for permission to proceed to judicial review.
NICE issued guidance that Aricept, along with Novartis' Exelon and Shire's Reminyl should only be prescribed for patients with moderate Alzheimer's. A fourth drug, Lundbeck's Ebixa, indicated for late-onset of the disease, is to be barred from the NHS altogether.
The guidance is due to come into effect on 22 November and has been greeted with outrage and dismay by health professionals, patients and carers across the UK.
Angry demonstrators across the country took to the streets on Friday, 17 November in a last-ditch effort to force NICE to change its mind.
Eisai/Pfizer are now calling on NICE to withdraw its current Final Appraisal Determination on the Alzheimer's drugs and disclose a fully transparent working version of the calculations used when making the decision to withdraw them from the NHS for the treatment of mild and late-onset Alzheimer's.
Dr Paul Hooper, managing director of Eisai, said: "We are deeply concerned about the way that NICE's decision on treatment recommendations for early Alzheimer's disease was reached."
A judicial review is now the only option remaining to us to ensure that NICE reconsiders how it arrived at such flawed conclusions. These flawed conclusions will have a devastating impact on the lives of thousands of people affected by this terrible disease.
Dr Oliver Brandicourt, managing director of Pfizer UK, commented: "NICE has failed to listen to the voices of patients, carers and numerous medical experts. By denying consultees the opportunity to check the accuracy of their economic analyses, NICE has left no option but to proceed in this way to ensure that patients with Alzheimer's disease are protected from failures in process."
Under normal circumstances, guidance to the NHS would be published at the same time as the decision made by NICE; however, the institute is also developing a clinical guideline on the management of all types of dementia, including Alzheimer's, jointly with the Social Care Institute for Excellence. This will be published on 22 November the same day Alzheimer's drugs guidance comes into force.
