The National Institute for Health and Clinical Excellence (NICE), the body that decides what treatments are supplied on the NHS in England and Wales, is facing a High Court challenge to its decision to restrict the use of drugs for Alzheimer's disease.
NICE rejected an appeal by drug companies in October over its guidance stating that patients with early or late stage Alzheimer's disease should not have access to donepezil (Aricept), galantamine (Reminyl), or rivastigmine (Exelon) (BMJ 2006;333:165).
The US drug company Pfizer and a Japanese biotechnology company, Eisai, announced last week that they would seek a judicial review of the process NICE followed in making its decision. The British company Shire later said it would join the legal challenge as an interested party.
Eisai, the licence holder of donepezil, and Pfizer, its co-promotion partner, said a letter had gone to NICE saying that the companies planned to apply for a judicial review. NICE, which has never before faced such a challenge, has 14 days to respond, after which the companies will have to get the court's permission to launch the proceedings.
Assuming they get the go ahead, which is likely, the companies' lawyers expect the case to reach court by late January or early February 2007.
The companies said they believed the decision making process was “unfair” because NICE had 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.”
Also, they argue, many of the conclusions in NICE's final guidance “cannot be supported legally, or are irrational.”
Olivier Brandicourt, managing director of Pfizer UK, said: “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.”
News of the legal challenge was welcomed by the Alzheimer's Society, which organised more than 30 protests against NICE's decision across England and Wales last week. The society said it was taking its own legal advice about a possible challenge.
NICE's chief executive, Andrew Dillon, said: “We will respond to Eisai's letter and act appropriately in any court proceedings which may follow. In the meantime we will publish our recommendations, both on the best ways of caring for people with all forms of dementia and on the use of drugs for treating Alzheimer's disease, on 22 November 2006.
“This will be the first time that health and social care advice has been combined in a single guideline, and we believe it is in the interests of those affected by this distressing condition to make it available now.”