Pfizer and Eisai have decided to apply for a judicial review of the process which led the National Institute for Health and Clinical Excellence (NICE) to ban the use of cholinesterase inhibitors in patients with newly-diagnosed, mild Alzheimer’s disease.
The companies will challenge NICE’s conclusion in the courts, claiming that its findings are irrational and cannot be supported legally. They also want to force the agency to disclose the cost-effectiveness model it used in the review process, to withdraw its current recommendations and postpone the final guidance on the matter, which is due on November 22.
Pfizer and Eisai make and market Aricept (donepezil), one of the cholinesterase inhibitors affected by NICE’s action. The others are Shire’s Reminyl (galantamine) and Novartis’ Exelon (rivastigmine). A fourth drug which works via a different mechanism, Lundbeck's Ebixa (memantine), has been limited to use in clinical trials for patients with moderate to severe symptoms only.
Dr Paul Hooper, managing director of Eisai Limited, 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.”
Industry has been joined by academia and medical charities in condemning the decision. For example, the Royal College of Nursing believes that Alzheimer's sufferers who are denied drugs in the early stages need longer-term care and actually cost the NHS more. It could also increase the use of sedatives and increase the number of patients needing long-term care at an earlier stage in their illness.
This is the first time that a NICE decision has been contested at this level. The agency has 14 days to respond to the proposed grounds for judicial review, and after that the companies can apply to the High Court for permission to proceed with the action.