Eisai has confirmed that it is taking the UK's cost-effectiveness body, the National Institute for Health and Clinical Excellence, to court over what the firm refers to as its “unfair and irrational decision on treatments for Alzheimer’s.”
Eisai and Pfizer, its co-promotion partner for Aricept (donepezil), noted that the former firm has formally applied to the High Court for permission to request a judicial review of the process by which NICE reached its decision last November to ban anti-dementia medicines for NHS patients with newly-diagnosed mild Alzheimer's disease.
Citing grounds for its appeal to the High Court, the company said that “since NICE has 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,” the process leading to the agency’s final appraisal document (FAD) on November 22 and the new treatment guidance “breached the principles of procedural fairness.”
Eisai added that “some of the assumptions made or conclusions drawn in the FAD are irrational or cannot be supported” and also claimed discrimination on the basis of human rights, as “the use of MMSE (mini mental state examination) scores as a rigid diagnostic tool discriminates against certain patient groups.”
The High Court has yet to confirm when it will be able to give consideration to the application but Eisai’s case is likely to be backed by Shire and Novartis which saw their drugs Reminyl (galantamine) and Exelon (rivastigmine) respectively, also rejected by NICE for patients with newly-diagnosed, mild Alzheimer's disease.
Support is also likely to come from the Alzheimer’s Society, whose chief executive, Neil Hunt, said at the time of the original ruling that “by releasing these guidelines, NICE is trying to cynically cloak its flawed evaluation of Alzheimer's drug treatments.”