EISAI, PFIZER PLAN LEGAL ACTION AGAINST NICE ON ARICEPT DECISION

Eisai has informed the UK's National Institute for Health and Clinical Excellence (NICE) that the company, along with Pfizer, plans to apply for a judicial review of NICE's decision on the companies' drug Aricept. Last month NICE announced it would recommend to the National Health Service that Aricept be used only to treat moderate Alzheimer's disease, not for newly diagnosed, mild Alzheimer's, rejecting the companies' appeal of an earlier decision.

Eisai and Pfizer believe that since NICE has not disclosed 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 final appraisal determination (FAD) and proposed new guidance was unfair.

The companies are calling on NICE to withdraw the current FAD and postpone issuing the new guidance next week, to disclose the calculations used in the cost-effectiveness model for independent evaluation and comment and to develop a new FAD using a more accurate cost-effectiveness model.

This would be the first time a NICE decision has been contested at this level, according to Eisai's announcement. Eisai is required to write to NICE outlining the grounds for the proposed review, and NICE has 14 days to respond, after which Eisai may apply for permission to proceed with the review.