Eisai and Pfizer confirm high court application

Eisai and Pfizer have confirmed that Eisai has applied for permission from the high court to request a judicial review of the process the National Institute of Health and Clinical Excellence (NICE) undertook in reaching a decision regarding disallowing anti-dementia medication for some NHS patients.

This request follows a letter from Eisai to NICE on November 2006 calling for the institute to withdraw its final appraisal document (FAD) and delay the issuing of its new guidance planned for November 22nd.

In this letter, Eisai also urged the institute to publish a working model of its procedure for determining cost-effectiveness and to use rational clinical assumptions to develop a new document.

“NICE responded to this letter, refusing to make any changes to the FAD or to disclose this requested model and published its guidance on November 22nd,” the company stated.

“As a result, Eisai, fully supported by Pfizer has now formally applied for permission to proceed to judicial review on ? three grounds,” it added.

The company is requesting a review on the grounds of a breach of procedural fairness, irrationality and discrimination against some patient groups.

In July 2006, Eisai claimed that the decision by NICE to not publicly disclose its model of determining cost-effectiveness was counter to both its own guidelines and the notion of natural justice.