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Eisai, NICE Claim Victory in Alzheimer’s Drug Legal Challenge

August 17, 2007

Both Eisai and the UK’s National Institute for Health and Clinical Excellence (NICE) are claiming a legal victory in a lawsuit challenging how the institute handled a cost-effectiveness determination for the company’s Alzheimer’s disease treatment Aricept.

“This is the first time that NICE has been challenged in the courts, and marks a major victory for the many critics of the process by which NICE reaches its often seemingly clinically perverse decisions,” Eisai and marketing partner Pfizer said.

Eisai brought the challenge after NICE issued guidance in November 2006 to the UK’s National Health Service that Aricept (donepezil HCl), Shire’s Reminyl XR (galantamine hydrobromide) and Novartis’ Exelon (rivastigmine tartrate) should be used to treat moderate Alzheimer’s disease only, and that administration of the products should be halted if a patient’s score on the Mini Mental State Examination (MMSE) falls below 10 points.

Justice Linda Dobbs of the High Court of Justice of England and Wales ruled Aug. 8 that NICE’s recommendations that patients be assessed with the MMSE test violated the UK’s Disability Discrimination Act, because it does not take into account factors such as English language skills and learning disabilities, for example, Down’s syndrome, NICE said.

However, during judicial proceedings on Aug. 9, Dobbs ruled that the institute did not have to start the entire appraisal process over again. Adding a paragraph to the guidance document would suffice, she said. The institute has 28 days to comply, NICE said.