CHICAGO, June 22 (Reuters) - The U.S. Medicare health plan on Thursday offered details of plans to collect patient data as a condition for reimbursement for Eisai Co Ltd (4523.T) and Biogen Inc's (BIIB.O) new Alzheimer's drug Leqembi, should it win traditional U.S. approval as expected by July 6.
If it wins traditional FDA approval, Leqembi would be the first disease-modifying drug ever to achieve the regulatory milestone.
Current treatments only treat symptoms but do not change the course of the disease, which affects 6 million Americans, according to the Alzheimer's Association.
On that basis, CMS said it would only pay for Leqembi if patients were enrolled in a clinical trial.
The CMS data requirements apply to all Alzheimer's treatments that reduce beta amyloid from the brain, including Eli Lilly and Co's donanemab, which recently reported positive results from its late-stage trial.
Persons:
Biogen, Eisai's Leqembi, Leqembi, Eli Lilly, Co's, “, Robert Egge, Julie Steenhuysen, Daniel Wallis
Organizations:
U.S, Eisai Co, Centers, Medicare, Medicaid Services, CMS, Alzheimer's Association, U.S . Food, Drug Administration, FDA, Alzheimer’s Association, Thomson
Locations:
U.S