Japan’s Eisai on Friday said it still planned to seek an accelerated approval pathway for its experimental Alzheimer’s drug even after the US government healthcare system decided to severely limit coverage of medicines approved in that manner.
On Thursday, the Centers for Medicare and Medicaid Services (CMS) said it would only pay for Biogen’s Aduhelm, and other similar drugs, for patients enrolled in valid clinical studies, unless they have demonstrated clear evidence of patient benefit.
The decision followed a months-long review and a pressure campaign from patient advocacy groups.
Medicare covers nearly 64 million Americans age 65 and older, so the coverage decision could affect 85% of people who might otherwise use the medications for the age-related condition.
Eisai’s lecanemab, like Aduhelm, is a monoclonal antibody designed to remove beta-amyloid, a type of protein fragment that accumulates in the brains of Alzheimer’s patients.
The Japanese drugmaker said it expects upcoming Phase III trial results to validate earlier-stage data under review by the US Food and Drug Administration.
Similar drugs are in advanced development at Eli Lilly and Co – which did not immediately respond to questions about the status of its accelerated FDA application – and Roche Holding AG, which is not seeking an accelerated FDA review.
The FDA in June authorised Biogen’s Aduhelm under the agency’s accelerated pathway based on the drug’s plaque-clearing ability, rather than proof it slows cognitive decline in Alzheimer’s patients.
It was the first drug in this class and the first US-approved Alzheimer’s treatment in 20 years.
Alzheimer’s drugs approved under the traditional FDA process based on “a direct measure of clinical benefit” would be covered as standard treatments without the limitations, CMS said.
Eisai, which has partnered with Biogen, said it still expects to complete a rolling FDA application for lecanemab, under the accelerated pathway, by mid-year. It said it also expects results from the 1,800-patient, Phase III trial later this year.
- Reuters, with additional editing by George Russell