Lecanemab Data On Benefit In Alzheimer’s Might Satisfy FDA – But What About Medicare?
Centers for Medicare and Medicaid Services’ standard for determining whether drugs produce a clinically meaningful improvement in cognition that would allow for broader Medicare coverage is unclear. But Eisai/Biogen’s lecanemab is likely to serve as a first test.
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Eisai says ‘narrow’ indication negated need for REMS on amyloid-related imaging abnormalities and hemorrhages in the brain. Unusual nature of accelerated approval and confirmatory trial timing means safety data from the Phase III is barely mentioned in label.
After the commercial and public relations debacle driven by Biogen’s original pricing for the companies’ predecessor drug for Alzheimer’s, Aduhelm, Eisai is feeling the heat to ensure the US price for lecanemab is in line with stakeholder expectations.
The US FDA is likely to end 2022 with noticeably fewer Accelerated Approvals granted than in recent years. But it is far too early to conclude that the agency is backing off the pathway – at least in spirit.