Medicare to cover Alzheimer's drugs granted full FDA approval
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In a major boost for developers of Alzheimer's disease treatments, CMS said that it will cover those therapies once granted full, traditional approval.
CMS Administrator Chiquita Brooks-LaSure on Thursday said the drugs would be covered "in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare." This means that physicians will submit data on their patients' experiences with a medication, once fully approved, through a CMS portal that will be added to a nationwide registry.
Brooks-LaSure had alluded to the change in comments made to a House subcommittee in April.
The clarity from CMS provides relief especially to Biogen (NASDAQ:BIIB) and Eisai. Their US FDA approved Alzheimer's therapy Leqembi (lecanemab) has yet to win broad Medicare coverage, crimping sales.
An agency advisory panel is meeting on June 9 to discuss data from a confirmatory trial that could lead to full approval as soon as the end of June.
Besides Biogen (BIIB) and Eisai (OTCPK:ESAIY), the new CMS policy could also benefit Eli Lilly (LLY), who released phase 3 data on their Alzheimer's candidate donanemab in May showing it slowed cognitive and functional decline in those in early stages of the disease.
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