Headshot of CMS Administrator Chiquita Brooks-LaSure
CMS Administrator Chiquita Brooks-LaSure

Medicare Part B will provide coverage for new amyloid-busting Alzheimer’s drugs as soon as the Food and Drug Administration grants traditional (full) approval, the Centers for Medicare & Medicaid Services announced Thursday morning. Coverage will require clinicians to participate in a patient data registry.

The decision applies to monoclonal antibody drugs shown to slow the progression of Alzheimer’s symptoms by targeting amyloid brain plaques. Two drugs in this class, aducanumab (Aduhelm) and lecanemab (Leqembi), have already received accelerated FDA approval. But to the dismay of patient advocates, CMS has previously denied coverage beyond clinical trials, saying that more real-world patient data is needed.

That real-world evidence may now be forthcoming, CMS said. FDA advisers on June 9 are scheduled to discuss confirming data for the Eisai product Leqembi, with possible traditional approval to follow within weeks. Other drugs in the class under consideration for full approval include Eli Lilly’s donanemab. 

“If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” Administrator Chiquita Brooks-LaSure said in a statement. “I’m pleased to make this announcement today as part of CMS’ mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon.”

Qualifying for coverage

To aid patients in receiving coverage, qualified physicians will need to participate in a HIPAA-protected, data-gathering registry, CMS said. Whenever a drug product receives traditional FDA approval, physicians and their clinical team will be able to submit evidence through one of these CMS-facilitated portals. The agency currently is encouraging multiple organizations to open registries.

To access coverage, patients will also need to be enrolled in Medicare Part B and be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease.

Patient advocates push back

Patient advocates, meanwhile, are pushing back against the CMS decision. Registry as a condition of coverage is an unnecessary barrier, the Alzheimer’s Association said in a Thursday statement

“Registries are important tools to gather much needed real-world evidence to transform and improve patient care,” the organization said. “But, registries should not be a requirement for coverage of a FDA-approved treatment.”

CMS said that there is strong precedent for using registries to gather more risk-benefit information on newly-approved treatments. When transcatheter aortic valve replacement (TAVR) was approved, for example, clinicians and hospitals were required to track patient outcomes, it noted.

Drug risks

CMS has repeatedly emphasized caution in its stance on coverage of Aduhelm and Leqembi. These and other drugs in the class are associated with headache and amyloid-related imaging abnormalities (ARIA). This can include  brain swelling and microbleeds, as seen in a minority of patients in clinical trials. Some clinicians have raised patient safety concerns based on these risks, and periodic MRI imaging is recommended to watch for asymptomatic ARIA in patients receiving the drugs.

In any case, expanded coverage may not come cheaply. According to one estimate, Medicare costs could rise ​​by $2 to $5 billion a year if Leqembi receives broader coverage, for example.

In the meantime, more details about the registries will become available as they come online, CMS said. Information about registries and Medicare drug coverage can be found on the agency’s ​​Coverage with Evidence Development webpage.

This is a developing story. Please check back for updates.

Related articles:

Medicare costs could rise by $5B annually with expanded Alzheimer’s drug coverage: study

Eli Lilly expects Medicare about-face on Alzheimer’s drugs coverage (April 2023)

Patient advocates decry CMS decision on Alzheimer’s drug coverage (Feb. 2023)