Medicare Coverage of Alzheimer’s Drugs Relies on FDA Traditional Approval

The Centers for Medicare and Medicaid Services (CMS) has announced that it will provide Medicare coverage for new Alzheimer’s drugs if they receive traditional approval from the Food and Drug Administration (FDA).

“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does. CMS has always been committed to helping people obtain timely access to innovative treatments that meaningfully improve care and outcomes for this disease,” CMS Administrator Chiquita Brooks-LaSure said in the press release.

“If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. 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.”

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will review the result of a confirmatory trial of Eisai’s Leqembi on June 9 and potentially grant traditional approval within weeks. Medicare coverage would start the same day the federal agency gives traditional approval.

The broader coverage policy will also apply to other drugs in the same class if FDA grants traditional approval. FDA granted accelerated approval to Leqembi in January 2023, marking the second accelerated approval of a drug in the class. However, none of the drugs have received traditional approval.

The coverage policy states that Medicare will cover drugs with traditional FDA approval when a physician and clinical team participate in collecting evidence on how the drugs work in the real world, known as a registry.

Registries have historically helped gather information on patient outcomes and newly approved treatment, including the transcatheter aortic valve replacement (TAVR), the press release noted.

Clinicians can submit the data through a nationwide portal run by CMS that will be available when a drug gains traditional approval. Researchers can then use the data to conduct studies and improve their understanding of how the drugs can potentially benefit people.

The process will adhere to privacy protections that follow federal laws and regulations, including HIPAA, CMS said. The agency is working with organizations preparing to open their own registries.

The coverage policy aligns with the CMS national coverage determination process. To be eligible for Medicare coverage, individuals must be enrolled in Medicare Part B, be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s disease, and have a qualified physician participating in a registry with an appropriate clinical team and follow-up care.