The Centers for Medicare & Medicaid Services (CMS) announced coverage plans June 1 for drugs that may slow the progression of Alzheimer’s disease once the medications get full approval from the Food and Drug Administration (FDA). Under the proposal, Medicare patients and prescribers will be required to participate in registries that collect real-world data.

“If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” CMS Administrator Chiquita Brooks-LaSure said in a statement. 

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee discussed the results of a confirmatory trial of Eisai’s product Leqembi on June 9. The committee advisors voted 6-0 that the data demonstrated a clinical benefit to patients.
 
According to CNBC, Eisai’s study of Leqembi found the drug slowed cognitive decline in early Alzheimer’s patients by 27%. However, it also carries serious risks of brain swelling and bleeding. During the study, 13% of patients who received Leqembi had swelling and 14% had bleeding.

A final decision on Leqembi by the FDA is expected to be made by July 7. Broader Medicare coverage would begin the same day the FDA grants traditional approval. Leqembi has a list price of $26,500 per year, making it possible for very few seniors to afford treatments. The Veterans Health Administration has, however, covered the cost for veterans.

Under CMS’ current coverage policy, if the FDA grants traditional approval to other drugs in this class, they would also be eligible for broader coverage. Currently, two drugs in this class – Leqembi and Biogen’s Aduhelm -- have received accelerated approval from the FDA, but no product has received traditional approval. 

Once approval is gained, clinicians will be required to submit evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval.

“This method, and any others that may follow, will adhere to robust privacy protections in accordance with applicable federal laws and regulations, including HIPAA,” the CMS announcement said. “Researchers will have access to the information to conduct studies, furthering knowledge of how these drugs can potentially help people. CMS is working with multiple organizations that are getting ready to open their own registries. More information will be released as it comes online.“

Other registries for drugs that may slow the progression of Alzheimer’s disease may become available in the coming weeks and months. Information will be available here.