Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure announced how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare. If the Food and Drug Administration (FDA) grants traditional approval, then Medicare will cover it in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee will discuss the results of a confirmatory trial of the Eisai product Leqembi on June 9, with a potential decision on traditional approval possible within weeks. Broader Medicare coverage would begin on the same day the FDA grants traditional approval. Under CMS’ current coverage policy, if FDA grants traditional approval to other drugs in this class they would also be eligible for broader coverage. Currently two drugs in this class have received accelerated approval from the FDA, but no product has received traditional approval.
Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this evidence through a nationwide, CMS-facilitated portal that will be available when any product gains traditional approval and will collect information via an easy-to-use format. This method, and any others that may follow, will adhere to robust privacy protections in accordance with applicable federal laws and regulations, including HIPAA. 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 they come 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 at https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development as studies come online.