Centers for Medicare & Medicaid: Broader Medicare Coverage of Leqembi Available Following FDA Traditional Approval

BALTIMORE, Maryland, July 7 (TNStalk) -- The U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services issued the following statement on July 6, 2023:

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Broader Medicare coverage is now available for Biogen and Eisai's Leqembi (the brand name for lecanemab) following the Food and Drug Administration's (FDA) move to grant traditional approval to the drug that treats individuals with Alzheimer's disease. The Centers for Medicare & Medicaid Services had previously announced this would be the case and released more details on coverage today.

"CMS today affirms our commitment to help people with Alzheimer's disease have timely access to innovative treatments that may lead to improved care and better outcomes," said CMS Administrator Chiquita Brooks-LaSure. "With FDA's decision, CMS will cover this medication broadly while continuing to gather data that will help us understand how the drug works. This is welcome news for the millions of people in this country and their families who are affected by this debilitating disease."

Now that the FDA has granted traditional approval, a CMS-facilitated registry is open for clinicians to access here (https://qualitynet.cms.gov/alzheimers-ced-registry). Additional background information is available for providers here (https://qualitynet.cms.gov/files/64a7151bd15911001c695b32?filename=Provider%20Factsheet%20Alzheimers%20Treatment.pdf), and for patients here (https://qualitynet.cms.gov/files/64a7152ed15911001c695b35?filename=Consumer%20Factsheet%20Alzheimers%20Treatment.pdf) and on medicare.gov.

To receive Medicare coverage, people will need to: 1) be enrolled in Medicare, 2) be diagnosed with mild cognitive impairment or mild Alzheimer's disease dementia, with documented evidence of beta-amyloid plaque on the brain, and 3) have a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care. Clinicians participating in the registry will only need to complete a short, easy-to-use data submission. Individuals with Medicare should speak to their physician about whether this drug is right for them.

Individuals with Original Medicare will pay the standard 20% coinsurance of the Medicare-approved amount for Leqembi once they meet their Part B deductible. Costs may be different for people with Medicare supplemental coverage (like a Medigap plan) or other secondary insurance, or those enrolled in a Medicare Advantage plan. Individuals should contact their plan for more specific cost information.

Consistent with CMS' National Coverage Determination, Medicare is covering this drug 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. Registries are common tools in clinical settings that have successfully gathered information on patient outcomes for decades. The CMS-facilitated registry is easy to use and adheres to robust privacy and security protections in accordance with applicable federal laws and regulations, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA).

Researchers will have access to the information to conduct studies intended to further the knowledge of how these drugs can help people with Medicare by answering the research questions outlined in the National Coverage Determination.

Other registries may become available in the coming months and will be posted on CMS' website. Physicians can select the study that works the best for them from the list of studies that will be available at https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-Development.

Under the Medicare National Coverage Determination, if FDA grants traditional approval to other drugs in this class, Medicare will cover them using this same coverage framework.

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Original text here: https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval