Medicare will provide broader coverage of Leqembi, a drug that has been shown to slow the progression of Alzheimer's disease, now that the drug has received full FDA approval.
The FDA approved Eisai and Biogen's medication targeting amyloid plaques in the brain June 6. In a news release, CMS said it would cover the drugs for Medicare patients under certain conditions.
The agency had previously only covered Leqembi and other drugs to treat Alzheimer's disease for patients in clinical trials.
"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," CMS Administrator Chiquita Brooks-LaSure said.
Here are five things to know about how the program will approach the Alzheimer's drug:
- To receive Medicare coverage of Leqembi, patients must be diagnosed with mild cognitive impairment or mild Alzheimer’s disease dementia and have documented evidence of beta-amyloid plaque on the brain.
- Providers prescribing the drug to Medicare patients will participate in a registry to "collect evidence about how these drugs work in the real world." Physician participation is also a requisite for Medicare coverage of the drug.
- Individuals with fee-for-service Medicare will pay 20 percent coinsurance for the drug after their part D deductible is met. Costs will vary by plan for individuals with Medigap or Medicare Advantage plans, CMS said.
- A year's supply of Leqembi costs $26,500. Researchers at University of California, Los Angeles estimated Leqembi could cost Medicare $2 billion to $5 billion annually.
- If the FDA grants approval to other drugs in Leqembi's class, CMS will use the same policies to cover them, according to the news release.