Now that Biogen and Eisai’s Leqembi (lecanemab) has received the U.S. Food and Drug Administration’s formal approval for the treatment of Alzheimer’s, the Centers for Medicare and Medicaid Services is moving forward with its promise to cover the drug. 

In a July 6 announcement, CMS shared that coverage is officially available for Leqembi for those who meet certain criteria. To obtain coverage, individuals must be enrolled in Medicare, have a diagnosis of cognitive decline or Alzheimer’s with documented evidence of beta-amyloid plaque on the brain, and be under the treatment of a physician who participates in a qualifying registry that collects real-world data on the treatments' effectiveness. 

“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.” 

Although out-of-pocket costs could vary based on whether an individual carries supplemental or secondary insurance, CMS indicates that those with traditional Medicare plans will pay the standard 20% coinsurance of the Medicare-approved amount for the drug once they have met their Part B deductible. 

Researchers will have access to the CMS-facilitated registry that providers prescribing the drug will be participating in as a means of tracking patients’ progress and identifying any adverse events. CMS indicates that additional registries of ongoing studies will become available in the coming months and that physicians will be able to choose a study they feel is most appropriate to submit their data to. 

The clinician registry can be found here.