Medicare Part B will cover future drug treatments for Alzheimer’s disease that the U.S. Food and Drug Administration approves, the federal government announced this week.
When the FDA grants traditional approval to a drug, Medicare will cover such treatments “in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs for people with Medicare,” according to the announcement from the Centers for Medicare & Medicaid Services (CMS).
In other words, a health care provider must agree to collect information about how an Alzheimer’s drug works “in the real world” for it to become eligible for Medicare coverage. CMS will provide a secure online portal for providers to report this information.
In the announcement, Chiquita Brooks-LaSure, CMS administrator, says:
“If the FDA grants traditional approval CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered. I’m pleased to make this announcement today as part of CMS’ mission to help improve the lives of Americans we serve. I hope we see more private sector partners in this work making their own announcements soon.”
Part B is the component of Medicare that covers outpatient care, while Part A covers hospital care.
On June 9, an FDA advisory committee will discuss results of a trial for Leqembi, a new drug from Eisai that attempts to slow the progression of Alzheimer’s early in the disease. The FDA, which already has granted accelerated approval for Leqembi, could announce a decision about whether to grant traditional approval for the drug “within weeks” of that meeting, CMS says.
If Leqembi receives traditional approval, broader Medicare coverage would begin the same day.
To date, no drugs like Leqembi have received traditional approval from the FDA.
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