The Food and Drug Administration late Thursday granted full approval of the early Alzheimer’s drug Leqembi (lecanemab), opening up long-awaited broad Medicare coverage of the medication shown to slow cognitive decline.
“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,” Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure said in a statement Thursday. “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.”
Alzheimer’s patient advocates cheered the FDA’s move.
“This treatment, while not a cure, can give people in the early stages of Alzheimer’s more time to maintain their independence and do the things they love,” Joanne Pike, DrPH, Alzheimer’s Association president and CEO, said in a statement.
She added, “People living with this fatal disease deserve the opportunity to discuss and choose, with their doctor and family, whether an FDA-approved treatment is right for them.”
The green light ends a controversial chapter for the drug and its drug class, monoclonal antibodies that target amyloid brain plaques. While the drug, which was developed by Eisai and sold in partnership with Biogen, received fast-tracked approval from the FDA in January, CMS maintained highly restrictive coverage of it. CMS’ stance prompted an outcry from advocates such as the Alzheimer’s Association, which argued that CMS covers all FDA-approved drugs but those in this new drug class.
“CMS’s role is to provide healthcare coverage,” Pike said at the time. “Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate.”
CMS said earlier this year that it may reconsider its decision when new evidence of clinical benefit becomes available, or when a drug in the class receives traditional FDA approval based on clinical benefit.
In June, an FDA panel determined that new data supports traditional approval of Leqembi.
With full approval, a CMS-facilitated registry is open for clinicians. Last month, CMS released information about patient data that clinicians will be required to provide to ensure Medicare coverage when prescribing Leqembi.
