Leqembi works to clear plaques of protein, called amyloid, in the brain.
It was previously given accelerated approval in January, based on data showing it could moderately slow cognitive decline in early stage Alzheimer’s patients.
The FDA panel meeting Friday is likely to recommend full approval, and the agency has a deadline of July 6 to make a determination. The FDA doesn’t have to follow the panel’s recommendation, but it usually does.
FDA staff in a briefing document were largely positive about the drug and indicated that data from a clinical trial supported Leqembi’s clinical benefit to patients.
Full approvals require more clinical evidence than accelerated approvals. There are also safety concerns — the positive review is tempered by a type of brain swelling or bleeding that is associated with these types of drugs. Critics have said the small benefits to some patients are insignificant compared to the risk.
The FDA doesn’t take price into consideration, but the cost is looming, and the agency’s decision is crucial for Medicare coverage.
The twice-a-month infusion costs $26,500 a year, and the Centers for Medicare and Medicaid Services (CMS) has said it won’t pay for any anti-amyloid drugs until they are fully approved.
The agency wants more data before changing its stance. CMS published its coverage rules last year in response to the controversy surrounding Leqembi’s predecessor, Aduhelm.
But according to Sen. Bernie Sanders (I-Vt.), the price tag is a major problem regardless of Medicare coverage.
Sanders said in a letter the price tag is “unconscionable” and urged the Department of Health and Human Services to use its authority to break Leqembi’s patent monopoly if Eisai, which developed the drug, and Biogen, which is manufacturing it, refuse to lower the price.
But Eisai has said the $26,500 annual list price for Leqembi is lower than the company’s estimate of the $37,600 total value of the drug for each patient.
According to the Kaiser Family Foundation, if only 10 percent of the 6.7 million older adults with Alzheimer’s disease take Leqembi, it would cost Medicare $17.8 billion, which is nearly half of what Medicare Part B spent on all drugs in 2021.
