Mass General Brigham (MGB) is aware of interest in lecanemab (Leqembi™), which received accelerated approval by the FDA on January 6, 2023 for the treatment of Alzheimer disease in patients with mild cognitive impairment or mild dementia. Accelerated approval was based on reduction in amyloid beta plaques observed in patients treated with lecanemab.
The FDA is required to decide by July 6, 2023 on full approval of lecanemab based on clinical benefit. The results of a Phase 3 randomized, controlled clinical trial to confirm lecanemab's clinical benefit have recently been reported.
The Centers for Medicare & Medicaid Services plan to review lecanemab to determine whether Medicare will cover the cost of this medication.
A second medication in the same class, donanemab, has more recently also been reported to slow progression of disease. Donanemab data have not yet been presented in full to the public or the FDA.
All drugs used within the MGB system are subject to review by the MGB Pharmacy & Therapeutics Committee that is charged with evaluating and providing recommendations for the use of medications. The evaluation includes a review of clinical, economic, and operational considerations. This process, with the goal of ensuring safe and cost-effective use of medications within MGB, is expected to take up to several months for FDA-approved medications. Additional information will be provided when it becomes available.
The MGB team will provide updates about lecanemab and donanemab on this website as soon as we learn more details about the status of full FDA approval and Medicare’s decisions about reimbursement.