The Veterans’ Health Administration (VHA) announced coverage of Esai’s LEQEMBI™ (lecanemab) for veterans with early stages of Alzheimer’s disease (AD), two months after the FDA approved LEQEMBI™ under the Accelerated Approval Pathway. This Pathway requires Eisai to continue phase IV testing to confirm its clinical benefit, and therapies under this pathway are not fully covered by the Centers for Medicare & Medicaid Services.
We reported on 5 March 2023 that the FDA accepted Eisai/Biogen’s sBLA and granted priority review for traditional approval of LEQEMBI™ for treatment of AD. On 27 February 2023 the companies announced that LEQEMBI™ was designated for Priority Review by the NMPA in China.