Medicare To Use ‘Coverage With Evidence Development’ To Ensure Availability Of New Alzheimer’s Drugs

On June 1, 2023, the Centers for Medicare & Medicaid Services (CMS) said it plans to use the Medicare “coverage with evidence development” (CED) policy for medications approved by the U.S. Food and Drug Administration (FDA) to slow progression of Alzheimer’s disease. The CED policy requires that beneficiaries taking such drugs must participate in registries that collect information on treatment results.

This policy affects Aduhelm (aducanumab) and Leqembi, (lecanemab) both manufactured by Eisai Co., Ltd. and Biogen Inc. (Biogen/Eisai). Both medications had initially been approved under an FDA emergency use authorization (EUA). On June 9, 2023, the . . .