The Centers for Medicare & Medicaid Services yesterday proposed that Medicare cover monoclonal antibodies that target amyloid to treat Alzheimer’s disease for beneficiaries enrolled in qualifying clinical trials. The Food and Drug Administration last June approved the first such Alzheimer’s treatment, Biogen’s Aduhelm (aducanumab), using its accelerated approval pathway. 

“This proposed National Coverage Determination is the result of robust evidence analysis conducted through a thorough review process that found while there may be the potential for promise with this treatment, there is also the potential for harm to patients,” said CMS Chief Medical Officer Lee Fleisher, M.D. “This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds.”

Under the proposed NCD, Medicare would cover the drug, related services and other routine costs, which may include PET scans if required by a trial protocol, CMS said. The agency will accept comments on the proposed NCD for 30 days.

Related News Articles

Headline
The AHA April 30 released a report highlighting how hospitals and health systems continue to experience significant financial headwinds that can challenge…
Headline
The Supreme Court April 29 ruled 7-2 in favor of the Department of Health and Human Services in a case that challenged how HHS applied Congress’ formula for…
News
The Centers for Medicare & Medicaid Services April 7 released finalized payment rates for calendar year 2026 Medicare Advantage and Part D plans. Payments…
Headline
The AHA today urged the Medicare Payment Advisory Commission to take specific actions on physician fee schedule payments following recommendations the…
Headline
The Centers for Medicare & Medicaid Services April 4 finalized changes to the Medicare Advantage and prescription drug programs for contract year 2026. The…
Chairperson's File
Public
Rural hospitals and health systems face big challenges, but together — with a unified voice — we can work to ensure people living in rural communities get the…