Biogen Submits Response to the Centers for Medicare and Medicaid Services (CMS) Proposed National Coverage Determination (NCD) for Anti-Amyloid Treatments in Alzheimer's Disease

Biogen, Inc. (Biogen) appreciates the opportunity to comment on the proposed national coverage determination (NCD) for monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease (CAG-00460N).1

The introduction of amyloid-directed monoclonal antibody therapies (mAbs) heralds a new, exciting era for the Alzheimer's disease community. The Food and Drug Administration's (FDA's) approval of ADUHELM (aducanumab-avwa) is the first approval in almost two decades of a new treatment for Alzheimer's disease. ADUHELM provides a first-ever option to treat the underlying pathology of this disease, and we are committed to constructively engaging with the Centers for Medicare & Medicaid Services (CMS) to ensure appropriate access for patients to this novel FDA-approved therapy and others that may follow. As is the case with any new medical innovation, we agree that ongoing data generation should continue to characterize the benefit-risk profile for this class of therapies. Specifically, we agree that there is a need for large scale real-world data generation to answer questions about efficacy and safety of amyloid-directed mAbs outside of a randomized controlled trial (RCT).

Contact:

Phone: [phone]

WEB: www.biogen.com

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