Biogen is urging CMS to reconsider a proposed guidance that would significantly limit coverage of its Alzheimer's drug Aduhelm.
The drugmaker, along with its partner Eisai, published an open letter to CMS about the coverage proposal Feb. 10. Under the current proposal, Medicare would only cover Aduhelm for patients in clinical trials, a move that would deny "almost all Medicare beneficiaries access to Aduhelm — the only FDA-approved treatment for Alzheimer's disease in nearly 20 years," Priya Singhal, MD, Biogen's head of research and development, wrote in the letter.
The restriction would also significantly limit and delay coverage for Aduhelm and future similar drugs and create a "major burden for providers, patients and CMS," Dr. Singhal added.
The drugmaker asked CMS to reverse its position and expand coverage of Aduhelm in accordance with its FDA-approved indications.
CMS is set to issue a final determination on Aduhelm coverage April 11.