CEVR and FDA Experts Discuss Medicare’s Options Regarding Aduhelm Coverage

The Food and Drug Administration recently approved Biogen’s new therapy for use in Alzheimer’s disease, Aduhelm. However, Medicare’s decision to cover the drug remains uncertain. Drs. James Chambers, Pei-Jung Lin, Peter Neumann, and Sean Tunis of the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center share their thoughts on the paths available to the Centers for Medicare and Medicaid (CMS).

The authors remark, “Aducanumab’s approval has thrust Medicare into the unenviable position of determining appropriate access in the face of highly uncertain evidence and huge potential costs. Given questions regarding aducanumab’s efficacy, side effects, and budget impact, the Medicare program and its beneficiaries would be best served if CMS pursued an NCD [national coverage determination] for aducanumab,” adding, “It would be wise for the agency to consider CED [coverage with evidence development] to collect data for all treated patients in a new clinical study or a patient registry.” Read more here.

(Source: Chambers et al., Health Affairs, 6/30/21)