June 24, 2021

Warren, Cassidy Call for Hearing on New Alzheimer’s Disease Drug Aduhelm

Text of Letter (PDF)

Washington, DC – United States Senators Elizabeth Warren (D-Mass.) and Bill Cassidy, M.D. (R-La.), both members of the Senate Committee on Finance, called for a hearing to examine questions and challenges arising from the Food and Drug Administration’s (FDA) recent approval of Biogen’s Aduhelm, the first new drug approved to treat Alzheimer’s disease in nearly two decades. 

“This is a historic, watershed moment in the fight against Alzheimer’s disease, but approval of the new product has dramatic implications for our health care system that stretch well beyond the scope of FDA’s jurisdiction. We thus urge you to convene a hearing to examine the vexing new questions and challenges that approval raises for the Medicare program and other health programs within the Senate Finance Committee’s jurisdiction,” the senators wrote. 

Alzheimer’s is one of the country’s most costly diseases, with projections that it will cost the nation $355 billion in 2021 – including $239 billion in Medicare and Medicaid payments. At the same time, Aduhelm will bear a list price of $56,000 per year, and has a potential patient population exceeding six million Americans. Under the broad label the FDA approved, the drug is available to all Alzheimer’s patients, and the agency did not place limits on treatment duration suggesting that patients could remain on the drug indefinitely.

“We are troubled by reports that those factors could lead the drug to command ‘somewhere between’ the $37 billion we currently spend on Medicare Part B and the $90 billion we currently spend on Medicare Part D. This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the program’s resiliency,” wrote the senators.