Today, Rep. Frank Pallone, Jr., Chairman of the Committee on Energy and Commerce, and Rep. Carolyn B. Maloney, Chairwoman of the Committee on Oversight and Reform, issued the following statement announcing the Committees will examine the approval and pricing of Biogen Inc.’s Alzheimer’s drug, Aduhelm:
“We have serious concerns about the steep price of Biogen’s new Alzheimer’s drug Aduhelm and the process that led to its approval despite questions about the drug’s clinical benefit.
“We strongly support innovative treatments to help the millions of Americans who suffer from Alzheimer’s disease, but Aduhelm’s approval and its $56,000 annual price tag will have broader implications for seniors, providers, and taxpayers that warrant close examination.
“Our Committees will be investigating this matter so Congress and the American people can better understand why this drug was approved, how Biogen set its price and what impact this will have on research for future Alzheimer’s treatments and federal health care programs."
The Food and Drug Administration (FDA) granted Aduhelm an accelerated approval on the basis that it reduces amyloid beta plaques in the brain-the only one of 23 experimental drugs that have targeted this surrogate endpoint to gain approval.
On November 6, 2020, the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) unanimously recommended against approving Aduhelm to treat Alzheimer’s disease. Following FDA’s approval of Aduhelm in June, three PCNS members resigned in protest.
Although Biogen’s clinical trials for Aduhelm were only conducted on early-stage Alzheimer’s patients with mild cognitive impairment, Aduhelm’s label indicates the drug can be used broadly “for the treatment of Alzheimer’s disease."
Biogen has announced a list price of $56,000 per year for Aduhelm. At this price, the Kaiser Family Foundation estimates that Medicare could spend $57 billion or more per year on Aduhelm, which is more than Medicare Part B spends on all other drugs combined.
