- Congressional committees are preparing to ask the Food and Drug Administration and Biogen tough questions about the approval and price of the Alzheimer's disease treatment Aduhelm, with two House committees preparing an investigation and growing numbers of key senators calling for hearings.
- Aduhelm's approval is expected to add tens of billions of dollars a year in spending by the federal Medicare program for the elderly, even though Biogen's clinical trial data are contradictory and, at best, show an only modest effect on Alzheimer's disease progression. The FDA approved it for a broad patient population and, for now, Medicare has no cost-control mechanism to only pay for use in those most likely to benefit.
- In approving Aduhelm, the FDA went against the recommendation of a panel of outside advisers that pointed to the mixed data Biogen presented as well as the failure of other drugs that work similarly. After approval, Biogen set an average price of $56,000 a year, far higher than what an influential nonprofit that reviews drug pricing said would be cost effective.
Aduhelm has already been infused into the first Alzheimer's patients post-approval, but Medicare hasn't readied any criteria for limiting eligibility. The FDA's approval, which applied to Alzheimer's patients broadly, didn't take into account the clinical trial population, which included only people with mild disease.
The price, the massive number of eligible patients and the FDA's unusually close relationship with Biogen in the review process will likely be raised in forthcoming investigations and, potentially, hearings, too.
In the House, the Oversight Committee and Energy and Commerce Committee, the latter of which has jurisdiction over Medicare and FDA, announced a joint investigation. In the Senate, Finance Committee Chair Ron Wyden, D-Ore., has called the price "unconscionable" and has been asked by committee members Elizabeth Warren, D-Mass., and Bill Cassidy, R-La., to convene hearings.
The repercussions have reached beyond hearings, with Sen. Joe Manchin, D-W. Va., recently indicating his opposition to Biden nominating Janet Woodcock, currently acting FDA commissioner and reportedly a frontrunner for the permanent appointment. Biden has not yet nominated a candidate for the important post.
Biogen estimated that between 1 to 2 million of the 6 million Alzheimer's patients in the U.S. would be eligible for Aduhelm based on the clinical trial criteria. If 1 million receive the drug, treatment could cost Medicare $57 billion a year, according to the Kaiser Family Foundation, a sum greater than the combined annual bill for all biologic drugs administered by healthcare professionals,
"If our assumptions around population size and uptake are fundamentally wrong, we stand ready to work with public and private payers to address pricing in order to achieve both patient access and support budget sustainability," a Biogen spokesperson said in an email to BioPharma Dive.
The U.S. Department of Health and Human Services, meanwhile, is convening a meeting of its Advisory Council on Alzheimer’s Research, Care, and Services on July 19 to "discuss the implications of and opportunities presented by the approval" of Aduhelm. That panel doesn't have the power to determine what patient groups should be eligible, however.
A National Coverage Determination on Aduhelm — one potential tool for shaping how Aduhelm is covered by federal health insurance — would be decided by the Medicare Evidence Development and Coverage Advisory Committee.