Two members of the US Senate Finance Committee on Thursday called for a hearing into the impact that the recent FDA approval of Biogen and Eisai's Alzheimer's disease therapy Aduhelm (aducanumab) will have, particularly on the Medicare programme. Bill Cassidy and Elizabeth Warren cautioned in a letter to Senate Finance Committee chairman Ron Wyden that "approval of the new product has dramatic implications for our health care system that stretch well beyond the scope of FDA's jurisdiction."
The FDA controversially granted accelerated approval to Aduhelm earlier this month, whilst also giving the anti-amyloid antibody, which has an annual price of $56,000, a broader label than expected. Cassidy and Warren noted in the letter that due to the lack of restrictions, the therapy "has a potential patient population exceeding 6 million Americans," adding that the agency "did not place limits on treatment duration suggesting that patients could remain on the drug indefinitely."
Recent estimates from the Kaiser Family Foundation suggested that the annual cost of Aduhelm for 1 million patients could top $57 billion in a single year, "far surpassing" current spending on all drugs covered by Medicare's Part B programme. "This level of potential new spending, particularly for just one product with limited evidence of clinical efficacy thus far, tests the programme's resiliency," Cassidy and Warren said.
"We thus urge you to convene a hearing to examine the vexing new questions and challenges that approval raises for the Medicare programme and other health programmes within the Senate Finance Committee's jurisdiction," Cassidy and Warren wrote.
The letter came the day after Biogen and Eisai indicated that they would consider adjusting the annual price of Aduhelm if it is prescribed to more people than anticipated. The companies also said they expect uptake to be "gradual," pointing out the drug has so far only been tested in patients who are in the early symptomatic stages of Alzheimer's disease with a confirmed presence of amyloid pathology, a population estimated to be between 1 million and 2 million people.
For related analysis, see Physician Views Results – Demand for Biogen’s Aduhelm set to be sky high.
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