June 25 (Reuters) – U.S. lawmakers on Friday announced an investigation into the approval and pricing of Biogen Inc’s (BIIB.O) Alzheimer’s drug, Aduhelm, amid concerns over its high price and doubts whether the clinical evidence proves that the drug works.
The drug, which has a list price of $ 56,000 per year, was approved by US regulators as the first treatment to attack a probable cause of Alzheimer’s disease on June 7.
“We have serious concerns about the high price of Biogen Aduhelm’s new Alzheimer’s disease drug and the process that led to its approval despite questions about the drug’s clinical benefits,” said the House Committee on Oversight and Reform in a press release.
The inquiry was announced by Representative Carolyn Maloney, Chair of the Oversight and Reform Committee, and Representative Frank Pallone, Jr., Chair of the Energy and Trade Committee.
Biogen said it “will of course cooperate with any inquiries we may receive from these committees,” in response to a request for comment from Reuters.
At $ 56,000 per year, the Kaiser Family Foundation estimates Medicare could spend $ 57 billion or more per year on Aduhelm, which is more than Medicare Part B spends on all other drugs combined, the House committee said. .
Health insurers and the Medicare program will bear most of the cost of the drug, the price of which will vary based on dosage and discounts.
The Food and Drug Administration (FDA) has approved the drug – despite strong objection from its own expert advisory group – for all patients with Alzheimer’s disease, although it has only been tested for patients in the early stages of the disease.
Three of the 11 members of the FDA’s independent advisory committee have resigned in protest against the agency’s decision. Read more
Shares of the drugmaker fell nearly 1% in aftermarket.
Reporting by Dania Nadeem in Bengaluru; Editing by Arun Koyyur
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