U.S. Docs Urge FDA To Junk Approval Of Expensive Drug vs Alzheimer's Disease

As Medicare officials grapple with whether to cover Biogen’s Aduhelm — an Alzheimer’s medication approved by federal regulators despite lack of evidence that the exorbitantly priced and potentially dangerous drug helps patients — many doctors are urging them not to, Kenny Stancil of Common Dreams wrote for Truthout.

Photo Insert: Aduhelm

Medicare plans to issue a preliminary decision this month on whether the federal health insurance program for US residents 65 and older will cover Aduhelm, a monoclonal antibody also known by its scientific name, aducanumab, The New York Times reported.

Following a public comment period, the high-stakes coverage decision is expected to be finalized by mid-April. Amid weak sales and on the same day that 18 scientists released a statement that slammed the FDA’s approval of Aduhelm as “indefensible in both scientific and clinical terms” and called for its immediate withdrawal from the market, Biogen on December 20 slashed the drug’s price.

The company is now charging $28,200 for an annual supply of infusions, which are administered monthly and necessitate regular MRI scans to monitor for potentially devastating side effects.

Following Biogen’s announcement, David Mitchell, the founder of Patients for Affordable Drugs, argued that “the 50% price cut for Aduhelm demonstrates how arbitrary drug prices are.” He added that there should be a corresponding roll back in Medicare’s planned premium increase.

“Please, please, please, do not cover this medicine,” Dr. James Castle, an Illinois neurologist who treats Alzheimer’s patients, wrote last July in the comment section of the Centers for Medicare and Medicaid Services (CMS) website. “Send a strong and clear message to the pharmaceutical industry that they need to show proof of both efficacy and safety before releasing their medicines on the market.”

The US Food and Drug Administration (FDA) has faced sharp criticism for approving Aduhelm in June even though clinical trials exposed serious safety risks — 41% of patients experienced brain bleeding or swelling — and failed to demonstrate that the drug benefits Alzheimer’s patients.

Three advisers resigned in protest. Regulators in the European Union on December 16 recommended against authorizing Aduhelm, and Canada’s leading Alzheimer’s research groups said last year that approving it “cannot be justified,” meaning that Medicare’s forthcoming decision could determine the drug’s fate.

James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, called the deliberations by CMS “truly unprecedented.” Sean Tunis, a former official with CMS who is now a senior fellow at the Tufts Medical Center, said that if Medicare denies coverage for Aduhelm, “it will be the first time ever that CMS has declined to pay for a drug that was approved by the FDA for its on-label indication.”

The looming coverage decision will also affect the financial well-being of Medicare and millions of seniors. In November, officials at CMS announced that one of the largest-ever increases in Medicare Part B premiums would be implemented in 2022 — due in large part to the possibility of covering Aduhelm, whose price tag at the time was $56,000 per year.

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