Consumer advocates are up-in-arms over the announcement that Medicare premiums for physician and hospital outpatient services will increase by 15% in 2022, the result, in large part, of government uncertainty about whether it will have to pay for the Alzheimer's drug aducanumab (Aduhelm).
The $56,000-a-year infusion was approved by the US Food and Drug Administration (FDA) in June over the objections of its advisory committee.
The Centers for Medicare and Medicaid Services (CMS) announced the Medicare Part B monthly premium will increase from $148.50 in 2021 to $170.10 in 2022, in part because of requirements that it have "contingency reserves."
"There is significant uncertainty regarding the potential for future coverage of clinician-administered Alzheimer's drugs (i.e., Aduhelm), requiring additional contingency reserves," the agency added.
Michael Carome, MD, director of the Washington, DC-based advocacy organization Public Citizen's Health Research Group, said the announcement was disheartening.
"All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA's reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer's patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone," Carome said in a statement.
He added that CMS should "promptly announce that it will exclude aducanumab from coverage," until there was substantial evidence that the drug provided cognitive benefit.
The American Association of Retired Persons (AARP) noted that the premium increase was the largest-ever for the Part B program.
"Once again, American seniors and taxpayers will pay the price for the outrageous pricing behavior of big drug companies," Bill Sweeney, AARP senior vice president for government affairs, said in a statement. "When Big Pharma sets a high drug price, everyone pays for it — not just those who need the medications," he said.
Sales of aducanumab have not been anywhere near as robust as expected. In August it was reported that sales had been forecasted to hit $81 million in 2021 and $1.3 billion next year. However, Biogen reported revenues of $2 million in its second quarter ended June 30, and sales of $300,000 in its third quarter ended September 30.
The company said in its third quarter report that it "assumes minimal Aduhelm revenue in 2021" but that it is expecting revenue to increase in 2022.
Reuters also reported that Biogen was frequently providing aducanumab free of charge to clinics while it awaits Medicare's national decision on coverage. Some Medicare contractors are paying for the infusions in the meantime, Alzforum reports.
In another blow, it appears the drug will not be approved in Europe. As reported by Medscape Medical News, earlier this week the Committee for Medicinal Products for Human Use of the European Medicines Agency voted against approval of aducanumab at its November meeting, making it highly unlikely the drug will be recommended for approval at its December meeting.
Alicia Ault is a Lutherville, Maryland-based freelance journalist whose work has appeared in publications including JAMA, Smithsonian.com, the New York Times, and the Washington Post. You can find her on Twitter @aliciaault.
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Cite this: Aduhelm Draws More Fire as it Triggers Spike in Medicare Premiums - Medscape - Nov 19, 2021.