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Medicare’s decision not to fund Aduhelm changes landscape for US pharma industry

BMJ 2022; 377 doi: (Published 19 April 2022) Cite this as: BMJ 2022;377:o996
  1. Owen Dyer
  1. Montreal

The decision by the agency responsible for Medicare to restrict coverage of Biogen’s Alzheimer’s drug aducanumab (Aduhelm) to patients enrolled in randomised controlled trials has soured the industry’s view of the accelerated approval process, in which drugs that are deemed urgent are approved faster by lowering the bar of evidence.

Patients taking Aduhelm in a randomised controlled trial cannot be billed as they might be receiving placebo, hence the decision also sounds the commercial death knell of a drug that six months ago was considered a threat to the financial viability of Medicare, costing $56 000 a year for each of up to six million patients.

The decision by the Centers for Medicare and Medicaid Services (CMS) to refuse broad coverage of a drug approved by the FDA last June1 was unprecedented, prompting the two agencies’ leaders to publish a joint statement of solidarity.

“The work of both of our agencies is critical,” wrote CMS …

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