19 April 2022 - 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.

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