In the wake of the US Centers for Medicare & Medicaid Services’ limited coverage decision for Biogen, Inc./Eisai Co., Ltd.’s Aduhelm, sponsors have been seeking assurances that CMS’ policy not to cover the Alzheimer’s therapy outside of clinical trials – in essence nullifying the US Food & Drug Administration’s Accelerated Approval action in 2021 – was a rare, one-off decision.
That is certainly the message that CMS has been sending ever since that controversial decision was made, most recently at the Duke-Margolis health policy conference, where both CMS and FDA officials strove to present the Aduhelm debate as an outlier – and a learning opportunity for both agencies on the benefits of a “parallel conversation” on data requirements