CMS official on Alzheimer's drug coverage decision: Don't read between the lines for other accelerated approvals
Almost a week after finalizing its restrictive decision for amyloid-targeted Alzheimer’s drugs, the Centers for Medicare and Medicaid Services (CMS) now appears to be walking back the idea that this decision will have a ripple effect across other accelerated approvals.
The comments, made at a Duke-Margolis event Tuesday and covered by multiple media outlets, come as biopharma industry groups have warned in recent days that this CMS coverage decision could create a “dangerous precedent” for drugs approved under the accelerated pathway — even as CMS has always had the ability to apply its so-called Coverage with Evidence Determination, but never has actually required an additional randomized controlled trial.
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