In a first, CMS will test paying less for drugs cleared via accelerated approval
The Centers for Medicare and Medicaid Services said Tuesday afternoon that it will start testing a program to pay drugmakers less for drugs approved via the FDA’s accelerated pathway, as a way to incentivize swifter confirmatory trials.
The move represents a big shift in CMS and the federal government’s thinking. Pharma companies sometimes drag their feet on these confirmatory trials, knowing that patients and payers are still paying full price even without the complete set of clinical evidence the agency typically requires for a full approval. Congress and President Joe Biden also recently signed off on new authority for the FDA to begin requiring these confirmatory trials to begin prior to the approval.
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