The US Food and Drug
Administration’s (FDA’s) accelerated Approval Program allows for expedited approval of drugs that treat serious conditions, and that fill an unmet medical need so long as they meet a surrogate endpoint.
Surrogate endpoints are markets or measures that are thought to predict clinical benefit, but are not themselves a measure of clinical benefit.
Richard Frank and coauthors hypothesize that positive confirmatory trials should increase the price of cancer drugs that were originally approved on the basis of limited evidence through the FDA’s accelerated approval process, as the efficacy of those drugs has now been demonstrated.
Yet, analyzing Medicare Part B data from 2012–2018, the authors find no price effect.
The authors indicate that this is a failure in the market that undermines a key economic incentive for drug companies to conduct and complete confirmatory trials for cancer drugs approved through the FDA’s accelerated pathway.
In their article, Frank and coauthors describe two pathways to remedying this situation.
This article is part of the Forefront series, produced with the support of Arnold
Ventures, on Medicare and Medicaid Integration.
Richard Hughes IV and Kala Shankle discuss how access to Paxlovid may be limited by a requirement that pharmacists access patient records and the absence of a pathway to reimbursement for the required patient assessment.
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