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## ICER white paper explores policy options to improve accelerated approval pathway The Institute for Clinical and Economic Review (ICER) has published a white paper exploring policy options to strengthen the US FDA's accelerated approval pathway (AAP) for prescription drugs. The paper used expert input from patient groups, former regulators, payers, and life science companies to assess potential impact of several reform options aiming to address the balance between uncertainty, access, innovation, and costs. Some of these policy reforms would be accomplished through FDA actions and included among other: strengthening the selection of surrogate endpoints, requiring greater use of randomised controlled trials, and tying economic incentives to the completion of confirmatory trials. Other policy options explored would require a mix of actions across US payers, drug manufacturers, and federal policymakers; for example, increasing mandatory federal rebate levels until full approva is obtainedl, pricing at marginal cost until confirmatory evidence is reviewed, and requiring payment for AAP therapies be tied to outcomes-based contracts. Commenting on the white paper, President of ICER, Dr

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Publisher

Springer Science and Business Media LLC

Published

2021

Language

EN

Field

Economics, Econometrics and Finance (Health Sciences)