Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits.

ABSTRACT: Many state Medicaid officials are concerned about rising prescription drug spending, particularly drugs approved through the Food and Drug Administration's (FDA) accelerated approval pathway. The authors examined how much of Medicaid programs' accelerated approval spending is attributable to products that have demonstrated clinical benefits versus those that have not. Their findings provide support for states' concerns that pharmaceutical companies often fail to complete their required postapproval confirmatory studies within the FDA's requested timeline. But the findings also highlight one issue that policy stakeholders have not yet devoted substantial attention to: the use of surrogate endpoints involved in the postapproval confirmatory studies for most of the products in this study's sa

SUBMITTER: Sachs RE 

PROVIDER: S-EPMC9789165 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature