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

Document Type

Article

Publication Date

2022

Publication Title

Journal of Health Politics, Policy and Law

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 post-approval 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 post-approval confirmatory studies for most of the products in this study’s sample. The granularity of the study’s results enabled an analysis of the impact of different policy recommendations on both the accelerated approval pathway and Medicaid programs. These findings inform the current policy debate, suggesting that policy stakeholders might focus attention on products converting their approval on the basis of surrogate outcomes rather than on clinical outcomes.

Keywords

Medicaid, Food And Drug Administration, Accelerated Approval, Drug Pricing

Publication Citation

Rachel E. Sachs, Shelley A. Jazowski, Kyle A. Gavulic, Julie M. Donohue & Stacie B. Dusetzina, Medicaid and Accelerated Approval: Spending on Drugs with and without Proven Clinical Benefits, 47 J. Health Pol. Pol'y & L. 673 (2022)

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