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State Medicaid programs are required to cover all drugs approved by the US Food & Drug Administration (FDA), including those that have received accelerated approval from the FDA to treat serious or life-threatening illnesses such as HIV or cancer. These drugs with accelerated approval may be beneficial based on surrogate end points such as changes in imaging or blood test results, but they have not yet been shown to improve health outcomes or survival. Rachel Sachs, JD, MPH, of the Washington University in St. Louis School of Law speaks with JAMA Health Forum Editor, John Ayanian, and Deputy Editor, Melinda Buntin, about how utilization and spending for costly drugs with accelerated approval have grown in the Medicaid program nationally since 1992, representing 9% of all Medicaid drug spending for just 0.2% of all prescriptions in 2018.
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