The Food and Drug Administration’s accelerated approval pathway enables expedited access to drugs that address an unmet need for serious and life-threatening diseases and conditions. Milliman analyzed the demographic characteristics of Medicaid beneficiaries who utilized accelerated-approval drugs in 2018 and 2019, using data from the Transformed Medicaid Statistical Information System. Overall, we found:

• Accelerated approval drug utilizers were more likely to be older and commonly eligible for Medicaid based on their disability status. 
• A higher proportion of Black and Asian beneficiaries using accelerated approval drugs than for all other drug utilizers.

This report was commissioned by PhRMA.