Chapter 1 looks at high-cost specialty drugs, which are increasingly driving Medicaid spending and creating financial pressure for states. The U.S. Food and Drug Administration (FDA) is approving more products through its accelerated approval pathway that allows drugs to come to market faster than under the traditional process. States have expressed concern about paying high list prices when these products do not have a verified clinical benefit. MACPAC’s work has been focused on how to address states’ concerns about the high and growing costs associated with specialty drugs, as well as how to ensure that beneficiaries who could benefit from these new therapies still have access to them.
The Commission recommends that Congress increase the minimum rebate percentage on drugs approved FDA through the accelerated approval pathway until the manufacturer has verified the clinical benefit. The Commission also recommends an increase in the additional inflationary rebate on drugs that receive approval from the FDA through the accelerated approval pathway. Once the FDA grants traditional approval, the Medicaid rebates would revert back to the standard amounts.
From: June 2021 Report to Congress on Medicaid and CHIP