States seek to limit coverage of drugs approved through the FDA’s accelerated approval pathway designed to accelerate availability of medications that treat serious or life-threatening conditions.
Analysis of Medicaid spending from 2007 to 2018 shows:
- Accelerated approval drugs accounted for less than 1 percent of Medicaid spending consistently every year.
- Medicaid spending on accelerated approval drugs remained steady at 0.6-0.8 percent a year after 2012 passage of the Food and Drug Safety and Innovation Act, which encouraged accelerated approval use for rare and other serious conditions in addition to oncology and HIV/AIDS treatments.
- These data support preserving access to accelerated approval drugs for the seriously ill.
FULL WHITE PAPER: Quantifying Impact of Accelerated Approval Drugs on Medicaid Spending: De Minimus Impact, Maximum Attention
American Journal of Managed Care Commentary: Limiting Access to Accelerated Approval Drugs: Costs and Consequences
PRESS RELEASE: New Analysis of Medicaid Spending Reinforces Value and Patient Impact of FDA Accelerated Approval Pathway
Letter to MACPAC about Considerations on Accelerated Approval Drugs: The Partnership to Fight Chronic Disease and 32 other signed organizations share grave concerns about the potential recommendations MACPAC is considering that threaten to undermine access to medicines and continued innovation for individuals living with serious illnesses.
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