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.
PATIENT VOICES: Faces of Accelerated Approval
- FDA's Expedited Programs: Getting Essential New Treatments to Patients
- What Experts Say About FDA's Expedited Programs
Patents and Accelerated Approval for Drugs
When it comes to saving a buck, rare and chronic disease patients are too often put on the chopping block. Accelerated approval drugs are key to treating life threatening diseases. So why is Medicaid and CHIP Payment and Access Commission (MACPAC) targeting these lifesaving treatments? Dr. Ken Thorpe of the Partnership to Fight Chronic Disease and rare disease advocate Marc Yale join the Patients Rising podcast to explain why this attempt at cost savings hurts patients. Plus, Terry and Dr. Bob look at the debate around waiving vaccine patents and alternative solutions to combating COVID-19.
This is Growing Old by the Alliance for Aging Research - Episode 27
Alliance for Aging Research President and CEO Sue Peschin interviews Ken Thorpe, the Robert W. Woodruff Professor and Chair of the Department of Health Policy & Management in the Rollins School of Public Health of Emory University, and Chair of the Partnership to Fight Chronic Disease, an organization that does incredible work to raise awareness of the impact of chronic disease on death, disability, and rising healthcare costs.