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 – many cancers, HIV/AIDS, sickle cell and several other rare diseases.
A new national and state analysis of Medicaid spending from 2007 to 2020 shows:
- From 2007 to 2020, accelerated approval medicines accounted for well under one percent of total Medicaid spending, not including drug rebates.
- At the national level, spending on accelerated approval drugs also accounted for just 0.5% of overall growth in national Medicaid spending between 2007 and 2020. Hospital spending (30%) and physician and clinical services (15.4%) were the primary drivers of growth. After accounting for drug rebates, retail prescription drugs accounted for 5.0% of growth.
- Accelerated approval drugs accounted for less than 1% of the growth in Medicaid spending in 48 states and the District of Columbia. Only Alabama (1.3%) and South Dakota (2.1%) were slightly higher.
- In states requesting Medicaid waivers due to cost concerns, 2020 spending data shows accelerated approval drug spend is miniscule - Massachusetts (0.1%), Tennessee (0.4%) and Oregon (0.1%).
These data support preserving access to accelerated approval drugs for the seriously ill.
FULL WHITE PAPERS:
May 2022 - Quantifying Impact of Accelerated Approval Drugs on Medicaid Spending: An Update through 2020 and State-Level Analysis
March 2021 - Quantifying Impact of Accelerated Approval Drugs on Medicaid Spending: De Minimus Impact, Maximum Attention
6/3/22 – Health Affairs Forefront: Accelerated Approval Drugs Are Not Driving Medicaid Spending
3/30/21 - American Journal of Managed Care: Limiting Access to Accelerated Approval Drugs: Costs and Consequences
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.
Accelerated Approval 101
Accelerated Approval: Getting Essential New Treatments to Patients
PATIENT VOICES: Faces of Accelerated Approval
- Patient-Centered Principles: Accelerated Approval
- Infographic: Accelerated Approval Drugs Do Not Drive Medicaid Spending
- FDA's Expedited Programs: Getting Essential New Treatments to Patients
- What Experts Say About FDA's Expedited Programs
- 6/3/22 - New Analysis Finds Accelerated Approval Drugs Do Not Drive Medicaid Spending
- 3/30/21 - New Analysis of Medicaid Spending Reinforces Value and Patient Impact of FDA Accelerated Approval Pathway
10/20/21 - FDA's Accelerated Approval Pathway: Separating Fact from Fiction - Pat Furlong, Annie Kennedy & Ken Thorpe
5/3/21 - Curtailing Medicaid coverage of accelerated approval therapies threatens patients' access - Terry Wilcox & Teonna Woolford
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.