Commercial Health Plan and Enrollee Out-of-Pocket Spending on Accelerated Approval Products in 2019

Author:

Jazowski Shelley A.1,Vaidya Avi U.1,Donohue Julie M.2,Dusetzina Stacie B.13,Sachs Rachel E.4

Affiliation:

1. Department of Health Policy, Vanderbilt University School of Medicine, Nashville, Tennessee

2. Department of Health Policy and Management, University of Pittsburgh School of Public Health, Pittsburgh, Pennsylvania

3. Vanderbilt-Ingram Cancer Center, Nashville, Tennessee

4. Washington University in St Louis School of Law, St Louis, Missouri

Abstract

This cross-sectional study examines spending by health care plans and enrollees on products with accelerated approval.

Publisher

American Medical Association (AMA)

Subject

Internal Medicine

Reference6 articles.

1. Medicaid and accelerated approval: spending on drugs with and without proven clinical benefits.;Sachs;J Health Polit Policy Law,2022

2. Medicare spending on drugs with accelerated approval.;Ballreich;Ann Intern Med,2022

3. Therapeutic value of drugs granted accelerated approval or conditional marketing authorization in the US and Europe from 2007 to 2021.;Vokinger;JAMA Health Forum,2022

4. Reforming reimbursement for the US Food and Drug Administration’s accelerated approval program to support state Medicaid programs.;Sachs;JAMA Health Forum,2022

5. US Dept of Health & Human Services Office of Inspector General. Delays in confirmatory trials for drug applications granted FDA’s accelerated approval raise concerns. OEI-01-21-00401. September 29, 2022. Accessed March 8, 2023. https://oig.hhs.gov/oei/reports/OEI-01-21-00401.asp

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