Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017
Bibliographic Data
| ID | 15808299 |
|---|---|
| Authors | Joshua J Skydel (0000-0002-3527-4277, Dartmouth–Hitchcock Medical Center), Alexander C Egilman (0000-0002-5343-4908, Brigham and Women's Hospital), Joshua D Wallach (0000-0002-2816-6905), Reshma Ramachandran (0000-0003-3845-3606, Yale University), Ravi Gupta (0000-0003-2583-563X, University of Pennsylvania), James Stirling Ro (0000-0002-9218-3320, Yale New Haven Health System, corresponding author) |
| Year | 2022 |
| Volume | 3 |
| Issue | 5 |
| Pages | e221158-e221158 |
| Publication date | 2022-05-27 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | JAMA Health Forum (JOURNAL) |
| Journal identifiers | ISSN: 2689-0186 • E-ISSN: 2689-0186 |
| Publisher | American Medical Association (PUBLISHER • US) |
| DOI | 10.1001/jamahealthforum.2022.1158 |
| PMID | 35977252 |
| OpenAlex | W4281753215 |
| Language | EN |
| Citations received | 2 |
| References cited | 3 |
The findings of this cross-sectional study indicate that most of the drugs granted FDA accelerated approval for original indications from 2012 to 2017 lacked confirmatory trials evaluating clinical outcomes to support conversion to standard approval. Automatic coverage mandates produced substantial CMS spending for drugs with unproven clinical benefits
Authorization · Clinical trial · Drug · Drug approval · Environmental health · Family medicine · Food and drug administration · Health care · Marketing authorization · Medicaid · Orphan drug · Health Systems, Economic Evaluations, Quality of Life · Medicine · Pharmaceutical Economics and Policy · Pharmaceutical studies and practices · Internal Medicine · Pharmacology
| Citations per year | 2 |
|---|---|
| Citation span | 2025 - 2026 (2) |
| Highly cited | No |