The Lag From FDA Approval to Published Cost-Utility Evidence

Expert Rev Pharmacoecon Outcomes Res. 2015 Jun;15(3):399-402. doi: 10.1586/14737167.2015.1001371. Epub 2015 Jan 12.


The lag between FDA approval and publication of cost-utility evidence can hamper payers from accounting for value for money in coverage and reimbursement decisions. We examine this gap, and whether it has changed over time. For drugs approved from 2000 to 2010 (n = 274), we searched the Tufts Medical Center Cost-Effectiveness Analysis Registry to identify relevant cost-utility analyses (CUAs). We identified 127 (46%) drugs associated with a CUA, 62 of which had a CUA published in the 3 years following its approval. Compared with drugs approved from 2000 to 2003, a greater proportion of those approved from 2004 to 2006, and from 2007 to 2010, was associated with a CUA published in the 3 years following approval (13 vs 25% [p = 0.06] and 13 vs 32% [p < 0.01], respectively). Study findings indicate that payers now have slightly more rapid access to published CUAs.

Keywords: FDA approvals; cost–effectiveness; coverage and reimbursement; evidence-based medicine; pharmaceuticals.

MeSH terms

  • Cost-Benefit Analysis
  • Drug Approval / economics
  • Drug Approval / statistics & numerical data*
  • Humans
  • Insurance, Health, Reimbursement / economics*
  • Pharmaceutical Preparations / economics*
  • Registries
  • Reimbursement Mechanisms
  • Time Factors
  • United States
  • United States Food and Drug Administration


  • Pharmaceutical Preparations