title: The lag from FDA approval to published cost-utility evidence.
abstract: 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.
authors.affiliation: Tufts Medical Center, Center for the Evaluation of Value and Risk in Health, 800 Washington Street #63, Boston, MA 02111, USA.
authors.forename: James D
authors.initials: JD
authors.lastname: Chambers
authors.forename: Teja
authors.initials: T
authors.lastname: Thorat
authors.forename: Junhee
authors.initials: J
authors.lastname: Pyo
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Neumann
mesh_terms: D003362:Cost-Benefit Analysis; D017277:Drug Approval / Q000191:economics / Q000706:statistics & numerical data*; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D004364:Pharmaceutical Preparations / Q000191:economics*; D012042:Registries; D012051:Reimbursement Mechanisms; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations
keywords: FDA approvals; cost–effectiveness; coverage and reimbursement; evidence-based medicine; pharmaceuticals