title: Assessing the Quality of Economic Evaluations of FDA Novel Drug Approvals: A Systematic Review.
abstract: To systematically review and assess the quality of the novel drugs' economic evaluation literature in print during the drugs' early commercial availability following US regulatory approval.
  
  
  
  MEDLINE and the United Kingdom National Health Service Economic Evaluation Database were searched from 1946 through December 2011 for economic evaluations of the 50 novel drugs approved by the FDA in 2008 and 2009.
  
  
  
  The inclusion criteria were English-language, peer-reviewed, original economic evaluations (cost-utility, cost-effectiveness, cost-minimization, and cost-benefit analyses). We extracted and analyzed data from 36 articles considering 19 of the 50 drugs. Two reviewers assessed each publication's quality using the Quality of Health Economic Studies (QHES) instrument and summarized study quality on a 100-point scale.
  
  
  
  Study quality had a mean of 70.0 ± 16.2 QHES points. The only study characteristics associated with QHES score (with P < 0.05) were having used modeling or advanced statistics, 75.1 versus 61.9 without; using quality-adjusted life years as an outcome, 75.9 versus 64.7 without; and cost-utility versus cost-minimization analysis, 75.9 versus 58.7. Studies most often satisfied quality aspects about stating study design choices and least often satisfied aspects about justifying design choices.
  
  
  
  The reviewed literature considered a minority of the 2008-2009 novel drugs and had mixed study quality. Cost-effectiveness stakeholders might benefit from efforts to improve the quality and quantity of literature examining novel drugs. Editors and reviewers may support quality improvement by stringently imposing economic evaluation guidelines about justifying study design choices.
authors.affiliation: University of Washington, Seattle, WA, USA awoersch@uw.edu.
authors.forename: Alex L
authors.initials: AL
authors.lastname: Woersching
authors.affiliation: University of New Mexico, Albuquerque, NM, USA.
authors.forename: Matthew E
authors.initials: ME
authors.lastname: Borrego
authors.affiliation: University of New Mexico, Albuquerque, NM, USA.
authors.forename: Dennis W
authors.initials: DW
authors.lastname: Raisch
mesh_terms: D003362:Cost-Benefit Analysis; D016208:Databases, Factual; D017277:Drug Approval / Q000706:statistics & numerical data; D015507:Drugs, Investigational / Q000191:economics* / Q000627:therapeutic use; D017850:Economics, Pharmaceutical; D006801:Humans; D019057:Quality-Adjusted Life Years; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015507:Drugs, Investigational
keywords: FDA issues; cost-effectiveness; drug development and approval; formulary; pharmacoeconomics