title: Payer decision-making with limited comparative and cost effectiveness data: the case of new pharmacological treatments for gout.
abstract: BACKGROUND
  The need for comparative effectiveness (CE) data continues to grow, fuelled by market demand as well as health reform. There may be an assumption that new drugs result in improved efficacy compared with the standard of care, therefore warranting premium prices. Gout treatment has recently become controversial, as expensive new drugs enter the market with limited CE data.
  
  
  METHODS
  The authors reviewed published clinical trials and conducted a cost effectiveness analysis on a new drug (febuxostat) versus the standard (allopurinol) to illustrate the limitations in using these data to inform evidence-based decision-making.
  
  
  RESULTS
  Although febuxostat trials included allopurinol as a comparator, methodological limitations make comparative effectiveness evaluations difficult. However, when available trial data were input to a decision analytic model, the authors found that a significant reduction in febuxostat cost would be required in order for it to dominate allopurinol in cost effectiveness analysis. This case exemplifies the challenges of using clinical trial data in comparative and cost effectiveness analyses.
authors.affiliation: Department of Rheumatology, Jefferson Medical College, Philadelphia, PA 19107, USA.
authors.forename: Michele
authors.initials: M
authors.lastname: Meltzer
authors.forename: Laura T
authors.initials: LT
authors.lastname: Pizzi
authors.forename: Eric
authors.initials: E
authors.lastname: Jutkowitz
mesh_terms: D000493:Allopurinol / Q000191:economics* / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D003657:Decision Making; D003663:Decision Trees; D000069465:Febuxostat; D006073:Gout / Q000188:drug therapy* / Q000191:economics*; D006074:Gout Suppressants / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D013844:Thiazoles / Q000191:economics* / Q000627:therapeutic use*
chemical_list: D006074:Gout Suppressants; D013844:Thiazoles; D000069465:Febuxostat; D000493:Allopurinol