title: Quality of clinical and economic evidence in dossier formulary submissions.
abstract: OBJECTIVE
  To investigate the quality and completeness of clinical and economic data in dossiers submitted by drug companies to a health plan using Academy of Managed Care Pharmacy guidelines (the Format) for formulary submissions.
  
  
  METHODS
  We reviewed the quality of economic analyses in dossiers submitted to Premera Blue Cross Health Plan (Mountlake Terrace, Washington; enrollment 1.6 million) between January 2002 and September 2005. For dossiers submitted in 2003, we examined the clinical studies included.
  
  
  METHODS
  Dossiers were audited with a data collection form to judge the types of clinical studies used to support labeled and off-label indications, and the quality and transparency of economic analyses. We compared economic analyses for high-cost (30-day treatment cost > $1000) versus low-cost products, and for "innovative" versus "me-too" drugs.
  
  
  RESULTS
  Evidence to support off-label indications often was included in 2003 dossiers, but the information was less extensive and of poorer quality than data for labeled indications. Of 115 dossiers submitted between 2002 and 2005, 53 (46%) included economic analyses. The economic analyses had low levels of compliance with standards: only 43% performed sensitivity analysis; 38% stated the study perspective; 37% discussed relevant treatment alternatives; 20% stated assumptions clearly; and 18% mentioned caveats to conclusions. Economic analyses of high-cost products and innovative products had higher compliance with recommended practices.
  
  
  CONCLUSIONS
  Drug companies are submitting dossiers of evidence to formulary committees. Dossiers often included clinical data to support off-label indications, but concerns persist about their quality. About half of dossiers included economic analyses, but these analyses had relatively low levels of compliance with recommended practices.
authors.affiliation: Harvard School of Public Health, Boston, MA, USA.
authors.forename: Fernando
authors.initials: F
authors.lastname: Colmenero
authors.forename: Sean D
authors.initials: SD
authors.lastname: Sullivan
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Palmer
authors.forename: Carmen A
authors.initials: CA
authors.lastname: Brauer
authors.forename: Kathleen
authors.initials: K
authors.lastname: Bungay
authors.forename: John
authors.initials: J
authors.lastname: Watkins
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Neumann
mesh_terms: D003362:Cost-Benefit Analysis; D004341:Drug Evaluation; D004345:Drug Industry; D017850:Economics, Pharmaceutical; D019317:Evidence-Based Medicine; D005569:Formularies as Topic / Q000592:standards*; D019983:Guideline Adherence; D006801:Humans; D008329:Managed Care Programs; D014481:United States