title: Estimating the economic benefits of positive shifts in fibromyalgia severity: an exploratory analysis based on modeling of clinical trial data of pregabalin.
abstract: OBJECTIVE
  To estimate the annualized differences in direct medical and indirect costs associated with improvement in fibromyalgia (FM) severity among pregabalin-treated patients.
  
  
  METHODS
  Data from three clinical trials of pregabalin in patients with FM were modeled; efficacy results were extrapolated. Mean annual costs (direct and indirect) were assigned based on FM severity levels (mild: $10,219; moderate: $26,217; severe: $42,456). FM severity levels were defined using established cut-points on the Fibromyalgia Impact Questionnaire (FIQ). Mean annualized costs at end-point were estimated for all patients within each cohort and the mean differences in costs were compared using a regression model.
  
  
  RESULTS
  Relative to placebo, there was a significantly higher proportion of subjects with mild FM at end-point with pregabalin 450 mg and a significantly lower proportion of subjects with severe FM. Mean total costs were lower with pregabalin (300 mg, $25,721; 450 mg, $24,103) than placebo ($26,162). The difference in mean annual costs was $2059 lower for pregabalin 450 mg (p = 0.003) and $441 lower for pregabalin 300 mg (p = 0.52). Mean direct medical costs were higher with pregabalin (300 mg, $4962; 450 mg, $4820) than placebo ($4364). The difference in mean annual direct medical costs was significantly higher for pregabalin 450 mg by $456 (p < 0.0001) and by $599 for pregabalin 300 mg (p < 0.0001). Mean indirect costs for pregabalin (300 mg, $20,783; 450 mg, $19,306) were lower than placebo ($21,735). The difference in mean annual indirect costs for pregabalin 450 mg was lower by $2429 (p < 0.0001); pregabalin 300 mg was lower by $951 (p = 0.12).
  
  
  CONCLUSIONS
  Use of 13-week end-point data from clinical trials to extrapolate to annual costs and an assumption of continuous therapy over the course of 1 year.
  
  
  CONCLUSIONS
  Improvements in FM severity were associated with overall reductions in cost. Reductions in indirect costs may offset the costs of treatment with pregabalin.
authors.affiliation: Pfizer Inc., Groton, CT , USA. joseph.c.cappelleri@pfizer.com
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Cappelleri
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Bushmakin
authors.forename: Gergana
authors.initials: G
authors.lastname: Zlateva
authors.forename: Arthi
authors.initials: A
authors.lastname: Chandran
mesh_terms: D000328:Adult; D000700:Analgesics / Q000191:economics* / Q000627:therapeutic use*; D003365:Costs and Cost Analysis; D005260:Female; D005356:Fibromyalgia / Q000188:drug therapy* / Q000503:physiopathology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D000069583:Pregabalin; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000191:economics / Q000627:therapeutic use
chemical_list: D000700:Analgesics; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid