title: Cost-effectiveness of recombinant activated factor VII in the treatment of intracerebral hemorrhage.
abstract: OBJECTIVE
  Intracerebral hemorrhage (ICH) is among the most costly and debilitating forms of stroke. Results from a recent Phase IIb clinical trial demonstrate that administration of recombinant activated factor VII (rFVIIa) reduces ICH mortality and improves functional outcome. In the current analysis, we examine the cost-effectiveness of early treatment with rFVIIa for ICH in the United States.
  
  
  METHODS
  A decision-analytic model was developed to estimate the lifetime costs and outcomes associated with rFVIIa treatment at doses of 40, 80 and 160 microg/kg compared with current standard of care in treating ICH, from a US third-party payer perspective. The patient population was similar to that of the Phase IIb clinical trial. Model structure and inputs were obtained from published literature, clinical trial data, claims databases, and expert opinion. All costs are presented in 2005 US dollars. Outcomes included incremental cost per life-year (LY) saved and incremental cost per quality-adjusted life-year (QALY) gained. Costs and outcomes were discounted at 3% annually. Univariate and multivariate sensitivity analyses were conducted to assess model robustness.
  
  
  RESULTS
  Compared with standard care, treatment with rFVIIa 40 microg/kg, and 160 microg/kg results in total lifetime cost-effectiveness ratios of 6308 dollars/QALY and 3152 dollars/QALY, respectively. Treatment with rFVIIa 80 microg/kg was found to be cost saving and a gain of 1.67 QALYs is achieved over a patient's lifetime. These results are robust to changes in input parameters.
  
  
  CONCLUSIONS
  Treatment of ICH with rFVIIa 40 microg/kg and 160 microg/kg appears to be cost-effective (<or=50,000 dollars/QALY). At the 80 microg/kg dose, rFVIIa was not only cost-effective, but also cost saving.
authors.affiliation: RTI Health Solutions, Research Triangle Park, NC, USA. searnshaw@rti.org
authors.forename: Stephanie R
authors.initials: SR
authors.lastname: Earnshaw
authors.forename: Ashish V
authors.initials: AV
authors.lastname: Joshi
authors.forename: Michele R
authors.initials: MR
authors.lastname: Wilson
authors.forename: Jonathan
authors.initials: J
authors.lastname: Rosand
mesh_terms: D000368:Aged; D002543:Cerebral Hemorrhage / Q000188:drug therapy* / Q000191:economics*; D003362:Cost-Benefit Analysis; D003661:Decision Support Techniques; D015942:Factor VIIa / Q000191:economics* / Q000627:therapeutic use*; D006801:Humans; D018803:Models, Economic
chemical_list: D015942:Factor VIIa