title: Incremental cost-effectiveness pharmacoeconomic assessment of hepatitis C virus therapy: an approach for less wealthy members of the common market.
abstract: OBJECTIVE
  To develop a new method of health-economic analysis based on a marginal approach.
  
  
  METHODS
  We tested the research hypothesis that a detailed comparative a priori incremental cost-effectiveness analysis provides the necessary input for budget impact analysis about the proper order of introduction of new therapies, and thus maximizes the cost-effectiveness bounded by the total budget constraint. For the analysis we chose a combination therapy for the treatment of hepatitis C virus (HCV) genotype 1 (GT1) infection, which was approved by the European Medicine Agency in 2015. We used the incremental cost-effective approach to assess the increase in the percentage of patients achieving sustained virological response (SVR) and the expenditure per additional SVR modulated by the new therapy's market entrance dynamics. Patient subpopulations were differentiated by their response to previous treatment, presence of cirrhosis, and HCV GT1 subtype. Final parameters were estimated by Monte Carlo simulations.
  
  
  RESULTS
  The new combination therapy had high efficacy, shorter duration, and was better tolerated than alternative interventions. The research hypothesis was confirmed: gradual introduction of the new therapy on the market, based on a priori incremental cost-effectiveness analysis, would result in average increase in successfully treated patients by 20%-40%, while additional costs would approximately be between 8%-40%, ie, ?21000-52000 per additional patient achieving SVR.
  
  
  CONCLUSIONS
  We showed the new combination therapy to be cost-effective for certain patient subpopulations, especially for experienced cirrhotic HCV GT1 patients. Results of the analysis are in agreement with the latest recommendations for HCV patients' treatment in Croatia. This economic evaluation could serve as a starting point for negotiations between pharmaceutical industry and insurance companies.
authors.affiliation: Diana Mance, Department of Physics, University of Rijeka, Radmile Matejčić 2, 51000 Rijeka, Croatia, diana.mance@uniri.hr.
authors.forename: Diana
authors.initials: D
authors.lastname: Mance
authors.forename: Davor
authors.initials: D
authors.lastname: Mance
authors.forename: Dinko
authors.initials: D
authors.lastname: Vitezić
mesh_terms: D000998:Antiviral Agents / Q000008:administration & dosage / Q000191:economics* / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis / Q000379:methods*; D017523:Croatia; D004359:Drug Therapy, Combination; D017850:Economics, Pharmaceutical; D005062:European Union; D005838:Genotype; D016174:Hepacivirus / Q000235:genetics; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D008103:Liver Cirrhosis / Q000453:epidemiology; D008875:Middle Aged; D009010:Monte Carlo Method; D000072230:Sustained Virologic Response
chemical_list: D000998:Antiviral Agents