title: Health Economic Evaluations of Sofosbuvir for Treatment of Chronic Hepatitis C: a Systematic Review.
abstract: OBJECTIVE
  The approval of sofosbuvir offers new therapeutic options for patients suffering from chronic hepatitis C. In phase III trials, it has demonstrated significantly greater efficacy and safety in comparison with the old standard of care. In addition, it provides the first interferon-free regimen allowing treatment of patients without previous therapeutic options. A current debate regarding pricing and affordability can be attributed to high treatment costs. The objective of this review was to compare health economic evaluations of sofosbuvir for the treatment of chronic hepatitis C in terms of models, patient populations, interventions and results.
  
  
  METHODS
  A systematic review was conducted using the data sources Medline (1946-09/2015), Embase (1974-09/2015), the Health Technology Assessment Database (September 2015) and the UK National Health Service Economic Evaluation Database (September 2015). We included health economic evaluations that measured the cost-effectiveness of sofosbuvir-based regimens compared with regimens without sofosbuvir for the treatment of adult patients infected with chronic hepatitis C. The articles were then critically appraised regarding the effectiveness data, cost data and models utilised.
  
  
  RESULTS
  Fourteen studies were included, which analysed the cost-effectiveness of sofosbuvir in seven different countries. Differences in study characteristics were found regarding study populations, modelling and willingness-to-pay thresholds. The study results demonstrated the cost-effectiveness of the treatment combination of sofosbuvir with pegylated interferon and ribavirin in comparison with the old standard of care. Dual therapy with sofosbuvir and ribavirin was considered cost effective only in comparison with no therapy.
  
  
  CONCLUSIONS
  Despite high costs, the included studies indicate that sofosbuvir-based regimens are cost effective in most patients. While the results are unequivocal with regard to sofosbuvir-based triple therapy, the cost-effectiveness of sofosbuvir-based dual therapy heavily depends on country-specific willingness to pay. Although interferon-containing triple therapy has now been replaced by newly approved direct-acting antivirals in most middle- and high-income countries, the availability of these oral treatment combinations is poor in low-income countries. Therefore, the findings of our review are still of relevance.
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany. miriam.luhnen@iqwig.de.
authors.forename: Miriam
authors.initials: M
authors.lastname: Luhnen
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany.
authors.forename: Siw
authors.initials: S
authors.lastname: Waffenschmidt
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Gerber-Grote
authors.affiliation: Institute for Quality and Efficiency in Health Care (IQWiG), Im Mediapark 8, 50670, Cologne, Germany.
authors.forename: Gloria
authors.initials: G
authors.lastname: Hanke
mesh_terms: D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D017048:Health Care Costs; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D000069474:Sofosbuvir / Q000191:economics / Q000627:therapeutic use*
chemical_list: D000998:Antiviral Agents; D000069474:Sofosbuvir