title: Estimating the cost-effectiveness of daclatasvir plus asunaprevir in difficult to treat Japanese patients chronically infected with hepatitis C genotype 1b.
abstract: OBJECTIVE
  Standard of care for chronic hepatitis C in Japan is currently a pegylated interferon (IFN)-α + ribavirin (PR)-based regimen, notably associated with efficacy and tolerability issues. The advent of novel direct-acting antivirals (DAA) has provided more efficacious and better tolerated treatments. This study investigated the cost-effectiveness of the daclatasvir + asunaprevir (DCV + ASV) DAA regimen in patients infected with hepatitis C virus (HCV) genotype 1b who had previously not responded to or were ineligible for IFN-containing regimens.
  
  
  METHODS
  A cost-utility analysis using an established Markov model compared DCV + ASV with simeprevir + PR (SMV + PR), telaprevir + PR (TVR + PR) and no treatment using Japanese-specific model inputs, with costs and utility values discounted at 2%. A cohort of patients was simulated until death and predicted quality-adjusted life-years (QALY) and costs were estimated. A subgroup analysis of patients with no DCV resistance was conducted.
  
  
  RESULTS
  In all scenarios, DCV + ASV was predicted to be dominant over the comparator; namely, DCV + ASV was associated with increased QALY gains and decreased cost. In patients treated during the chronic hepatitis C stage, cost reductions were ¥1 057 288-2 619 206, and in patients treated during the compensated cirrhosis (CC) stage, reductions were ¥1 032 224-2 531 930. QALY gains were 0.749-2.609 and 0.874-3.043, respectively. Results improved when considering the subgroup of patients without DCV resistance.
  
  
  CONCLUSIONS
  Cost-effectiveness conclusions are similar for patients treated in the chronic hepatitis C and CC disease stages, with DCV + ASV expected to be cost-saving versus standard of care in Japan for patients with HCV genotype 1b patients who have failed prior therapy or are IFN-ineligible/intolerant.
authors.affiliation: Health Economics and Outcomes Research, Monmouth, Wales, UK.|Center for Health Economics, Swansea University, Cardiff, Wales, UK.
authors.forename: Phil
authors.initials: P
authors.lastname: McEwan
authors.affiliation: Health Economics and Outcomes Research, Monmouth, Wales, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Ward
authors.affiliation: Health Economics and Outcomes Research, Monmouth, Wales, UK.
authors.forename: Samantha
authors.initials: S
authors.lastname: Webster
authors.affiliation: World Wide Health Economics and Outcomes Research, Bristol-Myers Squibb Pharmaceuticals, Princeton, New Jersey, USA.
authors.forename: Yong
authors.initials: Y
authors.lastname: Yuan
authors.affiliation: World Wide Health Economics and Outcomes Research, Bristol-Myers Squibb Pharmaceuticals, Princeton, New Jersey, USA.
authors.forename: Anupama
authors.initials: A
authors.lastname: Kalsekar
authors.affiliation: Graduate School of Public Policy, The University of Tokyo, Tokyo, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Kamae
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kobayashi
authors.affiliation: Health Economics and Outcomes Research, Bristol-Myers K.K., Tokyo, Japan.
authors.forename: Ann
authors.initials: A
authors.lastname: Tang
authors.affiliation: Department of Hepatology, Toranomon Hospital, Tokyo, Japan.
authors.forename: Hiromitsu
authors.initials: H
authors.lastname: Kumada
keywords: chronic hepatitis C; cost-effectiveness analysis; daclatasvir; direct-acting antivirals