Assessing the Budget Impact and Economic Outcomes of the Introduction of Daclatasvir + Asunaprevir and Sofosbuvir/Ledipasvir for the Treatment of Chronic Hepatitis C Virus Infection in Japan

Value Health Reg Issues. 2017 May;12:1-6. doi: 10.1016/j.vhri.2016.10.002. Epub 2016 Dec 24.


Background: The advent of highly efficacious, well-tolerated, all-oral direct-acting antiviral regimens has revolutionized the standard of care for patients chronically infected with hepatitis C virus. As efficacy and safety rates converge, prescribers and payers need to consider value for money.

Objectives: To evaluate the health economic value of daclatasvir + asunaprevir versus sofosbuvir/ledipasvir via a cost-effectiveness analysis, and determine the optimal treatment considering both costs and health outcomes in Japan.

Methods: A previously published Markov model was used to estimate the cost-effectiveness of daclatasvir + asunaprevir compared with sofosbuvir/ledipasvir on the basis of a matching-adjusted indirect comparison of pivotal trials and modeling inputs specific to the Japanese setting. A de novo budget impact model was developed and used to predict the cost implications of differing treatment sequences.

Results: Cost-effectiveness results demonstrated minimal difference in terms of benefit (0.037 fewer QALYs and 0.014 fewer life-years with daclatasvir + asunaprevir); nevertheless, a significant difference in cost was predicted (estimated ¥2,299,700 [US $21,695] reduction with daclatasvir + asunaprevir). The budget impact analysis estimated that treatment with daclatasvir + asunaprevir is expected to be less expensive than treatment with sofosbuvir/ledipasvir (as the proportion of patients initially treated with sofosbuvir/ledipasvir increased from 0% to 100%, total costs increased from ¥206 to ¥403 billion [US $1.94 billion to US $3.80 billion]).

Conclusions: On the basis of results from an established cost-effectiveness model and a conventional budget impact analysis, treatment with daclatasvir + asunaprevir is expected to be cost-saving compared with treatment with sofosbuvir/ledipasvir in Japan with similar health outcomes, regardless of treatment sequence.

Keywords: asunaprevir; budget impact; cost-effectiveness; daclatasvir; hepatitis C virus.

MeSH terms

  • Aged
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / administration & dosage*
  • Benzimidazoles / economics
  • Cost-Benefit Analysis*
  • Drug Therapy, Combination / methods
  • Female
  • Fluorenes / administration & dosage*
  • Fluorenes / economics
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Imidazoles / administration & dosage*
  • Isoquinolines / administration & dosage*
  • Japan
  • Male
  • Protease Inhibitors / therapeutic use*
  • Sofosbuvir
  • Sulfonamides / administration & dosage*
  • Uridine Monophosphate / administration & dosage
  • Uridine Monophosphate / analogs & derivatives*
  • Uridine Monophosphate / economics


  • Antiviral Agents
  • Benzimidazoles
  • Fluorenes
  • Imidazoles
  • Isoquinolines
  • Protease Inhibitors
  • Sulfonamides
  • ledipasvir, sofosbuvir drug combination
  • Uridine Monophosphate
  • daclatasvir
  • asunaprevir
  • Sofosbuvir