title: Assessment of cost of innovation versus the value of health gains associated with treatment of chronic hepatitis C in the United States: The quality-adjusted cost of care.
abstract: BACKGROUND
  New direct-acting antiviral (DAA) therapy has dramatically increased cure rates for patients infected with hepatitis C virus (HCV), but has also substantially raised treatment costs.
  
  
  OBJECTIVE
  The aim of this analysis was to evaluate the therapeutic benefit and net costs (i.e. efficiency frontier) and the quality-adjusted cost of care associated with the evolution of treatment regimens for patients with HCV genotype 1 in the United States.
  
  
  METHODS
  A decision-analytic Markov model.
  
  
  METHODS
  Published literature and clinical trial data.
  
  
  METHODS
  Life Time.
  
  
  CONCLUSIONS
  Third-party payer.
  
  
  METHODS
  This study compared four approved regimens in treatment-naïve genotype 1 chronic hepatitis C patients, including pegylated interferon and ribavirin (PR), first generation triple therapy (boceprevir + PR and telaprevir + PR), second generation triple therapy (sofosbuvir + PR and simeprevir + PR) and all-oral DAA regimens (ledipasvir/sofosbuvir and ombitasvir + paritaprevir/ritonavir + dasabuvir ± ribavirin).
  
  
  METHODS
  Quality-adjusted cost of care (QACC). QACC was defined as the increase in treatment cost minus the increase in the patient's quality-adjusted life years (QALYs) when valued at $50,000 per QALY.
  
  
  RESULTS
  All-oral therapy improved the average sustained virologic response (SVR) rate to 96%, thereby offsetting the high drug acquisition cost of $85,714, which resulted in the highest benefit based on the efficiency frontier. Furthermore, while oral therapies increased HCV drug costs by $48,350, associated QALY gains decreased quality-adjusted cost of care by $14,120 compared to dual therapy. When the value of a QALY was varied from $100,000 to $300,000, the quality adjusted cost of care compared to dual therapy ranged from - $21,234 to - $107,861, - $89,007 to - $293,130, - $176,280 to - $500,599 for first generation triple, second generation triple, and all-oral therapies, respectively. Primary efficacy and safety measurements for drug regimens were sourced from clinical trials data rather than a real-world setting. Factors such as individual demographic characteristics, comorbidities and alcohol consumption of the individual patients treated may alter disease progression but were not captured in this analysis.
  
  
  CONCLUSIONS
  New DAA treatments provide short-term and long-term clinical and economic value to society.
  
  
  BACKGROUND
  Gilead Sciences, Inc.
authors.affiliation: Center For Liver Disease, Department of Medicine, Inova Fairfax Hospital Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA University of Florida, Gainesville, FL Mount Sinai Medical Center, New York, NY University of California, Los Angeles, Los Angeles Stanford University, Standford, CA Henry Ford Hospital, Detroit, MI.
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
authors.forename: Haesuk
authors.initials: H
authors.lastname: Park
authors.forename: Douglas
authors.initials: D
authors.lastname: Dieterich
authors.forename: Sammy
authors.initials: S
authors.lastname: Saab
authors.forename: Aijaz
authors.initials: A
authors.lastname: Ahmed
authors.forename: Stuart C
authors.initials: SC
authors.lastname: Gordon
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D017048:Health Care Costs; D019698:Hepatitis C, Chronic / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D007349:Insurance, Health, Reimbursement / Q000191:economics*; D011787:Quality of Health Care / Q000191:economics*; D019057:Quality-Adjusted Life Years
chemical_list: D000998:Antiviral Agents