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

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.Aim: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.Design:A decision-analytic Markov model.Data source:Published literature and clinical trial data.Time horizon:Life Time.Perspective:Third-party payer.Intervention:This study compared four approved regimens in treatment-naive 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+dasabuvirribavirin).Outcome measure: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.Conclusion:New DAA treatments provide short-term and long-term clinical and economic value to society.Primary funding source:Gilead Sciences, Inc.