Background
The recently approved drugs, sofosbuvir and ledipasvir, for chronic hepatitis C virus (HCV) treatment are more efficacious and safer but are substantially more expensive than the old standard-of-care (oSOC). It remains unclear whether and in which patients their improved efficacy justifies their increased cost.
Objective
To evaluate the cost-effectiveness and budget impact of sofosbuvir- and ledipasvir-based therapies.
Design
Simulation model of the natural history of HCV.
Data Sources
Published literature.
Target population
Treatment-naive and treatment-experienced HCV population defined on the basis of HCV genotype, age and fibrosis distribution in the United States.
Time Horizon
Lifetime.
Perspective
Third-party payer.
Interventions
Simulation of sofosbuvir/ledipasvir-based therapies compared with the oSOC that consisted of interferon-based therapies.
Outcomes Measures
Quality-adjusted life years (QALYs), incremental cost-effectiveness ratios (ICERs), and 5-year spending on antiviral drugs.
Results of Base-Case Analysis
Sofosbuvir-based therapies added 0.56 QALY relative to the oSOC, at an incremental cost of $55 400 per additional QALY. The ICERs ranged from $9700 to $284 300 per QALY depending on the patient’s status with respect to prior treatment, HCV genotype, and the presence of cirrhosis. At $100 000 willingness-to-pay per QALY, sofosbuivr-based therapies were cost-effective in 83% of treatment-naive and 81% of treatment-experienced patients. Compared with the oSOC, new drugs would cost an additional $65 billion in the next 5 years to treat eligible HCV-infected people in the United States, whereas the resulting cost offsets would be $16 billion.
Results of Sensitivity Analysis
Results were sensitive to the drug price, drug efficacy and quality-of-life after a successful treatment.
Limitation
Data on real world effectiveness of new antivirals is lacking.
Conclusions
HCV treatment is cost-effective in the majority of patients, but additional resource and value-based patient prioritization are needed to manage HCV patients.