Economic Evaluation of the Hepatitis C Virus Treatment Extension to Early-Stage Fibrosis Patients: Evidence from the PITER Real-World Cohort

Objectives: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection. Methods: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanity). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted. Results: Policy 1 exhibits an incremental cost-effectiveness ratio of (sic)8,775/QALY gained and remains less than (sic)30,000/QALY in 94% of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97% when adopting a threshold of (sic)40,000/QALY gained. Conclusions: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.