The Cost-effectiveness of One-step Point-of-care Hepatitis C Virus RNA Testing in the United States

BackgroundThe standard of care (SOC) two-step laboratory-based hepatitis C virus (HCV) diagnostic algorithm is associated with high rates of undiagnosed cases, patients lost to follow-up, and low rates of treatment initiation. This study examines the cost-effectiveness of a one-step point-of-care HCV RNA diagnostic strategy (POC_RNA) compared to SOC across distinct settings of care serving people at high-risk of HCV infection. MethodsA hybrid decision tree and HCV transmission model was developed to estimate the clinical and economic outcomes of HCV testing strategies in community health centers (CHC), emergency departments (ED), harm reduction clinics (HRC), and mobile outreach / street medicine programs (MO/SM). The model analyzed costs from a U.S. third-party payer perspective and projected outcomes over a 1-year and lifetime horizons. Model inputs were sourced from real-world claims data and the published literature. One-way and probabilistic sensitivity analyses were performed to assess the impact of uncertainty on results. ResultsIn the base-case analysis, one-step POC_RNA was projected to increase rates of diagnosis, linkage to care, treatment initiation, successful treatment, and reduce first-generation transmitted cases when compared to SOC across all settings. Although one-step POC_RNA was estimated to increase initial treatment costs in the CRC, HRC, and MO/SM settings, these costs were offset in the longer-term by average savings from reduced incidence of chronic HCV infections and complications. DiscussionThis study suggests that a one-step POC HCV RNA testing strategy is optimal for high-risk populations and a critical component of HCV elimination efforts.