Cost-Effectiveness of Point-of-Care Hepatitis C Virus RNA Testing in the US.

Importance: The standard of care (SOC) 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, particularly among high-risk populations. Improving diagnostic efficiency is critical for HCV elimination. Objective: To evaluate the cost-effectiveness of a point-of-care (POC) HCV RNA-first diagnostic strategy compared with SOC across care settings in the US serving people at high-risk of HCV infection. Design, Setting, and Participants: This economic evaluation used a hybrid decision tree and HCV transmission model using real-world claims data and published literature. The model projected clinical and economic outcomes over 1-year and lifetime horizons. Hypothetical cohorts of individuals eligible for HCV testing were modeled in each of 4 care settings-community health centers, emergency departments, harm reduction clinics, and mobile outreach or street medicine programs in the US-and assumed to be primarily people who inject drugs. Exposure: POC HCV RNA-first testing vs SOC laboratory-based HCV antibody and reflex confirmatory RNA testing. Main Outcomes and Measures: The primary outcomes were rates of HCV diagnosis, linkage to care, treatment initiation, sustained virologic response at week 12 after treatment, forward transmission, long-term complications, costs, and incremental cost-effectiveness ratios. One-way and probabilistic sensitivity analyses assessed the impact of uncertainty on results. Results: Among modeled cohorts, POC HCV RNA-first testing identified 93.4% of cases vs up to 68.7% with SOC. POC HCV RNA-first testing increased linkage to care (by 37.6%-73.4%), treatment initiation (by 12.1%-48.9%), and sustained virologic response at week 12 after treatment (by 3.6%-26.4%) across care settings. Forward transmission was reduced by 16.3% to 53.3%. Initial costs were higher in some settings, but lifetime costs were lower, with savings of $3387 per person tested. The POC HCV RNA-first strategy was dominant (lower costs and improved outcomes) over SOC across all settings analyzed. Conclusions and Relevance: In this economic analysis of HCV testing strategies, a POC HCV RNA-first approach was found to be cost-effective and clinically optimal for high-risk populations, and may represent a critical component of HCV elimination efforts in the US.