Hepatitis C Screening: A Health Technology Assessment.

Background: Hepatitis C virus (HCV) infection causes liver inflammation that, if left untreated, can lead to scarring of the liver (cirrhosis), liver failure, liver cancer (hepatocellular carcinoma [HCC]), and death. For most people, this process usually progresses slowly, over 10 to 20 years or more, during which time the person may remain asymptomatic despite the ongoing process of liver damage. HCV screening aims to identify people with an HCV infection so that they can be linked to care and treatment. We conducted a health technology assessment of (1) one-time HCV screening for all adults in addition to risk-based HCV screening and (2) one-time HCV screening for people born between 1945 and 1975 (1945-1975 birth cohort) in addition to risk-based HCV screening, compared with risk-based HCV screening alone. This included an evaluation of effectiveness, cost-effectiveness, the budget impact of publicly funding onetime HCV screening in those populations, and patient preferences and values. Methods: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Risk of Bias in Nonrandomized Studies - of Interventions (ROBINS-I) tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a literature search of the quantitative evidence on the preferences for HCV screening of the adult population and health care providers. We performed a systematic economic literature search and conducted a cost-utility analysis with a lifetime horizon from a public payer perspective to compare (1) one-time HCV screening for all adults plus risk-based HCV screening and (2) one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening, against risk-based HCV screening alone. We also analyzed the budget impact of publicly funding one-time HCV screening for all adults plus risk-based HCV screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening in Ontario. We performed a literature search of the quantitative evidence on the preferences of adults and health care providers for HCV screening. To contextualize the potential value of expanding HCV screening, we spoke with people with HCV. Results: We included 3 observational studies in the clinical evidence review. The study findings suggest that one-time HCV screening for all adults plus risk-based HCV screening may identify more people with HCV and may result in more people with HCV linked to care compared with risk-based HCV screening alone (GRADE: Very low). No studies were identified for the assessment of one-time HCV screening for the 1945-1975 birth cohort or for the assessment of the quantitative preferences of adults and health care providers for HCV screening. One-time HCV screening for all adults plus risk-based HCV screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening are less costly and more effective than risk-based HCV screening alone. The probability of one-time HCV screening for all adults plus risk-based HCV screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening being cost-effective versus risk-based HCV screening alone is 100% at a willingness-to-pay of $50,000 per quality-adjusted life-year (QALY) gained and 100% at a willingness-to-pay of $100,000 per QALY gained. The annual budget impact of publicly funding one-time HCV screening for all adults plus risk-based HCV screening in Ontario over the next 5 years ranges from an additional $22 million in year 1 to $14 million in year 5. The annual budget impact of publicly funding one-time HCV screening for the 1945-1975 birth cohort plus risk-based HCV screening in Ontario over the next 5 years ranges from an additional $9 million in year 1 to $1 million in year 5. The people with HCV with whom we spoke reported that HCV negatively affected their health and social well-being, and they highlighted the emotional distress caused by the stigma associated with the infection. Conclusions: One-time HCV screening for all adults plus risk-based screening may identify more people with HCV and may result in more people with HCV linked to care compared with risk-based HCV screening alone, but the evidence is very uncertain due to concerns with generalizability of the study findings to the Ontario context. One-time HCV screening for all adults plus risk-based screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based screening are both less costly and more effective than riskbased HCV screening alone. We estimate that publicly funding one-time HCV screening for all adults plus risk-based screening and one-time HCV screening for the 1945-1975 birth cohort plus risk-based screening in Ontario would result in additional costs of $111 million and $32 million, respectively, over the next 5 years. People with HCV emphasized the need to expand HCV screening beyond traditionally defined high-risk groups to enable earlier diagnosis and treatment.