Abstract
<title>Abstract</title> <p>Background Hepatocellular carcinoma (HCC) imposes a substantial disease burden among Chinese patients with hepatitis B virus (HBV)-related cirrhosis, and cost-effective early screening strategies remain poorly defined. This study aimed to evaluate the cost-effectiveness of C-GALAD (with or without ultrasound [US]) for early HCC screening in this population, compared with conventional biomarker-based approaches. Methods A hybrid decision-analytic model integrating a screening decision tree and a Markov natural history model was constructed. A hypothetical cohort of Chinese patients with HBV-related cirrhosis was simulated over a 30-year horizon with 6-month cycles. Evaluated interventions included C-GALAD, single biomarkers (alpha-fetoprotein [AFP], des-γ-carboxy prothrombin [DCP]), combined biomarkers (AFP + DCP, AFP + AFP-L3%+DCP, GALAD), and all strategies paired with US. Primary outcomes were costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs), with a willingness-to-pay threshold of three times China’s 2024 per capita GDP (USD 13,448/QALY). Costs and QALYs were discounted at 5% annually; one-way and probabilistic sensitivity analyses assessed model uncertainty. Results In base-case analysis, C-GALAD was cost-effective versus AFP, AFP + DCP, triple biomarkers, and GALAD (ICERs: USD 1,567–4,912/QALY, all below the threshold), and dominated GALAD (lower cost, higher QALYs). Among US-combined strategies, GALAD + US was cost-effective vs. AFP + US (ICER: USD 4,648/QALY). Test sensitivity, specificity, and discount rate were the most influential parameters. Probabilistic analysis confirmed 100% cost-effectiveness probability for C-GALAD and GALAD + US in respective comparisons. Conclusions C-GALAD is the most cost-effective biomarker-only strategy for early HCC screening in Chinese patients with HBV-related cirrhosis; GALAD + US is also cost-effective. Both strategies merit broader adoption to improve early HCC detection and optimize healthcare resource allocation.</p>