OBJECTIVES: Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related deaths worldwide. National guidelines in the UK recommend biannual surveillance of high-risk groups using abdominal ultrasound (US) with or without AFP. Elecsys® GAAD is an approved in-vitro diagnostic digital tool that combines patient sex and age with Elecsys® AFP and Elecsys® protein induced by vitamin K absence-II (PIVKA-II) assay results to aid in the early detection of HCC. The objective of this study was to evaluate the cost-utility of GAAD versus US+AFP for HCC surveillance in patients with compensated liver cirrhosis in the UK

METHODS: A probabilistic micro-simulation state transition model was developed in Microsoft Excel®, from the perspective of the National Health Service, to calculate discounted quality-adjusted life-years (QALYs), costs, incremental cost-effectiveness ratios (ICER), and net monetary benefits (NBM). Parameters were sourced from published literature, national guidelines, and cost databases. One-way and scenario analyses were performed to evaluate the impact of parameter and structural uncertainty on the results.

RESULTS: In a simulated cohort of 100,000 patients, discounted results per patient totalled £7,696 and 5.42 QALYs for GAAD, and £8,364 and 5.41 QALYs for US+AFP. GAAD dominated US+AFP, with a saving of £669 and a gain of 0.01 QALYs. The NMB was estimated at £787. Overall, GAAD detected 351 additional early-stage HCC cases and resulted in 53,970 fewer false positives (FP) compared with US+AFP. The most relevant cost differences were attributed to lower surveillance costs, lower FP-related costs, and higher costs for HCC early-stage treatments. Sensitivity and scenario analyses suggest these results are robust.

CONCLUSIONS: These data suggest that GAAD dominates US+AFP in the UK by improving early detection of HCC and reducing FP diagnoses, leading to better outcomes for patients while saving healthcare resources.