Cost-Effectiveness Analysis of GAAD Algorithm for Hepatocellular Carcinoma Surveillance of Cirrhotic Patients Using Italian Real-World Data
Author(s)
Camilla Porta, MSc1, Lorenzo Pradelli, MD1, Giovanni Cirotto, MSc2, Maria Teresa Majorini, PhD2, Ulises Garay, BEc, MSc3, Vincenza Calvaruso, MD, PhD4, Tommaso Fasano, MD, PhD5, Lucia Napoli, MD6, Francesco Giuseppe Foschi, MD6, Pietro Lampertico, MD, PhD7.
1Adres HE&OR, Torino, Italy, 2Roche Diagnostics Spa, Monza, Italy, 3Roche Diagnostics International, Rotkreuz, Switzerland, 4Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy, 5Intercompany Department for Integrated Activities in Laboratory Medicine and Pathological Anatomy, AUSL Modena, Modena, Italy, 6Department of Internal Medicine, Ospedale per gli Infermi di Faenza, Faenza, Italy, 7Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
1Adres HE&OR, Torino, Italy, 2Roche Diagnostics Spa, Monza, Italy, 3Roche Diagnostics International, Rotkreuz, Switzerland, 4Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties, University of Palermo, Palermo, Italy, 5Intercompany Department for Integrated Activities in Laboratory Medicine and Pathological Anatomy, AUSL Modena, Modena, Italy, 6Department of Internal Medicine, Ospedale per gli Infermi di Faenza, Faenza, Italy, 7Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy.
OBJECTIVES: In patients with compensated liver cirrhosis (CLC), hepatocellular carcinoma (HCC) early diagnosis via screening can improve prognosis. Despite the implementation of several diagnostic strategies, the early detection of HCC remains a significant challenge. The GAAD algorithm (gender [biological sex], age, alpha-fetoprotein [AFP], protein induced by vitamin K absence-II [PIVKA-II]) demonstrated good performance for the detection of early-stage HCC. This study aimed to assess the cost-effectiveness of the GAAD algorithm for HCC surveillance in patients with CLC in Italy, from the Italian Health Service perspective.
METHODS: A probabilistic micro-simulation Markov model was adapted to the Italian context to estimate lifetime clinical outcomes and costs of CLC patients undergoing bi-annual screening with ultrasound (US), US+AFP, GAAD, and US+GAAD. Clinical inputs and utility values were derived from Italian real-world data and published literature. Direct healthcare costs, including screening, HCC confirmatory testing, symptomatic detection, disease monitoring, and treatment, were collected from Italian sources. Costs, updated to 2024-value, and health gains were discounted at an annual 3% rate. Sensitivity analyses were conducted to evaluate the uncertainties in input parameters.
RESULTS: US+GAAD and GAAD were the most effective strategies, yielding 6.58 and 6.57 QALYs per patient at costs of €35,939 and €35,423, respectively. Compared to US and US+AFP, GAAD was dominant, while US+GAAD was cost-effective (ICUR of €9,482 and €10,951 per QALY gained, respectively). At a willingness-to-pay threshold of €30,000, GAAD was the most cost-effective strategy. Sensitivity analyses confirmed the robustness of results.
CONCLUSIONS: GAAD, either alone or in combination with US, is a cost-effective strategy for HCC surveillance in Italy, significantly improving the detection of early-stage HCC.
METHODS: A probabilistic micro-simulation Markov model was adapted to the Italian context to estimate lifetime clinical outcomes and costs of CLC patients undergoing bi-annual screening with ultrasound (US), US+AFP, GAAD, and US+GAAD. Clinical inputs and utility values were derived from Italian real-world data and published literature. Direct healthcare costs, including screening, HCC confirmatory testing, symptomatic detection, disease monitoring, and treatment, were collected from Italian sources. Costs, updated to 2024-value, and health gains were discounted at an annual 3% rate. Sensitivity analyses were conducted to evaluate the uncertainties in input parameters.
RESULTS: US+GAAD and GAAD were the most effective strategies, yielding 6.58 and 6.57 QALYs per patient at costs of €35,939 and €35,423, respectively. Compared to US and US+AFP, GAAD was dominant, while US+GAAD was cost-effective (ICUR of €9,482 and €10,951 per QALY gained, respectively). At a willingness-to-pay threshold of €30,000, GAAD was the most cost-effective strategy. Sensitivity analyses confirmed the robustness of results.
CONCLUSIONS: GAAD, either alone or in combination with US, is a cost-effective strategy for HCC surveillance in Italy, significantly improving the detection of early-stage HCC.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
EE201
Topic
Economic Evaluation, Medical Technologies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Oncology