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Abstract Details
Optimizing diagnostic algorithms to advance Hepatitis C elimination in Italy: A cost effectiveness evaluation
Andrea Marcellusi12, Francesco Saverio Mennini12, Murad Ruf3, Claudio Galli4, Alessio Aghemo56, Maurizia R Brunetto78, Sergio Babudieri9, Antonio Craxi10, Massimo Andreoni1112, Loreta A Kondili13
Author information
1Economic Evaluation and HTA (EEHTA), CEIS, Faculty of Economics, University of Rome "Tor Vergata", Rome, Italy.
2Institute of Leadership and Management in Health, Kingston Business School, Kingston University, London, UK.
3Public Health, Medical Affairs, Gilead Science, London, UK.
4Global Medical and Scientific Affairs, Core Laboratory, Abbott, Rome, Italy.
5Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy.
6Division of Internal Medicine and Hepatology, Humanitas Research Hospital IRCCS, Rozzano, Italy.
7Internal Medicine, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.
8Hepatology Unit and Laboratory of Molecular Genetics and Pathology of Hepatitis Viruses, University Hospital of Pisa, Pisa, Italy.
9Infectious and Tropical Disease Unit, Department of Medical, Surgical and Experimental Sciences, University of Sassari, Sassari, Italy.
10Gastroenterology and Hepatology Unit, Department of Internal Medicine and Medical Specialties "PROMISE", University of Palermo, Palermo, Italy.
11Department of Systems Medicine, University of Rome "Tor Vergata", Rome, Italy.
12Infectious Diseases Clinic, University Hospital "Tor Vergata", Rome, Italy.
13Center for Global Health, Istituto Superiore di Sanità, Rome, Italy.
Abstract
Objectives: Optimized diagnostic algorithms to detect active infections are crucial to achieving HCV elimination. We evaluated the cost effectiveness and sustainability of different algorithms for HCV active infection diagnosis, in a context of a high endemic country for HCV infection.
Methods: A Markov disease progression model, simulating six diagnostic algorithms in the birth cohort 1969-1989 over a 10-year horizon from a healthcare perspective was used. Conventionally diagnosis of active HCV infection is through detection of antibodies (HCV-Ab) detection followed by HCV-RNA or HCV core antigen (HCV-Ag) confirmatory testing either on a second sample or by same sample reflex testing. The undiagnosed and unconfirmed rates were evaluated by assays false negative estimates and each algorithm patients' drop-off. Age, liver disease stages distribution, liver disease stage costs, treatment effectiveness and costs were used to evaluate the quality-adjusted life-years (QALYs) and the incremental cost-effectiveness ratios (ICER).
Results: The reference option was Rapid HCV-Ab followed by second sample HCV-Ag testing which produced the lowest QALYs (866,835 QALYs). The highest gains in health (QALYs=974,458) was obtained by HCV-RNA reflex testing which produced a high cost-effective ICER (€891/QALY). Reflex testing (same sample-single visit) vs two patients' visits algorithms, yielded the highest QALYs and high cost-effective ICERs (€566 and €635/QALY for HCV-Ag and HCV-RNA, respectively), confirmed in 99.9% of the 5,000 probabilistic simulations.
Conclusions: Our data confirm, by a cost effectiveness point of view, the EASL and WHO clinical practice guidelines recommending HCV reflex testing as most cost effective diagnostic option vs other diagnostic pathways.