Background: The aim of this study is to perform an economic analysis to estimate the cost-utility of the early innovative therapy in Italy for managing HCV-infected patients. Methods: The incremental cost-utility analysis was carried out to quantify the benefits of the early treatment approach in HCV subjects. A Markov simulation model including direct and indirect costs and health outcomes was developed from Italian National Healthcare Service and societal perspective. 5,000 Monte Carlo simulations were performed on two distinct scenarios: Standard of Care (SoC) which includes 14.000 Genotype 1 patients in Italy treated with innovative interferon-free in the Fibrosis stage 3 and 4 (F3-F4) vs Early-treatment Scenario (ETS) where 2.000 patients were additionally treated with simeprevir plus peginterferon and ribavirin in the Fibrosis stage 2 (F2) (based on AIFA reimbursement criteria). A systematic literature review was carried out to identify epidemiological and economic data, which were subsequently used to inform the model. Furthermore, a one-way probabilistic sensitivity was performed in order to measure the relationship between the main parameters of the model and the cost-utility results. Results: The model shows that, in terms of Incremental Cost Effectiveness Ratio (ICER) per QALY gained, ETS appeared to be the most cost-effective option compared from both perspective Societal (ICER = €11.396) and NHS (ICER = €14.733) over a time horizon of 10 years. The cost-effectiveness of ETS is more sustainable as it extends the time horizon analysis (ICER = € 6.778 per QALY to 20 years and € 4,474 per QALY to 30 years). From the societal perspective the ETS represents the dominant option at a time horizon of 30 years. If we consider the sub-group population of treated patients (16.000 patients of which 2.000 not treated in the SoC), the ETS scenario was dominant after only 5 years horizon and cost-effective at 2 years of simulation. The one-way sensitivity analysis on the main variables confirmed the robustness of the model for the early-treatment approach. Conclusions: In conclusion, our model represents a tool for policy makers and health care professionals provide information on the cost-effectiveness of early-treatment approach in patients HCV-infected in Italy. Starting innovative treatment earlier regimens keeps HCV-infected patients in better health and reduces the incidence of HCV related events; this generating a gain both in terms of health of the patients and correct resource allocation.
 

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