OBJECTIVES: New HCV antiviral treatments showed higher effectiveness (sustained virologic response - SVR) compared with that of available drugs. Due to the high cost of such treatments and in absence of scientific evidence on their economic impact on the Italian National Health Service (NHS), it is crucial to investigate the sustainability of their use in the Italian setting. The study aimed at evaluating the budget impact on the Italian NHS of the use of Daclatasvir for HCV treatment. METHODS: An analytical decision model was implemented with a five year time horizon. Two scenarios were structured considering the market shares of HCV treatments (expert opinion) with or without the use of Daclatasvir. The target population (HCV genotype 3 infected patients) was estimated based on literature data. Patients enter the model in fibrosis stage 3 and 4 and may evolve in an SVR state (based on effectiveness data), decompensated cirrhosis, HCC, liver transplant or death. The costs considered in the analysis were those of antiviral treatment, adverse events management and health state costs. RESULTS: The use of Daclatasvir, in comparison with the scenario without Daclatasvir, would lead to an increase of costs for the Italian NHS of 21.31 million euros in year 1, 21.33 million euros in year 2, 23.36 million euros in year 3, 23.26 million euros in year 4 and 17.20 million euros in year 5. CONCLUSIONS: Daclatasvir would lead to an increase of healthcare costs for the treatment of genotype 3 HCV infected patients in the first three years, followed by a reduction of the cost’s increase in years 4 and 5 (-0.44% in year 4 compared with year 3, and -26.0% in year 5 compared with year 4), thanks to the management of better health conditions, due to the higher effectiveness of Daclatasvir based therapies than the comparators.