OBJECTIVES: We estimated the cost consequence of the National Health System (NHS) investment on Direct-acting antiviral agents (DAA) according to Hepatitis C Virus (HCV) treatment access policies in Italy.

METHODS: A multistate 20-year time horizon Markov model of HCV liver disease progression was developed. Fibrosis stage, age and Genotypes distributions were derived from the Italian Platform for the Study of Viral Hepatitis Therapies (PITER) cohort. Treatment efficacy, disease progression probabilities and direct costs by each health state were obtained from the literature. Discounted break-even point in time (DBPT) was defined as the period of time required for the cumulative costs saved to recover the NHS investment on DAA treatment. Three different PITER enrolment periods, which covered the full DAA access evolution in Italy, were considered.

RESULTS: Disease stages of 2657 patients, who had consecutively undergone a DAA therapy from January 2015 to December 2017 in 30 PITER clinical centres, were standardized for 1,000 patients. The investment on DAAs was considered equal to €25 million, €15 million, €9 million during 2015, 2016 and 2017 respectively. For patients treated in 2015, the DBPT will not be achieved due to the disease severity of treated patients. For 2016 and 2017, the estimated DBPT were 6.6 and 6.2 years, respectively. The total cost saving after 20 years was €50.13 and €55.50 million for 1,000 patients treated from 2015 to 2017 respectively.

CONCLUSIONS: This study may be a useful tool for public decision-makers to understand how HCV epidemiological profiles influence the economic burden of HCV.