OBJECTIVES : Direct-acting antiviral agents (DAA) revolutionized HCV therapy, however their wide use is limited due to their high price. We aimed to estimate the net payback period to recover the initial investment on DAAs treatment from the Italian National Health System (NHS) perspective.

METHODS : A multistate Markov model of HCV liver disease progression was developed including 13 disease states from fibrosis stage (F0–F4), decompensated cirrhosis, hepatocarcinoma, liver transplantation and death. The liver disease progression rates were retrieved by the literature whereas liver disease stages treatment efficacy and direct costs according to each health state derived from real life PITER cohort data and clinical trial. Costs and Outcomes were discounted on annual rate of 3% and a 20-year time horizon was considered. The payback period was defined as the number of years required to recover the NHS investment on DAA treatment due to reduction of HCV related events and costs. Three different enrolment periods which cover the full evolution of different DAA access in Italy since 2014 were considered.

RESULTS In 2014-2015, the real-life PITER cohort study enrolled 5,158 HCV patients not treated at time of enrolment (52% in F0 – F2 stage); in 2016 4,090 patients (41% in F0-F2 stage) and in 2017, 1,066 patients (70% in F0-F2 stage). Standardising the real-life data in 1,000 patients, the investment on DAAs was 15 million euros during 2014-2016 and 9 million euros in 2017. For each of the 2014-2015, 2016 and 2017 enrolment period the payback periods estimated from the model were 11.5, 10.5 and 8.5 years respectively. The total cost saving after 20 years was 24.0, 29.9 and 24.7 million euros for 2014-2015, 2016 and 2017 respectively.

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