Background and objective Moderate-to-severe Ulcerative Colitis (UC), a chronic inflammatory disease affecting young adults, has a significant impact on patients’ quality of life (QoL). Different biological agents (BAs) have been approved for the treatment of patients who have responded inadequately to conventional therapy but the selection of BAs is still controversial due to the lack of head-to-head trials. Indirect economic comparisons of these costly drugs are available, however they are not available from Italian National Healthcare perspective. The objective is to evaluate cost-utility of BAs for the treatment of refractory moderate-to-severe UC from the Italian Healthcare perspective.
Methods A Markov model was constructed using the software R 3.3.1 markovchain-package to evaluate incremental cost-utility ratios (ICUR) of Adalimumab, Infliximab originator, Infliximab biosimilar, Golimumab and Vedolizumab treatments of patients over a ten-year time horizon from the perspective of the Italian Healthcare system. Three transition states were considered: remission, clinical response and relapse. Clinical parameters were derived from clinical trials. Direct healthcare costs (actualised treatment costs by 1.5%, hospital visits, lab tests, endoscopy examinations, hospital admissions) for every transition state were considered and obtained from the National database. Utility was expressed as QALY (Quality Adjusted Life Years).
Results From a National Healthcare System perspective, direct healthcare costs per treatment over a ten-year time horizon were respectively € 112,513.30, € 128,635.9, € 108,781.20, € 116,823.10 and € 112,144 for Adalimumab, Infliximab originator, Infliximab biosimilar, Golimumab and Vedolizumab with related QALY of 6.68, 6.66, 6.66, 6.70 and 7.02. Infliximab originator was the most expensive treatment with the same QALY as Infliximab biosimilar. Golimumab, Adalimumab and Infliximab originator were all dominated by Vedolizumab, although Vedolizumab was dominated by Infliximab biosimilar.
Conclusions The analysis showed Infliximab biosimilar had the best cost-utility profile. Cost-Utility Analysis (CUA) from a National perspective has shown to be a useful instrument to estimate the specific economic impact in order to be able to treat more patients and to ensure optimal choice.

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Key words: Ulcerative Colitis, Cost-Utility Analysis, Adalimumab, Infliximab, Golimumab, Vedolizumab, biosimilar