Background Moderate to severe ulcerative colitis (UC), a chronic inflammatory disease affecting young adults, has a significant impact on patients’ quality of life. 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, but they are not available from the Italian National Healthcare perspective.

Purpose The objective was to evaluate the cost utility of BAs for the treatment of refractory moderate to severe UC from the Italian Healthcare perspective.

Material and methods A Markov model was constructed using the software R 3.3.1 Markovchain package to evaluate incremental cost utility ratios (ICUR) for adalimumab, infliximab originator, infliximab biosimilar, golimumab and vedolizumab treatments in patients over a 10 year period 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, laboratory 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 perspective, direct healthcare costs per treatment over a 10 year period were, respectively, €112 513.30, €116 823.10, €128 635.9, €108 781.20 and €112 144 for adalimumab, golimumab, infliximab originator, infliximab biosimilar and vedolizumab, with related QALY of 6.68, 6.70, 6.66, 6.66 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.

Conclusion The analysis showed infliximab biosimilar had the best cost utility profile. Cost utility analyses from a national perspective are useful to estimate the specific economic impact, to be able to treat more patients and to ensure optimal choice.

No conflict of interest