Objectives: Tofacitinib is the first oral Janus kinase inhibitor approved for the treatment of moderate-to-severe ulcerative colitis (UC). The present study assessed the cost–effectiveness of tofacitinib versus vedolizumab and infliximab (biosimilar) for adult patients with moderate-to-severe UC, who have had an inadequate response, loss of response, or were intolerant to conventional therapy or a biologic agent, in Greece.
Methods: A Markov cohort was adapted for projecting lifetime costs and outcomes, for a cohort of patients with moderate-to-severe UC from a Greek third-party payer perspective. Patients entered the model in the active UC state and transitioned to a remission or response state otherwise they underwent colectomy. Following, an initial 8-week induction treatment, patients received maintenance therapy until loss of response. Non-responders could switch up to two subsequent biologic lines. Clinical efficacy, adverse event (AEs) rates and utilities were derived from OCTAVE trials and a network-meta-analysis (NMA), while AE-related disutilities were obtained from literature. Treatment pathways and resource use were obtained through an advisory board. Unit costs were derived from official national sources (€, 2018). Extensive deterministic and probabilistic sensitivity analyses (DSA and PSA) were conducted.
Results: Over a life-time horizon, treating moderate-to-severe active UC with tofacitinib resulted in additional quality-adjusted life-years (QALYs) and lower total costs compared to vedolizumab (0.018; €6,408) and infliximab (biosimilar) (0.009; €3,031), hence, tofacitinib was estimated to dominate over both comparators. DSA showed model results were mostly influenced by differences in treatment efficacy from the NMA and target patient population. PSA confirmed robustness of findings below a threshold of €34,000 in 100% and 98% of the simulations comparing tofacitinib to vedolizumab and infliximab respectively.
Conclusions: The results of the analysis suggest that in the Greek setting, tofacitinib could be considered a cost-effective (dominant) treatment option for the treatment of patients with moderate-to-severe active UC.