OBJECTIVES: To evaluate the cost-effectiveness of tofacitinib for the treatment of moderate-to-severe active ulcerative colitis (UC) after failure or intolerance to a first line of biologic treatment, from the Spanish National Health System perspective.

METHODS: A lifetime Markov model with eight-week cycle duration was developed including four health states: remission, response, active UC and remission after surgery. Three scenarios were defined to compare tofacitinib versus adalimumab, infliximab and vedolizumab after failure/intolerance to a biologic drug (bio-experienced population). A multinomial network meta-analysis (NMA) was conducted to determine transition probabilities at both induction and maintenance phases. Utility values for each health state were extracted from literature.

Each treatment’s posology was extracted from its summary of product characteristics. Direct costs were considered (€, 2019): drug acquisition costs (ex-factory price with mandatory deductions), administration, surgery, patient management and adverse event costs. Local unitary costs were applied from national databases. A 3% discount rate was applied to costs and outcomes. A €25,000€/quality-adjusted life-years (QALY) threshold value was considered. Probabilistic sensitivity analyses (PSA) were conducted.

RESULTS: Tofactinib is a dominant treatment and generates cost savings of €2,890.91 vs infliximab and €11,437.56 vs vedolizumab; with small QALY differences (<0.05). Compared to adalimumab, tofacitinib generates small QALY gains (0.09) and presents slight incremental costs (€961.68), mostly due to a lower efficacy of adalimumab (NMA) that would cause an increased treatment discontinuation and thereby reduce pharmaceutical costs. PSA showed that tofacitinib has a probability of being cost-effective of 59.70% vs adalimumab, and over 74% vs infliximab and vedolizumab.

CONCLUSIONS: According to the analysis results, after failure or intolerance to biologic therapy, tofacitinib is a cost-saving therapy for the treatment of bio-experienced moderate-to-severe UC patients with similar QALY gains vs infliximab and vedolizumab. Besides, it is a cost-effective alternative when compared to adalimumab (incremental cost-effectiveness ratio: €10,567.21/QALY).