OBJECTIVES: To evaluate the cost-effectiveness of tofacitinib for the treatment of moderate-to-severe ulcerative colitis (UC) after conventional therapy (mesalazine, corticosteroids or thiopurines) failure or intolerance, from the Spanish National Health System (NHS) perspective.

METHODS: A lifetime Markov model with eight-week cycle duration was developed including four health states relevant to the clinical practice and natural history of UC: remission, response, active UC and remission after surgery.

Tofacitinib was compared to adalimumab, infliximab and vedolizumab. A subsequent biologic treatment was allowed after failure for both initial treatments. A multinomial network meta-analysis was conducted to determine response and remission probabilities at both induction and maintenance phases. Health utilities and annual surgery rate were extracted from literature.

Each treatment’s posology was extracted from its summary of product characteristics. Only direct costs were considered (€, 2019): drug costs (ex-factory price with mandatory deductions), administration, surgery, patient management and adverse event costs. Unitary costs were obtained from national databases. Biosimilar acquisition prices were used when applicable. Costs and outcomes were discounted at 3% and a €25,000/quality-adjusted life-years (QALY) threshold value was used. Probabilistic sensitivity analyses (PSA) were conducted.

RESULTS: In biologic-naïve patients, tofacitinib is a dominant therapy vs adalimumab and vedolizumab. It is associated with substantial cost savings of €45,974.16 vs adalimumab; €53,275.70 vs infliximab and €98,379.93 vs vedolizumab. Differences in QALYs are smaller than 0.2 for all comparisons (being 0.19 and 0.00014 in favor of tofacitinib vs adalimumab and vedolizumab, respectively; and 0.06 in favor of infliximab). PSA showed that, for all comparisons, tofacitinib has a probability of being cost-effective above 98%.

CONCLUSIONS: According to our results, lifetime QALY gains appear to be similar for all three comparisons while tofacitinib is the most cost-saving therapy for treating moderate-to-severe UC in biologic-naïve patients after conventional therapy failure or intolerance, from the Spanish NHS perspective.