OBJECTIVES : Ulcerative colitis is a chronic inflammatory bowel disease whose main characteristic is the recurrent inflammation of the colon mucosa, which begins in the rectum and may extend to other segments of the organ. The objective of this study is to evaluate the budget impact of tofacitinib, in the treatment of patients with ulcerative colitis from moderate to severe, who have not responded to conventional medicines, in the perspective of Brazilian Ministry of Health (MoH).

METHODS : A budget impact analysis was performed to look at the overall cost to the SUS, considering a five-year time horizon and including only medicines direct costs. Tofacitinib was compared to the infliximab and vedolizumab. Data from SUS system computer department (DATASUS) was used to estimate the eligible population. This data was applied to the Brazilian population projection within a five-year period. The results were later evaluated in a deterministic sensitivity analysis, with three different scenarios.

RESULTS : A cohort of approximately 265 patients were eligible for tofacitinib treatment on year 1, up to 1,000 patients on year 5. The analysis resulted in a potential budgetary saving of approximately BRL 4,6 million in the first year of incorporation, reaching BRL 11,8 million in the fifth year. Over the five-year period, the accumulated savings were approximately BRL 37,8 million. The sensitivity analysis showed that the savings in costs provided by tofacitinib may vary from BRL 25,8 million to BRL 59,3 million accumulated over five years, depending of the chosen scenario.

CONCLUSIONS : Tofacitinib demonstrated potential savings in the treatment of patients who have not responded to conventional medicines. The incorporation could represent savings for the Brazilian MoH budget contributing to the rational use of health resources and to ensure access to the treatment of ulcerative colitis.