Abstract
Introduction: Ulcerative colitis is a chronic immune-mediated inflammatory condition of the large intestine, often associated with inflammation of the rectum. Currently, the Brazilian Unified Health System (SUS) provides medications like infliximab, vedolizumab, and tofacitinib for cases of steroid-dependent ulcerative colitis despite adequate doses of azathioprine for a minimum of 12 weeks. Objective: This study aims to evaluate the implementation, utilization, cost per patient-year of treatment, and budgetary impact of infliximab, vedolizumab, and tofacitinib for the treatment of moderate to severe ulcerative colitis within the SUS. Materials and Methods: A retrospective cohort study was conducted using data from the Health Intelligence Situation Room (Sabeis), derived from the Ambulatory Information System of SUS (SIA/SUS). The study included all patients with a primary ICD-10 diagnosis of ulcerative colitis who were receiving infliximab, vedolizumab, or tofacitinib. The analysis period ranged from the implementation of infliximab until December 2022. Results: Following their incorporation into SUS, these medications became available within periods ranging from 7 to 20 months. A total of 5,484 patients were treated, with 5,038 still receiving treatment in 2022. Infliximab was the most utilized (55%), possibly due to being the first implemented. However, vedolizumab showed the highest growth rate, with an increase of approximately 60 patients per month, followed by infliximab and tofacitinib with around 35 and 18 patients per month, respectively (p<0.001). Unit prices of these medications were lower than initially proposed upon incorporation and decreased further post-incorporation, except for tofacitinib in the latest acquisition. In 2022, vedolizumab had the highest cost per patient-year of treatment (R$25,802.16 in the first year and R$19,351.62 in the second year). Infliximab and tofacitinib were approximately 20% and 50% cheaper than vedolizumab, respectively, in the first and second year after implementation. The budgetary impact of infliximab and vedolizumab was similar in the first year (R$17,499,132.00 and R$15,259,756.00, respectively). In the second year of infliximab implementation, the budgetary impact nearly doubled due to wider adoption (R$33,474,056.94). The budgetary impact for infliximab and vedolizumab was lower than estimated in the incorporation report, which projected R$34,360,544.12 and R$45,922,752.22, respectively, for the first year. However, tofacitinib could not be fully evaluated due to its incorporation period being less than 12 months. Discussion and Conclusions: This study provides real-world data on infliximab, vedolizumab, and tofacitinib for treating ulcerative colitis, underscoring the importance of monitoring technologies incorporated into SUS.
