Post incorporation monitoring into the Brazilian Public Health System: an analysis of Infliximab, Vedolizumab and Tofacitinib for the treatment of ulcerative retocolitis

Abstract

Objective: to evaluate the implementation, use, cost of treatment per patient-year and the bu
dgetary impact of infliximab, vedolizumab and tofacitinib for the treatment of moderate
to severe ulcerative colitis in the SUS. Methods: A retrospective cohort study was carried
out using the Open Health Intelligence Situation Room, which originates from the SUS
Ambulatory Information System. All patients with primary ICD-10 ulcerative colitis and
using infliximab, vedolizumab or tofacitinib were included. The analysis period was from
May 2020 to December 2022. Results: After incorporation into the SUS, the time for
medicines to become available ranged from 7 to 20 months. Infliximab was the most
used (55%), but vedolizumab spread faster, with approximately 60 new patients per
month, followed by infliximab and tofacitinib with approximately 35 and 18 patients,
respectively. Unit prices for medicines were lower than those proposed in the incorpora
tion, except for tofacitinib in the last acquisition. In 2021, the cost per patient-year was
similar for infliximab and vedolizumab. In 2022, vedolizumab had the highest cost. The
budgetary impact of infliximab and vedolizumab was similar in the first year of imple
mentation and both had a lower budgetary impact than estimated at incorporation. In
the second year of infliximab implementation, the budgetary impact almost doubled due
to the greater dissemination of the drug. Conclusion: This analysis presents real-world
data, verifying the importance of monitoring the technologies incorporated by the SUS.