OBJECTIVES

Guideline for Ulcerative Colitis (UC) determining conduct in the treatment of patients of the Public Health System (SUS) in Brazil was published in 2002 and did not include biological drugs for moderate to severe UC. To update this guideline, we conducted a cost-effectiveness analysis of treatment with adalimumab (ADA), infliximab (IFX), golimumab (GOL) and vedolizumab (VDZ) to assist the National Technology Incorporation Committee in Health - Conitec in the evaluation of its incorporation in SUS.

METHODS

: Systematic review was performed using the MEDLINE (PubMed), EMBASE and LILACS databases to explore the efficacy and safety of biological products. Hybrid model of decision tree/Markov was developed using TreeAge Pro® 2018 software to simulate the progression in a cohort of patients with moderate to severe UC in the SUS perspective. Rates of adverse events, surgery, surgical complications and utilities were found in the literature. Treatment costs were estimated according to public purchase prices. Time horizon was a lifetime, with costs and results discounted at 5% per year. Cost, quality-adjusted life years (QALYs), and incremental cost-effectiveness indices (ICER) were reported. Unidirectional and probabilistic sensitivity analyzes were performed.

RESULTS

: IFX was the most economical biological compared to ADA, considering a limit of 3 GDP per capita / QALY (ICER: $ 9,435.37 / QALY). VDZ showed a worse ICER compared to adalimumab ($ 14,053.88 / QALY) and IFX ($ 18,273.91 / QALY). Sensitivity analyzes showed that the most sensitive results were the induction response to each treatment. Infliximab was superior to other biological considering the data on efficacy and cost-effectiveness for the SUS. Indirect evidence data showed that VDZ is comparable to IFX in efficacy.

CONCLUSIONS

: According to evidence Conitec recommended the incorporation of IFX and VDZ for treatment of moderate to severe UC, provided that the cost of treating VDZ is equal to the cost of IFX treatment.