Cost-utility of empagliflozin in type 2 diabetic patients with high cardiovascular risk in the Brazilian Public Healthcare System perspective

Abstract

Objective: To perform a cost-utility analysis of empagliflozin in type 2 diabetes (T2D) patients with high cardiovascular risk. Methods: The model was a discrete events simulation, with data based on the incidence of cardiovascular events in the EMPA-REG OUTCOME clinical trial. The target population was composed by patients with T2D and high cardiovascular risk (history of ischemic heart disease, stroke or peripheral vascular disease). We used a lifetime horizon, 5% discount rate and the Brazilian Public Healthcare System (SUS) perspective. Utility data were based both on Brazilian and international data. Costs employed reflected reimbursement SUS values. We conducted deterministic sensitivity analysis in main model parameters and a probabilistic sensitivity analysis to globally evaluate robustness of the results. Results: In the base case, empagliflozin generated incremental 0.66 QALY and R$ 19,176, resulting in an incremental cost-effectiveness ratio (ICER) of R$ 28,960/ QALY. Univariate sensitivity analysis showed variations in the ICER between R$ 23,644 and R$ 38,850/ QALY, with the diabetes status utility the variable with most influence in the ICER. In the probabilistic sensitivity analysis, 2.5% and 97.5% percentiles were R$ 22,336 and R$ 39,571/QALY. Conclusion: The study showed an ICER of R$ 28,960/QALY, which is below the value of one GDP per capita in Brazil (R$ 30,407 in 2016), which would therefore be deemed cost-effective under this threshold. In probabilistic sensitivity analysis, credible interval ranged between 0.73 and 1.30 per capita GDP, therefore showing robust results.