Cost-effectiveness of empagliflozin in patients with type 2 diabetes mellitus with high cardiovascular risk in the Brazilian private healthcare system perspective

Abstract

Objective: To evaluate the cost-effectiveness of empagliflozin added to usual care in type 2 diabetes mellitus (T2DM) in the private healthcare sector. Methods: We used a discrete events simulation model with effectiveness data based on the EMPA-REG OUTCOME trial. The population included patients with T2DM at high cardiovascular risk (history of ischemic heart disease, stroke, or peripheral vascular disease). A lifetime horizon and a 5% annual discount rate were used. The utility data used were predominantly from Brazilian studies. To estimate the cost of events/conditions with statistically significant difference in the EMPA-REG OUTCOME trial (heart failure, dialysis, cardiovascular death), a systematic review was performed to identify studies with data from the private healthcare system. A willingness-to-pay threshold of 1 GDP per capita (2017: R$ 31,587) was considered. Deter ministic sensitivity analysis and a probabilistic sensitivity analysis were performed. Results: In the base case, empagliflozin generated incremental 0.66 QALY as compared to usual care, with an added cost of R$ 12,630 and incremental cost-effectiveness ratio (ICER) of R$ 18,895/QALY. None of the pa[1]rameter variations evaluated by deterministic analysis generated ICERs above the cost-effectiveness threshold. Probabilistic sensitivity analysis revealed mean ICER of R$ 19,878/QALY (credibility interval 2.5% to 97.5%: R$ 5,237 to R$ 36,451). Considering 1 GDP per capita, 50% of the simulations would be cost-effective; considering 2 GDP per capita, over 90% would be cost-effective. Conclusion: Considering a threshold of 1 GDP per capita, the study shows that empagliflozin was cost-effective from the perspective of the Brazilian private healthcare sector.