Empagliflozin, a sodium-glucose cotransporter 2 inhibitor, is FDA approved to reduce the risk of CV death in adults with T2DM and established CV disease. EMPA-REG OUTCOME showed a significant reduction in major adverse CV event (MACE), CV death, and hospitalization for heart failure (HHF) for empagliflozin vs. placebo in addition to SoC. Recently, CANVAS showed significant reduction in MACE and HHF with canagliflozin vs. placebo in addition to SoC. The objective of this study was to assess the cost-effectiveness of empagliflozin vs. canagliflozin or SoC in patients with T2DM and established CV disease in the U.S. A discrete event simulation model was used to simulate CV, renal, and select adverse events from EMPA-REG OUTCOME. Occurrence of each event was modeled using event-free survival curves with time-dependent covariates. A hazard ratio for canagliflozin vs. empagliflozin on each modeled event was estimated from published CANVAS data and EMPA-REG OUTCOME using an indirect treatment comparison. U.S. costs and utilities were taken from public sources. Patients receiving empagliflozin were predicted to live longer by 0.93 years vs. canagliflozin and 1.86 years vs. SoC due to lower CV death rates. When compared to SoC, empagliflozin had fewer or similar events per 100 patients-years, except for nonfatal stroke (NFST) and genital mycotic infection (GMI). For empagliflozin vs. canagliflozin, there were less amputation (0.58 vs. 1.08), kidney injury (0.33 vs. 0.47), and bone fracture (1.12 vs. 1.45); similar nonfatal myocardial infarction (1.93 vs. 1.85), HHF (1.74 vs. 1.65), albuminuria progression (5.96 vs. 6.14), composite renal outcome (1.16 vs. 1.20), and GMI (1.80 vs. 1.79); but more NFST (1.20 vs. 0.85). Based on a $100,000/QALY threshold, empagliflozin was cost-effective compared with canagliflozin or SoC at $2,932/QALY or $55,489/QALY, respectively.
A. Kansal: None. O. Reifsnider: Consultant; Self; Evidera. J. Lee: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. K. Fahrbach: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. P. Gandhi: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc.. E. Pfarr: None. A.V. Ustyugova: Employee; Self; Boehringer Ingelheim GmbH.