OBJECTIVES: To evaluate the cost-effectiveness of empagliflozin, in addition to standard of care (SoC), for the treatment of adult patients with Type 2 diabetes mellitus (T2DM) and high cardiovascular risk (CV) in Greece.

METHODS: A health economic model was used to project clinical and economic outcomes of patients receiving empagliflozin plus SoC compared with those receiving SoC alone over a lifetime horizon. Long-term CV and renal event rates were derived from patient level data from EMPA-REG-OUTCOME trial by fitting time-dependent parametric survival functions. 5,000 individual patient profiles randomly sampled from the trial were simulated using a time to event approach. Model extrapolated outcomes included life years (LYs), quality-adjusted life years (QALYs), costs as well as incremental cost-effectiveness ratios (ICERs). Following a Greek third-party payer perspective, only direct medical costs related to drug acquisition as well as fatal and non-fatal developed diabetes-related complications were considered (€ 2016). Resource consumption associated with each treatment was based on experts’ advice. Cost units and utility data were extracted from literature and publicly available official sources. Sensitivity analyses explored the impact of changes in input data.

RESULTS: Over a patient’s lifetime, empagliflozin was predicted to result in longer mean survival (14.01 LY versus 11.87 LY with SoC) and reduced rate of clinical events accumulating 7.75 QALYs versus 6.83 QALYs on SoC alone at additional costs of €4,235. The generated ICER of empagliflozin was €4,633 per QALY gained. One-way sensitivity analysis confirmed empagliflozin cost-effective profile. At the defined willingness-to-pay threshold of €34,000 per QALY gained, probabilistic sensitivity analysis showed that empagliflozin was estimated to have a 100% probability of being cost-effective relative to SoC.

CONCLUSIONS: Empagliflozin added to SoC was estimated to be a highly cost-effective treatment option for the treatment of T2DM in adults with increased CV disease risk in Greece.