OBJECTIVES: The EMPA-REG OUTCOME trial showed that empagliflozin is effective in the treatment of type 2 diabetes (T2D) with a previous history of cardiovascular (CV) disease. The Objective of this study is the cost-effectiveness analysis of empagliflozin 10mg or 25mg for the treatment of T2D patients with a previous history of CV disease, from the Italian National Health Service (NHS) perspective.

METHODS: The analysis was performed with an individual simulation model predicting the time to any CV event or CV death through a set of time-dependent regressions estimated on the patient-level data of the EMPA-REG OUTCOME trial. The model was adapted to the Italian setting, considering local epidemiological data, baseline QoL utility, background mortality and unit costs for treatments and healthcare resources from current prices and tariffs. The cost perspective was that of the Italian health service and the horizon of the simulation was lifetime. Costs and benefits were discounted at a 3.5% rate.

RESULTS: Base case results were estimated on a cohort of 5,000 patients. Patients treated with empagliflozin in add-on to the standard of care (SoC) lived on the average 13.8 undiscounted years as compared to 11.8 years of patients on SoC alone. The gain in discounted QALYs was 1.0, due to improved survival and QoL linked to the reduced incidence of CV events and CV mortality. The ICER was Euro 4,811/QALY, well below the commonly applied threshold of Euro 30,000-50,000/QALY.

CONCLUSIONS: Empagliflozin in add-on to the standard of care is a highly cost-effective strategy for the treatment of T2D patients with known CV disease in the Italian setting.