OBJECTIVES:

We assessed the cost-effectiveness of empagliflozin in Japan based on the Asian subgroup analysis of the EMPA-REG OUTCOME trial.

METHODS:

In the EMPA-REG OUTCOME trial, empagliflozin reduced the risk of cardiovascular (CV) and renal events in patients with type 2 diabetes and established CV disease. Cost-effectiveness analysis based on the overall population of the EMPA-REG OUTCOME trial was reported previously by using lifetime discrete event simulation model. The same modeling frame was adapted to evaluate the cost-effectiveness of treatment with empagliflozin added to standard of care (SoC) compared to SoC in Japan. The time to relevant clinical events and the hazard ratios were derived from an Asian subgroup analysis of the EMPA-REG OUTCOME trial. The costs for each event were estimated from Japanese medical claims data. Direct medical cost, life expectancy and quality-adjusted life years (QALYs) were calculated from a payers’ perspective.

RESULTS:

Treatment with empagliflozin was estimated to increase life expectancy by 3.9 year and 2.1 QALYs while total cost increased by 814,764 yen (6,267 € at an exchange rate of 1 €=130 yen) compared to treatment with SoC. The incremental cost-effectiveness ratio (ICER) was 384,636 yen/QALY (2,959 €/QALY). In the sensitivity analysis, there was no case which was in excess of the reference value of ICER in the pilot introduction for price revision in Japan, 5 million yen/QALY (38,462 €/QALY).

CONCLUSIONS:

Based on the Asian subgroup analysis of the EMPA-REG OUTCOME trial, our results suggest that empagliflozin is highly cost-effective compared with SoC in Japan.