OBJECTIVES: EMPEROR-Preserved was a phase III, randomized and double-blind trial comparing empagliflozin to placebo, both added to Standard of Care (SoC), in patients with HFpEF. Empagliflozin showed a 21%-reduction in combined risks of cardiovascular (CV) death or HF-hospitalization (95%CI: 0.69-0.90, p<0.001) and a 27%-reduction in total number of HF-hospitalizations (95%CI: 0.61-0.88, p<0.001). A Markov model was adapted to assess the impacts of empagliflozin+SoC vs. SoC for HFpEF in France.

METHODS: The model health states were defined based on KCCQ-CSS quartiles in the ITT population of EMPEROR-Preserved. The SoC in EMPEROR-Preserved was considered consistent with clinical guidelines by French experts and clinical inputs (event rates) were obtained from the trial for both arms. Different costs were considered, including acquisition costs, disease management costs, etc. Resource use frequencies were derived from the FRESH cohort study linked to French health insurance claims. EQ-5D-5L utility data with French tariff were considered. The model outcomes included costs, HF-hospitalizations, life-years (LY) gained and quality-adjusted LY (QALY). Costs (€2021) were discounted at a 2.5%-annual rate.

RESULTS: Over a lifetime horizon, empagliflozin+SoC was predicted to result in longer survival vs. SoC (7.24 vs. 7.16 LY respectively) and a gain in QALYs (6.19 vs. 6.09 QALYs), resulting ICERs of 18,597€/LY and 13 902 €/QALY - meaning that empagliflozin should improve both survival and quality of life. In addition, empagliflozin was predicted to avoid 74 HF-hospitalizations, representing a gross cost-savings of 166K€, and 15 CV-deaths per 1000-patients treated, compared to placebo. Sensitivity analyses ensured the robustness of the model (about 73 HF-hospitalizations and 15 CV-deaths avoided with a 500-replications probabilistic analysis).

CONCLUSIONS: Over a lifetime horizon, this analysis shows that empagliflozin is highly cost-effective with ICERs lower than 20,000 €/LY and €/QALY. The utilization of empagliflozin would have a significant impact on public health in France, in terms of HF-hospitalizations and CV-deaths avoided.