OBJECTIVES: Empagliflozin is recently reimbursed in Italy for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction. Hence, a cost-effectiveness analysis was developed to demonstrate the empagliflozin health economic value.

METHODS: A Microsoft Excel®-based Markov model was developed from the perspective of the Italian NHS with a lifetime time horizon. The model estimated the cost-effectiveness of empagliflozin in addition to SoC, compared to SoC alone, based on clinical efficacy and safety outcomes collected in the EMPEROR-Reduced clinical trial, and assessing health-related quality of life, as well as key cost elements for the treatment of patients with HFrEF. The model was developed to simulate patients’ progression through health states based on KCCQ-CSS (Clinical Summary Score) quartiles over time. Costs included direct medical costs for treatment acquisition (ex-factory gross price), costs for the management of clinical events, adverse events (AE) and disease management. All costs were extrapolated from the Italian national tariffs. Utilities were accrued based on time spent in each KCCQ-CSS quartile, adjusted for disutilities associated to HF-related hospitalisations and AEs. A 3% annual discount rate was applied to costs and health outcomes. Deterministic and probabilistic sensitivity analyses were run to assess the robustness of results.

RESULTS: Over the lifetime horizon, patients treated with empagliflozin as an add on to SoC experienced lower rates of hHF (hospitalization Hearth Failure) and CV (cardiovascular) death compared to SoC alone. Considering the incremental total costs and QALYs, an ICER of €6,689 per QALY was demonstrated, thus significantly below the willingness-to-pay threshold of €30.000 - €60.000, defined acceptable for the evaluation of the cost effectiveness in Italy. The robustness of results was confirmed by sensitivity analyses.

CONCLUSIONS: The results clearly indicate that empagliflozin is a new cost-effective therapeutic option for the Italian NHS in the treatment of HFrEF patients on top of standard therapy.