ABSTRACT
INTRODUCTION: The efficacy and safety of empagliflozin in the treatment of heart failure with preserved ejection fraction (HFpEF) were demonstrated in the EMPEROR-Preserved trial, which showed a 21% reduction in combined risks of cardiovascular death or HF hospitalization [hazard ratio (HR) 0.79; 95% confidence interval (CI) 0.69-0.90, p < 0.001] and a 27% reduction in the total number of HF hospitalizations (HR 0.73; 95% CI 0.61-0.88, p < 0.001) compared with placebo. On the basis of these results, the present study aimed to assess the cost-effectiveness of empagliflozin + standard of care (SoC) compared with SoC alone in the treatment of HFpEF. METHODS: A published Markov model was adapted to compare the health and economic outcomes in France, considering a collective perspective, in patients treated with empagliflozin in addition to SoC versus patients treated by SoC alone. The model simulated the intention-to-treat (ITT) population of the trial, transitioning between four mutually exclusive health states representing the quartiles of the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS). For each arm, the model estimated (over a lifetime time horizon) the economics and the health outcomes (HF hospitalizations avoided, and life years and quality-adjusted life years (QALYs) gained) to calculate the incremental cost-effectiveness ratios (ICERs). The resources used were derived by pairing the FREnch Survey on HF (FRESH) cohort data to French health insurance claims data, and the utilities were derived on the basis of the EQ-5D-5L questionnaire valued on the French tariff. Both economic and health outcomes were discounted at a 2.5% annual rate. RESULTS: The model predicted that treatment of HFpEF patients with empagliflozin would prevent, for 1000 patients treated, 74 HF hospitalizations and 15 deaths attributable to cardiovascular events, resulting on average in a gain of 1 month in overall survival (7.24 versus 7.16 years with placebo) and 0.11 QALYs (6.14 versus 6.03 with placebo). Empagliflozin costs were partially offset by the cost savings from avoided hospitalizations. The ICERs were 18,597 per life year gained and 13,980 per QALY gained. The sensitivity analyses conducted showed that empagliflozin has a 65% probability to be cost-effective under the 25,000/QALY threshold. CONCLUSIONS: The base-case results showed that empagliflozin is a cost-effective strategy for management of HFpEF, in addition to the impact on public health by preventing HF-hospitalizations and deaths in France. Sensitivity analyses suggest that 65% of simulations are under the 25,000/QALY threshold.
ABSTRACT
BACKGROUND AND OBJECTIVES: Heart failure (HF) is one of the leading causes of morbidity and mortality, and economic burden on the healthcare system. The aim of this study was to estimate the current hospital resource utilization and costs for HF patients in France. METHODS: This retrospective cohort study included adult HF patients hospitalized in France between January 1, 2019 and December 31, 2019. Data related to sociodemographic characteristics, number and duration of hospital stays, use of medical procedures or expensive and innovative drugs/medical devices included in the "liste-en-sus", and comorbidities were retrieved from the French national hospital discharge database. Data were further stratified based on the presence or absence of cardiac decompensation, comorbidities, ejection fraction (EF) status, and incident/prevalent patients. RESULTS: In 2019, a total of 430,544 patients were hospitalized in France with HF as a primary or associated diagnosis, with 51.9% male and 48.1% female and a mean age of 79.0 years. More than 75% of the study population was composed of prevalent HF patients. About 3.1% of patients were diagnosed with at least one event of cardiac decompensation during follow-up. Also, 20.2% and 9.9% of patients were identified with preserved and reduced EFs, respectively. The average number and length of hospital stays were 1.7 per patient and 10.4 days per patient, respectively. The annual cost of hospitalization for HF was 8341.3 per patient. Presence of cardiac decompensation at index date or during follow-up, reduced EF, and comorbidities were associated with numerically higher frequency and length of hospitalization, and hospitalization cost. For hospitalization and 'liste-en-sus' medical devices, higher cost was observed in incident than prevalent HF patients, while for 'liste-en-sus' drugs, higher cost was reported in prevalent than incident HF patients. CONCLUSION: This study highlighted the high economic hospital burden of HF in France. More studies investigating different HF patient profiles must be conducted to help determine the main factors of hospital cost for HF.
