Abstract
Background
The DAPA-HF and DELIVER trials demonstrated the clinical benefits of dapagliflozin in heart failure (HF) patients across the entire ejection fraction (EF) spectrum. However, further investigation is needed for the real-world application of dapagliflozin in HF patients. This study examines the proportion of real-world HF patients eligible for dapagliflozin and evaluates the cost-effectiveness of adding dapagliflozin to current HF therapy.
Methods
Data from the nationwide prospective registry, the Korean Acute Heart Failure (KorAHF) registry, were used to determine dapagliflozin eligibility based on the enrollment criteria of the DAPA-HF/DELIVER trials. A cost-utility analysis was conducted using a Markov model to assess the cost-effectiveness of dapagliflozin by comparing it to the standard of care.
Results
Out of 5178 KorAHF patients, 48.7% met the enrollment criteria of the DAPA-HF/DELIVER trials, while 89.5% met the label criteria (US Food and Drug Administration, European Medicines Agency, and Korean Ministry of Food and Drug Safety). Eligibility was highest among HF patients with preserved EF (55.3% vs. HF with mildly reduced EF and HF with reduced EF 46.4%). Dapagliflozin proved to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of 4557 US dollar (US$) per quality-adjusted life year, which falls below the US$18,182 willingness-to-pay threshold. The cost-effectiveness benefit was more pronounced in patients with a left ventricular EF (LVEF) ≤ 40% (ICER US$3279 for LVEF ≤ 40% vs. US$8383 for LVEF > 40%).
Conclusions
Discrepancies in dapagliflozin eligibility were observed between real-world data and clinical trial results. The addition of dapagliflozin to HF therapy proved to be highly cost-effective across the entire EF spectrum.
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Acknowledgements
The authors express sincere gratitude to all participants, research coordinators, and investigators in the KorAHF registry who enabled this study.
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This work was supported by a National Research Foundation of Korea (NRF) Grant funded by the Ministry of Science and ICT (NRF-2021R1F1A1063430), the Catholic Medical Center Research Foundation (2023), AstraZeneca Korea Ltd. (ESR-21-21608), the Catholic University of Korea Research Fund (2020), and the Research of Korea Centers for Disease Control and Prevention (2010-E63003-00, 2011-E63002-00, 2012-E63005-00, 2013-E6300300, 2014-E63003-01, 2015-E63003-02, 2016-ER6303-00, and 2017-ER6303-01). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.
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The data that support the findings of this study are not publicly available due to reasons of sensitivity but are available from the corresponding author upon reasonable request.
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The study conformed to the principles outlined in the Declaration of Helsinki.
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E-SK, S-KP, and J-CY conceptualized the study. E-SK, S-KP, and DS-hC did the statistical analysis. J-CY, HSL, H-YL, H-JC, J-OC, E-SJ, SEL, M-SK, J-JK, K-KH, M-CC, SCC, S-MK, JJP, D-JC, B-SY, JYC, KHK, B-HO, and SHB participated in data curation. J-CY supervised the study. E-SK and S-KP wrote the original draft. E-SK, S-KP, J-CY, and BG reviewed and edited the manuscript. All authors read and approved the final manuscript.
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Kim, ES., Park, SK., Cho, D.Sh. et al. Eligibility and Cost-Utility Analysis of Dapagliflozin in Patients with Heart Failure Across the Whole Spectrum of Ejection Fraction in South Korea. Am J Cardiovasc Drugs 24, 313–324 (2024). https://doi.org/10.1007/s40256-024-00632-w
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DOI: https://doi.org/10.1007/s40256-024-00632-w