Slob Bart P H, Postma Maarten J, Weersma Maaike, Rocca Hans-Peter Brunner-La, de Jong Lisa A, Boersma Cornelis
Health-Ecore B.V., Zeist, The Netherlands.
Department of Health Sciences, Global Health Unit, University Medical Center Groningen, University of Groningen, 9713 GZ, Groningen, The Netherlands.
Am J Cardiovasc Drugs. 2025 Jul 12. doi: 10.1007/s40256-025-00749-6.
Clinical trials have demonstrated the efficacy of the sodium-glucose cotransporter-2 inhibitor (SGLT2i) empagliflozin in patients suffering from heart failure (HF), regardless of whether their left-ventricle ejection fraction (LVEF) is reduced (HFrEF), mildly reduced (HFmrEF), or preserved (HFpEF). This study aims to assess the cost-effectiveness of empagliflozin when added to standard of care (SoC), consisting of lifestyle changes, medications, and surgery or devices, compared to SoC alone in patients with chronic HF irrespective of LVEF in the Netherlands.
A Markov model was developed to simulate patient outcomes over a lifetime horizon, incorporating data from the EMPEROR-Reduced and EMPEROR-Preserved trials. Key outcomes included incremental cost-effectiveness ratios (ICERs) expressed in costs per quality-adjusted life-year (QALY) gained, life expectancy, and hospitalization rates. Probabilistic and one-way sensitivity analyses were conducted to assess the robustness of the results.
The analysis revealed that treatment with empagliflozin plus SoC resulted in higher life expectancy (6.58 vs. 6.47 years for HFrEF; 7.78 vs. 7.69 years for HFmrEF/HFpEF) and a lower incidence of HF hospitalizations compared to SoC alone. The ICERs were €8515/QALY for HFrEF and €9807/QALY for HFmrEF/HFpEF, both below the willingness-to-pay threshold of €50,000/QALY, indicating cost-effectiveness. Sensitivity analyses confirmed the robustness of the results, indicating there is a high probability (97% for HFrEF and 98% for HFmrEF/HFpEF) that empagliflozin plus SoC is cost-effective.
Empagliflozin, when added to SoC, is a cost-effective treatment option for patients irrespective of LVEF in the Netherlands.
临床试验已证明钠-葡萄糖协同转运蛋白2抑制剂（SGLT2i）恩格列净对心力衰竭（HF）患者有效，无论其左心室射血分数（LVEF）是降低（射血分数降低的心力衰竭，HFrEF）、轻度降低（射血分数轻度降低的心力衰竭，HFmrEF）还是保留（射血分数保留的心力衰竭，HFpEF）。本研究旨在评估在荷兰，与仅采用包括生活方式改变、药物治疗以及手术或器械治疗的标准治疗（SoC）相比，恩格列净添加到SoC中治疗慢性HF患者（无论LVEF如何）的成本效益。
建立了一个马尔可夫模型，以模拟患者一生的预后情况，纳入了EMPEROR-Reduced试验和EMPEROR-Preserved试验的数据。主要结局包括以每获得一个质量调整生命年（QALY）的成本表示的增量成本效益比（ICER）、预期寿命和住院率。进行了概率分析和单向敏感性分析，以评估结果的稳健性。
分析显示，与仅采用SoC相比，恩格列净加SoC治疗可提高预期寿命（HFrEF患者为6.58年对6.47年；HFmrEF/HFpEF患者为7.78年对7.69年），并降低HF住院发生率。HFrEF患者的ICER为每QALY 8515欧元，HFmrEF/HFpEF患者为每QALY 9807欧元，均低于每QALY 50000欧元的支付意愿阈值，表明具有成本效益。敏感性分析证实了结果的稳健性，表明恩格列净加SoC具有成本效益的概率很高（HFrEF患者为97%，HFmrEF/HFpEF患者为98%）。
在荷兰，对于无论LVEF如何的患者，恩格列净添加到SoC中是一种具有成本效益的治疗选择。
