inine ratio (UACR). This enables the cost-effectiveness analysis of empagliflozin in subgroups stratified by these two parameters. Methods: A cost-utility analysis using the Markov model was performed to evaluate the cost-effectiveness of adding empagliflozin to the standard treatment for CKD in Japan over 20 years of observation. Each cohort with the initial eGFR (≥45 but <60 ml/min per 1.73 m2, ≥30 but <45 ml/min per 1.73 m2, or ≥20 but <30 ml/min per 1.73 m2) and UACR (<30 mg/g, ≥30 but <300 mg/g, or ≥300 mg/g) within the defined ranges was analyzed. The changes in eGFR were determined based on the EMPA-KIDNEY study. An incremental cost-effectiveness ratio (ICER) of <¥5,000,000 (approximately $35,500) per quality-adjusted life-year (QALY) was considered cost-effective. One-way deterministic analyses, probabilistic sensitivity analyses and scenario analyses were conducted to ensure the robustness of the results. Results: The addition of empagliflozin to standard treatment was associated with lower costs and higher QALYs in the macroalbuminuria or microalbuminuria cohorts, while the ICERs in the negative albuminuria cohorts were >\5,000,000 per QALY, regardless of the initial eGFR. The probabilities of empagliflozin being cost-effective were >84% in the macroalbuminuria or microalbuminuria cohorts but <30% in the negative albuminuria cohorts. Scenario analyses where empagliflozin suppressed the eGFR decline in the negative albuminuria cohorts showed that the drug was cost-effective in CKD stage G3b and G4 cohorts. Empagliflozin was not cost-effective in patients with CKD stage G3a and microalbuminuria with the observation period of 10 years. Conclusion: In patients meeting the enrollment criteria for the EMPA-KIDNEY trial, the addition of empagliflozin to the standard treatment of CKD was judged as cost-effective for patients with albuminuria but not for those without albuminuria in Japanese healthcare system. Copyright © 2024 by the American Society of Nephrology...

中文翻译：

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恩格列净治疗伴或不伴蛋白尿的慢性肾脏病的成本效益


内线比（UACR）。这使得能够在按这两个参数分层的亚组中对恩格列净进行成本效益分析。方法：使用马尔可夫模型进行成本效用分析，以评估在日本 20 年观察中将恩格列净添加到 CKD 标准治疗中的成本效益。每个队列的初始 eGFR（每 1.73 m2 ≥45 但<60 ml/min，每 1.73 m2 ≥30 但<45 ml/min，或每 1.73 m2 ≥20 但<30 ml/min）和 UACR（<30 mg）分析定义范围内的≥30mg/g，但<300mg/g，或≥300mg/g）。 eGFR 的变化是根据 EMPA-KIDNEY 研究确定的。每个质量调整生命年 (QALY) 的增量成本效益比 (ICER) 为 <¥5,000,000（约 35,500 美元）被认为具有成本效益。进行了单向确定性分析、概率敏感性分析和情景分析，以确保结果的稳健性。结果：在标准治疗中添加恩格列净与大量白蛋白尿或微量白蛋白尿队列中较低的成本和较高的 QALY 相关，而阴性白蛋白尿队列中的 ICER 为 >\5,000,000/QALY，无论初始 eGFR 是多少。在大量白蛋白尿或微量白蛋白尿队列中，恩格列净具有成本效益的概率为 >84%，但在阴性白蛋白尿队列中为 <30%。恩格列净抑制蛋白尿阴性队列中 eGFR 下降的情景分析表明，该药物在 CKD G3b 和 G4 期队列中具有成本效益。对于观察期为 10 年的 CKD G3a 期和微量白蛋白尿患者，恩格列净并不具有成本效益。 结论：在日本医疗保健系统中，在符合 EMPA-KIDNEY 试验入组标准的患者中，在 CKD 标准治疗中添加恩格列净对于有蛋白尿的患者被认为具有成本效益，但对于无蛋白尿的患者则不然。版权所有 © 2024 美国肾脏病学会...