Heart and Kidney Protection with Empagliflozin (EMPA-KIDNEY) expanded the CKD population that may benefit from sodium-glucose cotransporter 2 inhibitors in terms of eGFR and urine albumin-to-creatinine ratio. This enables a 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 urine albumin-to-creatinine ratio (<30 mg/g, ≥30 but <300 mg/g, or ≥300 mg/g) within the defined ranges was analyzed. The changes in eGFR were determined on the basis of the EMPA-KIDNEY study. An incremental cost-effectiveness ratio 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 the standard treatment was associated with lower costs and higher QALYs in the macroalbuminuria or microalbuminuria cohorts while the incremental cost-effectiveness ratios 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. Conclusions 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 the Japanese health care system....

中文翻译：

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恩格列净治疗伴或不伴白蛋白尿的 CKD 的成本效益


恩格列净保护心脏和肾脏 （EMPA-KIDNEY） 扩大了 CKD 人群，这些人群可能在 eGFR 和尿白蛋白/肌酐比值方面受益于钠-葡萄糖协同转运蛋白 2 抑制剂。这使得能够对按这两个参数分层的亚组中的 empagliflozin 进行成本效益分析。方法 使用 Markov 模型进行成本效用分析，以评估 20 年观察中在日本 CKD 标准治疗中添加恩格列净的成本效益。初始 eGFR （≥45 但 <60 ml/min 每 1.73 m2，≥30 但 <45 ml/min 每 1.73 m2，或 ≥20 但 <30 ml/min 每 1.73 m2）和尿白蛋白与肌酐比值 （<30 mg/g，≥30 但 <300 mg/g，或 ≥300 mg/g）在规定范围内的每个队列被分析。eGFR 的变化是根据 EMPA-KIDNEY 研究确定的。每个质量调整生命年 （QALY） 的增量成本效益比为 <¥5,000,000（约合 35,500 美元）被认为是具有成本效益的。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 在标准治疗中加入恩格列净与大量白蛋白尿或微量白蛋白尿队列中的较低成本和较高 QALY 相关，而阴性白蛋白尿队列中的增量成本效益比为每 QALY >¥ 5,000,000，与初始 eGFR 无关。恩格列净在大量白蛋白尿或微量白蛋白尿队列中具有成本效益的概率为 >84%，但在阴性白蛋白尿队列中为 <30%。 恩格列净抑制阴性白蛋白尿队列中 eGFR 下降的情景分析表明，该药物在 CKD 期 G3b 和 G4 队列中具有成本效益。恩格列净对 CKD G3a 期和微量白蛋白尿患者（观察期为 10 年）没有成本效益。结论 在符合 EMPA-KIDNEY 试验入组标准的患者中，在日本医疗保健系统中，将恩格列净添加到 CKD 的标准治疗中被认为对白蛋白尿患者具有成本效益，但对无白蛋白尿的患者则不具有成本效益。