背景:将finerenone添加到当前的护理标准(SoC)中,根据中国指南的建议,在具有里程碑意义的FIDELIO-DKD试验中,CKD和2型糖尿病(T2D)患者在延缓慢性肾脏病(CKD)进展和降低心血管风险方面显示出实质性益处.本研究旨在从医疗保健系统的角度评估中国T2D和CKD患者中FinerenoneSoC与单独SoC的成本效益。
方法:已经开发并发布了成本效益模型(FINE-CKD),健康状态定义为CKD阶段(CKD1/2,CKD3,CKD4和CKD5,没有肾脏替代疗法(RRT),透析,或移植)和心血管事件病史。此外,该模型还考虑了不良事件.使用来自FIDELIO-DKD亚洲人群分析的患者水平数据得出过渡概率和事件风险。由于国家报销药品清单(NRDL)后的finenone价格是保密的,假设模型中finenone的成本与SoC的成本相同。其他卫生资源成本来自文献,并通过医生访谈进行补充。通过EQ-5D-5L问卷测量,根据中文EQ-5D-5L值集将生活质量转化为效用。
结果:每年按5.0%贴现,在一生的地平线上,finerenone+SoC的质量调整寿命年(QALYs)增益为0.321,而单独使用SoC(8.660vs.8.338QALYs),由于心血管事件和透析的发生率降低。在finerenone+SoC下,每位患者的总成本低于单独的SoC(381,130元人民币与392,390元人民币)。因此,与单用SoC相比,finerenone+SoC是主要的治疗策略。敏感性分析证实了本研究的稳健性。
结论:在中国CKD和T2D患者中,与单用SoC相比,在SoC中添加finenerone可能是一种主要或具有成本效益的治疗选择。
BACKGROUND: Adding finerenone to current standard of care (SoC), as recommended by Chinese guidelines, has shown substantial benefit in delaying chronic kidney disease (CKD) progression and reducing cardiovascular risk in patients with CKD and type 2 diabetes (T2D) in the landmark FIDELIO-DKD trial. This study aimed to evaluate the cost-effectiveness of finerenone + SoC versus SoC alone among Chinese patients with T2D and CKD from a healthcare system perspective.
METHODS: A cost-effectiveness model (FINE-CKD) has been developed and published, with health states defined for CKD stages (CKD 1/2, CKD 3, CKD 4, and CKD 5 without renal replacement therapy (RRT), dialysis, or transplant) and cardiovascular event history. Additionally, the model also considered adverse events. Transition probabilities and event risks were derived using patient-level data from Asian population analysis of FIDELIO-DKD. Since the price of finerenone after the national reimbursement drug list (NRDL) inclusion was confidential, the cost of finerenone in the model was assumed to be the same as that of SoC. Other health resource costs were gathered from literature and supplemented by physician interviews. Measured by the EQ-5D-5L questionnaire, quality of life was translated into utilities based on the Chinese EQ-5D-5L value set.
RESULTS: Discounted at 5.0% annually, over a lifetime horizon, finerenone + SoC resulted in a quality-adjusted life years (QALYs) gain of 0.321 versus SoC alone (8.660 vs. 8.338 QALYs), due to a reduction in the incidence of cardiovascular events and dialysis. Total costs per patient were lower under finerenone + SoC than SoC alone (381,130 CNY vs. 392,390 CNY). As a result, finerenone + SoC was a dominant treatment strategy compared with SoC alone. Sensitivity analysis has confirmed the robustness of this study.
CONCLUSIONS: Adding finerenone to SoC was likely to be either a dominant or cost-effective treatment option compared with SoC alone in Chinese patients with CKD and T2D.