Cherney David, Drzewiecka Aleksandra, Folkerts Kerstin, Levy Pierre, Millier Aurélie, Morris Stephen, Pochopień Michał, Roy-Chaudhury Prabir, Sullivan Sean D, Mernagh Paul
University Health Network, University of Toronto, Toronto, ON, Canada.
Putnam, Krakow, Poland.
J Med Econ. 2025 Dec;28(1):196-206. doi: 10.1080/13696998.2025.2451526. Epub 2025 Jan 23.
Chronic kidney disease (CKD) is the leading cause of kidney failure, end-stage kidney disease (ESKD), and cardiovascular (CV) events in patients with type 2 diabetes (T2D). The FIDELIO-DKD trial demonstrated that finerenone lowered the risk of renal and CV events in patients with CKD and T2D, regardless of cardiovascular disease history. This study evaluated the cost-effectiveness of finerenone added to background treatment (finerenone + BT) versus background treatment (BT) alone in patients with CKD and T2D from the perspective of the National Health Service in England and Wales.
A lifetime Markov model assessed the indicated usage of finerenone for the treatment of stage 3 or 4 CKD with albuminuria associated with T2D in adults, as per the relevant marketing authorization. The model structure considered kidney disease progression and CV risk, with health states encompassing patients' kidney disease stage and CV event profiles, using patient-level data from the FIDELIO-DKD trial. Model outcomes were life years, quality-adjusted life years (QALYs), per-patient costs, incremental costs, and incremental cost-effectiveness ratio (ICER). Sensitivity and scenario analysis were performed, including an analysis exploring the impact of real-world data which suggests more frequent sodium-glucose co-transporter-2 (SGLT2) inhibitor use in the United Kingdom since FIDELIO-DKD.
Patients receiving finerenone experienced kidney and CV benefits, including reduced rates of nonfatal CV events and CV deaths, translating to improvements in survival and quality-adjusted life years (QALYs) of 6.11 and 5.97 per patient for finerenone + BT versus BT, respectively. Total discounted per-patient costs were £48,940 for finerenone + BT and £47,716 for BT alone, resulting in an incremental cost-effectiveness ratio of £8,808 per QALY gained for finerenone + BT versus BT.
Sensitivity and scenario analyses, including more frequent SGLT2 inhibitor use consistent with real-world data, indicate a robust ICER that remains within the bounds of what is typically considered cost-effective.
慢性肾脏病（CKD）是2型糖尿病（T2D）患者肾衰竭、终末期肾病（ESKD）和心血管（CV）事件的主要原因。FIDELIO-DKD试验表明，非奈利酮可降低CKD和T2D患者发生肾脏和CV事件的风险，无论其心血管疾病史如何。本研究从英格兰和威尔士国家医疗服务体系的角度，评估了在CKD和T2D患者中，在背景治疗基础上加用非奈利酮（非奈利酮+BT）与单纯背景治疗（BT）相比的成本效益。
根据相关上市许可，采用终身马尔可夫模型评估非奈利酮在治疗成人3期或4期伴有T2D相关蛋白尿的CKD中的指定用途。模型结构考虑了肾脏疾病进展和CV风险，健康状态涵盖患者的肾脏疾病阶段和CV事件概况，使用来自FIDELIO-DKD试验的患者水平数据。模型结果包括生命年、质量调整生命年（QALY）、人均成本、增量成本和增量成本效益比（ICER）。进行了敏感性和情景分析，包括一项探索真实世界数据影响的分析，该数据表明自FIDELIO-DKD试验以来，英国钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂的使用更为频繁。
接受非奈利酮治疗的患者在肾脏和CV方面获益，包括非致命CV事件和CV死亡发生率降低，这分别转化为非奈利酮+BT组和BT组患者的生存期改善以及质量调整生命年（QALY）分别为每人6.11和5.97。非奈利酮+BT组的人均总贴现成本为48,940英镑，单纯BT组为47,716英镑，非奈利酮+BT组相对于BT组每获得一个QALY的增量成本效益比为8,808英镑。
敏感性和情景分析，包括与真实世界数据一致的更频繁的SGLT2抑制剂使用，表明一个稳健的ICER仍在通常认为具有成本效益的范围内。
