Cost-effectiveness of finerenone therapy for patients with chronic kidney disease and type 2 diabetes in England & Wales: results of the FINE-CKD model

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（Chronic kidney disease, CKD）是2型糖尿病（type 2 diabetes, T2D）患者发生肾衰竭、终末期肾脏病（end-stage kidney disease, ESKD）以及心血管（cardiovascular, CV）事件的首要病因。FIDELIO-DKD试验证实，无论患者是否合并心血管疾病病史，非奈利酮（finerenone）均可降低合并慢性肾脏病与2型糖尿病患者的肾脏及心血管事件风险。本研究从英格兰及威尔士国民保健服务（National Health Service）的视角，评估了在背景治疗（background treatment, BT）基础上加用非奈利酮（非奈利酮+BT）相较于单纯背景治疗（BT）用于合并慢性肾脏病与2型糖尿病患者的成本效用。本研究采用终身马尔可夫模型（Markov model），依据相关上市许可，评估了成人合并2型糖尿病的白蛋白尿性3或4期慢性肾脏病患者使用非奈利酮的获批适应证用法。该模型结构纳入了肾脏病进展与心血管风险，以患者的肾脏病分期及心血管事件谱作为健康状态，所用数据来自FIDELIO-DKD试验的患者水平数据集。模型结局指标包括生命年、质量调整生命年（quality-adjusted life years, QALYs）、单患者成本、增量成本以及增量成本效用比（incremental cost-effectiveness ratio, ICER）。研究开展了敏感性分析与情景分析，其中包含一项基于真实世界数据的分析：该数据显示，自FIDELIO-DKD试验开展以来，英国境内钠-葡萄糖协同转运蛋白2（sodium-glucose co-transporter-2, SGLT2）抑制剂的使用频率有所提升。接受非奈利酮治疗的患者可获得肾脏与心血管获益，具体表现为非致命性心血管事件及心血管死亡发生率降低，这转化为患者的生存获益与质量调整生命年改善：非奈利酮+BT组相较于单纯BT组，单患者的生命年与质量调整生命年分别提升6.11与5.97。非奈利酮+BT组的单患者折现总成本为£48,940，单纯BT组为£47,716，由此得出非奈利酮+BT相较于单纯BT的增量成本效用比为每获得1个质量调整生命年需花费£8,808。敏感性分析与情景分析（包括符合真实世界数据的更高频率使用SGLT2抑制剂的场景）结果显示，增量成本效用比结果稳健，仍处于临床通常认定的符合成本效用的区间内。