Zheng Cailin, Wu Jinneng, Li Na, Wei Xiaoxia, Huang Zhixiong, Chen Lingbin, Chen Zhou
School of Pharmacy, Fujian Medical University, Fuzhou, China.
Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China.
Diabetes Obes Metab. 2025 Jan;27(1):165-173. doi: 10.1111/dom.15997. Epub 2024 Oct 8.
To examine the cost-effectiveness of adding finerenone to standard of care (SoC) for treating type 2 diabetes mellitus (T2DM)-related chronic kidney disease (CKD) in the United States.
Based on the clinical data analysed by FIDELITY, we referenced the validated FINE-CKD model (Markov model) to evaluate the cost-effectiveness of SoC versus SoC + finerenone from the perspective of US payers. The model was cycled for 35 years in 4-month cycles, with cost and utility values derived from the published literature. The primary outcomes were incremental cost-effectiveness ratio (ICER) and quality-adjusted life years (QALYs). Deterministic and probabilistic sensitivity analyses were conducted to assess the robustness of the base-case results.
The treatment strategy of finerenone plus SoC led to gains of 6.95 QALYs and had a lifetime cost of $491 745.31. Compared to SoC, that strategy yielded 0.48 more QALYs at an added cost of $65 305.72. The ICER for finerenone was $135 257.06 per QALY, which is below the willingness-to-pay threshold of United States ($150 000/QALY). The results were sensitive to the hazard ratios associated with the efficacy of finerenone and its cost. Probabilistic sensitivity analyses showed that the probability that finerenone plus SoC would be cost-effective was 57.6%.
For patients with T2DM-related CKD, adding finerenone to SoC may be a cost-effective option in the United States. Reasonable price reductions for finerenone could potentially benefit more patients.
研究在美国，在标准治疗方案（SoC）基础上加用非奈利酮治疗2型糖尿病（T2DM）相关慢性肾脏病（CKD）的成本效益。
基于FIDELITY分析的临床数据，我们参考经过验证的FINE-CKD模型（马尔可夫模型），从美国医保支付方的角度评估SoC与SoC加非奈利酮的成本效益。该模型以4个月为周期循环35年，成本和效用值来自已发表的文献。主要结局指标为增量成本效益比（ICER）和质量调整生命年（QALYs）。进行确定性和概率性敏感性分析以评估基础病例结果的稳健性。
非奈利酮加SoC的治疗策略带来了6.95个QALYs的增益，终身成本为491745.31美元。与SoC相比，该策略在增加65305.72美元成本的情况下多产生了0.48个QALYs。非奈利酮的ICER为每QALY 135257.06美元，低于美国的支付意愿阈值（150000美元/QALY）。结果对与非奈利酮疗效及其成本相关的风险比敏感。概率性敏感性分析表明，非奈利酮加SoC具有成本效益的概率为57.6%。
对于T2DM相关CKD患者，在美国，在SoC基础上加用非奈利酮可能是一种具有成本效益的选择。非奈利酮合理降价可能会使更多患者受益。
