Negrier Sylvie, Bonastre Julia, Colrat Florian, Teitsson Siguroli, Knight Christopher, Ni Lei, Chevalier Julie, Branchoux Sébastien, Rouprêt Morgan
Department of Medical Oncology, Centre Léon Bérard, Université Claude Bernard Lyon 1, Lyon, France.
Biostatistics and Epidemiology, Institut Gustave Roussy Cancer Campus, Villejuif, France.
World J Urol. 2025 Apr 1;43(1):202. doi: 10.1007/s00345-025-05589-2.
To evaluate the cost-effectiveness of nivolumab for adjuvant treatment of adults with muscle-invasive urothelial carcinoma at high risk of recurrence (MIUC-HR) and tumour cell expression PD-L1 ≥ 1% following radical resection from the payer perspective in France.
A four-state (disease-free, loco-regional recurrence, distant recurrence, death) semi-Markov model was developed to simulate health outcomes and costs in a cohort of patients with MIUC-HR and tumour cell expression PD-L1 ≥ 1% following radical resection. Health state-specific costs and quality of life-adjusted life years (QALYs) were compared between two treatment strategies (nivolumab, surveillance). The time horizon was 15 years. Clinical and utility inputs were modelled from the data obtained in the Phase III trial CheckMate 274 (#NCT02632409). Cost inputs were extracted from French sources (notably the French National Cost Study). Model outputs were life-years and QALYs overall and by health-state, total costs and cost components. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR) between the two treatment strategies were calculated.
Life-years were 7.3 for nivolumab and 5.2 for surveillance; QALYs were 4.7 for nivolumab and 3.3 for surveillance. The between-strategy difference in QALYs was essentially accrued in the disease-free state (nivolumab: 4.2, surveillance: 2.6). Total costs were €129,150 for nivolumab and €93,031 for surveillance. The principal cost components were nivolumab acquisition (€ 44,054) and disease management (nivolumab: €29,831; surveillance: €27,233). The estimated ICER was € 17,228/LY gained and the estimated ICUR was €25,806/QALY.
Nivolumab in the adjuvant setting is likely to be cost-effective compared to surveillance in France.
从法国医保支付方的角度评估纳武利尤单抗辅助治疗高复发风险（MIUC-HR）且肿瘤细胞表达PD-L1≥1%的成人肌肉浸润性尿路上皮癌患者的成本效益。
建立一个四状态（无病、局部区域复发、远处复发、死亡）半马尔可夫模型，以模拟根治性切除术后MIUC-HR且肿瘤细胞表达PD-L1≥1%的患者队列的健康结局和成本。比较两种治疗策略（纳武利尤单抗、监测）之间特定健康状态的成本和质量调整生命年（QALY）。时间范围为15年。临床和效用输入数据来自III期试验CheckMate 274（#NCT02632409）。成本输入数据来自法国资料来源（特别是法国国家成本研究）。模型输出包括总体和按健康状态划分的生命年和QALY、总成本及成本组成部分。计算两种治疗策略之间的增量成本效益比（ICER）和增量成本效用比（ICUR）。
纳武利尤单抗治疗组的生命年为7.3，监测组为5.2；纳武利尤单抗治疗组的QALY为4.7，监测组为3.3。QALY的策略间差异主要出现在无病状态（纳武利尤单抗治疗组：4.2，监测组：2.6）。纳武利尤单抗治疗组的总成本为129,150欧元，监测组为93,031欧元。主要成本组成部分为纳武利尤单抗购置费用（44,054欧元）和疾病管理费用（纳武利尤单抗治疗组：29,831欧元；监测组：27,233欧元）。估计的ICER为每获得1个生命年17,228欧元，估计的ICUR为每获得1个QALY 25,806欧元。
在法国，与监测相比，辅助治疗中使用纳武利尤单抗可能具有成本效益。
