Department of Pharmacy, Maternal and Child Health Hospital of Hubei Province, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Front Public Health. 2022 Nov 3;10:1015702. doi: 10.3389/fpubh.2022.1015702. eCollection 2022.
The purpose of this study was to estimate the cost-effectiveness of sugemalimab plus chemotherapy (SC) vs. placebo plus chemotherapy (PC), as the first-line treatment for patients with non-small cell lung cancer (NSCLC) in China.
A three-state Markov model with a cycle of 3 weeks was built to assess the incremental cost-effectiveness ratio (ICER) of SC vs. PC as first-line treatment for patients with NSCLC over a 10-year horizon from Chinese health care perspective. Time-dependency transition probability and safety data were derived from a multicenter, randomized, double-blind, phase 3 clinical trial performed in China (GEMSTONE-302). Primary model outcomes included the costs in US dollars and health outcomes in quality-adjusted life-years (QALYs) and the ICER under a willingness-to-pay (WTP) threshold of $37,663/QALYs. Deterministic, scenario and probabilistic sensitivity analysis were employed to investigate the robustness of model outcomes.
In base-case analysis, compared with PC, first-line SC for intention-to-treat (ITT) population gained an additional 0.57 QALYs with an incremental cost of $62,404.15, resulting in an ICER of $109,480.97/QALYs gained. When a patient assistance program (PAP) was available, the ICER decreased to $52,327.02/QALYs. In subgroup analysis, the ICER values were above the WTP threshold with or without PAP. Sensitivity analysis results suggested that the model outcomes were reliable.
From the perspective of Chinese healthcare system, the SC was not cost-effective in comparison to PC as first-line treatment for NSCLC, regardless of PD-L1 tumor expression level and pathological subtype.
本研究旨在评估 sugemalimab 联合化疗（SC）与安慰剂联合化疗（PC）作为中国非小细胞肺癌（NSCLC）患者一线治疗的成本效果。
采用三状态 Markov 模型，以 3 周为一个周期，从中国卫生保健的角度评估了 sugemalimab 联合化疗（SC）作为 NSCLC 患者一线治疗的增量成本效果比（ICER），评估期为 10 年。时间依赖性转移概率和安全性数据来自中国多中心、随机、双盲、III 期临床试验（GEMSTONE-302）。主要模型结果包括美元成本和质量调整生命年（QALYs）的健康结果，以及意愿支付（WTP）阈值为 37663 美元/QALY 时的 ICER。采用确定性、情景和概率敏感性分析来检验模型结果的稳健性。
在基础案例分析中，与 PC 相比，意向治疗（ITT）人群一线使用 SC 可额外获得 0.57 个 QALYs，增量成本为 62404.15 美元，ICER 为 109480.97 美元/QALY。当实施患者援助计划（PAP）时，ICER 降低至 52327.02 美元/QALY。在亚组分析中，无论是否有 PAP，ICER 值均高于 WTP 阈值。敏感性分析结果表明模型结果可靠。
从中国医疗保健系统的角度来看，无论 PD-L1 肿瘤表达水平和病理亚型如何，sugemalimab 联合化疗（SC）作为 NSCLC 的一线治疗方案并不比 PC 更具成本效果。
