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.
OBJECTIVE: 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. MATERIAL AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.
目的: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。
材料与方法: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。
结果: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。
结论: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。
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