Raw data.

Objective
The effectiveness of sugemalimab vs. placebo in post-chemoradiotherapy patients with locally advanced, unresectable stage III NSCLC has been demonstrated and approved by China National Medical Products Administration. The purpose of this study was to assess the cost-effectiveness of sugemalimab vs. placebo for consolidation treatment of stage III NSCLC from the perspective of the Chinese healthcare system.
Methods
A 3-state Markov model with a 3-week cycle length was performed to appraise the incremental cost-utility ratio (ICUR) of sugemalimab consolidation therapy based on the GEMSTONE-301 clinical trial over a 10-year time horizon. Only direct medical costs, including costs of drug (maintenance and subsequent treatment), routine follow-up, best supportive care, and terminal care in end of life were considered in this model. Costs and health utilities were obtained from local databases and published articles. Sensitivity and scenario analyses were adopted to evaluate the model uncertainty. Internal and external data sources were used to justify the plausibility of the extrapolated portion of the survival model chosen.
Results
In comparison with the placebo, sugemalimab consolidation therapy was not cost-effective as it yielded an ICUR value of $90,277 and $49,692 for the concurrent chemoradiotherapy (cCRT) and the sequential chemoradiotherapy (sCRT) population at the willingness-to-pay (WTP) threshold of $37,663/QALYs, respectively. When taking the sugemalimab patient assistance program (PAP) into consideration, sugemalimab consolidation therapy was cost-effective with an ICUR dramatic decreases below the WTP. Sensitivity analyses demonstrated that the ICUR was most sensitive to the discount rate and subsequent treatment. However, none of the sensitive parameters could affect the cost-effective conclusions without or with PAP. Scenario analyses revealed that the model was particularly affected by assumptions regarding discount in sugemalimab, time horizon, mean duration of sugemalimab maintenance treatment.
Conclusions
From the perspective of Chinese healthcare system, sugemalimab consolidation therapy was not a cost-effective strategy in cCRT and sCRT patients with unresectable stage III NSCLC. Given that the sugemalimab PAP was available, sugemalimab consolidation therapy became a cost-effective option.

研究背景与目的
舒格利单抗（sugemalimab）对比安慰剂用于同步放化疗后局部晚期不可切除III期非小细胞肺癌（non-small cell lung cancer, NSCLC）患者的疗效已得到证实，并获中国国家药品监督管理局批准。本研究旨在从中国医疗卫生体系视角，评估舒格利单抗对比安慰剂用于III期非小细胞肺癌巩固治疗的成本效益。

研究方法
本研究基于GEMSTONE-301临床试验，采用周期长度为3周的三状态马尔可夫（Markov）模型，在10年研究时限下评估舒格利单抗巩固治疗的增量成本效用比（incremental cost-utility ratio, ICUR）。本模型仅纳入直接医疗成本，包括药物费用（维持治疗及后续治疗费用）、常规随访费用、最佳支持治疗费用以及终末期临终关怀费用。成本与健康效用值均来源于国内数据库及已发表文献。本研究采用敏感性分析与场景分析评估模型的不确定性，并通过内部与外部数据源验证所选用生存模型外推部分的合理性。

研究结果
与安慰剂相比，在意愿支付阈值为37663美元/质量调整生命年（quality-adjusted life year, QALYs）的情况下，舒格利单抗巩固治疗对于同步放化疗（concurrent chemoradiotherapy, cCRT）与序贯放化疗（sequential chemoradiotherapy, sCRT）人群的增量成本效用比分别为90277美元与49692美元，未达到成本效益标准。当纳入舒格利单抗患者援助项目（patient assistance program, PAP）时，舒格利单抗巩固治疗的增量成本效用比大幅降低至意愿支付阈值以下，此时方案具备成本效益。敏感性分析结果显示，增量成本效用比对贴现率与后续治疗费用最为敏感，但无论是否启用患者援助项目，上述敏感参数均未对成本效益结论产生显著影响。场景分析结果表明，模型结果易受舒格利单抗贴现假设、研究时限以及舒格利单抗平均维持治疗时长等参数的影响。

研究结论
从中国医疗卫生体系视角出发，舒格利单抗巩固治疗对于不可切除III期非小细胞肺癌同步放化疗及序贯放化疗人群均不具备成本效益。但若可使用舒格利单抗患者援助项目，舒格利单抗巩固治疗则成为具备成本效益的治疗方案。