Chen Pingyu, Wang Xintian, Zhu Shengwen, Li Hongchao, Rui Mingjun, Wang Yingcheng, Sun Haikui, Ma Aixia
School of International Pharmaceutical Business, China Pharmaceutical University, Nanjing, China.
Center for Pharmacoeconomics and Outcomes Research, China Pharmaceutical University, Nanjing, China.
Front Public Health. 2022 Aug 9;10:956792. doi: 10.3389/fpubh.2022.956792. eCollection 2022.
Sintilimab has superior efficacy and safety in patients with advanced or metastatic squamous non-small cell lung cancer (NSCLC), but its cost-effectiveness in China is unclear. This study is to evaluate the cost-effectiveness of sintilimab plus chemotherapy vs. pembrolizumab plus chemotherapy for locally advanced or metastatic squamous NSCLC in China.
From the perspective of the Chinese health system, the partitioned survival model with three health states was established in a 3-week cycle and a lifetime time horizon. The two-stage method was used to estimate the overall survival hazard ratios to avoid the bias by crossover design in ORIENT-12 and KEYNOTE-407 studies. The anchored matching adjusted indirect comparison method (MAIC) was used for indirect comparison based on the individual patient data from ORIENT-12 and the publicly published KEYNOTE-407 study due to the lack of head-to-head clinical trials. Only direct medical costs were included, and utilities were derived from the published literature in the base case analysis. Sensitivity analysis was also performed to verify the robustness of the model results. In addition, the scenario analysis where the utilities were derived from the Quality of Life Questionnaire-Core 30 (QLQ-C30) scale in the ORIENT-12 by mapping to the EuroQol-5-dimension 5-level (EQ-5D-5L) was carried out to explore the uncertainty of the results.
Compared with pembrolizumab + chemotherapy, sintilimab + chemotherapy incurred a lower lifetime cost ($12,321 vs. 36,371) and yielded fewer quality-adjusted life-years (QALYs) (0.9902 vs. 1.0085), which resulted in an incremental cost-effectiveness ratio (ICER) of $1,314,208/QALY. A sintilimab strategy is a cost-effectiveness option under the WTP of 1-3 times the GDP per capita in China ($11,250/QALY~$33,749/QALY). The utility value of the post-progression, the unit cost of albumin paclitaxel, and the utility value of the progression-free state were the main drivers in the deterministic sensitivity analysis (DSA). According to the probabilistic sensitivity analysis (PSA), sintilimab + chemotherapy was 100% cost-effective when the WTP was 1-3 times China's per capita GDP. The results of the scenario analysis showed that sintilimab + chemotherapy obtained more QALYs (1.2319 vs. 1.1815) and lower costs ($12,321 vs. 36,371), which implied that sintilimab + chemotherapy may dominate the pembrolizumab + chemotherapy.
Compared with pembrolizumab + chemotherapy, sintilimab + chemotherapy is more cost-effective for first-line treatment in Chinese patients with locally advanced or metastatic squamous NSCLC.
信迪利单抗在晚期或转移性鳞状非小细胞肺癌（NSCLC）患者中具有卓越的疗效和安全性，但其在中国的成本效益尚不清楚。本研究旨在评估信迪利单抗联合化疗与帕博利珠单抗联合化疗用于中国局部晚期或转移性鳞状NSCLC的成本效益。
从中国卫生系统的角度出发，建立了具有三种健康状态的分区生存模型，以3周为一个周期，时间跨度为终身。采用两阶段法估计总生存风险比，以避免ORIENT - 12和KEYNOTE - 407研究中交叉设计导致的偏差。由于缺乏头对头临床试验，基于ORIENT - 12的个体患者数据和公开发表的KEYNOTE - 407研究，采用锚定匹配调整间接比较法（MAIC）进行间接比较。仅纳入直接医疗成本，在基础病例分析中，效用值来源于已发表的文献。还进行了敏感性分析以验证模型结果的稳健性。此外，进行了情景分析，通过将ORIENT - 12中生活质量问卷核心30（QLQ - C30）量表映射到欧洲五维度五水平（EQ - 5D - 5L）来获取效用值，以探索结果的不确定性。
与帕博利珠单抗 + 化疗相比，信迪利单抗 + 化疗的终身成本更低（12,321美元对36,371美元），质量调整生命年（QALY）更少（0.9902对1.0085），这导致增量成本效益比（ICER）为1,314,208美元/QALY。在支付意愿为中国人均国内生产总值的1 - 3倍（11,250美元/QALY~33,749美元/QALY）的情况下，信迪利单抗策略是一种具有成本效益的选择。进展后效用值、白蛋白紫杉醇单位成本和无进展状态效用值是确定性敏感性分析（DSA）中的主要驱动因素。根据概率敏感性分析（PSA），当支付意愿为中国国内生产总值人均的1 - 3倍时，信迪利单抗 + 化疗具有100%的成本效益。情景分析结果表明，信迪利单抗 + 化疗获得了更多的QALY（1.2319对1.1815）和更低的成本（12,321美元对36,371美元），这意味着信迪利单抗 + 化疗可能优于帕博利珠单抗 + 化疗。
与帕博利珠单抗 + 化疗相比，信迪利单抗 + 化疗在中国局部晚期或转移性鳞状NSCLC患者一线治疗中更具成本效益。
