Xiang Zuojuan, Ma Ling, Fu Yingzhou, Pan Yong
Department of Pharmacy, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Hunan Cancer Hospital, Changsha, China.
Department of Clinical pharmacy, the First People's Hospital of Yunnan Province, the Affiliated Hospital of Kunming University of Science and Technology, Kunming, China.
Front Pharmacol. 2024 Sep 4;15:1411571. doi: 10.3389/fphar.2024.1411571. eCollection 2024.
The Chinese Society of Clinical Oncology (CSCO) has recommended sintilimab plus chemotherapy (SINT + Chemo) as a standard first-line therapy for advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC), based on the proven effectiveness and safety in the ORINT-16 trail. Its cost-effectiveness, however, remains to be evaluated.
We established a partitioned survival approach (PartSA) model with a 10-year time horizon to determine whether SINT + Chemo (vs. chemotherapy) was more cost-effective as a first-line treatment for unresectable advanced or metastatic GC/GEJC. Survival data was generated from the ORIENT-16 trail. Cost calculation was limited to direct medical costs. Database of Hunan Public Resources Trading Service Platform was used as the source for obtaining drug prices. Other cost and utility values were gathered from established literature. Incremental cost-effectiveness ratio (ICER) was the primary output. Additionally, we conducted sensitivity analysis, subgroup analysis, and scenario analysis.
In the base-case analysis, group SINT + Chemo showed an increase in utility value by 0.32 quality-adjusted life-years (QALYs) at an extra cost of $7988.43, resulting in an ICER of $25239.29/QALY, below the Chinese cost-effective willingness-to-pay (WTP) threshold of $38223.34. Upon further subgroup analysis according to patients' programmed death 1 ligand (PD-L1) combined positive score (CPS), the ICERs were $26341.01/QALY for patients highly expressing PD-L1 (CPS ≥5) and $17658.26/QALY for patients lowly expressing PD-L1 (CPS <5). Based on the sensitivity analysis, we found the PFS utility was the parameter that had the most significant impact on the model's outcomes. Moreover, in scenario analysis, the results remained consistent despite variations in the model's time frame.
In China, SINT + Chemo is a more cost-effective option (vs. chemotherapy) as a first-line therapy for unresectable advanced or metastatic GC/GEJC, irrespective of PD-L1 expression levels.
基于ORIENT-16试验中已证实的有效性和安全性，中国临床肿瘤学会（CSCO）已推荐信迪利单抗联合化疗（SINT + Chemo）作为晚期胃癌或胃食管交界癌（GC/GEJC）的标准一线治疗方案。然而，其成本效益仍有待评估。
我们建立了一个具有10年时间跨度的分区生存方法（PartSA）模型，以确定SINT + Chemo（与化疗相比）作为不可切除的晚期或转移性GC/GEJC的一线治疗方案是否更具成本效益。生存数据来自ORIENT-16试验。成本计算仅限于直接医疗成本。湖南省公共资源交易服务平台数据库被用作获取药品价格的来源。其他成本和效用值从已发表的文献中收集。增量成本效益比（ICER）是主要输出结果。此外，我们还进行了敏感性分析、亚组分析和情景分析。
在基础病例分析中，SINT + Chemo组的效用值增加了0.32个质量调整生命年（QALYs），额外成本为7988.43美元，导致ICER为25239.29美元/QALY，低于中国具有成本效益的支付意愿（WTP）阈值38223.34美元。根据患者程序性死亡1配体（PD-L1）联合阳性评分（CPS）进行进一步亚组分析时，高表达PD-L1（CPS≥5）患者的ICER为26341.01美元/QALY，低表达PD-L1（CPS<5）患者的ICER为17658.26美元/QALY。基于敏感性分析，我们发现无进展生存期效用是对模型结果影响最显著的参数。此外，在情景分析中尽管模型时间框架有所变化，但结果仍然一致。
在中国，SINT + Chemo作为不可切除的晚期或转移性GC/GEJC的一线治疗方案（与化疗相比）是一种更具成本效益的选择，无论PD-L1表达水平如何。
