Department of Pharmacy, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China.
Front Immunol. 2023 Jan 23;14:1092385. doi: 10.3389/fimmu.2023.1092385. eCollection 2023.
BACKGROUND: Sintilimab plus chemotherapy significantly prolongs overall survival (OS) for patients with advanced or metastatic oesophageal squamous cell carcinoma (OSCC). However, the cost-effectiveness of this high-priced therapy is currently unknown. We evaluated the cost-effectiveness of sintilimab plus chemotherapy vs chemotherapy alone as fist-line therapy in patients with advanced or metastatic OSCC from the perspective of Chinese healthcare system. METHODS: A partitioned survival model consisting of 3 discrete health states was constructed to assess the cost and effectiveness of sintilimab plus chemotherapy vs chemotherapy as first-line treatment of OSCC. Key clinical data in the model came from the ORIENT-15 trial. Costs and utilities were collected from published sources. Life-years, quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER), incremental net health benefits (INHB), and incremental net monetary benefits (INMB) were calculated for the two treatment strategies. One-way and probabilistic sensitivity analyses were conducted to account for uncertainty and model stability. Additional subgroup and scenario analyses were performed. RESULTS: Treatment with sintilimab plus chemotherapy provided an additional 0.37 QALYs and an incremental cost of $8,046.58 compared with chemotherapy, which resulted in an ICER of $21,782.24 per QALY gained. One-way sensitivity analysis revealed that the model was most sensitive to utility of progression-free survival (PFS) and the cost of sintilimab. The probabilistic sensitivity analysis indicated that the probability of sintilimab plus chemotherapy being cost-effective was 0.01%, 76.80% and 98.60% at the threshold of 1, 2 or 3 times GDP per capita per QALY, respectively. Subgroup analysis found that all subgroups other than PD-L1 expression combined positive scores < 1 subgroup favored sintilimab plus chemotherapy treatment due to its association with positive INHBs by varying the hazard ratios for OS and PFS. The scenario analyses showed altering the time horizon of the model or fitting survival curves separately did not reverse results of the model. CONCLUSION: Sintilimab plus chemotherapy was associated with improved QALYs and an additional cost but was estimated to be cost-effective compared with chemotherapy alone as a first-line treatment for patients with advanced or metastatic OSCC at the commonly adopted willingness-to-pay threshold of 3 times GDP per capita per QALY in China.
背景：信迪利单抗联合化疗显著延长了晚期或转移性食管鳞癌（ESCC）患者的总生存期（OS）。然而，这种高价治疗的成本效益目前尚不清楚。我们从中国医疗保健系统的角度评估了信迪利单抗联合化疗与单独化疗作为晚期或转移性 ESCC 一线治疗的成本效益。 方法：构建了一个由 3 个离散健康状态组成的分割生存模型，以评估信迪利单抗联合化疗与化疗作为 ESCC 一线治疗的成本和疗效。模型中的关键临床数据来自 ORIENT-15 试验。成本和效用数据来自已发表的来源。为两种治疗策略计算了生命年、质量调整生命年（QALY）、增量成本效果比（ICER）、增量净健康收益（INHB）和增量净货币收益（INMB）。进行了单因素和概率敏感性分析，以考虑不确定性和模型稳定性。还进行了额外的亚组和情景分析。 结果：与化疗相比，信迪利单抗联合化疗治疗可额外获得 0.37 QALY，并增加 8046.58 美元的增量成本，导致每获得 1 QALY 的增量成本为 21782.24 美元。单因素敏感性分析表明，该模型对无进展生存期（PFS）的效用和信迪利单抗的成本最为敏感。概率敏感性分析表明，在 1、2 或 3 倍人均 GDP 每 QALY 的阈值下，信迪利单抗联合化疗具有成本效益的概率分别为 0.01%、76.80%和 98.60%。亚组分析发现，除 PD-L1 表达联合阳性评分<1 亚组外，所有其他亚组由于 OS 和 PFS 的风险比与正 INHB 相关，均有利于信迪利单抗联合化疗治疗。情景分析表明，改变模型的时间范围或分别拟合生存曲线不会改变模型的结果。 结论：信迪利单抗联合化疗可改善 QALY 并增加额外成本，但与单独化疗相比，作为晚期或转移性 ESCC 的一线治疗，在中国人均 GDP 3 倍的常用意愿支付阈值下，估计具有成本效益。
Expert Rev Pharmacoecon Outcomes Res. 2023
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