斯鲁利单抗联合化疗一线治疗食管鳞癌的成本-效果分析

    Cost-effectiveness Analysis of Serplulimab Combined with Chemotherapy in the First-line Treatment for Advanced Esophageal Squamous Cell Carcinoma

    • 摘要:
      目的  从中国医疗保健体系的角度分析斯鲁利单抗联合化疗对比单独化疗一线治疗晚期食管鳞状细胞癌(esophageal squamous cell carcinoma,ESCC)的成本-效果。
      方法 建立三状态分区生存模型评估斯鲁利单抗联合化疗与化疗一线治疗ESCC的临床效果和成本消耗。模型中的生存数据通过ASTRUM-007试验中的Kaplan-Meier曲线外推得到。计算成本时仅纳入直接医疗成本,效用值来自文献。以增量-成本效果比(incremental cost-effectiveness ratio,ICER)作为主要的结果指标,以2022年中国人均国内生产总值的3倍作为意愿支付(willingness-to-pay,WTP)阈值。本研究进行单因素敏感性分析以评估参数不确定性对模型的影响,同时,还进行了亚组分析和情景分析。
      结果 基础分析结果显示,与化疗相比,斯鲁利单抗联合化疗产生的ICER为613 790元/QALY,远高于WTP阈值。单因素敏感性分析结果显示斯鲁利单抗的价格、患者的体质量和无进展生存期的效用值对模型影响较大。概率敏感性分析显示在1000次模拟中,斯鲁利单抗联合化疗均不具有经济性。亚组分析和情景分析的结果与基础分析的结果一致。
      结论 与化疗相比,斯鲁利单抗联合化疗一线治疗晚期ESCC不具有经济性。

       

      Abstract:
      OBJECTIVE To analyze the cost-effectiveness of serplulimab combined with chemotherapy versus chemotherapy alone in the first-line treatment for advanced esophageal squamous cell carcinoma(ESCC) from the perspective of the healthcare system in China.
      METHODS A three state partitioned survival model was established to simulate the clinical effectiveness and cost of serplulimab combined with chemotherapy versus chemotherapy lone in the first-line treatment for ESCC. Survival data in the model were derived by extrapolation of Kaplan-Meier curves from the ASTRUM-007 study. Only direct medical costs were included in the cost calculation, and utility values were obtained from the literature. The incremental cost-effectiveness ratio(ICER) was the main indicator of output. The willingness-to-pay(WTP) threshold was set at 3 times gross domestic product per capita 2022 in China. Sensitivity analysis was performed to assess the effect of parameter uncertainty on the model, and subgroup analysis and scenario analysis were also conducted.
      RESULTS The results of basic analysis showed that the ICER generated by serplulimab combined with chemotherapy was ¥613 790/QALY compared with chemotherapy, which was far above the WTP threshold. The results of one-way sensitivity analysis demonstrated the price of serplulimab, weight of patients and utility value in progression-free survival stage had the greatest impact on the model. Probabilistic sensitivity analysis illustrated that serplulimab combined with chemotherapy was not economical in 1 000 simulations. The results of subgroup analysis and scenario analysis were consistent with the results of the base analysis.
      CONCLUSION Serplulimab combined with chemotherapy is not economical for the first-line treatment of advanced ESCC in comparison with chemotherapy.

       

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