基于分区生存模型的帕博利珠单抗治疗晚期PD-L1阳性三阴性乳腺癌的经济学评价

Evaluation of the Economics of Pembrolizumab for Advanced PD-L1-Positive Triple-Negative Breast Cancer Based on Partitioned Survival Analysis

关键词:  帕博利珠单抗  分区生存模型  乳腺癌  经济学评价

Key words:  Pabolizumab  Partitioned Survival Analysis  breast cancer  economic evaluation

摘要:

目的 分析帕博利珠单抗联合化疗一线治疗PD-L1 CPS≥10的晚期三阴性乳腺癌(TNBC)的成本效果。方法 基于KEYNOTE-355临床试验数据,构建分区生存模型,评价帕博利珠单抗的经济性。根据KEYNOTE-355试验的无进展生存期曲线(PFS)和总生存期曲线(OS)拟合生存函数,成本数据来自于本院,效用数据及不良反应成本、发生率来自于文献,对参数进行敏感性分析。结果 基础分析结果显示,相比于化疗组,帕博利珠单抗组的增量成本效果比为1187081.46元/QALY。不确定性分析显示帕博利珠单抗价格和PFS效用值对结果的变化影响较大,其中帕博利珠单抗价格的影响最大。结论 在中国人均3倍GDP(￥257094)和北京人均3倍GDP(￥570000)的意愿支付阈值下,帕博利珠单抗方案均不具有成本效果,可以通过降低帕博利珠单抗的价格增加其经济性。

Abstract:

OBJECTIVE To analyze the cost-effectiveness of pembrolizumab combined with basal chemotherapy for the first-line treatment of advanced steno-negative breast cancer (TNBC) with PD-L1 CPS ≥10. METHODS Based on the KEYNOTE-355 clinical trial data, a survival partitioning model was constructed to evaluate the economics of pabolizumab combined with chemotherapy. Survival functions were fitted based on progression-free survival (PFS) curves and overall survival (OS) curves from the KEYNOTE-355 trial, cost data were obtained from our institution, utility data and cost and incidence rates related to adverse reactions were obtained from the literature, and sensitivity analyses were performed on the parameters. RESULTS The results of the base analysis showed that the incremental cost-effectiveness ratio of the trial group treated with combination pabolizumab was ￥1187081.46/QALY compared to the chemotherapy group. Uncertainty analyses showed that the price of pabolizumab and the utility value of PFS had a large impact on the variability of the results, with pabolizumab having the largest impact. CONCLUSION Under the willingness-to-pay thresholds of 3 times the per capita GDP in China (￥257094) and 3 times the per capita GDP in Beijing (￥570,000), pabolizumab did not have a cost effect, and its affordability could be increased by lowering the price of pabolizumab.