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奥希替尼治疗 EGFR 突变阳性非小细胞肺癌患者一线 EGFR TKI 治疗进展后的成本效益分析。

Cost-Effectiveness of Osimertinib for EGFR Mutation-Positive Non-Small Cell Lung Cancer after Progression following First-Line EGFR TKI Therapy.

机构信息

Medical Decision and Economic Group, Department of Pharmacy, Ren Ji Hospital, South Campus, School of Medicine, Shanghai Jiaotong University, Shanghai, People's Republic of China.

Department of Respiratory Medicine, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, People's Republic of China.

出版信息

J Thorac Oncol. 2018 Feb;13(2):184-193. doi: 10.1016/j.jtho.2017.10.012. Epub 2017 Oct 31.

Abstract

OBJECTIVE

The aim of this study was to investigate the cost-effectiveness of osimertinib for the treatment of advanced NSCLC with an EGFR T790M mutation after the failure of first-line EGFR tyrosine kinase inhibitor (TKI) therapy.

METHODS

A mathematical model was established by combining a decision tree and the Markov approach to project the cost-effectiveness of osimertinib versus standard chemotherapy for the treatment of patients who harbor an EGFR T790M mutation and have disease progression after first-line EGFR TKI therapy with or without metastases to the central nervous system. The clinical and outcome data were derived from randomized clinical trials and published reports. The health outcome data included quality-adjusted life-years (QALY). The cost data were estimated from the perspectives of the payer in the United States and the health care system in the People's Republic of China. All costs and incremental cost-effectiveness ratios (ICERs) were presented in 2017 U.S. dollars. Sensitivity and scenario analyses with three different settings of T790M mutation testing were performed.

RESULTS

Compared with chemotherapy, molecular testing in plasma and tissue followed by osimertinib treatment yielded an additional 0.359 and 0.313 QALYs in the entire U.S. population and the population of those with central nervous system metastases and an EGFR T790M mutation. For these populations, the incremental costs were $83,515 and $74,924 per patient, respectively, and the ICERs were $232,895 and $239,274 per QALY, respectively. For the entire Chinese population and the Chinese population with central nervous system metastases, the ICERs were $48,081 and $53,244 per QALY, respectively. For those with a known T790M mutation, the ICERs of osimertinib over chemotherapy also exceeded the willingness-to-pay threshold. The most influential parameter was the price of osimertinib.

CONCLUSION

Osimertinib treatment for T790M mutation NSCLC is unlikely to be cost-effective from the perspectives of the United States and the People's Republic of China. If the price of osimertinib could be decreased, the economic outcome might become favorable.

摘要

目的

本研究旨在探讨奥希替尼治疗第一代 EGFR 酪氨酸激酶抑制剂(TKI)治疗失败后有 EGFR T790M 突变的晚期 NSCLC 的成本效益。

方法

通过结合决策树和马尔可夫方法建立了一个数学模型,以预测奥希替尼与标准化疗相比在治疗有 EGFR T790M 突变且在一线 EGFR TKI 治疗后有疾病进展的患者中的成本效益,这些患者有无中枢神经系统转移。临床和结果数据来自随机临床试验和已发表的报告。健康结果数据包括质量调整生命年(QALY)。成本数据是根据美国支付者和中华人民共和国医疗保健系统的角度进行估计的。所有成本和增量成本效益比(ICER)均以 2017 年美元表示。进行了三种不同 T790M 突变检测设置的敏感性和情景分析。

结果

与化疗相比,在整个美国人群和有中枢神经系统转移和 EGFR T790M 突变的人群中,通过血浆和组织进行分子检测,然后进行奥希替尼治疗,可分别获得额外的 0.359 和 0.313 QALY。对于这些人群,每个患者的增量成本分别为 83515 美元和 74924 美元,增量成本效益比分别为 232895 美元和 239274 美元/QALY。对于整个中国人群和有中枢神经系统转移的中国人群,增量成本效益比分别为 48081 美元和 53244 美元/QALY。对于已知 T790M 突变的患者,奥希替尼治疗与化疗相比的增量成本效益比也超过了支付意愿阈值。最具影响力的参数是奥希替尼的价格。

结论

从美国和中华人民共和国的角度来看,奥希替尼治疗 T790M 突变 NSCLC 不太可能具有成本效益。如果奥希替尼的价格能够降低,经济结果可能会变得有利。

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