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乌地德龙联合卡培他滨治疗中国转移性乳腺癌的成本效果分析。

Cost-effectiveness analysis of utidelone plus capecitabine for metastatic breast cancer in China.

机构信息

a Departmen of Oncology , Xiangya Hospital, Central South University , Changsha , PR China.

b Department of Respiratory , The Seventh Affiliated Hospital of Sun Yat-sen University , Shenzhen , PR China.

出版信息

J Med Econ. 2019 Jun;22(6):584-592. doi: 10.1080/13696998.2019.1588125. Epub 2019 Mar 20.

Abstract

To estimate the cost-effectiveness of utidelone plus capecitabine therapy compared to capecitabine alone in patients with metastatic breast cancer (MBC) resistant to anthracyclines and taxanes treatment in the Chinese context and provide a reference for the marketing of utidelone in China. A Markov model was developed based on the NCT02253459 clinical trial to simulate the clinical course of patients with metastatic breast cancer who had received taxanes and anthracycline therapy. The quality-adjusted life years (QALYs) and Incremental Cost Effectiveness Ratio (ICER) were then analyzed to evaluate the benefits. Two-parametric Weibull distribution was conducted to fit PFS and OS curves by using R. Sensitivity analyses were performed to evaluate the stability of the model designed. The addition of utidelone increased the cost and QALYs by $13,370.25 and 0.1961, respectively, resulting in an increased ICER of $68,180.78 per QALY. The most sensitive influential parameter on ICER was the price of utidelone. At the threshold of willingness-to-pay (WTP) of $24,380 (3 per capita GDP of China), the cost of utidelone per 30 mg of less than $18.5, $33.7, and greater than $48.8 resulted in a 100%, 50%, and 0% possibility of cost-effectiveness, respectively. The addition of utidelone was not cost-effective when it was $115.4 per 30 mg-the price of its analog paclitaxel. In consideration of varied economics levels across China, cost-effectiveness could be achieved with the price of utidelone ranging from $5.2 to $35.9. The survival curves extended beyond the follow-up time horizon, of which data were generated not from the real analyses but from our established two-parameter Weibull survival model. It is recommended that the price of utidelone would be less than $18.5 per 30 mg in order to obtain cost-effectiveness for metastatic breast cancer patients resistant to anthracyclines and taxanes treatment in China.

摘要

在中国背景下,评估 utidelone 联合卡培他滨对比卡培他滨单药治疗蒽环类和紫杉类耐药转移性乳腺癌(MBC)患者的成本效果,为 utidelone 在中国的上市提供参考。本研究基于 NCT02253459 临床试验,构建 Markov 模型模拟接受过紫杉类和蒽环类药物治疗的转移性乳腺癌患者的临床病程。通过分析质量调整生命年(QALY)和增量成本效果比(ICER)来评估获益。采用 R 语言对 PFS 和 OS 曲线进行两参数 Weibull 分布拟合。进行敏感性分析以评估模型设计的稳定性。加入 utidelone 将使成本和 QALY 分别增加 13,370.25 美元和 0.1961,ICER 增加 68,180.78 美元/QALY。对 ICER 最敏感的影响参数是 utidelone 的价格。在 24,380 美元(3 倍中国人均 GDP)的意愿支付阈值(WTP)下,30mg utidelone 的价格低于 18.5 美元、33.7 美元和大于 48.8 美元,分别使成本效果的可能性为 100%、50%和 0%。当 utidelone 的价格为 115.4 美元/30mg(其类似物紫杉醇的价格)时,加入 utidelone 不具有成本效果。考虑到中国不同的经济水平,utidelone 的价格在 5.2 美元至 35.9 美元之间可实现成本效果。生存曲线延长至随访时间范围之外,这些数据不是来自真实分析,而是来自我们建立的两参数 Weibull 生存模型。建议 utidelone 的价格低于 18.5 美元/30mg,以使中国蒽环类和紫杉类耐药转移性乳腺癌患者获得成本效果。

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