曲妥珠单抗-美坦新偶联物二线治疗中国 HER2 阳性乳腺癌的成本效果分析。

Cost-effectiveness Analysis of Trastuzumab Emtansine as Second-line Therapy for HER2-Positive Breast Cancer in China.

机构信息

Department of Pharmacy, Fuyang Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.

Department of Gynaecology, Fuyang Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.

出版信息

Clin Drug Investig. 2021 Jun;41(6):569-577. doi: 10.1007/s40261-021-01035-4. Epub 2021 Apr 20.

Abstract

BACKGROUND AND OBJECTIVE

Trastuzumab emtansine (T-DM1) is the standard second-line option for the treatment of patients with human epidermal growth factor receptor-2 (HER2)-positive breast cancer for its superior clinical efficacy in prolonging progression-free survival. The objective of this study was to evaluate the cost effectiveness of T-DM1 from the Chinese healthcare perspective. Capecitabine (Cap), capecitabine + lapatinib (Cap + Lap), capecitabine + trastuzumab (Cap + Tra), capecitabine + trastuzumab + pertuzumab (Cap + Tra + Per) were selected as comparators.

METHODS

A three-state Markov simulation model was performed. The state transition probabilities were estimated based on the results of a published network meta-analysis, and utilities were derived from the published literature. The costs populated in the model were acquired from the local charge or previously published studies. One-way sensitive analysis and probabilistic sensitivity analyses were performed to test the robustness of the results.

RESULTS

Compared with Cap, Cap + Lap, Cap + Tra, and Cap + Tra + Per, T-DM1 was estimated to increase the cost by US$109,699.1, $106,019.1, $97,506.3, and $67,121.9, respectively, and yield a gain of 0.544 quality-adjusted life years (QALYs), 0.383 QALYs, 0.367 QALYs, 0.087 QALYs, respectively. Corresponding incremental cost-effectiveness ratios (ICERs) were $201,652.9, $276,812.5, $265,685.0, and $771,516.1 per QALY. The probabilities of T-DM1 as the dominant option were 0% at the willingness-to-pay (WTP) threshold of $31,245.1/QALY.

CONCLUSIONS

T-DM1, as second-line therapy in the treatment of HER2-positive breast cancer, is not a cost-effective option in China. Given the significant clinical efficacy, an appropriate price reduction of T-DM1 is required to benefit more HER2-positive breast cancer patients.

摘要

背景与目的

曲妥珠单抗-美坦新偶联物(T-DM1)因其在延长无进展生存期方面的临床疗效优于其他药物,是治疗人表皮生长因子受体 2(HER2)阳性乳腺癌的标准二线选择。本研究旨在从中国医疗保健的角度评估 T-DM1 的成本效益。选择卡培他滨(Cap)、卡培他滨+拉帕替尼(Cap + Lap)、卡培他滨+曲妥珠单抗(Cap + Tra)和卡培他滨+曲妥珠单抗+帕妥珠单抗(Cap + Tra + Per)作为对照。

方法

采用三状态马尔可夫模型进行分析。状态转移概率基于已发表的网络荟萃分析结果进行估计,效用值则来源于已发表的文献。模型中使用的成本数据来自当地收费标准或先前的研究。进行单因素敏感性分析和概率敏感性分析以检验结果的稳健性。

结果

与 Cap、Cap + Lap、Cap + Tra 和 Cap + Tra + Per 相比,T-DM1 预计将分别增加 109699.1 美元、106019.1 美元、97506.3 美元和 67121.9 美元的成本,并分别获得 0.544 个质量调整生命年(QALY)、0.383 个 QALY、0.367 个 QALY 和 0.087 个 QALY 的收益。相应的增量成本效益比(ICER)分别为每 QALY 201652.9 美元、276812.5 美元、265685.0 美元和 771516.1 美元。在支付意愿(WTP)阈值为 31245.1 美元/QALY 时,T-DM1 作为首选方案的概率为 0%。

结论

作为治疗 HER2 阳性乳腺癌的二线治疗药物,T-DM1 在我国并非一种具有成本效益的选择。鉴于其显著的临床疗效,需要适当降低 T-DM1 的价格,以使更多的 HER2 阳性乳腺癌患者受益。

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