Department of Pharmacy, Fuyang Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.
Department of Gynaecology, Fuyang Hospital of Traditional Chinese Medicine, Hangzhou, Zhejiang, China.
Clin Drug Investig. 2021 Jun;41(6):569-577. doi: 10.1007/s40261-021-01035-4. Epub 2021 Apr 20.
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.
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.
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.
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.
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。
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。
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%。
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。