芦康沙妥珠单抗治疗不可切除的局部晚期或转移性三阴性乳腺癌的成本-效果分析

Cost effectiveness analysis of Luconsartuzumab in the treatment of unresectable locally advanced or metastatic triple negative breast cancer

关键词:  芦康沙妥珠单抗  三阴性乳腺癌  成本-效果分析  Markov模型

Key words:  Sacituzumab tirumotecan  triple negative breast cancer  Cost-effectiveness Analysis  Markov Model.

摘要:

目的 从中国医疗卫生体系角度出发，评估芦康沙妥珠单抗治疗不可切除的局部晚期或转移性三阴性乳腺癌的经济性。方法 基于OptiTROP-Breast01临床试验中期分析数据构建三状态Markov模型评估芦康沙妥珠单抗与化疗的成本效用。设置循环周期为3周，研究时限10年，以5%贴现率测算总成本和质量调整生命年，并应用增量成本-效果比（ICER）进行经济性分析。对模型涉及的相关参数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 相较于化疗组，芦康沙妥珠单抗可使不可切除的局部晚期或转移性三阴性乳腺癌患者获得增量效用0.34QALY，同时增加治疗成本308473元，ICER值为918179元/QALY。单因素敏感性分析结果显示，芦康沙妥珠单抗每周期成本对结果影响最大；概率敏感性分析结果显示，芦康沙妥珠单抗在设定支付意愿阈值（22340元/QALM）下具有经济性的概率为0。情境分析结果显示，本研究结论在不同研究时限（5、10、15年）下均稳健。结论 基于中国医疗卫生体系角度，芦康沙妥珠单抗在目前价格（9399元/200mg）下，相比化疗用于不可切除的局部晚期或转移性三阴性乳腺癌后线治疗不具有经济性。

Abstract:

Objective To assess the cost-effectiveness of Sacituzumab tirumotecan in the treatment of unresectable locally advanced or metastatic triple negative breast cancer(TNBC) from the perspective of Chinese healthcare system.. Methods A three-state Markov model was constructed based on the interim analysis data of the OptiTROP-Breast01 clinical trial to evaluate the cost-utility of Sacituzumab tirumotecan relative to chemotherapy. The cycle length was set at 3 weeks, with a study horizon of 10 years. Total costs and quality-adjusted life years (QALYs) were calculated using a 5% discount rate. The incrementalcost-effectiveness(ICER) was employed for economic evaluation. Univariate sensitivity analysis and probabilistic sensitivity analysis were conducted on relevant model parameters to verify the robustness of the results. Result Compared with the chemotherapy group, Sacituzumab tirumotecan provided an incremental utility of 0.34 QALYs for patients with unresectable locally advanced or metastatic TNBC, while incurring an additional treatment cost of 308473 yuan. The ICER was determined to be 918179 yuan/QALY. Univariate sensitivity analysis revealed that the per-cycle cost of Sacituzumab tirumotecan had the most significant impact on the results. Probabilistic sensitivity analysis indicated that the probability of Sacituzumab tirumotecan being cost-effective at the pre-defined willingness-to-pay threshold of 22,340 yuan/QALY was 0. Scenario analysis demonstrated that the study conclusions remained robust across different study durations (5, 10 and 15 years). Conclusion From the perspective of Chinese healthcare system, at its current price of 9,399 yuan per 200 mg, Sacituzumab tirumotecan is not cost-effective compared with chemotherapy for the later-line treatment of unresectable locally advanced or metastatic TNBC.