Rezaei Mohammad Ali, Pourasghari Hamid, Karimi Fereshte, Rajaie Soheila, Shahmohammady Amirreza, Behzadifar Masoud, Dehqan Amir Hossein, Azari Samad
Hospital Management Research Center, Health Management Research Institute, Iran University of Medical Sciences, Tehran, Iran.
Research Center for Emergency and Disaster Resilience, Red Crescent Society of the Islamic Republic of Iran, Tehran, Iran.
Eur J Clin Pharmacol. 2025 Sep 9. doi: 10.1007/s00228-025-03915-6.
Metastatic breast cancer (mBC) is a major global health challenge. Antibody-drug conjugates (ADCs), including trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), and sacituzumab govitecan (SG), offer clinical benefits but are associated with high costs, making cost-effectiveness assessments essential for policy decisions.
This systematic review analyzed economic evaluations comparing T-DM1, T-DXd, and SG with conventional treatments in breast cancer. A search of four databases and gray Literature up to November 2024 included studies reporting ICERs, QALYs, and LYGs. Data were extracted per PRISMA and CHEERS guidelines.
Twenty-nine studies from the USA, China, Brazil, Germany, Finland, Singapore, and Canada were reviewed. In the USA, ICERs for T-DXd ranged from $194,424/QALY (HR-) to $406,900/QALY, often exceeding WTP thresholds ($100K-$200K). It was cost-effective in HR- patients and those with good ECOG. In China, ICERs > $50,000/QALY exceeded the national threshold (~ $36,475/QALY). In Finland, T-DXd was cost-effective vs. T-DM1 (€55,360/QALY). T-DM1 was cost-effective in Canada (-$3,844/QALY) and select U.S. studies, but not in Brazil ($99,699/QALY) or China. Drug pricing was a key driver; U.S. results varied, perhaps due to modeling differences and sponsor bias. SG was not cost-effective in any country. ICERs ranged from $237,816/QALY (Singapore) to > $1.3 million/QALY (USA). In China, the cost-effectiveness probability was 0% at current prices.
T-DXd and T-DM1 may be cost-effective in select groups and high-income countries. SG is not cost-effective anywhere. Drug prices are the main determinant of value, highlighting the need for price negotiations and more regional studies.
转移性乳腺癌(mBC)是一项重大的全球健康挑战。抗体药物偶联物(ADC),包括曲妥珠单抗恩美曲妥珠单抗(T-DM1)、曲妥珠单抗德曲妥珠单抗(T-DXd)和赛托珠单抗戈维汀(SG),虽能带来临床益处,但成本高昂,因此成本效益评估对于政策决策至关重要。
本系统评价分析了比较T-DM1、T-DXd和SG与乳腺癌传统治疗方法的经济学评价。检索截至2024年11月的四个数据库和灰色文献,纳入报告增量成本效果比(ICER)、质量调整生命年(QALY)和生命年增益(LYG)的研究。数据按照PRISMA和CHEERS指南提取。
对来自美国、中国、巴西、德国、芬兰、新加坡和加拿大的29项研究进行了综述。在美国,T-DXd的ICER范围为每QALY 194,424美元(激素受体阴性[HR-])至406,900美元,常常超过意愿支付阈值(10万至20万美元)。在HR-患者和东部肿瘤协作组(ECOG)状态良好的患者中具有成本效益。在中国,ICER>50,000美元/QALY超过了国家阈值(约36,475美元/QALY)。在芬兰,与T-DM1相比,T-DXd具有成本效益(每QALY 55,360欧元)。T-DM1在加拿大(每QALY -3,844美元)和美国部分研究中具有成本效益,但在巴西(每QALY 99,699美元)或中国则不然。药物定价是一个关键驱动因素;美国的结果各不相同,可能是由于模型差异和申办方偏差。SG在任何国家都不具有成本效益。ICER范围从每QALY 237,816美元(新加坡)到>130万美元(美国)。在中国,按当前价格计算,成本效益概率为0%。
T-DXd和T-DM1在特定人群和高收入国家可能具有成本效益。SG在任何地方都不具有成本效益。药物价格是价值的主要决定因素,凸显了进行价格谈判和开展更多区域研究的必要性。