University Hospital of Créteil, Créteil, France.
Boehringer Ingelheim, Paris, France.
J Thorac Oncol. 2017 Oct;12(10):1496-1502. doi: 10.1016/j.jtho.2017.07.013. Epub 2017 Jul 24.
The irreversible ErbB family blocker afatinib and the reversible EGFR tyrosine kinase inhibitor gefitinib were compared in the multicenter, international, randomized, head-to-head phase 2b LUX-Lung 7 trial for first-line treatment of advanced EGFR mutation-positive NSCLCs. Afatinib and gefitinib costs and patients' outcomes in France were assessed.
A partitioned survival model was designed to assess the cost-effectiveness of afatinib versus gefitinib for EGFR mutation-positive NSCLCs. Outcomes and safety were taken primarily from the LUX-Lung 7 trial. Resource use and utilities were derived from that trial, an expert-panel questionnaire, and published literature, limiting expenditures to direct costs. Incremental cost-effectiveness ratios (ICERs) were calculated over a 10-year time horizon for the entire population, and EGFR exon 19 deletion or exon 21 L858R mutation (L858R) subgroups. Deterministic and probabilistic sensitivity analyses were conducted.
For all EGFR mutation-positive NSCLCs, the afatinib-versus-gefitinib ICER of was €45,211 per quality-adjusted life-year (QALY) (0.170 QALY gain for an incremental cost of €7697). ICERs for EGFR exon 19 deletion and L858R populations were €38,970 and €52,518, respectively. Afatinib had 100% probability to be cost-effective at a willingness-to-pay threshold of €70,000/QALY for patients with common EGFR mutations.
First-line afatinib appears cost-effective compared with gefitinib for patients with EGFR mutation-positive NSCLCs.
在多中心、国际、随机、头对头的 2b 期 LUX-Lung 7 试验中,比较了不可逆的 ErbB 家族阻滞剂阿法替尼和可逆的 EGFR 酪氨酸激酶抑制剂吉非替尼,用于治疗晚期 EGFR 突变阳性 NSCLC 的一线治疗。评估了法国阿法替尼和吉非替尼的成本和患者结局。
设计了一个分区生存模型,以评估阿法替尼与吉非替尼治疗 EGFR 突变阳性 NSCLC 的成本效益。主要结局和安全性来自 LUX-Lung 7 试验。资源使用和效用来自该试验、专家小组问卷调查和已发表的文献,将支出限制在直接成本内。在 10 年的时间内,对整个人群和 EGFR 外显子 19 缺失或外显子 21 L858R 突变(L858R)亚组计算增量成本效益比(ICER)。进行了确定性和概率敏感性分析。
对于所有 EGFR 突变阳性 NSCLC,阿法替尼与吉非替尼的 ICER 为每质量调整生命年(QALY)€45211(增加 7697 欧元成本可获得 0.170 个 QALY 增益)。EGFR 外显子 19 缺失和 L858R 人群的 ICER 分别为€38970 和€52518。对于常见 EGFR 突变患者,阿法替尼在愿意支付的阈值为€70000/QALY 时,有 100%的可能性具有成本效益。
与吉非替尼相比,一线阿法替尼治疗 EGFR 突变阳性 NSCLC 具有成本效益。