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1.河北医科大学第三医院药学部,石家庄 050051
2.河北医科大学研究生学院,石家庄 050017
3.河北省药物与卫生技术综合评估学会,石家庄 050051
硕士研究生。研究方向:药物经济学。E-mail:2449898635@qq.com
主任药师,硕士生导师,硕士。研究方向:药物经济学、卫生技术评估、合理用药。E-mail:36700774@hebmu.edu.cn
收稿:2025-10-22,
修回:2026-03-02,
录用:2026-03-02,
纸质出版:2026-03-15
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刘冉,高胜男,张羽曦,等.埃万妥单抗联合兰泽替尼一线治疗EGFR突变晚期NSCLC的成本-效用分析 Δ[J].中国药房,2026,37(05):633-638.
LIU Ran,GAO Shengnan,ZHANG Yuxi,et al.Cost-utility analysis of amivantamab combined with lazertinib in the first-line treatment of EGFR-mutated advanced NSCLC[J].ZHONGGUO YAOFANG,2026,37(05):633-638.
刘冉,高胜男,张羽曦,等.埃万妥单抗联合兰泽替尼一线治疗EGFR突变晚期NSCLC的成本-效用分析 Δ[J].中国药房,2026,37(05):633-638. DOI: 10.6039/j.issn.1001-0408.2026.05.14.
LIU Ran,GAO Shengnan,ZHANG Yuxi,et al.Cost-utility analysis of amivantamab combined with lazertinib in the first-line treatment of EGFR-mutated advanced NSCLC[J].ZHONGGUO YAOFANG,2026,37(05):633-638. DOI: 10.6039/j.issn.1001-0408.2026.05.14.
目的
2
从我国卫生体系角度出发,评价埃万妥单抗联合兰泽替尼(以下简称“AL”)方案一线治疗
EGFR
突变晚期非小细胞肺癌(NSCLC)的经济性。
方法
2
根据MARIPOSA研究最新数据构建分区生存模型,模拟时限设置为10年,循环周期为28 d,以质量调整生命年(QALY)为主要输出指标,以3倍2024年我国人均国内生产总值为意愿支付(WTP)阈值(287 247元/QALY),采用成本-效用分析法,计算AL相对于奥希替尼单药方案一线治疗
EGFR
突变晚期NSCLC的增量成本-效果比(ICER);采用单因素敏感性分析和概率敏感性分析评估模型的稳健性;采用情境分析评估不同健康状态效用值对结果的影响,并确定AL方案具有经济性时埃万妥单抗和兰泽替尼的降价幅度。
结果
2
相对于奥希替尼单药方案,AL方案一线治疗
EGFR
突变晚期NSCLC的ICER为2 062 096.15元/QALY,远高于本研究设定的WTP阈值。单因素敏感性分析结果显示,无进展生存状态效用值和埃万妥单抗价格是影响ICER的主要因素。概率敏感性分析结果显示,当WTP阈值为2 050 000元/QALY时,AL方案才开始具有经济性。情境分析结果显示,改变效用值,AL方案依然不具有经济性;当埃万妥单抗(350 mg)价格分别下降80%、85%、90%时,兰泽替尼(80 mg)需分别降价95.97%、40.63%、5.29%,才能让AL方案的ICER稳定落在上述WTP阈值内。
结论
2
在本研究设定的WTP阈值下,相对于奥希替尼单药方案,AL方案一线治疗
EGFR
突变晚期NSCLC不具有经济性;联合药物需要同时大幅降价,才能减轻患者的用药负担。
OBJECTIVE
2
To evaluate the cost-effectiveness of amivantamab combined with lazertinib (hereinafter referred to as “AL”) regimen as first-line treatment for
EGFR
-mutated advanced non-small cell lung cancer (NSCLC) from the perspective of China’s healthcare system.
METHODS
2
A partitioned survival model was established based on updated data from the MARIPOSA study, with a 10-year time horizon and 28-day cycles. The primary outcome index was quality adjusted life year (QALY), and the willingness-to-pay (WTP) threshold was set at three times China’s per capita GDP in 2024 (287 247 yuan/QALY). Cost-utility analysis was used to calculate the incremental cost-effectiveness ratio (ICER) of AL regimen versus osimertinib monotherapy regimen as first-line treatment for
EGFR
-mutated advanced NSCLC. One-way and probabilistic sensitivity analyses were performed to test model robustness. Scena
rio analyses were conducted to explore the impact of utility values for different health states on the outcomes and determine the required price reductions of amivantamab and lazertinib to achieve cost-effectiveness.
RESULTS
2
Compared with the osimertinib monotherapy regimen, the ICER for the AL regimen as first-line treatment for advanced
EGFR
-mutated NSCLC was 2 062 096.15 yuan/QALY, significantly exceeding the WTP threshold established in this study. One-way sensitivity analysis revealed that the utility value of progression-free survival state and the price of amivantamab were the primary factors influencing the ICER. Probabilistic sensitivity analysis revealed that the AL regimen only became cost-effective when the WTP threshold was set at 2 050 000 yuan/QALY. Scenario analysis indicated that altering the utility value still rendered the AL regimen non-cost-effective. When amivantamab (350 mg) prices decreased by 80%, 85%, and 90% respectively, lazertinib (80 mg) prices would need to decrease by 95.97%, 40.63%, 5.29%, respectively. This would enable the AL regimen’s ICER to consistently fall within the WTP threshold established in this study.
CONCLUSIONS
2
At the WTP threshold established in this study, the AL regimen does not demonstrate cost-effectiveness for first-line treatment of advanced
EGFR
-mutated NSCLC compared to the osimertinib monotherapy regimen. Significant price reductions for both drugs would be required to alleviate the financial burden on patients.
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