机构地区:[1]河北医科大学第三医院药剂科,石家庄050051
出 处:《中国药房》2025年第6期715-720,共6页China Pharmacy
基 金:河北省2023年度医学科学研究课题计划(No.20230746)。
摘 要:目的从中国卫生体系视角,评价埃万妥单抗联合化疗相比于单纯化疗用于在接受奥希替尼单药治疗期间或之后出现疾病进展的EGFR突变的晚期非小细胞肺癌(NSCLC)的经济性。方法根据MARIPOSA-2试验构建Markov模型,模拟时限设置为10年,循环周期为21 d,计算埃万妥单抗联合化疗相比于单纯化疗治疗EGFR突变的晚期NSCLC的增量-成本效果比(ICER),并与本研究设定的意愿支付(WTP)阈值[3倍我国2023年人均国内生产总值(GDP),即268200元/质量调整生命年(QALY)]进行比较,以评估两种治疗方案的经济性;采用单因素敏感性分析和概率敏感性分析以评估模型稳定性;采用情境分析以确定方案具有经济性时的埃万妥单抗价格。结果与单纯化疗相比,埃万妥单抗联合化疗方案的成本更高(1248411.60元vs.89023.39元),但患者的生存获益也更多(0.756 QALY vs.0.584 QALY),ICER为6757285.38元/QALY。无进展生存状态的效用值和埃万妥单抗价格对ICER的影响最大。当埃万妥单抗价格下降至每350 mg 310.3元时,相比于单纯化疗,埃万妥单抗联合化疗方案才开始具有经济性。结论从中国卫生体系角度出发,当WTP阈值为3倍我国2023年人均GDP时,埃万妥单抗联合化疗方案较于单纯化疗用于EGFR突变的晚期NSCLC不具有经济性;埃万妥单抗价格需大幅下降才能提高患者的可负担性。OBJECTIVE From the perspective of China’s healthcare system,to evaluate the cost-effectiveness of amivantamab combined with chemotherapy versus chemotherapy alone for patients with EGFR-mutated advanced non-small cell lung cancer(NSCLC)who experience disease progression during or after treatment with osimertinib monotherapy.METHODS The Markov model was established according to MARIPOSA-2 clinical trial.The simulation time limit was 10 years and the cycle period lasted for 21 days.The incremental cost-effectiveness ratio(ICER)of amivantamab combined with chemotherapy versus chemotherapy alone for the treatment of EGFR-mutated advanced NSCLC was calculated,and then compared with the willingness-to-pay(WTP)threshold set in this study[3 times the per capita gross domestic product(GDP)of China in 2023,which was 268200 yuan per quality-adjusted life year(QALY)],in order to assess its cost-effectiveness.Single-factor sensitivity analysis and probability sensitivity analysis were performed to evaluate the stability of the model;scenario analysis was carried out to determine the potential price of amivantamab at which the regimen became cost-effective.RESULTS Compared with chemotherapy alone,the cost of amivantamab combined with chemotherapy was higher(1248411.60 yuan vs.89023.39 yuan),but at the same time,there were also more benefits of survival(0.756 QALY vs.0.584 QALY),ICER was 6757285.38 yuan/QALY.ICER was most affected by the utility of progression-free survival and the price of amivantamab.The price of amivantamab decreased to 310.3 yuan per 350 mg,and the combination therapy became cost-effective,compared with chemotherapy alone.CONCLUSIONS From the perspective of Chinese health system,when the WTP threshold is set at three times the per capita GDP of the Chinese population in 2023,amivantamab combined with chemotherapy is not costeffective for EGFR-mutated advanced NSCLC;the patients’affordability can be improved when the price of amivantamab experiences a significant decrease.
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