摘要
目的:从中国卫生体系角度,评估度普利尤单抗对比奥马珠单抗作为背景疗法的附加治疗用于重度哮喘患者的经济性。方法:构建Markov模型,通过随机对照临床试验、已发表文献和临床专家咨询获得临床疗效、健康收益及成本数据,计算并模拟2种治疗方案下患者的终身疾病转归、效用及成本。采用增量成本-效果比(incremental cost-effectiveness ratio,ICER)指标,以2倍人均GDP(178716元,2023年)作为成本-效果可接受阈值。同时,进行情境分析、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:基础分析结果显示,度普利尤单抗组和奥马珠单抗组的总成本分别为679459元和615213元,健康产出分别为13.11和12.68质量调整生命年(quality-adjusted life years,QALYs),增量成本为64246元,增量QALYs为0.43,ICER为149661元·QALY^(-1),低于阈值,表明度普利尤单抗具有经济优势。情境分析中度普利尤单抗的经济优势更加明显,若采用2024年版国家医保目录中的度普利尤单抗谈判价格,则度普利尤单抗呈绝对优势。敏感性分析验证了上述结果的稳健性。结论:以2倍人均GDP作为成本-效果可接受阈值,度普利尤单抗相比于奥马珠单抗用于重度哮喘患者显示出成本-效果优势。
Objective:To evaluate the cost-effectiveness of dupilumab plus background therapy compared with omalizumab plus background therapy in the treatment of severe asthma from the perspective of Chinese health system.Methods:A Markov model was established.The clinical efficacy,health benefit and cost data were obtained from the randomized controlled trials,published literatures and clinical expert consultation results.Lifetime disease outcomes,effectiveness,and costs under each intervention were calculated.With incremental cost-effectiveness ratio(ICER)as the index,the economy of each intervention was evaluated under the threshold of 2 times GDP per capita(178716 yuan in 2023).Scenario analysis,one way sensitivity analysis and probability sensitivity analysis were carried out to verify the robustness of the results.Results:The total costs were 679459 and 615213 CNY in the groups of dupilumab and omalizumab,respectively.Total quality-adjusted life year(QALY)were 13.11 and 12.68.Compared with omalizumab,dupilumab increased costs by 64246 CNY and QALY by 0.43.ICER was 149661 CNY per QALY,which was lower than the 2 times per-capita GDP threshold,indicating that dupilumab was cost-effective compared with omalizumab.In the two scenarios set in the study,the group of dupilumab was more economical than the group of omalizumab.In the three scenarios set in the study,the group of dupilumab was more economical.If the negotiated price of dupilumab in the 2024 edition of the National Medical Insurance Drug List is used,the group of dupilumab is obviously superior.Sensitivity analysis verified the robustness of the above results.Conclusion:Under the threshold of 2-time Chinese GDP per capita,dupilumab is more cost-effective than omalizumab in the treatment of severe asthma patients.
作者
许诺铭
江欣悦
贺小宁
XU Nuo-ming;JIANG Xin-yue;HE Xiao-ning(School of Pharmaceutical Science and Technology,Faculty of Medicine,Tianjin University,Tianjin 300072,China;Center for Social Science Survey and Data,Tianjin University,Tianjin 300072,China)
出处
《中国新药杂志》
北大核心
2025年第19期2109-2116,共8页
Chinese Journal of New Drugs
