基于定量药理学的阿仑膦酸钠原研药与仿制药的成本效果评价  

Cost-effectiveness analyses of brand and generic alendronate tablets based on pharmacometrics

作　　者：林夕涵 刘婷[1] 王琳[1] 万元胜 刘金玉 张玉[1] 游如旭 LIN Xihan;LIU Ting;WANG Lin;WAN Yuansheng;LIU Jinyu;ZHANG Yu;YOU Ruxu(Department of Pharmacy,Union Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430022,China;Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Hubei Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属协和医院药学部,湖北武汉430022 [2]华中科技大学同济医学院附属同济医院药学部,湖北武汉430030

出　　处：《中国医院药学杂志》2025年第5期495-502,共8页Chinese Journal of Hospital Pharmacy

摘　　要：目的:基于中国卫生体系角度,评价阿仑膦酸钠原研药与仿制药的成本效果。方法:通过建立药物代谢动力学-药物效应动力学模型,模拟阿仑膦酸钠治疗3年后的临床效果,计算骨折发生率的预测值。基于Markov模型,输入阿仑膦酸钠治疗的有效性参数,计算疾病转归、效用与成本,以增量成本效果比(incremental cost-effectiveness ratio,ICER)评价经济性。结果:使用定量药理学计算获得的阿仑膦酸钠有效性指标与临床试验结果相似,表明模型拟合结果良好。基础分析结果表明,与生物利用度为80%(F=0.8)的仿制药相比,原研药质量调整生命年(quality-adjusted life year,QALY)增加0.0004,成本增加846.89元,ICER为1875214元/QALY,高于3倍人均国内生产总值,表明原研药不具有经济性,而F=1.25的仿制药相对原研药具有绝对成本效果优势。结论:该研究通过定量药理学-药物经济学联合模型证明阿仑膦酸钠仿制药具有成本效果。OBJECTIVE To evaluate the cost-effectiveness of brand and generic oral alendronate from the healthcare per⁃spectives in China.METHODS A pharmacokinetics-pharmacodynamics model was developed to estimate the clinical effect of 3-year treatment period of alendronate and calculate the predictive value of fractures.Then a Markov model was established to calcu⁃late lifetime disease transition,health benefits and cost based on the prediction of incidence of fractures calculated from the param⁃eters of alendronate efficacy.The cost-effectiveness was assessed by calculating the incremental cost-effectiveness ratio(ICER).RESULTS The clinical effect of alendronate simulated from the pharmacometrics model was close to published clinical trials to indicate the well-fitting.The additional quality-adjusted life-years(QALYs)of the brand alendronate was 0.0004 and increased cost was 846.89 CNY compared with the generic alendronate(80%of bioavailability,F=0.8;ICER of 1875214 CNY/QALY),which was higher than 3 times gross domestic product per capita.It suggested that the brand alendronate did not have a cost-effectiveness,and the generic alendronate with F=1.25 showed dominant cost-effectiveness.CONCLUSION This study demonstrated that generic alendronate is cost-effective by pharmacometrics-pharmacoeconomics model.

关 键 词：定量药理学 药物经济学 骨质疏松 阿仑膦酸钠 

分 类 号：R956[医药卫生—药学]