制剂包装规格优化改善肿瘤患者经济负担——以曲妥珠单抗为例  

Optimization of Formulation Packaging to Improve the Economic Burden of Cancer Patients:Trastuzumab as an Example

作　　者：陈婉欣 霍晓潼 黄昭慧 吴成密 李沙[2] 蒋杰[1,2] CHEN Wan-Xin;HUO Xiao-Tong;HUANG Zhao-Hui;WU Cheng-Wi;LI Sha;JIANG Jie(Southern Institute of Pharmacoeconomics and Health Technology Evaluation,Jinan University,Guangzhou 511436,China;College of Pharmacy,Jinan University,Guangzhou 511436,China)

机构地区：[1]暨南大学南方药物经济学与卫生技术评估研究所 [2]暨南大学药学院

出　　处：《中国药物经济学》2024年第12期30-35,46,共7页China Journal of Pharmaceutical Economics

摘　　要：目的提出改善肿瘤患者使用生物靶向药经济负担的新思路。方法利用医药行业数据库信息,对肿瘤靶向药的上市现状和在国内的价格变化进行分析,阐明肿瘤治疗的经济负担现状。以曲妥珠单抗为案例,采用最小成本分析法分析药品包装规格优化对药品经济性的影响。结果1997—2023年25年间靶向药所占比例越来越高。目前国内共上市了31个抗肿瘤生物靶向药,生物类似药的上市,也在一定程度上降低了这类药品的费用,如利妥昔单抗、曲妥珠单抗。31个抗肿瘤生物靶向药中,80%的制剂需按人体表面积或体重计算给药,实际应用中可能会造成药物浪费的情况。目前国内上市的曲妥珠单抗共6个品种,静脉输注用和皮下注射用原研药赫赛汀■和4个国产生物类似药汉曲优■、安瑞泽■、赛妥■、安赛汀■。研究结果表明,针对我国人表皮生长因子受体-2(HER-2)阳性乳腺癌患者的体重特征,将曲妥珠单抗类似物汉曲优■的两种小规格150 mg和60 mg合理配置使用,所需的药品年费用最低,使用440 mg大规格的原研药品曲妥珠单抗年费用最高。进一步采用蒙特卡洛模拟方法模拟患者体重进一步验证结果的稳定性发现,对比其他曲妥珠单抗品种,有双规格的汉曲优■更可能使更多的患者支出药品费用更低。结论制剂包装规格优化不失为一种可行性强的有效降低按体重或体表面积用药药品的治疗费用、减轻患者经济负担的药品研发设计方式。Objective To propose a new approach to alleviate the economic burden of cancer patients using biologics targeting therapy.Methods Firstly,utilizing information from the pharmaceutical industry database,an analysis was conducted on the market status of targeted cancer drugs and the pricing changes in the domestic market,elucidating the current economic burden of cancer treatment.Subsequently,using trastuzumab as an example,the method of minimum cost analysis was employed to assess the impact of optimizing drug specifications on the economic viability of the drug.Results In the 25 years from 1997 to 2023,the proportion of targeted drugs is increasing.At present,a total of 31 anti-tumor biological targeted drugs have been listed in China,and the listing of biosimilar drugs has also reduced the cost of such drugs to a certain extent,such as rituximab and trastuzumab.Among the 31 anti-tumor biological targeted drugs,80%of the preparations need to be administered according to the human surface area or body weight,which may cause drug waste in practical application.Currently,there are six varieties of trastuzumab available in the domestic market,including the original drug Herceptin■for intravenous infusion and subcutaneous injection,and four domestic biosimilars,namely Zercepac■,Anruize■,Saituo■,and Ansaiting■.It was indicated that Zercepac■resulted in the lowest annual drug cost,which could be used within the combination use of the specifications of 150 mg and 60 mg,while the use of the Herceptin■with 440 mg incurred the highest annual drug cost.Further validation of the results using Monte Carlo simulation to simulate patient weight stability revealed that,compared to other trastuzumab varieties,for the majority of patients,the expenditure on drug costs for the dual-specification Zercepac■was lowest.Conclusion Optimizing the drug specifications can be a robust and effective approach to significantly reduce the costs of drugs which are administered according to body weight or body surface area,thereby

关 键 词：生物靶向药 曲妥珠单抗 制剂包装 药物经济学 蒙特卡洛模拟 

分 类 号：R979.1[医药卫生—药品] R956[医药卫生—药学]