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北京市85家二、三级公立医院心血管类原研药与仿制药利用分析
Originals and Generics Utilization Analysis of Cardiovascular Medicines in 85 Secondary and Tertiary Public Hospitals in Beijing
  
DOI:
中文关键词:  心血管类药物  原研药  仿制药  替代  价格比  北京地区  药物利用
英文关键词:Cardiovascular medicine  Originators  Generics  Substitution  Cost saving  Beijing  Price ratio
基金项目:
作者单位
黄智然 刘诗洋 魏晓晶 王鼎 王绪艳 孙静 ①中国医学科学院/北京协和医学院公共卫生学院(北京100730)②中国医学科学院血液研究所③中国医学科学院药物研究所 
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中文摘要:
      摘 要 目的:以心血管类药物为例,分析原研药和仿制药在公立医院的销售量、销售价格和销售金额,为促进仿制药的使用提供证据支持和提出政策建议。方法:从国家食品药品监督管理总局南方医药经济研究所医药数据库及北京市医药阳光采购综合管理平台提取数据,选择其中包含的北京市全部公立医院(共计85家二级和三级医院)的11种心血管类药物,分析2015年每种药物的原研药和仿制药销售量占比、销售金额占比、价格比和仿制药替代原研药的潜在费用节省率。结果:11种目标心血管类药物原研药与仿制药的平均销售金额占比分别为81.07%和18.93%;平均销售量占比分别为74.68%和25.32%;价格比在1.01~5.77之间,价格比平均值为2.09,中位数为1.61;仿制药替代原研药潜在可节省费用总计4.10亿元,费用节省率达59.21%。结论:11种目标心血管类药物的仿制药2015年在北京市二、三级公立医院中占有的市场份额很少。在公立医院中以质量和疗效有保障的仿制药替代原研药将节约大量药品费用。建议加快仿制药质量和疗效一致性评价,增强公众对仿制药质量和疗效的信心,以便尽快建立仿制药替代制度,通过医保支付配套政策鼓励仿制药的采购、处方和使用,以节省医药费用支出
英文摘要:
      ABSTRACT Objective:To analyze the consumption volume, value and price of originators and generics of cardiovascular medicines in public hospitals, taking this as a case study, to produce evidence and to propose policy recommendations for the promotion of generics uptake in China. Methods: We extracted data from the medicines database of the Southern Medicines Economics Institute of China Food and Drug Administration and Beijing medicines procurement management platform. We included all public hospitals in Beijing (85 secondary and tertiary hospitals) and 11 cardiovascular medicines, analyzed the proportions of consumption volume and value, and price ratio of the originators and generics, and estimated the potential cost savings from substituting the originals with equivalent generics. Results:The average ratios of consumption volume and value of the originals and generics of 11 targeted cardiovascular medicines were 81.07% and 18.93%, and 74.68% and 25.32% respectively. The price ratio of the originals and generics ranged between 1.01 and 5.77, the mean ratio was 2.09, and the median ratio was 1.61. There could be a total of CNY 410 million potential cost savings if the originators were substituted with equivalent generics, and the rate of cost savings was 59.21%. Conclusion:The market share of the generics of the 11 targeted cardiovascular medicines in Beijing public hospitals was low in 2015. Substituting originators with equivalent quality secured generics in public hospitals could save huge medicines costs. It was recommended to speed up the consistency evaluation of the quality and efficacy of generics, and to strengthen the public confidence of generics, so as to establish the generic substitution system as soon as possible, which aims to promote the procurement, prescription and use of generics with health insurance payment policies as a leverage, and to contain the rapid growth of medicines expenditures.
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