摘要
目的:为我国公共决策视野下评估及应用药品临床综合价值进行科学决策提供依据。方法:结合相关文件和文献、其他国家或地区药品临床综合价值指标,确定我国药品临床综合价值评价的核心指标,对各指标概念及评价方法进行梳理和分析,并提出相关建议。结果与结论:笔者建议我国药品临床综合价值评价的核心指标为安全性与有效性、经济性与可支付性、可及性与公平性、依从性、适宜性。其中安全性、有效性、经济性、可支付性和依从性的概念界定清晰,评价方法系统,数据来源充分,研究设计国际间存在共识。可及性尚未有统一定义,包含可获得性、可供应性、可利用性、可负担性和用药及时性。公平性概念界定清晰,评价方法系统,但数据来源不够充分。适宜性通过药品适宜性指数进行评价但缺乏清晰的概念界定。以有效性为例,有效性包括中间指标、结果指标和生命质量指标,常采用流行病学研究、系统评价与专家共识确认。笔者建议在选取或制订药品临床综合价值指标时尽可能采用真实世界的研究数据,借助多准则决策分析,由专业评估机构提供技术支持,配合专家和研究人员对上述指标赋权,形成不同公共决策部门对于一项药品的临床综合价值判断,从而决定是否采购、临床使用和纳入医保。
OBJECTIVE:To provide reference for scientific decision-making of evaluation and application of clinical comprehensive value of drugs from the perspective of the public decision-making in China. METHODS:Based on relevant documents and literatures,drug clinical comprehensive value in other countries and areas,the core indicators of drug clinical comprehensive value evaluation in China were confirmed. The concept and evaluation methods of each indicator were evaluated,and relevant suggestions were put forward. RESULTS & CONCLUSIONS:It’s suggested that the core indicators of China’s drug clinical comprehensive value evaluation are safety and efficacy,economy and affordability,accessibility and fairness adherence,suitability. The concepts of safety,efficacy,economy,affordability and adherence indexes are clearly defined,evaluation methods are systematic,data sources are sufficient,and international consensus exists in research design. There is no uniform definition of accessibility which composed of availability,deliverability,availability,affordability and timeliness. The concept of equity is clearly defined and the evaluation method is systematic,but the data source is insufficient. Appropriateness is evaluated by drug suitability index but there is no clear definition. Taking efficacy as an example,efficacy includes intermediate indicators,outcome indicators and quality of life indicators,which are often confirmed by epidemiological research,systematic evaluation and expert consensus. It’s suggested that the Real World Study data should be used as much as possible when selecting or formulating the clinical comprehensive value indicators of drugs. With the help of multi-criteria decision-making analysis,technical support should be provided by professional evaluation institutions,and with the support of experts and researchers,the above indicators should be empowered to form the clinical comprehensive value judgment of a drug by different public decision-making departments,so as to decide whether to purchase,us
作者
孔凡心
马爱霞
李洪超
唐文熙
KONG Fanxin;MA Aixia;LI Hongchao;TANG Wenxi(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China;Center for Pharmacoeconomics Evaluation and Research,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国药房》
CAS
北大核心
2020年第5期539-544,共6页
China Pharmacy
基金
国家自然科学基金资助项目(No.71603278)
中国药科大学教改课题项目(No.2017XJQN32)
2019年度江苏省社科应用研究精品工程课题(No.19SYC-097)
关键词
公共决策视野
药品临床综合价值
测量
评价
决策
Perspective of the public decision-making
Drug clinical comprehensive value
Measurement
Assessment
Decision-making
