开启中国模式的创新药物定价规则

Promoting China's model of innovative drug pricing rules

目的介绍2024年中国医疗保障局发布的《关于建立新上市化学药品首发价格形成机制鼓励高质量创新的通知》政策内容、意义,并提出完善建议。方法通过政策和文献分析,总结高、中、低3类不同创新程度的新药经济性分析的内容和要求,并对美国、德国、法国及加拿大对创新药附加效益的分类进行比较。结果近年来中国创新药的研发获得很大进展。坚持药品价格由市场决定的基本原则,发挥政府对新上市药品价格的支持和指引作用。现提出从药学基础、临床价值及循证证据3个维度评价新药的创新程度。评价体系包含3个一级指标、13个二级指标及34个三级指标,按分值进入高(90~150分)、中(50~90分)及低(50分以下)3个组别,引导药企自我测评新上市化学药品的创新程度。结论新政策鼓励高质量创新药物的发展,以临床价值为导向,重视新药的附加治疗效益,明确中国建立境外参考价格的国家和地区的“篮子”和“首发价格”的构成,包括生产制造成本、期间费用、销售利润、税费及流通环节差价5个部分。充分调动药企自主评价、行业协会推荐书、医疗机构出具临床专业意见书,以及调动卫生技术评估专业评价机构、多学科专家的积极性,对药品价格进行社会共治。

Objective To introduce the contents,significance of the policy on''Notice on Establishing Initial Launching Market Price Formation for Newly Original Chemicals and Encouraging High-Quality Innovation''issued by the China Healthcare Security Administration in 2024 and put forward suggestions for improvement.Methods The contents and requirements of economic analysis of new drugs with high,middle and low innovative degrees were summarized through policies analysis and literature review,the classification of added benefits of innovative drugs in America,Germany,France and Canada was compared.Results Great progress has been made in the research and development of innovative drugs in China in recent years.We should adhere to the basic principle that drug prices should be determined by the market,and give full play to the role of the government in supporting and guiding the prices of newly listed drugs.The innovation degree of new drugs is evaluated from three dimensions:pharmaceutical basis,clinical value and evidence-based information.The evaluation system consists of 3 first-grade indexes,13 second-grade indexes and 34 third-grade indexes,which are classified into high(90—150 scores),middle(50—90 scores)and low(below 50 scores)categories according to the scores value,to guide pharmaceutical companies to self-evaluating the innovation degree of newly listed chemicals.Conclusion The new policy encourages the development of high-quality innovative drugs,and takes the clinical value as the priority,paying attention on the added therapeutic benefit assessment.The new policy clarifies the composition of the''basket''and''initial price''of countries and regions of external reference pricing that has been established in China.The composition including 5 parts,the manufacturing costs,production period costs,sales profits,taxes,and distributor/wholesaler's markup.It should fully mobilize the initiative of free-pricing system by the pharmaceutical enterprises,recommendation from trade associations,clinical professional opinions issued by medical institutions,mobilize the enthusiasm of health technology assessment agencies and multi-disciplinary experts,finally conduct the social co-governance of drug prices in China.