欧盟生物类似药医保准入与使用政策对我国的启示

Medical insurance access and clinical use policy of biosimilars in European Union and its enlightenment to China

随着近些年生物类似药的研发与上市的不断踊现,生物类似药凭借其价格优势赢得了广大患者与各国医保部门的青睐。本文希望通过制度比较、案例分析及资料汇整方法对欧盟各国生物类似药的医保准入政策进行详细研究,以明晰欧盟各国在生物类似药的卫生技术评估、医保准入流程、定价支付标准等方面的先进经验,以期为我国生物类似药医保准入政策的制定提供参考和借鉴。通过在学习欧盟监管方法的基础上,我国应当扩大生物类似药的影响力、细化生物类似药相关医保准入规定、完善生物类似药医保准入配套政策。

In recent years,the development and listing of biosimilars have shown a'blowout'phenomenon.Biosimilars have won the favor of patients and medical insurance departments in various countries because of their price advantage.The article aims to conduct a detailed study on the medical insurance access policy of biosimilars in European Union through system comparison,case analysis and data collection methods,in order to clarify the advanced experience of European Union in health technology assessment,medical insurance access process and reimbursement standard of biosimilars,so as to provide reference for the publication and development of China’s biosimilars insurance access policy.By studying the EU’s regulatory methods,China should expand the influence of biosimilars,refine the medical insurance access policy related to biosimilars,and improve the medical insurance access process of biosimilars.