医保视角下新药创新性认定与价格管理政策的国际对比分析

International comparative analysis of innovation recognition and price management of new drugs from the perspective of national healthcare security

目的为我国创新药价格体系的完善提供参考。方法基于我国创新药医保管理现状,对比分析国际典型国家或地区创新药认定与价格管理政策,提出完善我国创新药价格体系的建议。结果与结论中国台湾地区、日本、澳大利亚、德国以及英国对于药品创新性认定与分级、区分定价以及后续价格管理3个环节做法不同,但整体而言,都是主要依据药品的临床价值进行创新性认定和分级,依据分级进行差异化定价,并采用风险分担协议或主动价格调整进行价格管理。基于国内外政策对比,建议我国在创新药管理中进一步明晰创新的内涵与分级,应用多种定价方式促进创新分级管理,探索引入风险分担协议,并进一步构建主动药价调整机制,以完善我国创新药价格体系。

OBJECTIVE To provide reference for the improvement of the price system of innovative drugs in China.METHODS Based on the current situation of innovative drug healthcare management in China,innovation recognition and price management of innovative drugs in typical countries or regions were compared and analyzed,and the suggestions were put forward to improve the price system of innovative drugs in China.RESULTS&CONCLUSIONS Taiwan of China,Japan,Australia,Germany and the United Kingdom have different practices in recognition and grading of drug innovation,differentiated pricing and subsequent price management.However,the mainstream practice is to identify and grade drugs mostly based on clinical value,differentiate pricing based on the grading,and carry out risk-sharing agreement or active price adjustment to manage the price.Based on the comparative analysis,it is suggested that China should further clarify the connotation and classification of innovation in the management of innovative drugs,apply a variety of pricing methods to promote differentiated management of innovative drugs,explore the introduction of risk-sharing agreements,and further build an active drug price adjustment mechanism to improve the price system of innovative drugs in China.