真实世界数据在创新药医保准入中的应用情境及路径  

Application Scenarios and Paths of Real-World Data in Innovative Drug Medical Insurance Admission

作　　者：李芬 刘宇晗 胡嘉浩 朱碧帆 侯晓慧 范珂也 金春林 

机构地区：[1]上海市卫生和健康发展研究中心,上海200040 [2]上海市卫健委财务管理事务中心,上海200040 [3]中国药科大学,南京210009

出　　处：《中国医疗保险》2024年第11期28-33,共6页China Health Insurance

基　　金：海南省医疗保障局“真实世界数据支持化学制药医保准入技术路径和标准规范”(2023030GB)。

摘　　要：我国创新药医保准入进程正在逐步加快,但准入决策风险也随之上升。规范应用真实世界数据可以为医保准入评估提供重要证据,从而降低决策风险。本文分析真实世界数据的优劣势及其在医保准入中的应用情境,梳理国内外现有政策框架和指南规范,提出真实世界数据在我国创新药医保准入中的研究规范和应用路径,为真实世界数据研究应用于医保准入提供参考。The process of innovative drug medical insurance admission in China is gradually accelerating,but the risk of admission decision-making is also increasing.Standardizing the application of real-world data can provide important evidence for medical insurance admission assessment,thereby reducing decision-making risks.This article analyzes the advantages and disadvantages of real-world data and application scenarios in medical insurance access,summarizes current policy frameworks and guidelines at home and abroad,and proposes research standards and application paths for real-world data in China's innovative drug medical insurance access,providing references for the application of real-world data research in medical insurance access.

关 键 词：真实世界数据 创新药 医保准入 应用情境 研究规范 应用路径 

分 类 号：F840.684[经济管理—保险]