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亚太地区医疗技术证据开发项目的覆盖情况：以日本和韩国为例

Coverage with Evidence Development Programs for Medical Technologies in Asia-Pacific Regions: A Case Study of Japan and South Korea.

作者信息

Myung Jae-Eun, Tanaka Yuji, Choi Hyunsook, Strachan Liesl, Watanuki Tomohiro, Lee Ji-Hyun, Hwang Hyojung, Lee Sang-Soo

机构信息

Healthcare Economics and Government Affairs, Medtronic Korea Ltd., Seoul, South Korea.

Healthcare Economics and Government Affairs, Medtronic Japan Ltd., Tokyo, Japan.

出版信息

JMA J. 2021 Oct 15;4(4):311-320. doi: 10.31662/jmaj.2021-0011. Epub 2021 Sep 13.

DOI:10.31662/jmaj.2021-0011
PMID:34796285
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8580702/
Abstract

In this article, the operational characteristics of coverage with evidence development (CED) programs in Asia-Pacific regions, focusing on two countries-Japan and South Korea-are reviewed. Both countries recommended the introduction of CED to overcome the barrier of lack of robust clinical evidence in the early stages of the introduction of a medical technology. However, each country has a unique approach to CED implementation that reflects the differences in establishment and healthcare and policy environments. Japan adopted a "Challenge Application (CA)" program in 2018, and South Korea introduced the "Conditional Selective Benefit (CSB)" program in 2014. Despite the positive effects of CED programs, their governance and implementation should be improved to benefit patients in both countries from the improved access to new and innovative medical technologies. To this end, CED practices in the United States (the USA) can provide insights on how to improve CED operations in both countries.

摘要

本文回顾了亚太地区循证开发（CED）项目的运作特点，重点关注日本和韩国这两个国家。两国都建议引入CED，以克服在引入医疗技术初期缺乏有力临床证据的障碍。然而，每个国家在实施CED方面都有独特的方法，这反映了其制度、医疗保健和政策环境的差异。日本在2018年采用了“挑战申请（CA）”项目，韩国在2014年引入了“有条件选择性福利（CSB）”项目。尽管CED项目有积极影响，但仍应改进其治理和实施，以使两国患者能从更好地获取新型创新医疗技术中受益。为此，美国的CED实践可为如何改进两国的CED运作提供见解。