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

CED Challenge Application Conditional Selective Benefit Japan South Korea coverage with evidence development medical technology policy

Journal

JMA journal
ISSN: 2433-3298
Titre abrégé: JMA J
Pays: Japan
ID NLM: 101769797

Informations de publication

Date de publication:
15 Oct 2021
Historique:
received: 01 02 2021
accepted: 15 06 2021
entrez: 19 11 2021
pubmed: 20 11 2021
medline: 20 11 2021
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 34796285
doi: 10.31662/jmaj.2021-0011
pmc: PMC8580702
doi:

Types de publication

Journal Article Review

Langues

eng

Pagination

311-320

Informations de copyright

Copyright © Japan Medical Association.

Déclaration de conflit d'intérêts

All authors are the employees of Company Medtronic and stockholder.

Références

Health Aff (Millwood). 2006 Sep-Oct;25(5):1218-30
pubmed: 16966717
Value Health. 2014 Jun;17(4):476-81
pubmed: 24969010
Eur Heart J. 2017 May 1;38(17):1339-1344
pubmed: 28329139
J Am Coll Cardiol. 2018 Jun 12;71(23):2603-2611
pubmed: 29880119
Value Health. 2020 Apr;23(4):425-433
pubmed: 32327159
Health Policy. 2014 Sep;117(3):345-52
pubmed: 24957419
Int J Technol Assess Health Care. 2009 Jul;25 Suppl 1:42-52
pubmed: 19500435
JACC Cardiovasc Interv. 2015 Mar;8(3):377-381
pubmed: 25703888
Health Policy. 2009 Feb;89(2):184-92
pubmed: 18619704
Europace. 2011 May;13 Suppl 2:ii54-8
pubmed: 21518751
Value Health. 2019 Aug;22(8):878-883
pubmed: 31426928
Value Health. 2016 Jan;19(1):17-9
pubmed: 26797231
Value Health. 2009 Jun;12(4):404-6
pubmed: 19138305
Front Pharmacol. 2017 Apr 04;8:171
pubmed: 28420990
Value Health. 2009 Jun;12(4):402-4
pubmed: 19138306
Int J Technol Assess Health Care. 2010 Jan;26(1):79-85
pubmed: 20059784
Int J Health Plann Manage. 2019 Apr;34(2):583-593
pubmed: 30549085
Eur J Health Econ. 2019 Mar;20(2):217-232
pubmed: 29974285
Eur Heart J. 2014 Sep 14;35(35):2352-62
pubmed: 24771721
Int J Technol Assess Health Care. 2007 Fall;23(4):425-32
pubmed: 17937829
N Engl J Med. 2012 Jan 12;366(2):120-9
pubmed: 22236222

Auteurs

Jae-Eun Myung (JE)

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

Yuji Tanaka (Y)

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

Hyunsook Choi (H)

Healthcare Economics and Government Affairs, Medtronic Korea Ltd., Seoul, South Korea.
Department of Health Convergence, Ewha Womans University, Seoul, South Korea.

Liesl Strachan (L)

Global Health Policy, Medtronic Australasia Pty Ltd., Sydney, Australia.

Tomohiro Watanuki (T)

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

Ji-Hyun Lee (JH)

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

Hyojung Hwang (H)

Healthcare Economics and Government Affairs, Medtronic Korea Ltd., Seoul, South Korea.
Department of Health Policy, Graduate School of Public Health, Yonsei University, Seoul, South Korea.

Sang-Soo Lee (SS)

Healthcare Economics and Government Affairs, Medtronic Korea Ltd., Seoul, South Korea.
Graduate School for Medical Device Management and Research, SAIHST (Samsung Advanced Institute for Health Science & Technology), Sung Kyun Kwan University, Seoul, South Korea.

Classifications MeSH