Examining the Impact of the Current Reimbursement Regulation on Patient Access to Innovative Medical Devices in Taiwan: Insights From 8 Years' Reimbursement Data.

Autor: Peng JY; Graduate Institute of Business Administration, Fu-Jen Catholic University, New Taipei City, Taiwan; Associate Manager of Market Access and Public Policy, Roche Diagnostics Ltd., Taipei, Taiwan., Lee SS; Sr. Director of Health Care Economics & Government Affairs, Medtronic North Asia, Korea and Japan; Head of Center of Expertise (COE), Health Care Economics & Government Affairs, Medtronic Asia Pacific; Adjunct Professor, Graduate School for Medical Device Management and Research, SAIHST (Samsung Advanced Institute for Health Science & Technology), Sung Kyun Kwan University, Seoul, South Korea., Lin CR; Department of Medical Education, Chang Gung Memorial Hospital, Taoyuan City, Taiwan., Lee H; College of Pharmacy, Pharmaceutical Medicine & Regulatory Science, Yonsei University, Incheon, Republic of Korea; Data Science Center, College of Medicine, Fu-Jen Catholic University, Taipei, Taiwan., Chen YC; Data Science Center, College of Medicine, Fu-Jen Catholic University, Taipei, Taiwan; Master Program of Big Data in Biomedicine, College of Medicine, Fu-Jen Catholic University, Taipei, Taiwan. Electronic address: 137159@mail.fju.edu.tw.
Jazyk: angličtina
Zdroj: Value in health regional issues [Value Health Reg Issues] 2024 Jul; Vol. 42, pp. 100978. Date of Electronic Publication: 2024 Feb 12.
DOI: 10.1016/j.vhri.2023.12.009
Abstrakt: Objectives: This study aimed to assess the impact of the reimbursement regulation of medical devices (Regulation), introduced by the National Health Insurance Administration (NHIA) in 2013, on patients' access to innovative medical devices in Taiwan.
Methods: Analysis of the amount of time needed from application for NHIA reimbursement for new medical devices to receiving the decision from NHIA was done using the nonreimbursement product list featured on the NHIA website. Additionally, Welch analysis of variance was used to compare the amount of time it took from application to NHIA with reimbursement decisions made by the NHIA for different nonreimbursement code categories. Further, related Pharmaceutical Benefit Reimbursement Scheme meeting minutes were analyzed to obtain more detailed information concerning medical devices' reimbursement or not.
Results: From December 2012 to June 2021, the overall reimbursement percentage was 56.7%, and the average amount of time between application and reimbursement was 856.7 ± 474.7 days. The mandatory reimbursement rate was about 45%. NHIA reimbursement decisions as special medical devices also take a longer amount of time, because the applicants need to agree to the decision (P < .05). The NHIA decision-making process for nonreimbursement medical devices requires a significantly longer amount of time than for general materials (eg, suture, etc) decisions.
Conclusions: Although the Regulation resolves payment issues, it also increases the amount of time to reach reimbursement decisions, thus hindering patient access to innovative medical devices. The study suggests that the review process needs to be simplified concerning reimbursement notification, using local real-world data to support reimbursement decisions.
Competing Interests: Author Disclosures Author disclosure forms can be accessed below in the Supplemental Material section.
(Copyright © 2024 International Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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