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.
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.
Value Health Reg Issues. 2024 Jul;42:100978. doi: 10.1016/j.vhri.2023.12.009. Epub 2024 Feb 12.
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.
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.
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.
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.
本研究旨在评估国家健康保险署（NHIA）于 2013 年推出的医疗器械报销规定（Regulation）对台湾地区创新型医疗器械患者可及性的影响。
通过分析 NHIA 网站上的非报销产品清单，评估从申请 NHIA 报销新医疗器械到获得 NHIA 决定所需的时间。此外，采用 Welch 方差分析比较不同非报销代码类别下从申请到 NHIA 报销决定的时间。此外，还分析了相关的药品福利报销计划会议记录，以获取有关医疗器械报销或不报销的更详细信息。
2012 年 12 月至 2021 年 6 月，总体报销比例为 56.7%，从申请到报销的平均时间为 856.7±474.7 天。强制性报销率约为 45%。NHIA 作为特殊医疗器械的报销决定也需要更长的时间，因为申请人需要同意该决定（P<.05）。NHIA 对非报销医疗器械的决策过程所需的时间明显长于对一般材料（如缝线等）的决策。
尽管 Regulation 解决了支付问题，但它也增加了获得报销决定的时间，从而阻碍了患者获得创新型医疗器械的机会。研究表明，报销通知的审查过程需要简化，使用本地真实世界的数据来支持报销决策。
