Authors' objectives: This study aims to evaluate the relative efficacy and safety of the "Micra Leadless Pacemaker System" used in transcatheter pacemaker implantation or replacement. It also conducts a local economic analysis and a financial impact analysis tailored to Taiwanˇ¦s healthcare context.

Authors' results and conclusions: Currently, no controlled trials exist for the Micra pacemaker, and the follow-up period in available studies is less than two years. Comparisons with wired pacemakers are based on post-hoc analyses, and the available clinical evidence remains limited. The local economic analysis using the minimum cost method could not determine which pacemaker type has the lowest cost due to the lack of reimbursement guidelines and epidemiological data for leadless pacemakers in Taiwan. However, given the Micra leadless pacemaker's advantage of reducing major complications and the low likelihood of overuse due to patient cost-sharing, its inclusion in NHI would have a limited budgetary impact. One possible approach is to initially approve reimbursement for high-risk patients prone to complications, allowing clinicians and patients an alternative treatment option. A re-evaluation in three to five years, based on longer-term international data and local reimbursement trends, could determine whether to expand coverage. According to an INAHTA survey, Finland has approved reimbursement for the Micra pacemaker, while Australia has not implemented nationwide coverage, though it is reimbursed in public hospitals in Queensland. The U.S. Centers for Medicare & Medicaid Services (CMS) has granted conditional reimbursement under the Coverage with Evidence Development (CED) framework for elderly, disabled, or low-income patients. In contrast, Austria declined reimbursement due to insufficient evidence, and Norway rejected coverage based on an incremental cost-effectiveness ratio (ICER) that did not meet cost-effectiveness thresholds.

Authors' methods: The efficacy assessment involved a literature search in major electronic databases, including Cochrane Library, PubMed, Embase, the Taiwan Periodical Literature Index System, the Taiwan Theses and Dissertations Knowledge Value-Added System, AiritiLibrary, and the Wanfang Database. In addition, health technology assessment (HTA) reports from various countries were reviewed, and a questionnaire was distributed among International Network of Agencies for Health Technology Assessment (INAHTA) members to gather details on reimbursement policies. For economic evaluation, a systematic review of economic studies was conducted, followed by a cost analysis, local economic evaluation, and financial impact analysis of transcatheter pacemaker implantation or replacement in Taiwan.

Project Status: Completed

Year Published: 2018

URL for published report: https://www.cde.org.tw/media/2kvdnial/107%E5%B9%B4%E7%B6%93%E5%B0%8E%E7%AE%A1%E5%BF%83%E5%BE%8B%E8%AA%BF%E7%AF%80%E5%99%A8%E7%BD%AE%E6%94%BE%E6%88%96%E7%BD%AE%E6%8F%9B%E8%A1%93-1090504%E6%96%B0%E5%A2%9E.pdf?mediaDL=true

English language abstract: There is no English language summary available

Publication Type: Full HTA

Organisation Name: Center for Drug Evaluation

Contact Address: 3F.,No.465, Sec.6, Zhongxiao E. Rd., Taipei 11557, Taiwan. R.O.C.

Contact Name: Li Ying (Grace) Huang

Contact Email: lyhuang277@cde.org.tw