Cost-effectiveness Analysis on Remote Monitoring for CIEDs in Japan by Using Systematic Review Methodology

Completed

• Conditions: Cardiovascular Diseases; Heart Failure
• Interventions: Device: CIEDs Remote Monitoring System

• Registration Number: NCT03747809
• Lead Sponsor: The Open University of Japan

Brief Summary

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

Detailed Description

2018 Revision of Health Reimbursement in Japan recognized non face-to-face diagnostics, such as Online Treatment, as the standard of care. There was a significantly additional cost for Cardiovascular Implantable Electronic Devices (CIEDs) Management Fee as well. The adaption of Remote Monitoring for CIEDs patients is recommended by the societies based on the clinical evidences. However, how QALYs earned by CIEDs Remote Monitoring are justified in Japanese reimbursement environment from the cost-effectiveness standpoint is still not so clear. The evaluation about the impact on the health economics about the installation of CIEDs Remote Monitoring has not been enough due to the lack of the researches around this field. Therefore this research is designed to examine the impact of the installation of CIEDs Remote Monitoring from the health economics perspective by considering the health insurance system and the clinical process in Japan, through Systematic Review methodology.

Study Timeline

• Study Start: 2018-09-01
• Study First Submitted: 2018-11-17
• Study First Submitted QC: 2018-11-17
• Study First Posted: 2018-11-20
• Primary Completion: 2019-06-16
• Study Completion: 2019-06-16
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Studies that involves CIEDs Remote Monitoring, such as Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy, and Pacemaker
• Follow-up periods more than or equal to 12 months
• Prospective studies
• QALYs available to make ICER analysis possible
• Published after Year of 1971

Exclusion Criteria

• Studies that are not related with CIEDs
• Follow-up periods less than 12 months
• Not prospective studies
• QALYs unavailable
• Published before Year or 1971

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with CIEDs having Remote Monitoring	CIEDs Remote Monitoring System	-

Primary Outcome Measures

Name	Time	Method
Differences of ICERs based on earned QALYs from selected studies by applying to Japanese reimbursement environment.	12 months

Trial Locations

Locations (1)

The Open University of Japan; 🇯🇵 Chiba, Japan