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

Heart Failure Clinical Trial

Official title:

Cost-effectiveness Analysis on Remote Monitoring for Cardiovascular Electronic Implantable Devices in Japan by Using Systematic Review Methodology - 2018 Reimbursement Update

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03747809
• Other study ID #: OUJ11200212018111801
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: June 16, 2019

Study information

• Verified date: September 2022
• Source: The Open University of Japan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 16, 2019
• Est. primary completion date: June 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Failure

Intervention

Device:
• CIEDs Remote Monitoring System
Cardiac device remote monitoring system

Locations

Country	Name	City	State
Japan	The Open University of Japan	Chiba

Sponsors (1)

Lead Sponsor	Collaborator
The Open University of Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of ICERs based on earned QALYs from selected studies by applying to Japanese reimbursement environment.		12 months