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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Diseases, Heart Failure

Intervention / Treatment
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* Device: CIEDs Remote Monitoring System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CIEDs having Remote Monitoring<br> | Device: CIEDs Remote Monitoring System<br>* Cardiac device remote monitoring system<br>|
| Patients with CIEDs having no Remote Monitoring<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences of ICERs based on earned QALYs from selected studies by applying to Japanese reimbursement environment. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Monitoring