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KMID : 1146320220100010029
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Journal of Health Technology Assessment
2022 Volume.10 No. 1 p.29 ~ p.37
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Review on Recent New Technology Add-on Payment Decisions of Medical Devices by Center for Medicare and Medicaid Services and Its Implications
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Chun Sae-Im
Choi Hyun-Sook
Kim Min-Joon
Kim Mi-Ri
Kang Da-Ye
Yang Jang-Mi
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Abstract
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Medical devices have different characteristics from pharmaceuticals including the limitations on evidence generation and it needs to be considered at the time of value assessment. This article provides an review on recent new technology add-on payment (NTAP) decisions in terms of evidence requirements for medical devices. We investigated recent NTAP cases for interventions, biologics, in vitro diagnosis, and artificial intelligence-based devices regarding substantial clinical improvement. Evidence from published or unpublished information sources such as clinical trials, peer reviewed journal articles, study results, meta-analyses, consensus statements and whitepapers may be sufficient to demonstrate substantial clinical improvement. Real world evidence are also used as the critical source even in the unpublished form. In addition, clinical improvement can be evaluated by reviewing the overall status of the existing treatment of the disease and analyzing the clinical impact for current and future healthcare environments. It is not limited to direct comparative clinical study results for substantial clinical improvement for NTAP decision. It also transparently discloses the details of review process and what evidences were discussed. It is expected that patient accessibility can be improved through revision of current technology evaluation system in evaluating breakthrough or improved medical devices based on the implications on the NTAP.
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KEYWORD
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Innovative medical technology, Value appraisal, Add-on payment
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