Analysis of the Impact of Medical-Engineering Collaboration on the Insurance Listing Process for Innovative Medical Devices Requiring New Technical Fee (Category C2)

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  • MATSUMOTO Toru
    Cooperative Major in Advanced Biomedical Sciences of Tokyo Women’s Medical University and Waseda University TERUMO Corporation, Regulatory Affairs
  • TAMURA Manabu
    Cooperative Major in Advanced Biomedical Sciences of Tokyo Women’s Medical University and Waseda University
  • MASAMUNE Ken
    Cooperative Major in Advanced Biomedical Sciences of Tokyo Women’s Medical University and Waseda University

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  • Analysis of the Impact of Medical-Engineering Collaboration on the Insurance Listing Process for Innovative Medical Devices Requiring New Technical Fee（Category C2）

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<p>In order to encourage the development of medical devices in Japan, it is important to foster the “medical-engineering collaboration.” In the insurance listing of innovative medical devices requiring new technical fees (Category C2), it is assumed that there is an organized collaboration between medical device companies and professional societies. This study aims to clarify the actual situation of such collaborations in the insurance listing process, and to understand the influence of collaboration on the determination of technical fees. Two analyses were conducted using data for Categories C1 and C2 from FY2012 to FY2021. (1) Analysis of collaboration trends in the insurance listing process. In Category C2, there was an increase in the issuance of practical guides for appropriate use. The percentage of items with collaboration in Category C1 was 20% (26/130), while that in Category C2 was significantly higher, i.e., 63% (72/114) (p<0.01). (2) The data were divided into two groups based on the presence or absence of collaboration, and a comparison of the percent discrepancy between companies’desired technical fees and the final determined technical fees in Category C2 was analyzed. The mean discrepancy was 76% in the group with collaboration (n=38) and 48% in the group without collaboration (n=10) (p=0.24). Collaboration with professional societies has progressed in Category C2 insurance listings. The practical guides for appropriate use include detailed information on intended patients and methods of use as well as training and standards for practitioners or facilities. While insurance coverage promotes high-quality medical care, training for appropriate use, and establishment of standards is important. Collaboration with professional societies is considered essential for the development of innovative medical devices and insurance coverage.</p>

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