Mordin M, Bhogal P, Warttig S, Gildea L, Long J, D'Souza V, Kinderas M, Ling C, Hartley L. What is the medical technology HTA process in Japan? Poster presented at the ISPOR 2024; May 6, 2024. Atlanta, GA.

OBJECTIVES: Detailed, publicly available information on the process and methods for health technology assessment (HTA) of medical technologies (MTs) can be difficult to find. Our objective was to understand the process and methods for MT HTA used by the Center for Outcomes Research and Economic Evaluation for Health (C2H) in Japan.

METHODS: A review of publicly available information from the C2H website was performed and supplemented by an online survey. The survey requested information on the selection process, types of MT evaluated, timelines, and types of evidence considered as part of the HTA process. Quantitative and qualitative data were obtained and collated in Excel.

RESULTS: The C2H website provides little information about process and methods used to review MTs. Survey results revealed that C2H evaluates invasive devices but not non-invasive devices, diagnostics, or digital technologies. An external referral process is used to select topics. C2H uses either a general HTA process (e.g., as used for assessing pharmaceuticals) or a dedicated HTA process specifically designed for assessing MTs. For the dedicated process, C2H considers clinical and economic data. It usually takes more than 12 months to complete an MT HTA. The survey highlights that C2H uses cost-utility analysis as its main method for economic evaluation for HTA. However, the website generalises cost-utility analysis, cost-effectiveness analysis, and cost minimization analysis under cost-effectiveness analysis.

CONCLUSIONS: A major challenge for MT companies is establishing whether a technology requires or is eligible for HTA in different markets. For Japan, information was not explicitly clear on the C2H website. HTA agencies should include MT-related information on their websites to help inform MT companies of their processes, and MT companies should be prepared to contact HTA agencies directly to obtain necessary information to inform evidence generation and market access strategies, and HTA submission plans.

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