OBJECTIVES: The Health Insurance Review and Assessment Service (HIRA) facilitates pharmaceutical and medical device reimbursement in South Korea. Medical device reimbursement follows a complex pathway encompassing Medical Services (MS) and Medical Materials (MM). To address gaps in literature around HIRA’s decision outcomes regarding medical devices, this study aims to present these trends and key factors for rejections to help improve submission quality.

METHODS: Publicly available data between January 2020 to March 2023, retrieved from MS and MM Assessment Reports on HIRA’s database, was analysed for decision outcomes and key factors associated with non-reimbursement. These were classified into economic, clinical, and procedural, with sub-categories like low cost-effectiveness, non-reimbursement of related MS.

RESULTS: Reimbursement decisions for 117 MS and 212 MM were analysed. Findings for MS showed, 54% with full reimbursement, 26% selective reimbursement and 20% non-reimbursement. Notably, full reimbursement rates declined from 2020-2022 (69% to 45%) while non-reimbursement rates increased (2% to 34%). Major rejection reasons were insufficient evidence (28%), no unmet need (17%) and similar MS not reimbursed (14%).

CONCLUSIONS: The analysis reveals HIRA’s high reimbursement rate for medical devices and provides unprecedented evidence on common reasons for rejections. To improve submission quality, manufacturers must effectively demonstrate the unmet need, clinical effectiveness in relevant patients and consider the potential impact of reimbursement status of related MS on their submissions.