Establishment and Publication of the Guidelines for Reassessment of Health Technology
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On September 4, 2025, the Ministry of Health and Welfare (MOHW) and the National Evidence-based Healthcare Collaborating Agency (NECA) officially issued and published the "Guidelines for Reassessment of Health Technology" (hereinafter referred to as "Guidelines").
This follows the enforcement of Article 4, Section 3 "Reassessment of Health Technology" of the Rules on New Health Technology Assessment, which was amended and promulgated on March 6, 2025. The Guidelines will initially apply to items selected to be subject of reassessment on or after September 7, 2025; the full-scale implementation of the reassessment program is scheduled to begin in 2026.
The reassessment program is designed to reanalyze and reexamine existing health technology—originally introduced through the New Health Technology Assessment (nHTA)—in terms of their clinical safety and efficacy, etc. To this end, a dedicated Reassessment Expert Committee will be established, consisting of clinical specialists, research methodology experts, health policy professionals, and representatives recommended by medical organizations.
According to the Guidelines, candidate technologies for reassessment will be selected from a preliminary list generated through demand surveys, topic proposals, and internal monitoring, subject to deliberation by the Reassessment Expert Committee. Demand surveys and topic proposals will be open to a wide range of stakeholders, including medical societies, healthcare professionals, the general public, civic groups, government agencies, and other healthcare-related parties.
The selection criteria for reassessment as stipulated in the Guidelines are as follows:
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Health technology that shows an increased number of reports of serious adverse events either domestically or internationally; or subject to safety warnings by regulatory authorities.
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Health technology whose relative effectiveness, etc. has significantly changed compared to alternative technologies due to clinical advancements, shifts in standard treatment practices, etc.
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Health technology with new or updated findings reported in domestic/overseas clinical guidelines, health technology assessments, clinical studies, etc.
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Health technology with significant changes in usage rate, necessitating reassessment due to potential change in clinical safety and efficacy, or appropriate use, etc.
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Health technology with high clinical utility in diagnosis or treatment that are recognized as a standard method, but undervalued in Korea’s healthcare system.
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Any other health technology deemed necessary for reassessment by the Minister of Health and Welfare.
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Selected health technologies will undergo systematic reviews and, depending on their characteristics, may also be assessed through outcomes research, surveys, and other quantitative or qualitative methodologies. Results will be disclosed in a reassessment report, categorized into five outcome grades (including deferral). Based on these results, the Minister of Health and Welfare may issue official notices regarding the scope of reassessment and related findings on safety and efficacy, etc.
With the implementation of health technology reassessment, technologies found to lack safety or efficacy may be delisted from the New Health Technology catalog and potentially removed from health insurance coverage. Conversely, health technologies demonstrating improved relative effectiveness or expanded indications (i.e., through updated clinical guidelines, etc.) may benefit from expanded reimbursement scope or levels, thereby enhancing patient access.
This reform provides new opportunities for under-recognized or highly effective technologies to improve their reimbursement status through the reassessment program. We recommend stakeholders to carefully consider the potential implications of this new reassessment program. For further inquiries, please feel free to contact MDREX.
Thank you.
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