HIRA Issues a Commissioned Study to Develop Improved Listing Process for Health Insurance Reimbursement of Medical Technologies
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The Health Insurance Review and Assessment Service (“HIRA”) has commissioned a study to objectively evaluate the health insurance reimbursement process that has been in place since the 2010 transfer of the new Health Technology Assessment (“nHTA”) to the National Evidence-based Healthcare Collaborating Agency (“NECA”) and to identify areas for improvement aimed at establishing a more systematic and reasonable operational framework.
The main scope of the study includes linkage analysis of the procedures and current reimbursement status from the determination of eligibility for reimbursement (hereinafter “technology determination”) through to the final decision on reimbursement as well as a comparative analysis of similar systems in foreign countries.
Additionally, during the technology determination stage, the study will review improvement measures for the criteria applied, including: ① development of handling measures for medical technologies that are significantly inferior in clinical effectiveness, and ② revision of terminology related to eligibility for nHTA application.
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◇ Handling Measures for Medical Technologies Significantly Inferior in Clinical Effectiveness
· It is necessary to propose specific implementation measures, including the feasibility of handling during the technology determination process, potential issues arising therefrom, and the scope of responsibility of relevant agencies, etc.
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◇ Revision of Terminology Regarding Eligibility for nHTA Application
· Despite being subject to verification (for safety and efficacy), some technologies are frequently misunderstood as being superior to existing technologies, necessitating clarification of terminology.
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In the reimbursement decision phase, the study will also cover an analysis of:
① development of decision-making measures for the management of practices that lack clinical usefulness, but present risks of misuse or overuse, and ② the need for improvements to the evaluation criteria under the current regulations for reimbursement decisions, particularly by establishing objective criteria to assess social demand and related factors.
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◇ Decision-Making Measures for Managing Practices Lacking Clinical Usefulness but Risk of Misuse or Overuse
· This includes practices such as those where, at the time of reimbursement application, procedures are widely performed at high customary prices by many medical institutions following MFDS approval and early market entry, even though subsequent safety and effectiveness evaluations by NECA result in the lowest grade (anticipated).
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◇ Need for Improvement of Evaluation Criteria for Reimbursement Decisions, Particularly in Presenting Objective Measures for Social Demand
· Criteria include clinical usefulness, cost-effectiveness, patient out-of-pocket burden, societal benefits, and the financial status of the national health insurance system.
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In addition, the study is expected to propose the reestablishment of the governance structure for decision-making, and to draft amendments to related laws and regulations, in order to concretely implement the suggested improvements.
Since the outcome of this commissioned study is expected to lead to reforms in the current technology determination procedures, reimbursement assessments, and reimbursement listing processes, it is recommended to closely monitor the study results, scheduled for release in December 2025, and to proactively explore appropriate response strategies.
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Considering the above institutional reform directions,
and the current status of the Korean medical device industry,
we recommend establishing a more effective market entry strategy.
If you have any questions regarding the above institutional reforms or market entry strategies, please feel free to contact MDREX at pro@mdrex.co.kr
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