Sang-Soo (SS) Lee, Ph.D., MBA

• Sr. Director, Health Care Economics & Government Affairs, Medtronic North Asia (Korea & Japan)
• Head, Center of Expertise (COE), Health Care Economics & Government Affairs, Medtronic Asia Pacific
• Chair, ISPOR Asia Consortium Industry Committee
• Lead, Market Access Working Group (MAWG), APACMed
• Chair, Reimbursement Committee, Korea Medical Devices Industry Association (KMDIA)
• Adjunct Professor, Graduate School of Medical Device Management and Research, SAIHST (Samsung Advanced Institute for Health Science & Technology), Sung Kyun Kwan University, South Korea
• Adjunct Professor, Graduate Program of Industrial Pharmaceutical Sciences, Yonsei University, South Korea

On January 27, 2022, the Ministry of Health and Welfare (MoHW) announced some amendments to the ‘Rules on New Health Technology Assessment’ effective on January 28. 2022 [1]. Through the amended rules, the target and application period of new health technology that is eligible for the early market entry in the medical field will be expanded, and safety management for the use of new health technology will be strengthened. Since the introduction of the new health technology assessment (nHTA) program in 2007, the efforts to develop pathways to quickly provide new health technologies to the public and promote entry of new health technologies into the market for the growth of the bio-health industry have been strengthened.

The MoHW improves the 'temporary deferment of nHTA' program to expand the scope of technologies eligible for the program and period of deferment and ease the requirements for deferment. In addition, the authority strengthens the safety management of health technologies that enter the market in advance without official nHTA approval to protect the health of the public. The authority also improves relevant regulations to promote the development of health technology. The newly established regulations for this purpose are as follows:

1. In-vitro diagnostic technologies that have been excluded from 'temporary deferment of nHTA' program are now applicable to the temporary deferment program. Non-invasive diagnostic technologies which have little concern about safety are eligible for the temporary deferment program with the submission of ‘clinical trial evidence’ that is used for regulatory approval from the Ministry of Food and Drug Safety (MFDS), not with the 'comparative clinical evidence'. It is possible to apply for a deferment of evaluation only with 'data on the subject'.
2. The period for early entry into the medical field without nHTA approval has also been extended from one to two years. Thus manufacturers will have more opportunities to generate clinical evidence for safety and efficacy (effectiveness).
3. For the technology which has gone through nHTA and failed to pass it, it will have an opportunity to apply for temporary deferment program under the condition that there was no safety concern in the previous nHTA carried out.
   
   To protect the health of the public, the 'temporary deferment of nHTA' program and the safety management mechanism for early market access of technologies without nHTA approval have been strengthened, and the details are as follows:
   1. As the 'temporary deferment of nHTA' program is expanded and the requirements is eased, a process is newly created to review safety through an ‘expert committee’ and deliberated by the ‘new health technology assessment committee’ before entering a medical field.
   2. Three programs which have been operated to allow early market access of new health technology without official nHTA approval – 1) 'temporary deferment of nHTA' program, 2) ‘conditional nHTA approval’ program, and 3) 'innovative health technology' program - have been managed by each committee. These three committees will be combined into one committee called ‘evidence development expert committee,’ and the newly unified committee will systemically perform the assessment process management and rigorous review about safety of technologies.
   3. The requirement for mandatory reporting of serious adverse events is made to prevent additional harm when adverse events occur while using health technologies. The risk level review and discontinuation of use of technologies are also explicitly specified.
      

      Reference

      1. https://www.mohw.go.kr/react/al/sal0301vw.jsp?PAR_MENU_ID=04&MENU_ID=0403&page=1&CONT_SEQ=369970