SUPPORTING EVIDENCE GENERATION THROUGH LIFE-CYCLE SCIENTIFIC ADVICE: FIVE-YEAR EXPERIENCE OF KOREA'S HTA GUIDE PROGRAM
Author(s)
wonji ko, Jr., MPH1, Wonjung Choi2, Ji Eun Choi, PhD3.
1seoul, Korea, Republic of, 2Seoul, Korea, Republic of, 3National Evidence-based Collaborating Agency, Seoul, Korea, Republic of.
1seoul, Korea, Republic of, 2Seoul, Korea, Republic of, 3National Evidence-based Collaborating Agency, Seoul, Korea, Republic of.
OBJECTIVES: The proliferation of AI-based medical devices, digital therapeutics (DTx), and electroceuticals has increased the need for HTA bodies to provide early scientific advice to developers. In August 2021, the National Evidence-based Healthcare Collaborating Agency (NECA) of Korea established the HTA Guide Programme, a publicly funded life-cycle scientific advice programme that provides six months of longitudinal support to selected developers from the prototype stage onward through a competitive application process.
METHODS: The outcomes of the HTA Guide Programme were analysed for 240 technologies supported between August 2021 and June 2025 across 16 programme rounds. Technologies were characterised according to developmental stage, technology category, and innovation characteristics. Six advisory streams were analysed. Outcomes were defined as regulatory or market-access achievements and tracked through December 2025. Participant satisfaction with the programme was assessed using a 100-point survey completed by 104 participants.
RESULTS: A total of 658 advisory interactions were delivered across 240 technologies (mean 2.7 per technology) via six streams. Of these, 70.8% were at pre-authorisation stage (prototype 28.7%, pre-IND 26.2%, pre-marketing authorisation 15.8%). AI/Big Data technologies comprised 32.9%; technologies with innovative characteristics (DTx, electroceuticals, VR/AR, and others) accounted for 59.2%. Eighty-six programme outcomes were confirmed: new HTA or fast-track application/approval (41.9%), IND application/approval (29.1%), marketing authorisation (15.1%), existing technology confirmation by the Health Insurance Review and Assessment Service (HIRA) (7.0%), and others (7.0%). Nineteen technologies achieved clinical deployment (mean 14.8 months to listing), including 2 via standard HTA and 17 via expedited pathways. Mean participant satisfaction with the programme was 90.3 out of 100.
CONCLUSIONS: Most applications were submitted before regulatory authorisation, indicating substantial demand for early HTA scientific advice. High participant satisfaction further suggests that developers value structured HTA engagement before key regulatory milestones. These findings support the role of publicly funded life-cycle scientific advice in facilitating the development of innovative health technologies.
METHODS: The outcomes of the HTA Guide Programme were analysed for 240 technologies supported between August 2021 and June 2025 across 16 programme rounds. Technologies were characterised according to developmental stage, technology category, and innovation characteristics. Six advisory streams were analysed. Outcomes were defined as regulatory or market-access achievements and tracked through December 2025. Participant satisfaction with the programme was assessed using a 100-point survey completed by 104 participants.
RESULTS: A total of 658 advisory interactions were delivered across 240 technologies (mean 2.7 per technology) via six streams. Of these, 70.8% were at pre-authorisation stage (prototype 28.7%, pre-IND 26.2%, pre-marketing authorisation 15.8%). AI/Big Data technologies comprised 32.9%; technologies with innovative characteristics (DTx, electroceuticals, VR/AR, and others) accounted for 59.2%. Eighty-six programme outcomes were confirmed: new HTA or fast-track application/approval (41.9%), IND application/approval (29.1%), marketing authorisation (15.1%), existing technology confirmation by the Health Insurance Review and Assessment Service (HIRA) (7.0%), and others (7.0%). Nineteen technologies achieved clinical deployment (mean 14.8 months to listing), including 2 via standard HTA and 17 via expedited pathways. Mean participant satisfaction with the programme was 90.3 out of 100.
CONCLUSIONS: Most applications were submitted before regulatory authorisation, indicating substantial demand for early HTA scientific advice. High participant satisfaction further suggests that developers value structured HTA engagement before key regulatory milestones. These findings support the role of publicly funded life-cycle scientific advice in facilitating the development of innovative health technologies.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA410
Topic
Health Policy & Regulatory, Health Technology Assessment, Medical Technologies
Topic Subcategory
Decision & Deliberative Processes, Systems & Structure
Disease
No Additional Disease & Conditions/Specialized Treatment Areas