Korea’s Ministry of Health and Welfare announced on June 30 a pilot program to speed up health insurance listing for rare disease treatments. The process will take only 100 days, down from 240 days. Under the pilot, cost-effectiveness assessments will happen after listing, instead of beforehand, based on real-world clinical outcomes. Price negotiations will be replaced with pre-agreed terms. Drug prices will be set at 90% of the lowest adjusted price among eight reference countries (US, UK, Germany, France, Italy, Switzerland, Japan, Canada). To be eligible, rare disease drugs must be approved or under approval review, and listed in at least three of the eight reference countries. The Ministry will select up to five drugs, weighing factors like availability of alternative therapies, disease severity, fiscal impact, and patient access plans.
Also, on June 30, Korea’s Ministry of Food and Drug Safety (MFDS) issued new guidelines for approval of Large-Language-Model-based (LLM-based) digital medical devices, such as clinical decision support tools, medical record summarizers, and image interpretation aids. The guidelines expand on the MFDS’s January 2025 rules for generative AI medical devices, adding detail specific to LLM technology. They were developed with input from device manufacturers, medical institutions and academic experts. Key contents include examples of LLM-based devices, guidance on preparing license applications, and methods for verifying clinical and functional performance. A major focus is verifying LLM-specific risks, such as errors in long conversations, omitted or distorted information, and misreading context. The MFDS expects the rules to speed up the commercialization of LLM-based medical devices.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.