- Policy
- Will the general diabetes criteria be revised after 14 yrs?
- by Lee, Tak-Sun Jul 16, 2025 06:09am
- The National Health Insurance Service (NHIS) is currently reviewing a comprehensive revision of the general principles for diabetes drug reimbursement criteria, which have been in place for 14 years. It is garnering significant attention from the industry. Following recent trends, significant changes are anticipated, including the remova
- Policy
- Gov't pursues 'project to produce unstable supply drugs'
- by Lee, Jeong-Hwan Jul 15, 2025 06:08am
- The Ministry of Health and Welfare (MOHW) plans to continue its project of providing government funding for the production of drugs with unstable supply. The MOHW plans to proceed with the currently budgeted project to support one item, while also working to secure additional budget to support more items. A MOHW official recently met w
- Policy
- How Trodelvy was applied flexible ICER for innovativeness
- by Lee, Tak-Sun Jul 14, 2025 06:04am
- The ADC breast cancer drug Trodelvy (sacituzumab govitecan, Gilead), which was reimbursed in June for triple-negative breast cancer, was the first case in which the ICER (incremental cost-effectiveness ratio) threshold was flexibly applied in recognition of its innovation. So how did the Drug Reimbursement Evaluation Committee (DREC) of t
- Policy
- Orphan drug 'Bylvay Cap' wins reimb approval after reeval
- by Lee, Tak-Sun Jul 14, 2025 06:03am
- 'Bylvay Cap,' which is being considered for the expedited reimbursement listing process as a designated drug for 'Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,' received reimbursement appropriateness decision after reevaluation. Consequently, Bylvay Cap will be subjected to ne
- Policy
- Will drugs subject to reimbursement reevals be expanded?
- by Lee, Tak-Sun Jul 11, 2025 06:11am
- The government is reportedly planning to tighten the selection criteria ahead of the second phase of the drug reimbursement adequacy reevaluations, which is set to begin next year. As a result, it is expected that the number of ingredients subject to reassessment may be expanded. According to industry sources on the 10th, the Health In
- Policy
- Pfizer discontinues the supply of 'Viviant' in KOR
- by Lee, Tak-Sun Jul 11, 2025 06:09am
- Pfizer announced of discontinuing the supply of its 'Viviant Tab (bazedoxifene acetate)' in Korea. They stated that supply discontinuation is due to the difficulty in securing a stable and continuous supply. Viviant had previously been out of stock in May due to delays in the manufacturing site. An analysis suggests that Viviant's marke
- Policy
- Hanmi’s BTK inhibitor poseltinib approved for P1T in KOR
- by Lee, Hye-Kyung Jul 11, 2025 06:09am
- Hanmi Pharmaceutical's BTK inhibitor ‘poseltinib,’ which was licensed out to Nobo Medicine last year, will enter Phase I clinical trials in Korea as a monotherapy. On the 7th, the Ministry of Food and Drug Safety approved an open, multicenter, monotherapy, dose escalation Phase I clinical trial of NB02 (poseltinib) for patients with rel
- Policy
- Discussion on "Indication-specific drug pricing system"
- by Lee, Tak-Sun Jul 10, 2025 06:09am
- The Health Insurance Review & Assessment Service (HIRA) announced that the issue of 'indication-specific drug pricing system' proposed by the pharmaceutical industry may require further discussion, and the immeditate implementation is difficult. They explained that further discussion is needed, particularly regarding the prevention of co
- Policy
- Introduction of AI for drug approval and review in Korea
- by Lee, Hye-Kyung Jul 10, 2025 06:09am
- The Ministry of Food and Drug Safety is conducting follow-up research to introduce generative artificial intelligence (AI) to the domestic drug approval and review field starting next year. The Pharmaceutical and Medical Device Research Department of the National Institute of Food and Drug Safety Evaluation is conducting an ISP project to est
- Policy
- Daewoong’s generic version of Migbose approved in Korea
- by Lee, Hye-Kyung Jul 9, 2025 06:09am
- Daewoong Pharmaceutical has been approved to sell a generic version of the diabetes treatment Migbose Film-Coated Tablets (miglitol) in Korea. On the 7th, the Ministry of Food and Drug Safety approved Daewoong Pharmaceutical's Daewoong Miglitol Tab. (miglitol). Like the original Migbose, Daewoong Miglitol Tab is a film-coated tablet indica
