- Policy
- 'Pivlaz Inj' makes another attempt to be reimb in KOR
- by Lee, Tak-Sun Jan 3, 2025 06:27am
- 'Pivlaz Inj,' which is supplied·distributed in South Korea by Handok, has been submitted for another attempt at reimbursement. The marketing authorization for Pivlaz was approved in South Korea in December 2023. Then, the company applied for reimbursement but voluntarily withdrew the reimbursement application in June 2024. According t
- Policy
- New Year's drug pricing policy highlights
- by Lee, Tak-Sun Jan 3, 2025 06:27am
- The new drug pricing system in 2025 is expected to be volatile due to Korea’s political turmoil. Whether the external reference pricing reevaluations and re-evaluation of the listed PE exemption drugs, which were reviewed or discussed last year, will be carried out this year is also the focus of attention. However, as most of the detai
- Policy
- Prices for Vyndamax, Ocrevus in negotiations with NHIS
- by Lee, Tak-Sun Jan 3, 2025 06:27am
- Pfizer's cardiomyopathy drug Vyndamax Cap and Roche's multiple sclerosis drug Ocrevus Inj are undergoing drug price negotiations with the National Health Insurance Service (NHIS) in Korea. Therefore, it will be interesting to see if the drugs will be able to finalize negotiations and their reimbursement listing agenda be submitted to the He
- Policy
- Orphan drug 'Voxzogo' wins nod
- by Lee, Hye-Kyung Jan 2, 2025 06:11am
- The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on December 31 that it has approved 'Voxzogo (vosritid),' an orphan drug used to treat achondroplasia in children over four months whose growth plates are not closed. Achondroplasia is a bone growth-related genetic disease caused by a mutation in the FGFR3, a ge
- Policy
- Changes made to the drug approval system in the new year
- by Lee, Hye-Kyung Jan 2, 2025 06:11am
- Various changes will be made to the drug approval and management system in the new year of 2025, including the new drug approval innovation plan. On December 31st, the Ministry of Food and Drug Safety (MFDS) announced the changes that will be enforced from January, including ▲ the implementation of a new drug approval innovation plan ▲ refo
- Policy
- ICER threshold for anticancer drugs set same as in 2024
- by Lee, Tak-Sun Jan 2, 2025 06:10am
- The Health Insurance Review and Assessment Service released the results of the incremental cost-effectiveness ratio (ICER) of drugs submitted for pharmacoeconomic evaluation from 2019 to 2023, which has shown a decrease in the maximum ICER threshold set for anticancer drugs. The ICER threshold did not appear to have changed much from the prev
- Policy
- Once-weekly insulin 'Awiqli' wins nod in KOR
- by Lee, Hye-Kyung Dec 31, 2024 05:56am
- A once-weekly insulin to treat patients with adult diabetes has been approved in South Korea. On December 23, the Ministry of Food and Drug Safety has approved Novo Nordisk's 'Awiqli Pre-Filled Pen 700 Units/mL (insulin icodec, recombinant).' This drug is a once-weekly subcutaneous injection of insulin, providing a more convenient treat
- Policy
- Approval of the 48hr Nurtec ODT for migraine imminent in KOR
- by Lee, Hye-Kyung Dec 31, 2024 05:55am
- ‘Nurtec (Rimegepant),’ which is used for both the treatment and prevention of migraine, will soon receive marketing authorization in Korea. According to industry sources on the 31st, the Ministry of Food and Drug Safety completed the safety and efficacy review of Pfizer's Nurtec Oral Disintegrating Tablet 75 mg. Pfizer submitted a ma
- Policy
- 29 new drugs with 45 ingredients reimb this year
- by Lee, Tak-Sun Dec 31, 2024 05:55am
- This year, 45 new drugs with 29 ingredients were listed for reimbursement benefits under Korea’s health insurance. Among them, the only homegrown new drug was 'Zastaprazan citrate', a P-CAB-based gastroesophageal reflux disease treatment. As of the 30th, 45 new drugs were listed for reimbursement in Korea’s National health insurance syst
- Policy
- Yungjin Pharm wins the 1st trial against Ofev
- by Kim, Jin-Gu Dec 31, 2024 05:44am
- Yungjin Pharm has won the usage patent dispute for Ofev (nintedanib), a treatment for idiopathic pulmonary fibrosis (IPF). Based on the victory, Yungjin is one step closer to the early launch of its generic version of Ofev. The pharmaceutical industry suggests this decision is significant beyond Yungjin Pharmaceutical's avoidance of Ofe
