- Policy
- Zolgensma shows 94% effect during post-evaluations
- by Lee, Tak-Sun Jan 6, 2025 05:56am
- The spinal muscular atrophy (SMA) treatment Zolgensma (onasemnogene abeparvovec) showed promising results suited to its high price. The use of the once-daily, one-shot treatment, which has an insurance cap set at KRW 2, requires a post-marketing evaluation to measure its cost-effectiveness. According to industry sources on the 5th, Z
- Policy
- MFDS’s 2nd GIFT drug Nefecon applies for reimbursement
- by Lee, Tak-Sun Jan 6, 2025 05:56am
- Nefecon (micronized budesonide), the only drug approved by the U.S. FDA to treat lgA (immunoglobulin A) nephropathy, has applied for domestic health insurance reimbursement coverage in Korea. The drug was approved in November last year as its 2nd GIFT (Global Innovative Drug Fast Track) drug, MFDS’s fast track program. According to in
- 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
