- Policy
- GSK starts domestic trial on its B7-H3-targeted ADC
- by Lee, Hye-Kyung May 19, 2025 05:56am
- GSK's antibody-drug conjugate (ADC) drug candidate 'GSK5764227,' designated as a breakthrough therapy by the US FDA last year, will begin clinical trials in Korea. On the 16th, the Ministry of Food and Drug Safety approved GSK's application for a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and clinical a
- Policy
- New drugs Bimzelx and Adempas reimbursed from June
- by Lee, Jeong-Hwan May 19, 2025 05:55am
- UCB Pharma Korea's Bimzelx and Bayer Korea's Adempas will be reimbursed by national health insurance starting on the first of next month. The Ministry of Health and Welfare announced an amendment to the Details on the standards for application of drug reimbursement (drugs). Bimzelx is a monoclonal antibody drug that targets both interl
- Policy
- Trodelvy and new drugs reached an agreement with the NHIS
- by Lee, Tak-Sun May 16, 2025 06:21am
- Three new drugs, including the triple-negative breast cancer (TNBC) treatment Trodelvy (sacituzumab govitecan), have completed negotiations with the National Health Insurance Service (NHIS) and are about to be included in the reimbursement list. These drugs passed the Health Insurance Review and Assessment Service (HIRA)'s Drug Reimbursem
- Policy
- CDDC to discuss partial reimb of anticancer drug combos
- by Lee, Tak-Sun May 16, 2025 06:18am
- The Health Insurance Review and Assessment Service announced today (14th) that it held a Cancer Disease Review Committee meeting and discussed the list of drugs eligible for partial reimbursement as anticancer drug combination therapies, as it had recently announced. The reimbursement standard for anticancer drugs will be revised starting ne
- Policy
- Gov't begins patient advocacy service for medical incidents
- by Lee, Jeong-Hwan May 15, 2025 06:24am
- The Ministry of Health and Welfare (MOHW) will start implementing the 'patient advocacy service,' which provides a legal representative matching service for mediating disputes to strengthen the rights of patients who are victims of medical incidents, effective this month (May). The service supports the conflict between a patient and a medi
- Policy
- Reimb of comb cancer therapies w/o detailed criteria
- by Lee, Tak-Sun May 14, 2025 06:09am
- The reimbursement policy for combination cancer therapies, announced this month, has been implemented without detailed criteria, causing further confusion in medical practices. This was contributed by the Ministry of Health and Welfare (MOHW) and the Health Insurance Review and Assessment Service (HIRA), which had differing schedules for revi
- Policy
- CDRC to talk partial reimb details for comb cancer therapy
- by Lee, Tak-Sun May 13, 2025 06:06am
- An additional date has been set to discuss detailed criteria regarding partial reimbursement of combination cancer therapy, as announced this month. The Health Insurance Review and Assessment Service (HIRA) has decided to convene another Cancer Drug Review Committee (CDRC) meeting, which was not scheduled. According to industry sources
- Policy
- Reimb expansion for Benlysta in negotiations with NHIS
- by Lee, Tak-Sun May 12, 2025 05:59am
- Negotiations are underway to expand reimbursement for Benlysta (belimumab, GSK), a treatment for active systemic lupus erythematosus in adults. The drug was added to the reimbursement list in 2021 through the risk-sharing agreement (RSA), 8 years after its approval in Korea in 2013. According to industry sources on the 9th, the Nationa
- Policy
- Fitusiran for hemophilia receives orphan drug designation
- by Lee, Hye-Kyung May 9, 2025 06:01am
- A long-acting treatment for all types of hemophilia, administered every 2 months, has been designated as an orphan drug in South Korea. According to the “Regulations on the Designation of Orphan Drugs” released by the Ministry of Food and Drug Safety on the 7th, Sanofi's Fitusiran was designated as the 386th orphan drug in Korea. Fitusi
- Policy
- Ofev reimbursed from May... inflow of generic versions
- by Lee, Hye-Kyung May 9, 2025 05:59am
- The generic drug market is growing for Boehringer Ingelheim's idiopathic pulmonary fibrosis treatment ‘Ofev Soft Capsules (nintedanib),’ which was granted reimbursement and was listed from this month, 8 years after approval. On the 7th, the Ministry of Food and Drug Safety approved 2 items, 100 mg and 150 mg of Whan In Pharm’s ‘Ofenip
