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2025-07-12 16:40
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Policy
Citus generics price raised, Ameliebou Inj huge price cut
by
Lee, Tak-Sun
May 20, 2025 06:00am
Prices of Citus generic drugs will be raised. As the price of original Citus has been adjusted, the prices of generic drugs that were reimbursement-listed in January have been recalculated. Meanwhile, the price of Samsung Bioepis' Lucentis biosimilar 'Ameliebou Inj' has been substantially cut, resulting in a significant difference from the or
Policy
MFDS to review reference drug application every 2 months
by
Lee, Hye-Kyung
May 20, 2025 05:59am
The change in the procedure for selecting reference drugs for pharmaceutical equivalence tests is being well received by the domestic pharmaceutical industry. The Ministry of Food and Drug Safety recently announced a revision to the 'Guideline for Selecting Reference drugs for Pharmaceutical Equivalence Tests' and is seeking opinions on the c
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
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