- Policy
- Drugs for NSCLC harboring MET alterations pass CDRC review
- by Lee, Tak-Sun Oct 7, 2024 05:48am
- A treatment for non-small cell lung cancer (NSCLC) harboring MET alterations has passed the first stage for reimbursement coverage by national health insurance. Merk's Tepmetko is the drug that passed. On October 2nd, the Cancer Disease Review Committee (CDRC) of the Health Insurance Review and Assessment Service (HIRA) commenced the 7th m
- Policy
- 'Qarziba' to be reconsidered for the DREC review in KOR
- by Lee, Tak-Sun Oct 7, 2024 05:48am
- Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a "Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations" will be reconsidered for the Drug Reimbursement Evaluation Committee (DREC) review. Qarziba was considered for the DREC review in August but re
- Policy
- EUA for Novavax's COIVD-19 vaccine targeting the variant
- by Lee, Hye-Kyung Oct 2, 2024 05:49am
- The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced emergency use authorization of Novavax's 'COVID-19 Vaccine corresponding to JN.1 strain of SARS-CoV-2 (2024-2025 Formula).' The emergency use authorization is a system designed to respond appropriately to a public health crisis, including infectious disease pande
- Policy
- "Hundreds of doctors have received pharmaceutical rebates"
- by Kang, Shin-Kook Sep 30, 2024 05:47am
- After conducting a tax audit of 16 pharmaceutical companies, Korea's National Tax Service (NTS) announced that it would impose an income tax for doctors who received rebates. The NTS mentioned that over hundreds of doctors received rebates, and rebate-associated medical-pharmaceutical cartels became a significant issue. As a result, the NTS w
- Policy
- Stelara biosimilar Steqeyma IV approved for use in Korea
- by Lee, Hye-Kyung Sep 30, 2024 05:46am
- Upon receiving approval for ‘Steqeyma IV,’ a biosimilar version of the autoimmune disease treatment Stelara (ustekinumab), Celltion has now received approval for all its Steqeyma formulations. By adding the interleukin (IL) inhibitor option to the existing family of tumor necrosis factor (TNF)-α inhibitors, which includes Remsima, Rems
- Policy
- COVID-19 drugs to be reimbursable, "KRW 50,000 co-payment"
- by Lee, Jeong-Hwan Sep 27, 2024 05:53am
- The National Health Insurance will cover two COVID-19 treatments, Paxlovid and Veklury, starting on October 1st. The government will list COVID-19 treatments for reimbursement and make a policy revision to support the patient co-payment at the previous price of KRW 50,000. The National Health Insurance coverage for Takeda Pharmaceutica
- Policy
- 2nd Approval-Evaluation-Negotiation pilot project imminent
- by Kim, Jin-Gu Sep 26, 2024 05:51am
- The initiation of the 2nd pilot project for the ‘approval-evaluation-negotiation linkage system,’ which was introduced to shorten the time from drug approval to reimbursement, is imminent. The Ministry of Health and Welfare has completed receiving drug submissions for the 2nd pilot project from pharmaceutical companies and is in the final revi
- Policy
- Higher dosage Eylea expected to strike back at biosimilars
- by Lee, Tak-Sun Sep 26, 2024 05:51am
- The competition in the market for the macular degeneration drug Eylea has recently intensified with Samsung Bioepis and Celltrion, which have recently launched biosimilars. The original developer is set to strike back against the competitors. Bayer will release Eylea Inj 8 mg (aflibercept), with an extended treatment interval, into the
- Policy
- Potential expanded indication for obestiy drug 'Wegovy'
- by Lee, Hye-Kyung Sep 26, 2024 05:51am
- A clinical trial for Novo Nordisk Pharma's obesity drug, 'Wegovy (semaglutide),' will be conducted in South Korea for expanded indication. On September 20th, the Ministry of Food and Drug Safety (MFDS) has approved the 'Phase 2 clinical trial to evaluate the efficacy, safety, and dosage testing of NNC0519-0130, subcutaneously administere
- Policy
- First generic version of Qudexy XR Cap is approved in KOR
- by Lee, Hye-Kyung Sep 25, 2024 05:49am
- The first generic version of the topiramate-based extended-release epilepsy treatment ‘Qudexy XR Cap’ has been approved in Korea. The Ministry of Food and Drug Safety granted marketing authorization for Intrio Biopharma’s ‘Topimed XR Tab. 50mg’ on the 23rd. Unlike ‘Qudexy XR Cap’ which is an oblong hard capsule formulation, Topi
