- Policy
- HLB Pharma applies for reimb of 'Citrelin ODT' for SCD
- by Lee, Tak-Sun Dec 16, 2024 05:52am
- HLB Pharma has reportedly applied to the Health Insurance Review and Assessment Service (HIRA) for reimbursement of 'Citrelin ODT,' a domestically distributed treatment for spinocerebellar degeneration. This product was approved in South Korea in 2015, but it has been distributed to the Korean market as a non-reimbursed drug. However, wit
- Policy
- Otezla generics enter negotiations for reimb
- by Lee, Tak-Sun Dec 13, 2024 05:52am
- Generic to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, is being considered for reimbursement negotiations with the National Health Insurance Service (NHIS). Attention has been drawn to whether a generic drug will be listed for reimbursement, the process in which a company with the original drug gav
- Policy
- Martial law impacts the launch of the Pharma-Bio Committee
- by Lee, Jeong-Hwan Dec 13, 2024 05:51am
- The National Bio Committee directly under the President, which was scheduled to be launched this month, has been disrupted by President Suk-Yeol Yoon’s declaration of emergency martial law. As the National Assembly is in the early stages of voting on an impeachment bill against President Suk-Yeol Yoon, who was supposed to chair the commi
- Policy
- HIRA sets plan for performance assessment of 'Qarziba'
- by Lee, Tak-Sun Dec 12, 2024 05:49am
- The Health Insurance Review and Assessment Service (HIRA) has established a performance assessment plant for Qarziba and notified healthcare providers to submit documents. Qarziba is a high-cost treatment for severe diseases. As of December 1, the drug was listed for reimbursement under the condition of patient performance-based Risk Shari
- Policy
- New drug approval fee to rise next year
- by Lee, Hye-Kyung Dec 12, 2024 05:49am
- The Ministry of Food and Drug Safety has begun finalizing plans to raise the new drug approval fee KRW 410 million from January 1 next year. The MFDS recently collected opinions on the “Operating Procedures for Approval and Examination of New Drug Products (Guideline for public officials)” from October 18 to November 15, and released the f
- Policy
- Cancellation policy for innovative pharmas certification
- by Kang, Shin-Kook Dec 9, 2024 05:47am
- It has been reported that the cancellation standards of 'Innovative Pharmaceutical Companies Certification' will be relaxed for pharmaceutical companies fined for rebates. Some argue that certification requirements for illegal rebates are strict. Further criticism is anticipated as these measures deviate from the government’s longstandin
- Policy
- Janssen seeks reimb for Balversa in Korea
- by Lee, Tak-Sun Dec 9, 2024 05:46am
- ’Balversa (erdafitinib, Janssen),’ which has been approved as a targeted therapy for bladder cancer, has reportedly applied for reimbursement 2 years after being approved in Korea. It is believed that the company is seeking Balversa’s entry into Korea’s health insurance market based on its proven effectiveness in patients who have used
- Policy
- Reimb extension discussions for Kyprolis break down
- by Lee, Tak-Sun Dec 6, 2024 05:57am
- The proposal to extend reimbursement coverage for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has failed to make it past the negotiating stage with the National Health Insurance Service. The negotiations, which began last October, have broken down. The National Health Insurance Service announced the news of Kyprolis' negoti
- Policy
- Expanded clinical use of orphan drug 'Joenja' in children
- by Lee, Hye-Kyung Dec 6, 2024 05:56am
- The administration·dosage in children for a clinical trial of 'Joenja (leniolisb),' an APDS treatment designated as an orphan drug in South Korea, is expected to be expanded. The meeting record of the Central Pharmaceutical Affairs Advisory Committee (CPAC), released by the Ministry of Food and Drug Safety (MFDS) on December 4, indicat
- Policy
- Linking 'Prior review-performance evaluation-reevaluation'
- by Lee, Tak-Sun Dec 6, 2024 05:56am
- The Health Insurance Review and Assessment Service announced that it has been reviewing a measure that links preliminary review, performance evaluation, and reevaluation for newly listed high-priced drugs. In other words, for newly listed high-priced drugs, the authorities will conduct a proper cost-effectiveness evaluation through a pre
