- Policy
- MOHW agrees to review current prior authorization system
- by Lee, Jeong-Hwan Dec 12, 2023 05:38am
- Medical professionals are raising concerns about significant disparities in approval rates of the 'rare diseases drug prior authorization system,' which differ by patients and by diseases, and the ambiguity of the criteria. The government appears to be failing to provide a direction for system improvement and address these concerns. Howev
- Policy
- Roche’s DLBCL treatment Columvi approved in Korea
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Commissioner Oh Yu-Kyoung of the Ministry of Food and Drug Safety (MFDS) announced on the 7th that MFDS has approved Roche Korea's rare disease drug 'Columvi (glofitamab)' for the treatment of diffuse large B cell lymphoma (DLBCL). The drug is a CD20/CD3 bispecific monoclonal antibody that binds to CD3 on the surface of T cells and CD20
- Policy
- Pfizer conducts trial for its RSV drug sisunatovir in KOR
- by Lee, Hye-Kyung Dec 11, 2023 05:02am
- Pfizer will be conducting a clinical trial for its Respiratory Syncytial Virus (RSV) treatment PF-07923568 (sisunatovir) on infants and children in Korea. On the 7th, the Ministry of Food and Drug Safety approved Pfizer Korea's ‘Interventional, phase 1B, randomized, double-blinded, sponsor-open, placebo-controlled, multicenter, dose-find
- Policy
- First Depakote generic is being reviewed for reimb in KOR
- by Lee, Tak-Sun Dec 8, 2023 05:55am
- The first generic of Abbot Korea’s epilepsy drug ‘Depakote ER Tab’ is undergoing a reimbursement process in Korea. The drug is ‘Divalpro ER Tab 500mg,’ developed by Korea Pharma. The drug was first approved in Korea on November 8th. It is the first generic drug to contain divalproex sodium, the main active ingredient of Depakote ER.
- Policy
- HIRA’s reimb reevaluation results to be released on the 7th
- by Lee, Tak-Sun Dec 7, 2023 05:47am
- The final results of the 2023 reimbursement adequacy reevaluations will be released on the 7th. On the day, the Health Insurance Review and Assessment Service’s Drug Reimbursement Evolution Committee will deliberate on the final reevaluation results that reflect the appeals made by pharmaceutical companies on the first results. In gener
- Policy
- Bill proposed to prioritize domestic drugs and vaccines
- by Lee, Jeong-Hwan Dec 6, 2023 06:00am
- A bill has been presented to prioritize purchases and use of domestic drugs and vaccines when Korea's national and local governments conduct drug stockpiling and National Immunization Programs (NIP). The bill also contains a provision to strengthen Korea's pharmaceutical sovereignty, including a plan to promote self-sufficiency of drug
- Policy
- New price adj guidelines set for drugs with unstable supply
- by Lee, Tak-Sun Dec 6, 2023 06:00am
- On the 5th, the National Health Insurance Service established the ‘Pricing adjustment negotiation guidelines for insurance ceiling price of drugs.’ The guideline gained attention for specifying the negotiation content for drugs that have an unstable supply. The guideline also includes the submission of pre-negotiation materials for d
- Policy
- MOHW will expand drugs subject to price adjustments
- by Lee, Tak-Sun Dec 5, 2023 05:48am
- To ensure higher drug prices for medicines in short supply, the Ministry of Health and Welfare (MOHW) announced its plan to revise the evaluation standard for drugs eligible to apply for pricing adjustments to increase the upper limit price (list price). Accordingly, national essential drugs and those selected by public-private consult
- Policy
- Tagrisso and Leclaza complete drug pricing negotiations
- by Lee, Tak-Sun Dec 4, 2023 05:13am
- The National Health Insurance Serivce was found to have completed pricing negotiations with the companies for the reimbursement of Tagrisso (AZ, osimertinib) and Leclaza (Yuhan, lasertinib) as first-line treatments for non-small cell lung cancer through the risk-sharing agreement (RSA) system. However, as the two were applied different t
- Policy
- Preferential pricing plan will be further discussed by HIPDC
- by Lee, Tak-Sun Dec 4, 2023 05:12am
- The government’s announcement of the plan to improve Korea’s drug pricing system to properly compensate for the innovation value of new drugs (hereinafter referred to as the New Drug Preference Pricing Plan) is expected to be made around the end of this month. The plan was originally set to be presented for deliberation at the general m
