- Policy
- Bill pending on substituting dispositions for illegal rebate
- by Lee, Jeong-Hwan Dec 20, 2023 05:40am
- A bill that would allow companies to substitute the price cut/rebate suspension dispositions made on their respective drugs due to rebates has been put on hold at the Standing Committee’s Legislation and Judiciary Subcommittee stage. The review for the bill continued after the Ministry of Health and Welfare, the ministry in charge of the
- Policy
- Forxiga generics continue being released in the Korean mkt
- by Lee, Tak-Sun Dec 20, 2023 05:40am
- Generic versions of Forxiga’s salt-modified drug, which were released in April, will be reimbursed from next month. These generics were released later than other Forxiga generics because the original salt-modified drug obtained first generic exclusivity in Korea, banning the sales of other salt-modified drugs that contain the same ingre
- Policy
- New drugs Zeposia, Koselugo, Trimbow are reimbursed
- by Lee, Tak-Sun Dec 19, 2023 05:53am
- New drugs including Zeposia Cap, Koselugo Cap, and Trimbow Cap will be listed for reimbursement starting January next year. In addition, Dong-A ST's diabetes combination drug ‘Sugatree XR Tab’ will also be reimbursed, and the reimbursement standards for drugs that have undergone reevaluation of their reimbursement adequacy will be adjus
- Policy
- PVA price cut rate will be raised by up to 15%
- by Lee, Tak-Sun Dec 18, 2023 05:31am
- From next year, items with higher insurance claims will be subject to higher price cuts when negotiating prices through the Price-Volume Agreement (PVA) system. The maximum price cut rate is also expected to be raised to 15% from the current 10%. However, the exclusion limit will also be raised to KRW 3 billion from the current 2 billion
- Policy
- Global orphan drug Lamzede receives GIFT designation
- by Lee, Hye-Kyung Dec 15, 2023 05:51am
- 'Lamzede Inj (velmanase)’ received the Global Innovative Products on Fast Track (GIFT) designation and will receive an expedited review in Korea. Lamzede is an orphan drug for which Kwang Dong Pharmaceutical signed an exclusive sales and distribution agreement with Italy's Chiesi Farmaceutical in July this year. As the GIFT program see
- Policy
- HER2-positive metastatic breast cancer drug Tukysa approved
- by Lee, Hye-Kyung Dec 15, 2023 05:51am
- The Ministry of Food and Drug Safety (MInister: Yu-kyoung Oh) approved two dosage forms (50mg, 150mg) of MSD Korea’s new breast cancer drug Tukysa (tucatinib) on the 14th. The drug is used in combination with trastuzumab and capecitabine, for patients with locally advanced or metastatic HER2-positive breast cancer who have received two o
- Policy
- Non-inferior drugs likely to receive preferential pricing
- by Lee, Tak-Sun Dec 15, 2023 05:51am
- Non-inferior drugs from Korea innovative pharmaceutical companies will likely be eligible for preferential drug pricing starting next year. Previously, non-inferior drugs were priced below the weighted average of alternative drugs. However, through improvement measures, if the patent of an alternative drug is still active, non-inferior d
- Policy
- Will Enhertu be reimbursed using flexible ICER threshold?
- by Lee, Tak-Sun Dec 14, 2023 05:47am
- With the government reportedly planning to flexibly apply the Incremental Cost-Effective Ratio (ICER) threshold, whether the breast cancer treatment Enhertu (fam-trastuzumab deruxtecan, Daiichi Sankyo) will finally find its way to reimbursement is gaining attention in Korea. The drug’s reimbursement review is currently stuck in HIRA’s
- Policy
- Only CKD and Jeil have high-dose Xeljanz generics approved
- by Lee, Hye-Kyung Dec 13, 2023 05:38am
- Jeil Pharm received approval for its ‘Topazan Tab 10mg,’ a high-dose generic version of the rheumatoid arthritis treatment ‘Xeljanz (tofacitinib citrate).’ With the Ministry of Food and Drug Safety’s approval of Topazan Tab 10mg on November 11 in addition to the Topazan Tab 5mg that was approved on November 27, Jeil Pharm now owns b
- Policy
- KIDS ‘Oral VEGFR-TKI use may increase risk of AAD’
- by Lee, Hye-Kyung Dec 12, 2023 05:38am
- The Korea Institute of Drug Safety & Risk Management (President: Jeong Wyan Oh, KIDS) announced that the use of Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor (VEGFR-TKI) was associated with an increased risk of aneurysm and artery dissection occurrence. The findings were published in the internationally recognized
