- Policy
- New reimbursed price for Imfinzi, Venclaxta and Blincyto
- by Kim, Jung-Ju Mar 20, 2020 06:25am
- From next month, health insurance reimbursement would be granted on AstraZeneca Korea’s locally advanced non-small cell lung cancer (NSCLC) treatment Imfinzi (durvalumab) and AbbVie Korea’s chronic lymphocytic leukemia (CLL) treatment Venclaxta (venetoclax). Two treatments have accepted risk sharing agreement (RSA) terms set down on the
- Policy
- Antiepileptic drug Fycompa may face follow-on drugs soon
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- Drugs using same substance as Eisai’s Fycompa film coated tablet, used to treat patients with partial-onset seizure, is preparing for a market release. Myung In Pharm and Whan In Pharm recently requested for negative scope confirmation on Fycompa’s crystalline form patent (to be expired on Oct. 14, 2026) to evade infringement. As the p
- Policy
- Boryung’s imported quadrivalent vaccine gets greenlit
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- After receiving an approval on imported quadrivalent influenza vaccine, Boryung Biopharma now owns three manufactured or imported vaccine items. Sources predict the Korean company would choose an item to launch and its quantity based on the purchase price. On Mar. 16, Ministry of Food and Drug Safety (MFDS) granted an approval on Boryun
- Policy
- MFDS “All Korean and U.S. COVID-19 test kits use RT-PCR"
- by Lee, Tak-Sun Mar 19, 2020 06:26am
- On Mar. 15, Korea’s Ministry of Food and Drug Safety (MFDS) has dismissed the news articles accusing Korea’s COVID-19 test kit is not even adequate for an emergency use, citing the U.S. Food and Drug Administration’s (FDA) review. According to earlier news reports by a number of Korean media, Rep. Mark Green has reportedly claimed dur
- Policy
- All traveler record accessible via DUR from Mar. 18
- by Lee, Hye-Kyung Mar 18, 2020 06:37am
- From 2 p.m., Mar. 18, information of all travelers entering Korea would be provided to healthcare providers via Drug Utilization Review (DUR) system and International Traveler Information System (ITS). Health Insurance Review and Assessment Service (HIRA) has been providing real-time information of travelers from China, Italy, Iran, Singapor
- Policy
- Ranexa by Menarini was approved in Korea
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- 'Ranexa', a new treatment for cardiovascular disease, has approved Ranexa is a Ranolazine-based drug that was approved by the US FDA in January 2006. The MFDS approved Menarini Korea's 'Ranexa' (Ranolazine) as a new drug to treat angina. Ranexa is a drug developed by CV Therapeutics, which was acquired by Gilead, and Menarini owns domes
- Policy
- Avigan is not imported for COVID-19
- by Lee, Tak-Sun Mar 18, 2020 06:35am
- It was found that the health authorities decided not to import special cases of 'Avigan' (Favipiravir), a new H1N1 flu treatment used in Japan as a treatment for COVID-19. This is because there is not enough clinical evidence to use COVID-19 as a treatment. It is said that the KCDC did not make any special requests to the MFDS to decide on
- Policy
- Would HIRA disclose DREC review result to drug industry?
- by Lee, Hye-Kyung Mar 18, 2020 06:34am
- Health Insurance Review and Assessment Service (HIRA) is contemplating on expanding the scope of disclosure regarding the Drug Reimbursement Evaluation Committee (DREC) deliberation. The contemplation would focus on whether or not to extend details of the deliberation to pharmaceutical companies after sufficiently reflecting their opinion
- Policy
- The NHIS recalculates ￦2 billion refund for pharmaceuticals
- by Lee, Hye-Kyung Mar 17, 2020 06:29am
- The NHIS has taken corrective action to settle the refund amount of the refund-type risk sharing agreement (RSA) through an internal audit. In the case of RSA drugs that have a 'double drug price' that differs from the drug price and the actual selling price, the NHIS notifies the pharmaceutical company of the payment of the medical instituti
- Policy
- The MFDS encourages production of KF80 masks
- by Lee, Tak-Sun Mar 16, 2020 06:29am
- In order to encourage the KF80 standard health mask to be produced, the MFDS decided to temporarily grant permission to change items that are currently approved under the KF94 standard to KF80. It is judged that the KF80 has less filter requirements than the KF94, which can lead to an increase in mask production. However, there is criti
