- Policy
- Novavax’s COVID-19 vaccine receives EUA in KOR
- by Lee, Hye-Kyung Dec 1, 2023 05:35am
- The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced that it had granted emergency use authorization (EUA) for Novavax’s ‘Novavax COVID-19 Vaccine 2023-2024’ to respond to the Omicron subvariant (XBB.1.5). The Minister of Food and Drug Safety grants emergency use authorization when the head of relevant central adminis
- Policy
- Imfinzi's 3-drug combo burden reduced despite nonreimb
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- An unprecedented decision was made at the Cancer Disease Review Committee meeting that was held on the 22nd. At the meeting, AstraZeneca failed to establish reimbursement standards for its Imfinzi Inj (durvalumab) as part of a three-drug combination therapy for biliary tract cancer, but the CDDC decided to grant reimbursement for the ge
- Policy
- External ref price reevals will be carried out as planned
- by Lee, Tak-Sun Nov 30, 2023 05:55am
- The Health Insurance Review and Assessment Service decided to thoroughly discuss its external reference price reevaluation plan with the industry. Although the government’s original plan of preparing a final draft by December is also expected to be postponed somewhat due to the prolonged discussions, HIRA explained that there is no change t
- Policy
- BeiGene applies for reimb of its 2nd new drug after Brukinsa
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Chinese new drug developer BeiGene is working to quickly receive reimbursement for its 2nd new drug, Tevimbra (tislelizumab) following its first new drug, Brukinsa (zanubrutinib). According to industry sources, the company had immediately applied for reimbursement listing of its Tevimbra upon its approval on the 20th. Tevimbra is a
- Policy
- HIRA starts preparing for RWE-based reimb reevaluations
- by Lee, Tak-Sun Nov 29, 2023 05:50am
- The Health Insurance Review and Assessment Service are accelerating the establishment of a plan to reevaluate Korea’s reimbursed drugs based on RWD (Real World Data)/RWE (Real World Evidence). The idea of RWD/RWE-based reimbursement reevaluations took shape at the public hearing for the ‘Performance-based reimbursement management plan
- Policy
- DPM Choo ‘will finalize telemedicine plans this year'
- by Kang, Shin-Kook Nov 28, 2023 05:42am
- The direction of the government's policy to institutionalize non-face-to-face treatment has been set to institutionalize non-face-to-face treatment for overseas Korean nationals and prepare an improvement plan for the domestic non-face-to-face treatment pilot project within the year. Deputy Prime Minister Kyung-Ho Choo presided over the Emerg
- Policy
- Enspryng and Jemperli will be reimbursed through RSA
- by Lee, Tak-Sun Nov 22, 2023 05:30am
- The new Neuromyelitis optica spectrum disorder (NMOSD) drug Enspryng Prefilled Syringe Inj (satralizumab, Roche) and new PD-1 inhibitor immune-oncology drug ‘Jemperli Inj (dostarlimab, GSK) will be reimbursed in Korea from December 1st this year. Also, the insurance price ceiling for Xeljanz Tab 5mg, for which reimbursement has been exte
- Policy
- Will PE exemption drugs be reevaluated based on RWD?
- by Lee, Tak-Sun Nov 22, 2023 05:30am
- Will ultra-high-priced drugs or drugs exempted from receiving pharmacoeconomic evaluations be reevaluated based on actual patient administration data after being listed for reimbursement? Starting with Kymriah first last year, as drugs were applied a performance-based refund type RSA for reimbursement, an interpretation that it would no
- Policy
- Global bioleaders gather in Seoul for World Bio Summit
- by Lee, Jeong-Hwan Nov 21, 2023 05:48am
- Vaccine and bio leaders from around the world will gather in Seoul, Korea to discuss response strategies for the next global pandemic that may come after COVID-19. On the 19th, the Ministry of Health and Welfare and the World Health Organization (WHO) announced they will hold the '2023 World Bio Summit' from the 20th to the 21st at the Conrad
- Policy
- Results of the 2nd price ceiling reevals to be released soon
- by Lee, Tak-Sun Nov 20, 2023 05:50am
- The National Health Insurance Service plans to hold a preliminary briefing session before starting its main negotiations for the 2nd drug price ceiling re-evaluations. The authorities decided upon this measure to inform companies in advance about the documents that would need to be submitted for negotiations due to the tight 10-day neg
