- Policy
- "Long-waited patent expiration"…17 Xeljanz generics
- by Jung, Heung-Jun Oct 24, 2025 06:16am
- Pfizer Korea's rheumatoid arthritis treatment 'Xeljanz (tofacitinib)' is set to be included on the National Health Insurance reimbursement list next month, joining the market competition. According to the industry on October 23, 12 pharmaceutical companies and 17 items will receive reimbursement coverage as of November 23, the next day af
- Policy
- NA presses for reimb of Vyloy, Imjudo, Yescarta
- by Jung, Heung-Jun Oct 24, 2025 06:14am
- The National Assembly directly mentioned drugs for severe diseases like Vyloy, Imjudo, Yescarta, and pressed the Ministry of Health and Welfare to promptly grant the drug’s reimbursement expansions. The Ministry responded, “We will expedite the process,” which is expected to act as a tailwind for HIRA's reimbursement decision discussio
- Policy
- "Will establish preferential pricing for drug R&D"
- by Lee, Jeong-Hwan Oct 23, 2025 06:12am
- Minister of Health and Welfare Jeong Eun Kyeong is drawing attention after stating, "It is necessary to reform the pharmaceutical company compensation system through a drug pricing system linked to R&D investment. The Ministry will prepare measures to improve the drug pricing system." Minister Jeong also promised, "The Ministry will prepa
- Policy
- ‘Expanding dual pricing under review to mitigate risks’
- by Jung, Heung-Jun Oct 23, 2025 06:11am
- The Ministry of Health and Welfare has expressed its commitment to actively review plans to expand the dual drug pricing system to resolve risks associated with the introduction of innovative new drugs. The MOHW expressed consensus on the need for the expansion as a countermeasure to the Most-Favored-Nation (MFN) drug pricing system intro
- Policy
- MOHW to institutionalize a fast-track listing system
- by Jung, Heung-Jun Oct 23, 2025 06:10am
- The Ministry of Health and Welfare (MOHW) has announced plans to institutionalize a fast-track reimbursement system based on the outcomes of the ongoing “approval&8211;evaluation&8211;negotiation” pilot program, aimed at accelerating patient access to innovative new drugs. It also stated its intention to expedite the reimbursement dec
- Policy
- 'Distrust in MFDS rises after Leqembi safety issue'
- by Jung, Heung-Jun Oct 22, 2025 06:09am
- The Ministry of Food and Drug Safety (MFDS) has been criticized for losing public trust due to inadequate safety verification of the dementia drug Leqembi (Lecanemab) and poor post-marketing adverse event management measures. On the 18th, during the National Assembly audit of the MFDS, Representative Jin-sook Jeon of the Democratic Party of K
- Policy
- Parliamentary inspection of the MFDS to highlight
- by Lee, Jeong-Hwan Oct 21, 2025 06:19am
- During the upcoming parliamentary inspection of the Ministry of Food and Drug Safety (MFDS), the National Assembly is expected to highlight the need to increase the number of reviewers and support the formation of dedicated teams to provide customized approval services, all aimed at shortening the review period for domestically developed new
- Policy
- Keytruda, Dupixent begin negotiations for reimb expansions
- by Jung, Heung-Jun Oct 17, 2025 06:10am
- The immuno-oncology drug Keytruda (pembrolizumab) and the atopic dermatitis treatment Dupixent Pre-filled (dupilumab) have entered price negotiations, moving one step closer to expanding reimbursement in Korea. Both MSD Korea’s Keytruda and Sanofi-Aventis Korea’s Dupixent received reviews deeming reimbursement adequate for expanded indi
- Policy
- "Korea Passing concerns…'dual pricing system' under review"
- by Lee, Jeong-Hwan Oct 17, 2025 06:10am
- Minister of Health and Welfare Jeong Eun Kyeong announced that the Ministry would strengthen administrative efforts for 'fast track National Health Insurance (NHI) listing of new drugs' and review the introduction of a 'dual pricing system' to prevent global pharmaceutical companies from "Korea Passing" of their new drugs. On October 14,
- Policy
- Bylvay granted orphan drug designation for Alagille syndrome
- by Lee, Tak-Sun Oct 16, 2025 06:21am
- From this month, Bylvay Cap (odevixibat, Ipsen Korea)&8212;which was recently listed for reimbursement as a treatment for progressive familial intrahepatic cholestasis (PFIC)&8212;has been designated as an orphan drug for treating cholestasis-associated symptoms in patients with Alagille syndrome. The orphan designation is expected to a
