- Policy
- GSK's Shingrix has been granted
- by Lee, Tak-Sun Sep 8, 2021 06:05am
- GSK's shingles virus vaccine has been approved in Korea. As a result, competition between MSD and SK Bioscience is expected to take place for the lead in the market. The MFDS approved GSK's gene recombinant shingles vaccine Shingrix on the 6th. This product is a vaccine used to prevent shingles in adults over the age of 50 and those who a
- Policy
- Roche’s Herceptin+Perjeta combo is approved in Korea
- by Lee, Tak-Sun Sep 7, 2021 05:53am
- Roche’s developed a fixed-dose combination using two of its breast cancer treatments, Herceptin (trastuzumab) and Perjeta (pertuzumab). The Ministry of Food and Drug Safety approved Roche Korea’s ‘Phesgo (trastuzumab/pertuzumab) on the 6th. Trastuzumab and pertuzumab are commonly used ingredients for breast cancer. The original bra
- Policy
- The request for Zolgensma's benefit is growing
- by Lee, Jeong-Hwan Sep 7, 2021 05:53am
- Although only one intravenous administration has proven to be nearly cured of spinal muscular dystrophy (SMA), the administration costs about &8361;2.5 billion, increasing the demand for insurance benefits for Zolgensma (Onasemnogene Abeparvovec), which is called an "extremely high-priced one-shot treatment. Following the U.S. and Japan,
- Policy
- Letrozole for ovulation-inducing use is not allowed
- by Lee, Hye-Kyung Sep 7, 2021 05:53am
- An application to use Letrozole (Bretra, Femara, Letrozole) as non-reimbursment has been rejected. The HIRA is receiving applications in advance for the use of non-reimbursement from the MFDS to prevent the use of drugs that lack medical grounds or are concerned about safety. According to The HIRA's recent details of "disapproval of use fo
- Policy
- Insurance benefit denied for 3 Soliris and 1 Ultomiris cases
- by Lee, Hye-Kyung Sep 6, 2021 05:58am
- Last month, ‘Soliris (eculizumab)’ and ‘Ultromiris (ravulizumab),’ which both require prior approval to be administered with reimbursement, saw mixed results in the rate of approval of their preliminary applications. In July, the Health Insurance Review and Assessment Service’s Healthcare Review and Assessment Committee deliberated reimb
- Policy
- JAK Inhibitors increases heart attack
- by Lee, Tak-Sun Sep 6, 2021 05:58am
- The health authorities warned that taking JAK inhibitors, which are used as a treatment for rheumatoid arthritis, could cause serious heart problems such as heart attacks. The target items are Tofacitinib, Baricitinib, and Upadacitinib, which have been actively used in the market recently, so medical professionals will need to examine them mo
- Policy
- The Committee discusses the permission for Mifegymiso
- by Lee, Tak-Sun Sep 5, 2021 08:25pm
- Mifegymiso, which Hyundai has applied for permission, will be discussed at the Central Pharmaceutical Advisory Committee, the MFDS' legal advisory body. The Central Pharmaceutical Advisory Committee's consultation is expected to determine whether Mifegymiso will conduct a bridging study in Korea. The MFDS will hold a meeting at the Cen
- Policy
- GOV to bring 1.5 mil COVID-19 vaccines from Romania
- by Kim, Jung-Ju Sep 3, 2021 06:03am
- The Korean government has secured 1,503,000 doses of Pfizer and Modena’s COVID-19 vaccines from Romania and will bring the vaccines to Korea in two shipments this week and next week. The swap was made in line with cooperation for preventive measures against the pandemic that was discussed between the two countries from last month to exch
- Policy
- Eligibility for adjustment applications improved
- by Lee, Hye-Kyung Sep 2, 2021 05:59am
- The criteria for adjustment applications that affect drugs subject to pricing calculations will be improved. On the 2nd, the Health Insurance Review and Assessment Service (HIRA) will present the ‘proposal to improve the assessment criteria for drugs that apply for drug pricing adjustments’ as an agenda for deliberation for its Drug Rei
- Policy
- The MOHW objected to improved benefit for Prolia
- by Lee, Jeong-Hwan Sep 1, 2021 05:57am
- The MOHW objected to the criticism that it should continue to apply health insurance benefits of advanced bio-new drug Prolia (Denosumab), which treats osteoporosis, regardless of bone density figures. The MOHW said patients who still have low bone density measurements in follow-up tests after administering osteoporosis treatments such as Pro
