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2025-07-03 13:23
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Policy
Handok and JW¡¯s new imported drugs reimbursed from July
by
Lee, Tak-Sun
Jun 23, 2025 06:00am
In July, four new drugs, including an oral drug for paroxysmal nocturnal hemoglobinuria (PNH), a new biological agent for severe atopic dermatitis, and a new drug for immune thrombocytopenia (ITP), will be reimbursed by health insurance and be available with coverage for patients. On the 19th, the MOHW announced the establishment of reim
Policy
Rapid adjustment of insurance prices for rare drugs granted
by
Lee, Hye-Kyung
Jun 20, 2025 06:08am
The insurance price ceiling adjustment term for insured drugs supplied by the Korea Orphan Drug Center (KOEDC) is expected to be significantly reduced from the initial 8-9 months to around 4 months. Previously, it took at least 8-9 months to adjust the price cap, raising concerns about supply disruptions and financial losses for the cente
Policy
SGLT2 Jardiance likely to receive expanded reimb for CKD
by
Lee, Tak-Sun
Jun 20, 2025 06:06am
The SGLT-2 inhibitor Jardiance (empagliflozin, Boehringer Ingelheim) is expected to be reimbursed for the treatment of chronic kidney disease (CKD). This drug is currently reimbursed for the treatment of diabetes and chronic heart failure. If expanded reimbursement is approved for CKD, the volume of usage is likely to be increased. Further
Policy
Growing role of the Korea Orphan & Essential Drug Center
by
Lee, Hye-Kyung
Jun 19, 2025 06:03am
"The emergency import of essential medicines through the Korea Orphan & Essential Drug Center (KOEDC) will be expanded, and support for pharmaceutical companies producing domestic products will be planned." President Lee Jae-myung made this pledge on his Facebook page on May 28, during his campaign for the presidency. President Lee emphasized
Policy
Petition filed urging expedited reimbursement of Livmarli
by
Lee, Jeong-Hwan
Jun 17, 2025 06:00am
A national petition has been filed to urge for the health insurance reimbursement of Livmarli (maralixibat), which is used to treat pruritus (itching) in patients with Alagille syndrome. The petition period runs until the 12th of next month, with over 1,600 signatures signed as of the 16th. Alagille syndrome is a condition in which the in
Policy
Atopic dermatitis drug Ebglyss reimbursed from next month
by
Lee, Tak-Sun
Jun 16, 2025 06:03am
With pricing negotiations between the National Health Insurance Service and the manufacturer of the new atopic dermatitis drug ¡®Ebglyss Autoinjector (Lebrikizumab, Lilly Korea)¡¯ complete, the drug is expected to be listed for reimbursement next month in Korea. Once listed, the number of biological agents available for atopic dermatitis
Policy
Roche¡¯s SMA drug Evrysdi Tab approved in Korea
by
Lee, Hye-Kyung
Jun 16, 2025 06:03am
The table formulation of Roche's blockbuster drug for spinal muscular atrophy (SMA), Evrysdi (risdiplam), has received marketing authorization in Korea. On the 13th, the Ministry of Food and Drug Safety approved Roche Korea's ¡®Evrysdi 5 mg (risdiplam).¡¯ With the approval, SMA patients in Korea may now be prescribed the 5 mg tablet fo
Policy
Ruling party proposes bill for free HPV vaccination
by
Lee, Jeong-Hwan
Jun 13, 2025 06:02am
The Democratic Party of Korea has submitted a bill to the National Assembly to significantly expand the scope of Korea¡¯s National Immunization Program for human papillomavirus (HPV) vaccines. The bill proposes to provide free HPV vaccinations to all males and females aged 12 to 26, regardless of gender or income level. This legislatio
Policy
Measures to reduce industry burden for stronger GMP
by
Lee, Hye-Kyung
Jun 12, 2025 06:04am
With the Ministry of Food and Drug Safety set to enforce the revised GMP standards for aseptic drugs reflecting the international Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards from December, measures are being prepared by the industry to reduce its burden. Ahead of its rejoin into PIC/S in 2023, the MFDS announced the ¡°Regu
Policy
Qlaris starts Phase II trial for its glaucoma drug in KOR
by
Lee, Hye-Kyung
Jun 12, 2025 06:03am
Qlaris Bio, a US biotech company, is conducting a Phase II clinical trial in Korea for 'QLS-111,' a drug candidate for primary open-angle glaucoma (POAG) and ocular hypertension (OHT). On the 5th, the Ministry of Food and Drug Safety approved a randomized, active-controlled, multicenter, double-blind, preliminary study to evaluate the saf
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