- Policy
- Switching between JAKis approved for atopic dermatitis
- by Lee, Tak-Sun Oct 28, 2024 05:53am
- Reimbursement for switching between severe atopic dermatitis drugs may be approved soon in Korea. However, further efforts by pharmaceutical companies would be needed to share the additional finances required. Therefore, it is analyzed that pharmaceutical companies will overcome the Health Insurance Review and Assessment Service’s review p
- Policy
- Directly injected gene scissor therapy receives PT3 approval
- by Lee, Hye-Kyung Oct 25, 2024 05:49am
- An in vivo gene scissor therapy that is injected directly into the body will enter Phase III clinical trials in Korea. On the 23rd, the Ministry of Food and Drug Safety (MFDS) approved a Phase III clinical trial to evaluate the efficacy and safety of ‘NTLA-2001’ in participants suffering from Transthyretin Amyloidosis with Cardiomyopath
- Policy
- Reimb discussions restart for BMS’s Camzyos in KOR
- by Lee, Tak-Sun Oct 25, 2024 05:48am
- The National Health Insurance Service was found to have restarted reimbursement discussions for the obstructive hypertrophic cardiomyopathy treatment Camzyos (mavacamten, BMS). BMS and the NHIS entered into drug price negotiations for Camzyos in August but failed to reach an agreement within the 60-day deadline. However, the deadline has
- Policy
- MFDS says 'no procedural issues' regarding 'Leqembi'
- by Lee, Hye-Kyung Oct 24, 2024 05:52am
- The Ministry of Food and Drug Safety (MFDS) stated that there was no procedural issue during the approval of 'Leqembi (lecanemab),' a dementia treatment, that omitted the review by the Central Pharmaceutical Affairs Advisory Committee (hereafter referred to as the "Advisory Committee"). Out of 33 active ingredients of new drugs that recei
- Policy
- 'Preferential drug pricing for K-made new drugs' revision
- by Lee, Jeong-Hwan Oct 24, 2024 05:52am
- It was pointed out that upon receiving criticism that the recently announced amendment plan for drug pricing system lacked provision to provide preferential drug pricing for new drugs made by Korean pharmaceutical companies, the Ministry of Health and Welfare (MOHW) posted an administrative notice detailing amendment to be made for 'Pharmace
- Policy
- Will non-face-to-face prescriptions of Wegovy be banned?
- by Lee, Jeong-Hwan Oct 24, 2024 05:51am
- Yu-Kyoung Oh, Minister of the Ministry of Food and Drug Safety, said the ministry will discuss the issue of Wegovy, a new obesity drug, being prescribed through non-face-to-face treatment with the Ministry of Health and Welfare. The MOHW Minister Kyoo-hong Cho also responded that he would actively engage in Oh's request for discussions.
- Policy
- Overseas direct purchases of GLP-1 obesity drugs banned
- by Lee, Hye-Kyung Oct 23, 2024 05:50am
- The government has begun blocking direct purchases of GLP-1 obesity drugs overseas in the wake of the ‘Wegovy’ craze. The Ministry of Food and Drug Safety (Minister: Yu-Kyung Oh) and Korea Customs Service (Comissioner: Kwanghyo Ko) announced on the 22nd that they would block the direct purchase of recently launched GLP-1-based obesity d
- Policy
- New drug expenditure is 13.5% of NHI finance's drug spending
- by Whang, byung-woo Oct 23, 2024 05:49am
- It was found that the total expenditure on new drugs listed in the past six years since the Positive List System policy was implemented amounted to 13.5% of the National Health Insurance pharmaceutical spending, which is the lowest compared to the averages of A8 countries and OECD countries. The Korean Research-based Pharmaceutical Industr
- Policy
- Dongkook receives reimb for s-amlodipine triple-drug combo
- by Lee, Tak-Sun Oct 22, 2024 05:52am
- Dongkook Pharmaceutical has succeeded in becoming the first Korean company to receive reimbursement for a three-drug combination drug for hypertension that combines the CCB ‘s-amlodipine,’ ARB ‘olmesartan’ and diuretic ‘hydrochlorothiazide’. The combination therapy is expected to be useful for patients whose blood pressure is not ad
- Policy
- MFDS grants EUA to COVID-19 variant vaccine for infants
- by Lee, Hye-Kyung Oct 22, 2024 05:51am
- The Ministry of Food and Drug Safety (Minister Oh Yu-kyoung, MFDS) announced on October 21st that it has granted Emergency Use Authorization for 'Comirnaty JN.1 Inj 0.033 mg/mL (bretovameran),' a SARS-coV variant (JN.1) vaccine for infants aged 6 months-4 years. Emergency Use Authorization is a system designed to respond appropriately to
