- Policy
- Fasenra's reimb application passes DREC review
- by Lee, Tak-Sun Mar 11, 2024 05:55am
- Fasenra, the last of 3 antibody drugs used for severe asthma to apply for reimbursement in Korea, has now passed the Drug Reimbursement Evaluation Committee (DREC) stage, increasing the likelihood of its reimbursement. The drug, like Nucala, is seeking reimbursement through the risk-sharing arrangement (RSA) scheme. The industry is paying att
- Policy
- Pfizer starts trial for its RSV drug sisunatovir on adults
- by Lee, Hye-Kyung Mar 8, 2024 05:19am
- Pfizer will initiate a clinical trial for its respiratory syncytial virus (RSV) infection drug sisunatovir in adults in Korea. The company had previously initiated a trial for the drug on pediatric patients in Korea. On the 7th, the Ministry of Food and Drug Safety (MFDS) approved Pfizer's "interventional Phase II/III, adaptive, multicent
- Policy
- Pharmas impacted by ‘minoxidil’ bioequivalence test result
- by Lee, Hye-Kyung Mar 8, 2024 05:18am
- Bioequivalence test outcomes result in different paths for prescription drugs containing the active ingredient ‘minoxidil,’ which was first introduced as a hypertension drug but is now commonly used as a hair-loss drug. The Ministry of Food and Drug Safety (MFDS) recently issued a two-month sales suspension order on Binex’s ‘Bimo Tab
- Policy
- CSL Behring’s hemophilia B Tx Idelvion reattempts reimb
- by Lee, Tak-Sun Mar 8, 2024 05:18am
- CSL Behring, a subsidiary of Australian multinational pharmaceutical giant CSL, is reattempting to receive reimbursement benefits for its hemophilia treatment in Korea. CSL Behring holds the domestic marketing authorization and reimbursement rights for the hemophilia drug Afstyla Inj which was developed by SK Chemicals. According to in
- Policy
- 2yr use restriction lifted for Alimta+Keytruda combo reimb
- by Lee, Tak-Sun Mar 8, 2024 05:18am
- The reimbursement period for the Alimta+Keytruda+platinum-based chemotherapy is set to be extended. Previously, the 3-drug combination was covered for up to 2 years, but the Cancer Disease Deliberation Committee decided to remove this restriction from the reimbursement standards. The Health Insurance Review and Assessment Service announced th
- Policy
- DPK urges doctors to return to work
- by Lee, Jeong-Hwan Mar 7, 2024 07:16am
- The Democratic Party of Korea (DPK) urged trainee doctors who walked off the job en masse to return to their medical sectors. Furthermore, the DPK suggested that medical community negotiate a reasonable capacity of medical school admissions. The ruling party has temporarily allowed non-face-to-face medical treatment to address the curr
- Policy
- High-strength Ebixa generics start receiving approval again
- by Lee, Hye-Kyung Mar 7, 2024 07:16am
- Approvals for generic versions of the high-strength Ebixa 20mg (memantine hydrochloride), a treatment for severe Alzheimer's, that had been slowing down lately, have begun to gain momentum again. On March 5, the Ministry of Food and Drug Safety approved Dongkook Pharmaceuticals 'Memantine Tab 20mg.' Eighteen years after the 10mg formulatio
- Policy
- Once-weekly growth hormone Sogroya is approved in Korea
- by Lee, Hye-Kyung Mar 7, 2024 07:16am
- A growth hormone that can be administered once weekly was approved in Korea. The Ministry of Food and Drug Safety approved Novo Nordisk’s ‘Sogroya Prefilled Pen (somapacitan-beco)’ 5mg, 10mg, and 15mg on June 6. Sogroya is a once-weekly treatment for adult hormone deficiency and is indicated for the replacement of endogenous growt
- Policy
- The RSA track to include drugs for chronic diseases, asthma
- by Lee, Tak-Sun Mar 7, 2024 07:15am
- The Risk Sharing Agreement (RSA) will cover chronic and severe diseases that cannot be treated with substitute drugs and result in irreversible deterioration in the quality of life. It was announced last year as part of ‘The drug pricing system to ensure fair-value compensation for innovative new drugs.’ Since the announcement, the
- Policy
- Will Ferinject be reimbursed this time?
- by Lee, Tak-Sun Mar 5, 2024 05:48am
- Reimbursement for JW Pharmaceutical’s high-dose iron injection ‘Ferinject Inj’ is imminent in Korea. Although the company failed to pass the pricing negotiation stage once in 2020, analysts are seeing a true possibility for its reimbursement this time, as the company's willingness for its reimbursement is stronger than ever.
