- Policy
- Lorviqua, Tevimbra, Pemazyre enter NHIS negotiations
- by Lee, Tak-Sun Feb 18, 2025 05:53am
- Three items, including Lorviqua (lorlatinib, Pfizer Korea), Tevimbra Inj 100 mg (tislelizumab, BeiGene Korea), and Pemazyre (pemigatinib, Handok), are currently under negotiations with the National Health Insurance Service. These drugs were deliberated by the Health Insurance Review and Assessment Service Drug Reimbursement Evaluation Co
- Policy
- Daewoong’s P-CAB Fexuclue completes first PVA
- by Lee, Tak-Sun Feb 17, 2025 05:53am
- Daewoong Pharmaceutical's new drug for gastroesophageal reflux disease, ‘Fexuclue,' has agreed to complete negotiations through the price-volume agreement system with the National Health Insurance Service for the first time since its reimbursement listing. Before negotiations, Daewoong Pharmaceutical was known to have wanted to apply the
- Policy
- Vivozon’s VVZ-2471 patent registered in China
- by Lee, Jeong-Hwan Feb 14, 2025 05:58am
- On the 23rd, Vivozon (CEO: Doo-hyun Lee), a company specializing in the development of innovative new drugs, announced that it completed registering the product patent for its oral non-narcotic analgesic VVZ-2471, which is being developed as a treatment for pain and addiction, and its derivatives in China. This is the company’s third pa
- Policy
- Six of Keytruda's indications fail reimbursement
- by Lee, Tak-Sun Feb 14, 2025 05:58am
- After 5 failed attempts, MSD succeeded in receiving reimbursement standards for 11 additional indications of its immuno-oncology drug Keytruda in its 6th attempt. However, the company unfortunately has been denied reimbursement 6 indications. The six indications that have been denied reimbursement this time can only be reviewed if the com
- Policy
- MOHW "Why is HIRA concerned about substitute prescriptions?"
- by Lee, Tak-Sun Feb 14, 2025 05:58am
- The Ministry of Health and Welfare (MOHW) announced adding 'HIRA's Business Portal System' as part of the post-notification procedures for substitute prescriptions. However, an issue has been raised regarding differing opinions between the MOHW, which is responsible for the policy implementation, and the Health Insurance Review and Assessme
- Policy
- P3T for Sanofi’s Itepekimab in rhinosinusitis approved
- by Lee, Hye-Kyung Feb 12, 2025 06:13am
- Sanofi Aventis' biological drug 'Itepekimab' is entering Phase III trial in Korea to secure an indication for chronic rhinosinusitis following chronic obstructive pulmonary disease (COPD). On the 10th, the Ministry of Food and Drug Safety approved Sanofi’s 52-week Phase III randomized, double-blind, placebo-controlled, parallel-group cli
- Policy
- Boryung’s Lenvima generic approved in Korea
- by Lee, Hye-Kyung Feb 11, 2025 06:03am
- Boryung has received approval for a generic version of the liver cancer treatment 'Lenvima Cap (lenvatinib).' It received approval as an incrementally modified drug (new salt version) and added a 12 mg dose, which is not available with the original drug. The Ministry of Food and Drug Safety (MFDS) approved three items on the 6th, includin
- Policy
- KAPO ‘CDDC should pass Keytruda’s reimb extension agenda’
- by Lee, Tak-Sun Feb 11, 2025 06:02am
- A patient group has called for the immediate expansion of the coverage of the immuno-oncology drug 'Keytruda'. With the National Health Insurance Service's Cancer Disease Deliberation Committee scheduled to meet on the 12th, the group is asking for the establishment of reimbursement standards to strengthen patient access to treatment. In
- Policy
- Pricing negotiations complete for Pfizer’s Vyndamax
- by Lee, Tak-Sun Feb 10, 2025 05:50am
- Pfizer has completed pricing negotiations with the National Health Insurance Service for its cardiomyopathy drug, Vyndamax Cap (tafamidis). As a result, the drug is soon expected to be listed for reimbursement benefits in Korea. Four and a half years after its approval in August 2020, the drug is finally being included in Korea’s health
- Policy
- HIRA to develop RWE guidelines for post-listing drug evals
- by Lee, Tak-Sun Feb 7, 2025 05:51am
- The Health Insurance Review and Assessment Service (HIRA) has begun developing real-world evidence (RWE) guidelines for the evaluation of drugs listed under the post-listing drug control condition, with the goal of resolving uncertainties in the reimbursement decision-making process On the 5th, HIRA announced a request for proposals for r
