- Policy
- Guideline to be revised to prevent unintentional impurities
- by Lee, Hye-Kyung Mar 4, 2024 05:52am
- Amid the recent recall of sitagliptin combination products due to excess detection of impurities, the Ministry of Food and Drug Safety appears to be busy preparing a system to manage unintentional impurities at all times. The MFDS aims to revise the 'Guideline for Safety Management of Impurities in Drug Products’ within June to establis
- Policy
- Will the novel anticancer drug Enhertu be reimb in April?
- by Lee, Tak-Sun Mar 4, 2024 05:52am
- After going through two Cancer Disease Deliberation Committee meetings and two Drug Reimbursement Evaluation Committee meetings, the anticancer drug ‘Enhertu’ has finally started drug pricing negotiations with the National Health Insurance Service. As the drug has passed drug evaluations after repeated revisions, the negotiations are ex
- Policy
- Patients bear 100% of Imfinzi cost for biliary tract cancer
- by Lee, Tak-Sun Feb 28, 2024 05:50am
- Reimbursement standards have been prepared for the use of combination therapy in biliary tract cancer in Korea. However, in consideration of health insurance finances, patients are required to the full cost of the high-priced immuno-oncology drugs. The Health Insurance Review and Assessment Service recently added the combination of immun
- Policy
- AbbVie Korea will discontinue supply of Kaletra
- by Lee, Tak-Sun Feb 27, 2024 05:45am
- The HIV drug Kaletra, which was used as a first-line antiviral treatment during the COVID-19 outbreak, will be withdrawn from the domestic market. The decline in domestic demand is cited as the reason. On the 23rd, AbbVie Korea reported to the Ministry of Food and Drug Safety that will stop supplying Kaletra Tab(lopinavir + ritonavir
- Policy
- Expedited domestic supply of suspended essential medicines
- by Lee, Hye-Kyung Feb 27, 2024 05:45am
- The timelines for domestic distribution of supply-disrupted essential medicines will likely be shortened to two months from four months starting this year. The Korea Orphan & Essential Drug Center (KOEDC) announced on the 27th their plans to ensure a stable supply through monitoring the supply and demand of orphan drugs and essential medicine
- Policy
- Delayed actual transaction price cuts slash expected savings
- by Lee, Tak-Sun Feb 26, 2024 05:25am
- The implementation of the actual transaction price system intended to reduce the drug price has been postponed. Since the system was initially scheduled to take effect in January, the price monitoring investigation reached conclusion. However, the price adjustments are being delayed for various reasons. Pharmaceutical companies may ben
- Policy
- Competition intensifies in 3-combo drug mkt for COPD·asthma
- by Lee, Tak-Sun Feb 23, 2024 05:48am
- Competition in the market for three-drug combinations used to treat COPD (chronic obstructive pulmonary disease) and asthma has become somewhat complicated. Kolon Pharma’s Trimbow, which was introduced in January, triggered the competition, and GSK’s Trelegy Ellipta, which had enjoyed its sole lead in the market till then, strengthened
- Policy
- Gov't 'Too soon to price immune-oncology drugs by indication
- by Lee, Jeong-Hwan Feb 22, 2024 05:49am
- The Ministry of Health and Welfare has reaffirmed its stance that it will use the health insurance finances saved by the follow-up management measures, including reevaluation of benefit adequacy and reevaluation of the reimbursement standards and conditions, to reimburse drugs that have proven their innovativeness, such as immuno-oncology an
- Policy
- ‘Gavreto’ withdrawn from KOR amid reimb rejection
- by Lee, Hye-Kyung Feb 21, 2024 05:45am
- ‘Gavreto Cap. 100mg (pralsetinib),’ previously managed by Roche Korea, will be withdrawn from the Korean market. In February 2023, Roche announced its decision to terminate the global partnership agreement with Blueprint Medicines Corporation (BPM), the drug’s original developer. Furthermore, Gavreto did not clear the reimbursement h
- Policy
- President Yoon asks doctors to 'stop collective action'
- by Lee, Jeong-Hwan Feb 21, 2024 05:45am
- President Seok-Yul Yoon said, "Doctors should not hold the lives and health of the people hostage and take collective action, no matter what,” in response to doctors who submitted a collective resignation letter and medical students who decided to take a collective leave of absence in protest to the government’s plan to increase medical
