- Policy
- ‘Skilarence’ may be reimbursed if it accepts PBAC's price
- by Lee, Hye-Kyung Oct 13, 2021 05:46am
- Kolon Pharma’s plaque psoriasis treatment 'Skilarence Enteric Coated Tab. (Dimethyl fumarate)' will be reimbursed if the company accepts a price lower than the price assessed by the Pharmaceutical Benefit Assessment Committee. On the 8th, the National Health Insurance Service (President Sun-min Kim) disclosed the deliberation results on the
- Policy
- Drug prices are the key to easing the PAH benefit standard
- by Choi-sun Oct 13, 2021 05:46am
- There is a possibility that PAH tx benefit standard, which has been criticized by strict standards, will be eased. As the HIRA mentioned that it has prepared an amendment that fully reflects the opinions of the society on the application indicators of combination therapy and the initial three-drug combination pointed out as a problem, the public
- Policy
- Hanmi's HM15912 is approved for phase 2 in Korea
- by Lee, Tak-Sun Oct 12, 2021 05:50am
- Hanmi Pharmaceutical is developing a rare disease treatment aimed at the global market and is conducting phase 2 clinical trials in Korea. With HM15912 as a candidate for the treatment of Short bowel syndrome (SBS), clinical trials will be conducted at Samsung Medical Center. The MFDS approved Hanmi's phase 2 clinical plan for HM15912 on t
- Policy
- Gov “It was the experts’ decision to not list Kymriah”
- by Kim, Jung-Ju Oct 12, 2021 05:49am
- In response to NA’s criticism regarding the delayed reimbursement listing of Kymriah, the government has expressed its difficulties as the decision was a result of an expert assessment. Also, the government denied the claim that that insurance coverage is only being extended for mild diseases. This was the response Health and Welfare
- Policy
- The MOHW expressed reluctance to Keytruda's primary benefit
- by Lee, Jeong-Hwan Oct 12, 2021 05:49am
- Minister of Health and Welfare Kwon Deok-cheol expressed reluctance to applying MSD immuno-cancer drug Keytruda as a primary treatment for lung cancer, citing enormous health insurance financial needs. On the 6th, Minister Kwon responded to a question from Kang Sun-woo (the Democratic Party of Korea) at the National Assembly Welfare Commit
- Policy
- Pfizer vaccines from Romania not transported in official box
- by Lee, Jeong-Hwan Oct 8, 2021 05:56am
- Criticism has been raised that the 1,053,000 doses of Pfizer’s COVID-19 vaccine that the government received from Romania last month were not stored in transport boxes that were officially authorized by its manufacturer, Pfizer. Pfizer’s vaccines require ultra-low-temperature storage for quality maintenance and should be stored in Pfizer’
- Policy
- Expanding the submission of opinions reflecting permission
- by Lee, Tak-Sun Oct 7, 2021 05:54am
- Opportunities for submitting opinions from industries will be expanded when reflecting permits based on the results of the reexamination. A pre-announcement procedure is added to the previous opinion inquiry. The MFDS announced that since the 27th of last month, the procedure for reflecting permits based on the results of the reexamination
- Policy
- ’With Covid’ scheme unclear with over 5,000 cases expected
- by Lee, Jeong-Hwan Oct 7, 2021 05:53am
- Concerns have been raised that Korea will be unable to adopt the ‘With Corona’ scheme due to the public’s distrust in vaccinations, the government’s non-acceptance of casualties of adverse reactions from vaccines, and the surge in daily COVID-19 cases, etc. Based on the mathematical model that took into account current incidence, the tran
- Policy
- Nexviazyme has been applied for domestic permission
- by Lee, Tak-Sun Oct 7, 2021 05:53am
- Sanofi plans to release a new Pompe's disease treatment in Korea. It is known that Nexviazyme, which was approved by the U.S. FDA in August, recently applied for permission from the MFDS. According to the MFDS on the 1st, Sanofi Aventis Korea submitted a report on the results of clinical trials by Nexviazyme (Avalglucosidase alfa-ngpt) and
- Policy
- Introduction of pre-registration is difficult
- by Kim, Jung-Ju Oct 7, 2021 05:53am
- The government said it is difficult due to concerns over weakening NHIS' drug price negotiation power, while various fields are proposing the introduction of a system that is first registered and evaluated later for access to treatments for severe rare and intractable diseases. Regarding referring to Korean drug prices such as China, the gove
