- Policy
- Improvement of reimbursement standards for Prolia is needed
- by Lee, Hye-Kyung Oct 20, 2020 09:15am
- The government has announced that it will comprehensively review the reimbursement standards for osteoporosis treatments such as 'Prolia (Denosumab)'. The MOHW expanded Prolia, which was used as a second-line treatment for osteoporosis last year, as a first-line treatment, and recognized reimbursement even if continuous administration is n
- Company
- Submission of α-GPC clinical reevaluation plan is imminent
- by Chon, Seung-Hyun Oct 20, 2020 06:35am
- Pharmaceutical companies are preparing in earnest with two months ahead of the deadline for submitting data for the clinical reevaluation plan of Choline alfoscerate. They are contemplating the indications for clinical trials and clinical work. The method of paying the cost of clinical trials and the process of selecting participating companies
- Company
- Can novel bone-builder Evenity win reimbursement this year?
- by Eo, Yun-Ho Oct 20, 2020 06:34am
- Apparently, a novel bone-builder Evenity is making its last push to nab the National Health Insurance (NHI) benefit by the end of the year. The South Korean pharmaceutical industry sources reported, Amgen Korea and National Health Insurance Service (NHIS) have recently initiated a pricing negotiation on an osteoporosis drug Evenity (rom
- Company
- The government restricted the exemption to antibacterials
- by Eo, Yun-Ho Oct 19, 2020 06:19am
- The government restricted the exemption from economic evaluation to only antibacterial agents. There is great backlash. The HIRA confirmed the amendment to the regulations regarding evaluation standards and procedures, such as whether or not drugs are eligible for medical care benefits, by publicizing internal regulations on the 8th. The r
- Opinion
- [Editor’s View] Why still linger on bioequivalence test?
- by Chon, Seung-Hyun Oct 19, 2020 06:19am
- The South Korean government seems to be still lingering on the notion of restricting the joint bioequivalence test the Regulatory Reform Committee has put a brake on. At the recently convened National Assembly Annual Audit, Minister Lee Eui-kyung of Food and Drug Safety stated that she “fundamentally agrees with the restricting the ‘on
- Policy
- President Moon Jae-in visited the SK Bio Research Institute
- by Lee, Jeong-Hwan Oct 19, 2020 06:19am
- President Moon Jae-in visited the COVID-19 vaccine/treatment development site on the 15th and promised to become a 'strong supporter' that helps the final development while encouraging researchers to check the development status and participate in clinical trials. President Moon urged domestic COVID-19 vaccine and treatment developers to d
- Policy
- KHIDI “COVID-19 drug grants checks feasibility first"
- by Lee, Jeong-Hwan Oct 19, 2020 06:19am
- The Korea Health Industry Development Institute (KHIDI) noted the contingency budget on seeking the COVID-19 treatment and vaccine can only be provided for drugs submitted an application with realistic anticipation to result in treatment performance. At the National Assembly Health and Welfare Committee audit session on Oct. 15, Presiden
- Policy
- CKD-516, clinical approval for combined use of 'Imfinzi'
- by Lee, Tak-Sun Oct 19, 2020 06:19am
- Chong Kun Dang's new anticancer drug candidate'CKD-516' is in a clinical trial to determine the effectiveness of the combination of immunotherapy for cancer ‘Imfinzi’ (Durvalumab, AZ). At the American Cancer Society (AACR) 2019 that was held last year, the possibility of combined use of immuno-cancer drugs was highlighted, and then the
- Policy
- Immune checkpoint inhibitors require many considerations
- by Lee, Tak-Sun Oct 17, 2020 06:37am
- The MOHW showed a cautious attitude toward the expansion of the benefits of the primary lung cancer treatment for immune checkpoint inhibitors. This is because the patient's treatment opportunities expand, but enormous insurance finances may be required. The MOHW made this statement in a written answer to a question related to Jongseong
- Company
- Issues to look into when pricing drug by each indication
- by Eo, Yun-Ho Oct 17, 2020 06:37am
- Amending a regulatory system is not a simple work. Moreover, introducing the indication-specific drug pricing would have to entirely change the premise of the National Health Insurance (NHI) system that grants ‘unified insured pricing on a single drug.’ Regardless of the final result, the government would need to have detailed discussions
