- Policy
- HIRA deletes GDP phrase but maintains current ICER threshold
- by Lee, Hye-Kyung Nov 3, 2021 05:47am
- The industry has requested an explanation on why the Health Insurance Review and Assessment Service deleted the ‘reference to per GDP capita’ phrase in its ICER threshold regulations. On the 23rd, HIRA disclosed the ‘Detailed Evaluation Criteria for drugs subject to negotiation such as new drugs, etc.,' and changed the ICER threshold crite
- Policy
- The new system doesn't stop benefits for anticancer drugs
- by Lee, Jeong-Hwan Nov 3, 2021 05:47am
- The MOHW promised to operate a system that does not cause damage to patients due to the suspension of high-priced anticancer drug benefits due to the expansion of the new comprehensive insurance system. The plan is to review and operate measures to ensure continuity of treatment for existing patients taking expensive anticancer drugs such as
- Policy
- The number of licenses for Rx drugs in October exceeded 100
- by Lee, Tak-Sun Nov 3, 2021 05:46am
- The number of monthly permits increased again as the generic release of AstraZeneca's diabetes combination drug "Xigduo XR (Metformin+Dapagliflozin Propanediol Hydrate)" first appeared in October. As many as 31 generics for Xigduo XR were approved in October, all of which are consignment items manufactured by Richwood Trading Company. It
- Policy
- It is impossible to exclude PVA from domestic new drugs
- by Lee, Jeong-Hwan Nov 2, 2021 05:54am
- The government has virtually expressed opposition to the National Assembly and the pharmaceutical industry's demand to exclude PVA from innovative development drugs. PVA is a system that shares the burden of health insurance spending between health insurance financial authorities and pharmaceutical companies, and the government explains t
- Policy
- 342 items unable for supply voluntarily withdraw listing
- by Lee, Hye-Kyung Nov 2, 2021 05:53am
- In just one year since the pharmaceutical negotiation system that had been only used for new drugs and usage volume negotiations was expanded to include generics, etc., 342 items that cannot be immediately supplied were deleted from the reimbursement list by ‘voluntary withdrawal.’ The National Health Insurance Service announced that it had
- Policy
- Is the first generic release of the ADHD tx Concerta?
- by Lee, Tak-Sun Nov 2, 2021 05:53am
- Alvogen Korea has begun to develop a generic development of the ADHD treatment Concerta OROS (Methylphenidate, Janssen Korea). Since there is currently no generic for Concerta in Korea, it is expected to be the first generc if approved. As of the 28th, the MFDS approved AK-D309 54mg's biological equivalence test plan. In this test, Alvoge
- Policy
- Generics for Jardiance have obtained generic for exclusivity
- by Lee, Tak-Sun Nov 2, 2021 05:53am
- Generics of SGLT-2 inhibitory diabetes treatment Jardiance (Empagliflozin, Beringer Ingelheim, Korea) have obtained a number of generic for exclusivity. The number of target items alone amounts to 93. Most of the licensed products have won generic for exclusivity. It will be applied for nine months from October 24, 2025, the date of sale.
- Policy
- Redundancies in CDRD and PBAC roles in continuous dispute
- by Lee, Hye-Kyung Nov 1, 2021 05:56am
- [News follow-up from a friendly reporter] The functional redundancies in the Cancer Disease Review Committee (CDRC) and Pharmaceutical Benefit Appraisal Committee (PBAC) arose as an issue at the NA Health and Welfare Committee audit recently. At the audit, the National Assembly Health and Welfare Com
- Policy
- HIRA clarifies ‘Opdivo·Keytruda·Tecentriq’ eligibility
- by Lee, Hye-Kyung Nov 1, 2021 05:56am
- The 'Stage ⅢB or higher’ phrase was added to the subjects eligible for reimbursement of ‘Opdivo (nivolumab),’ ‘Keytruda (pembrolizumab),’ and ‘Tecentriq (atezolizumab)’ in NSCLC. The Health Insurance Review and Assessment Service announced that it will implement the ‘Amendment to the Notice on Drugs Prescribed and Administered to
- Policy
- Concerns about the introduction of the Reference Price
- by Kim, Jung-Ju Nov 1, 2021 05:55am
- The government expressed concern over the National Assembly's proposal to review the introduction of the Reference Pricing System. Although they sympathize with the need for rational drug price management, side effects such as an increase in the patient's economic burden are predicted from the reference price system itself. Regarding price
