- 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
- Policy
- 'Symbenda' withdraws from Korean market 3 years after reimb.
- by Lee, Tak-Sun Oct 29, 2021 05:54am
- A blood cancer drug that took 7 years from approval to reimbursement is being removed from the market only 3 years since starting its sale in earnest. The company that sells the product has pointed to the termination of their agreement as to the cause of its market withdrawal, however, the analysis is that profitability has declined due to d
- Policy
- KDCA “will monitor development of oral COVID-19 treatments"
- by Lee, Hye-Kyung Oct 29, 2021 05:53am
- The government expressed its determination to introduce a safe treatment with verified efficacy by continuously monitoring the COVID-19 treatment trends, including the US Merck & Co. (MDS)'s oral COVID-19 treatment, 'molnupiravir .' That was the KDCA's response to when NA member Young-seuk Seo of the Democratic Party of Korea asked in vi
- Policy
- The government needs to create a sovereign wealth fund
- by Lee, Jeong-Hwan Oct 29, 2021 05:53am
- The National Assembly's Health and Welfare Committee urged both ruling and opposition parties to create tens to hundreds of trillion won worth of sovereign wealth funds to develop blockbuster vaccines and new drugs. As COVID-19 Pandemic has confirmed high demand in the global market for pharmaceutical and bio sectors such as vaccines and new
