- Policy
- Marketing authorization imminent for Obizur in Korea
- by Lee, Hye-Kyung Mar 17, 2023 05:46am
- Marketing authorization for Takeda Pharmaceuticals Korea’s ‘Obizur Inj (susoctocog alfa)’ is imminent in Korea. Obizur Inj is a treatment for bleeding episodes in adults with acquired hemophilia A. The drug has been used as a treatment for hemophilia A in Korea after receiving an orphan drug designation in July 2021. According to
- Policy
- Upper limit re-evaluation of drugs in the negotiation stage
- by Lee, Tak-Sun Mar 16, 2023 05:45am
- The re-evaluation of the drug cap amount according to the standard requirement has now moved to the negotiation stage with the NHIS. Pharmaceutical companies that submitted their primary drugs to the HIRA by last February will proceed with prior consultation with the NHIS in March. After that, the main negotiations will be completed and the
- Policy
- MFDS, approval of Vadadustat for anemia tx of renal disease
- by Lee, Hye-Kyung Mar 15, 2023 05:56am
- Vadadustat, which is used to treat anemia in patients with chronic kidney disease, has received domestic product approval. The Ministry of Food and Drug Safety (Minister Yu-Kyoung Oh) announced on the 13th that it had approved two doses (150 and 300mg) of Vadadustat from Mitsubishi Tanabe Pharma Korea Co., Ltd., a new drug for the treatment o
- Policy
- MOHW provides real-time confirmation service
- by Lee, Jeong-Hwan Mar 15, 2023 05:56am
- When the government requests pharmaceutical companies to expand drug reimbursement standards, the government plans to use the information system to provide administrative services to check the progress of evaluation tasks at each stage. Drugs with clear efficacy for survival-threatening diseases will strengthen patient accessibility by imple
- Policy
- SGLT2 + DPP4 combi benefit expansion has increased
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- As the insurance authorities decided to expand the combined coverage of major diabetes drugs from April, applications for reimbursement for related complex drugs are continuing. MSD Stegluzan's application for benefits was recently confirmed, and Dong-A ST Sugadapa, which was approved on the 13th, plans to apply for benefits this month. Accor
- Policy
- Voluntary withdrawal of reimbursement for Tepmeko
- by Lee, Tak-Sun Mar 14, 2023 05:50am
- It was found that Tepmeko, a MET mutated anti-cancer drug that failed to set reimbursement standards, recently voluntarily withdrew its application for reimbursement. Tepmeko has not been recognized as valid as a result of discussing the reimbursement standard in HIRA. According to the industry on the 10th, Merck announced its intention to vo
- Policy
- Innovative plans for domestic vaccines/txs to face post-pand
- by Lee, Jeong-Hwan Mar 13, 2023 05:53am
- The government will promptly import vaccines and treatments for new infectious diseases that will occur in Korea after Corona 19 and improve laws and systems so that domestic products can be produced quickly. For now, only the big direction has been set, and the government plans to announce a comprehensive plan in May after consultations wit
- Policy
- Pfizer’s Cibinqo to undergo NHIS negotiations for reimb
- by Lee, Tak-Sun Mar 13, 2023 05:53am
- Pfizer has accepted the conditions set by the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee for the reimbursement of its Cibinqo Tab (abrocitinib) in Korea. The drug received conditional approval at the DREC meeting that was held on March 2. The committee deemed Cibinqo’s reimbursement will be
- Policy
- Industry unsatisfied with the proposed PVA improvements
- by Lee, Tak-Sun Mar 10, 2023 05:50am
- Companies that have released new drugs in Korea have expressed discontent over the measures to improve the price-volume agreement (PVA) system that had been recently disclosed by the National Health Insurance Service. The new measure will put drugs that undergo PVA Type A negotiations at a relative disadvantage. According to the measur
- Policy
- Dupixent, Cibinqo, Rinvoq to be reimb for pediatric AD in 1H
- by Lee, Tak-Sun Mar 10, 2023 05:49am
- The three drugs that are attempting to receive reimbursement as a treatment for pediatric·adolescent patients with atopic dermatitis - Dupixent (dupilumab), Cibinqo (abrocitinib), and Rinvoq (upadacitinib) &8211; are expected to be approved for reimbursement within the first half of the year. With all 3 drugs passing the Health Insuran
