- Policy
- Forxiga, solvate modifier applied for the first permit
- by Lee, Tak-Sun Dec 5, 2019 06:22am
- Domestic pharmaceutical companies have developed a solvate modified drug for the SGLT-2 inhibitory diabetic drug Forxiga (Dapagliflozin, AstraZeneca Korea) and has entered into the application process. Once approved, the market sale will be available from April 8 2023, when material patents will be terminated. According to the MFDS on 3
- Policy
- HIRA unveils listed drug reevaluation guideline
- by Kim, Jung-Ju Dec 5, 2019 06:14am
- The government unveiled the details of the post-marketing reevaluation criteria and procedure of reimbursed drug. The scope of listed drug reevaluation mainly centers expensive drug items, such as anticancer and rare disease treatments, covered by insurance benefit despite their uncertainty in clinical efficacy. The evaluation borrows
- Policy
- Opdivo label changes but reimbursed scope unchanged
- by Lee, Hye-Kyung Dec 3, 2019 05:55am
- Ono Pharmaceutical’s immunotherapy Opdivo’s (nivolumab) 240 mg dose secured an approval from the regulator and expanded scope of administration on the label, but apparently the treatment’s reimbursed level of dose would remain unchanged. Health Insurance Review and Assessment Service (HIRA) recently collected public comments on the r
- Policy
- Hyperalgesia possibility if Fentanyl mucosa not control pain
- by Lee, Tak-Sun Dec 3, 2019 05:54am
- Fentanyl mucosal drug, a typical narcotic analgesic used for the treatment of cancer patients, may not be controlled by hyperalgesia and resistance, will be reflected in the permit. This was done by the Agency by reviewing safety information from the European Medicines Agency (EMA). The permission change adds that fentanyl mucosal medic
- Policy
- HIRA rejects reimbursed use of Spinraza on 14-year-old
- by Lee, Hye-Kyung Dec 3, 2019 05:53am
- Approval on reimbursed use of Spinraza (nusinersen) on a 14-year-old male patient with 5q spinal muscular atrophy (SMA) was denied. The application submitted by the hospital was rejected as it did not clarify if the patient had developed clinical symptoms of SMA before 36 months. On Nov. 29, Health Insurance Review and Assessment (HIRA,
- Policy
- Stivarga's price-volume agreement, 3.2% down
- by Kim, Jung-Ju Dec 3, 2019 05:53am
- Bayer Korea's Stivarga 40mg is targeted for price-volume agreement linkage and has been negotiated with the National Health Insurance Service. Lartruvo inj will be reduced to &8361;10,394,464 from February 1 2022. Daewoong Pharmaceutical's 10 mg and 30 mg of Aliga Capsules are listed at &8361;3,703 and &8361;7,408, respectively, bas
- Policy
- Reimbursement standards expanded ADHD combined & Somatropin
- by Kim, Jung-Ju Dec 2, 2019 05:56am
- From next month, the combination of treatment with attention-deficit hyperactivity disorder (ADHD), which differs in the mechanism of action, and the reinforcement reimbursement standards for growth hormones such as Somatropin, etc., will expand and insurance coverage will be widened. The reimbursement criteria for Somatropin injections are
- Policy
- 'Ongentys' by SK Chemicals approved in Korea
- by Lee, Tak-Sun Dec 2, 2019 05:56am
- SK Chemicals obtained a domestic item approval for Parkinson's disease treatment,‘ Ongentys Capsule (Opicapone)’. This product is expected to be a new drug in the Parkinson's disease market after a long interval. The Ministry of Food and Drug Safety approved the marketing of SK Chemicals 'Ongentys Capsule 25mg, 50mg' on the 26th. Thi
- Policy
- Generics for Galvus, focus on development strategy
- by Lee, Tak-Sun Dec 2, 2019 05:56am
- The development of generic drugs for Galvus (Vildagliptin by Novatis Korea), which is a DPP-4 inhibitor for diabetes mellitus is continuing. In particular, while Ahn-gook pharmaceuticals and Hanmi Pharmaceuticals have already completed their commercialization and anticipated market preoccupation, pharmaceutical companies' strategies to pe
- Policy
- “Cost-effectiveness review inevitable for high-cost drugs”
- by Lee, Jeong-Hwan Nov 30, 2019 05:51am
- Korean Minister of Health and Welfare Park Neung-hoo stated the ministry would approach the issue of National Health Insurance (NHI) coverage on super expensive drugs by evaluating cost-effectiveness of treatment and pharmaceutical opportunity cost. Particularly, Minister Park highlighted insurance covered drug pricing system in Korea i
