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2025-07-07 09:21
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Policy
Cancellation policy for innovative pharmas certification
by
Kang, Shin-Kook
Dec 9, 2024 05:47am
It has been reported that the cancellation standards of 'Innovative Pharmaceutical Companies Certification' will be relaxed for pharmaceutical companies fined for rebates. Some argue that certification requirements for illegal rebates are strict. Further criticism is anticipated as these measures deviate from the government¡¯s longstandin
Policy
Janssen seeks reimb for Balversa in Korea
by
Lee, Tak-Sun
Dec 9, 2024 05:46am
¡¯Balversa (erdafitinib, Janssen),¡¯ which has been approved as a targeted therapy for bladder cancer, has reportedly applied for reimbursement 2 years after being approved in Korea. It is believed that the company is seeking Balversa¡¯s entry into Korea¡¯s health insurance market based on its proven effectiveness in patients who have used
Policy
Reimb extension discussions for Kyprolis break down
by
Lee, Tak-Sun
Dec 6, 2024 05:57am
The proposal to extend reimbursement coverage for the multiple myeloma drug Kyprolis (carfilzomib, Amgen) has failed to make it past the negotiating stage with the National Health Insurance Service. The negotiations, which began last October, have broken down. The National Health Insurance Service announced the news of Kyprolis' negoti
Policy
Expanded clinical use of orphan drug 'Joenja' in children
by
Lee, Hye-Kyung
Dec 6, 2024 05:56am
The administration¡¤dosage in children for a clinical trial of 'Joenja (leniolisb),' an APDS treatment designated as an orphan drug in South Korea, is expected to be expanded. The meeting record of the Central Pharmaceutical Affairs Advisory Committee (CPAC), released by the Ministry of Food and Drug Safety (MFDS) on December 4, indicat
Policy
Linking 'Prior review-performance evaluation-reevaluation'
by
Lee, Tak-Sun
Dec 6, 2024 05:56am
The Health Insurance Review and Assessment Service announced that it has been reviewing a measure that links preliminary review, performance evaluation, and reevaluation for newly listed high-priced drugs. In other words, for newly listed high-priced drugs, the authorities will conduct a proper cost-effectiveness evaluation through a pre
Policy
Astellas¡¯s Xtandi Tab 40mg and 80mg approved in KOR
by
Lee, Hye-Kyung
Dec 5, 2024 05:53am
Astellas, the original company of the oral androgen receptor inhibitor (ARTA) class prostate cancer treatment, became the first company to receive marketing authorization for the tablet formulation of Xtandi in Korea. The Ministry of Food and Drug Safety approved two dosage forms of Astellas' Xtandi Tab - 40 mg and 80 mg &8211; on Mar
Policy
30-day negotiation window for essential medicines
by
Lee, Tak-Sun
Dec 4, 2024 05:57am
The National Health Insurance Service (NHIS) has started revising guidelines related to the government's initiative to improve the drug pricing system to 'reflect on the new drug innovative value.' First, the NHIS announced to introduce Risk Sharing Agreement (RSA) types and has reduced the time required to negotiate pricing adjustments f
Policy
Legislation of ¡®INN prescriptions¡¯ for drugs begin
by
Lee, Jeong-Hwan
Dec 4, 2024 05:56am
The government is promoting legislation to recommend international non-proprietary name prescriptions for national essential medicines and drugs with unstable supply and demand and to encourage the use of 'product name and the international non-proprietary name¡¯ when obtaining a marketing authorization. The bill also includes a provision
Policy
17 drugs receive essential medicine designations
by
Lee, Hye-Kyung
Dec 3, 2024 05:53am
Seventeen medicines that are essential for pediatric patients, cancer patients, and others, but require government support due to unstable supply, have been newly designated as national essential medicines. The Ministry of Food and Drug Safety (MFDS, Yu-Kyung Oh) announced on the 29th that it held a meeting on the stable supply of national es
Policy
Janssen¡¯s Tremfya¡¯s price cut 2yrs due to increased use
by
Lee, Tak-Sun
Dec 3, 2024 05:52am
The upper limit price of Tremfya, Janssen's autoimmune disease treatment, is expected to be reduced under the price-volume agreement system for the second consecutive year.&160; According to industry sources, the National Health Insurance Service and Janssen recently finalized PVA negotiations for the reimbursement of Tremfya on the 1s
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