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2025-02-07 04:50
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Policy
Basic refund type-drugs granted early RSA termination
by
Lee, Tak-Sun
Dec 20, 2024 05:46am
Only drugs categorized as a basic refund type are possible when a pharmaceutical company wishes to terminate the Risk Sharing Agreement (RSA) early. However, pharmaceuticals on the cost-effectiveness evaluation waiver track, demonstrating cost-effectiveness, can be submitted for negotiation through the renewal of the agreement. The Nati
Policy
Cinacalcet impurities spread¡¦Huons recalls product
by
Lee, Hye-Kyung
Dec 19, 2024 05:53am
The detection of excess 'N-nitroso cinacalcet' impurity has led to the recall of the kidney drug cinacalcet hydrochloride. The Ministry of Food and Drug Safety announced on the 17th that Huons¡¯ Calcepara Tab 25 mg (cinacalcet hydrochloride) with 3 manufacturing numbers TTB201 (2025-08-16), TTB301 (2026-05-18), and TTB302 (2026-05-21) will be
Policy
Sanofi signs PVA negotiations for hemophilia drug 'Alprolix'
by
Lee, Tak-Sun
Dec 19, 2024 05:52am
The ceiling price for Sanofi's 'Alprolix,' a new treatment for hemophilia B, is expected to decrease through price-volume agreement (PVA) negotiations. This drug was approved in May 2017, and reimbursement listed in June of the following year. According to industry sources on December 18, the National Health Insurance Service (NHIS) a
Policy
Hyperphosphatemia treatments undergo generation change
by
Lee, Tak-Sun
Dec 19, 2024 05:52am
Drugs that improve hyperphosphatemia in patients with chronic kidney disease are undergoing a generation change in the domestic market. Following the launch of the new drug Nephoxil Cap (ferric citrate, Kyowa Kirin Korea) last year, generic drugs containing sevelamer have continued to grow, and news of the withdrawal of existing drugs is
Policy
Prior notification of drug permit changes extended to 2025
by
Lee, Hye-Kyung
Dec 19, 2024 05:52am
The operation of the pilot program, 'Advance Notification System for Drug Change Permit', which allows drug manufacturers and importers to apply for change permits on their preferred date, will be extended. According to industry sources on the 18th, the Ministry of Food and Drug Safety (MFDS) will extend the pilot project until December 31 ne
Policy
Generic drugs without originals released in KOR
by
Lee, Tak-Sun
Dec 18, 2024 05:54am
Generic versions of drugs whose original versions are unavailable in Korea are expected to be released one after another. This is becoming a Korean phenomenon, where original drugs withdraw from the domestic market due to low drug prices and generics fill the void. According to industry sources, the National Health Insurance Service has
Policy
Reimb of PE exemption drugs can be ex officio rejected
by
Lee, Tak-Sun
Dec 16, 2024 05:53am
In the future, drugs that sign refund-type risk-sharing agreements will be reviewed briefly by the Health Insurance Review and Assessment Service, focusing on changes, when a drug is reimbursed through the signing of the risk-sharing agreement more than 3 times. In addition, if a drug applies as a drug that can skip submission of pharma
Policy
NHIS to expand the special estimate case system in 2025
by
Lee, Tak-Sun
Dec 16, 2024 05:52am
The National Health Insurance Service (NHIS) (Chairman: Jung Ki Suck) has announced plans to expand the reimbursement criteria for special cases of new rare diseases, starting on January 1, 2025. The NHIS aims to enhance essential medical support for individuals who currently do not benefit from receiving healthcare, including patients with r
Policy
HLB Pharma applies for reimb of 'Citrelin ODT' for SCD
by
Lee, Tak-Sun
Dec 16, 2024 05:52am
HLB Pharma has reportedly applied to the Health Insurance Review and Assessment Service (HIRA) for reimbursement of 'Citrelin ODT,' a domestically distributed treatment for spinocerebellar degeneration. This product was approved in South Korea in 2015, but it has been distributed to the Korean market as a non-reimbursed drug. However, wit
Policy
Otezla generics enter negotiations for reimb
by
Lee, Tak-Sun
Dec 13, 2024 05:52am
Generic to Otezla (apremilast, Amgen), which is used to treat psoriatic arthritis and psoriasis, is being considered for reimbursement negotiations with the National Health Insurance Service (NHIS). Attention has been drawn to whether a generic drug will be listed for reimbursement, the process in which a company with the original drug gav
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