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2024-09-19 16:12
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Policy
'Need patient engagement for reimb of high-priced drugs'
by
Lee, Tak-Sun
Apr 8, 2024 05:46am
A study has shown that there is a need for a formal process for patient organizations and patients to participate in discussions for the reimbursement of high-priced drugs in Korea. With the reimbursement of high-priced drugs rising as a social issue and patient organizations and others raising concerns, the opinion has risen on the need for
Policy
Recalls of antiplatelet drugs containing 'clopidogrel'¡¦
by
Lee, Hye-Kyung
Apr 5, 2024 05:44am
The recall of the products due to exceeding safety standards for miscellaneous impurities in safety tests for the antiplatelet drugs containing the ingredient 'clopidogrel' is expanding. The Ministry of Food and Drug Safety (MFDS) reported that a total of 29 items have been recalled until April 2, starting with Daewoong Bio¡¯s 'Clovons Tab'
Policy
Orphan drug Ilaris receives conditional pass for reimb again
by
Lee, Hye-Kyung
Apr 5, 2024 05:43am
Although the government restarted reimbursement discussions for Novartis Korea's orphan drug Ilaris Inj (canakinumab) after 2 months, the results were the same. According to the "Results of the 4th 2024 Drug Reimbursement Review Committee Deliberations," which was released on the 4th by the Health Insurance Review and Assessment Service, Ilar
Policy
HIRA in final stages of preparing expense report survey
by
Lee, Tak-Sun
Apr 5, 2024 05:43am
The Health Insurance Review and Assessment Service is busy preparing a survey and public disclosure of the expenditure reports on economic benefits pharmaceutical companies and medical device companies provided to doctors and pharmacists. As the data submitted by pharmaceutical companies through the survey will be subject to public dis
Policy
Trajenta generics enter reimbursement pricing¡¦
by
Lee, Tak-Sun
Apr 5, 2024 05:43am
The generic version of Trajenta (linagliptin), a DPP-4 inhibitor class, has applied for reimbursement pricing ahead of its launch in June. This year, generic market is drawing attention to Trajenta. With the exclusive rights for Trajenta is set to expire, after Forxiga and Januvia last year, the diabetes market is expected to see new c
Policy
Eye drops late to submit test results pass reivew
by
Lee, Hye-Kyung
Apr 4, 2024 05:59am
Amid the ongoing equivalence reevaluations being conducted on eye drops, products that received dispositions for failing to submit equivalence data in time received a final compliant decision. The Ministry of Food and Drug Safety (MFDS) released the results of the ¡®2022 drug equivalence reevaluation¡¯ that contained such results on the 3rd.
Policy
K-CAB is in talks to extend refund-type PVA
by
Lee, Tak-Sun
Apr 4, 2024 05:59am
HK inno.N is in talks with the National Health Insurance Service (NHIS) to extend the refund-type price-volume agreement (PVA) for K-CAB (tegoprazan), a drug developed in Korea for gastroesophageal reflux disease. K-CAB is the only drug under the refund-type price-volume agreement (PVA). Since its release in 2019, K-CAB¡¯s claim amount
Policy
Novartis¡¯ 'Ilaris' will be reconsidered for the DREC review
by
Lee, Tak-Sun
Apr 3, 2024 05:50am
The rare disease drug 'Ilaris Injection (canakinumab, Novartis Korea)' will be reconsidered for review by the Drug Reimbursement Evaluation Committee (DREC) of the Health Insurance Review and Assessment Service (HIRA) after two months. Ilaris is a drug used to treat a rare disease called 'periodic fever syndromes (PFS)' for which there
Policy
3 more successful Zolgensma treatment cases reported¡¦
by
Lee, Tak-Sun
Apr 2, 2024 05:54am
Zolgensma, a one-shot treatment for spinal muscular atrophy (SMA), is demonstrating a high effect post-reimbursement. The government has been conducting a post-marketing performance evaluation on the drug since its reimbursement in August 2022, and so far, there has been only 1 case of failure reported after its use. The drug costs a
Policy
Oppo parties also promise 'drug price system reform'
by
Lee, Jeong-Hwan
Apr 2, 2024 05:54am
Following the ruling party¡¯s pledge, the opposition parties also announced their general election pledges to promote Korea¡¯s growth into a pharma-bio powerhouse, by investing in research and development (R&D) and preparing customized drug pricing systems for the global entry of Korea¡¯s new drugs, heralding their intent to foster and devel
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