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2025-05-02 23:46
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Policy
Handok paces its efforts to reimburse Pivlaz in KOR
by
Lee, Tak-Sun
Jun 11, 2024 05:47am
Handok is taking a break from its pursuit of reimbursement for ¡®Pivlaz,¡¯ a new drug used to prevent cerebral vasospasm in patients with subarachnoid hemorrhage that the company is supplying and distributing in Korea. The company immediately applied for Pivlaz¡¯s reimbursement to the Health Insurance Review and Assessment Service after
Policy
Roche applies for Ocrevus' reimbursement in KOR
by
Lee, Tak-Sun
Jun 10, 2024 05:41am
Roche Korea applied for reimbursement of 'Ocrevus Inj. (ocrelizumab, Roche Korea),¡¯ its multiple sclerosis treatment that was approved last month, to the Health Insurance Review and Assessment Service. The drug is administered twice a year, which is considered to have dramatically improved the dosing convenience for MS patients. The d
Policy
Latuda¡¤Dupixent enter negotiations with the NHIS
by
Lee, Tak-Sun
Jun 7, 2024 05:50am
'Latuda (lurasidone),' a medication used to treat schizophrenia and imported and distributed by Bukwang Pharmaceutical, and 'Dupixent (dupilumab),' which aims to expand reimbursement for young children, have entered negotiations with the National Health Insurance Service (NHIS). When an agreement with the National Health Insurance Service
Policy
Gov¡¯t will maintain criteria for KIPC recertifications
by
Lee, Jeong-Hwan
Jun 5, 2024 05:47am
The government has decided to maintain the recertification process and criteria for Korea Innovative Pharmaceutical Companies. Therefore, the government decided not to accept the demands of some in the pharmaceutical industry on easing the decertification regulations, ¡®2 or more rebate detections and administrative disposition¡¯, and t
Policy
Lorviqua fails to receive reimb as first-line therapy
by
Lee, Tak-Sun
Jun 4, 2024 05:47am
The reimbursement extension application for Lorviqua, a treatment for anaplastic lymphoma kinase (ALK)-positive non-small-cell cancer, &160;has failed to go beyond the negotiation stage with the National Health Insurance Service. With the breakdown of the negotiations, the company will have to start over from the application stage for Lo
Policy
Takeda¡¯s Zejula Tab receives marketing authorization in KOR
by
Lee, Hye-Kyung
Jun 3, 2024 05:49am
Takeda Pharmaceuticals¡¯ poly ADP-ribose polymerase Inhibitor ¡®Zejual (niraparib)¡¯ has been granted marketing authorization in Korea in its tablet form. The Ministry of Food and Drug Safety (MFDS) approved Zejula Tab 100 mg on the 31st. Like its capsule formulation, Zejula Tab is indicated ¡ãas monotherapy for adult patients with ova
Policy
Qarziba¡¯s reimb standard has been set before approval
by
Lee, Tak-Sun
May 31, 2024 05:51am
The reimbursement standard has been set for Qarziba (dinutuximab, Recordati Korea), which was designated as the 1st drug for a ¡°Pilot Project for Integration of Product Approvals, Reimbursement Coverage Reviews, and Drug Price Negotiations,¡± even though it has not yet received approval from the Ministry of Food and Drug Safety (MFDS). Qarzi
Policy
MFDS approves the orphan drug 'Pluvicto' for prostate cancer
by
Lee, Hye-Kyung
May 31, 2024 05:51am
The Ministry of Food and Drug Safety (MFDS) stated that on May 29th, it has granted approval of the orphan drug 'Pluvicto inj (Lutetium(177Lu) Vipivotide Tetraxetan)' for the treatment of prostate cancer. Pluvicto is imported by Novartis Korea. It is a radioligand therapy comprised of radioisotope Lutetium(177Lu), which binds to prostate
Policy
Korea-US gov't pledge to strengthen biohealth cooperation
by
Lee, Jeong-Hwan
May 31, 2024 05:51am
The Korean government has decided to strengthen cooperation with the U.S. Department of Commerce in the field of telemedicine and digital health, including non-face-to-face medical treatment. CareLabs and Lulu Medic, Korea¡¯s leading healthcare platforms including domestic non-face-to-face treatment applications, Teladoc, the No. 1 teleme
Policy
Research on reforming post-management of pharmaceuticals
by
Lee, Tak-Sun
May 30, 2024 05:50am
The government has initiated research on developing a comprehensive reform of post-insurance management of pharmaceuticals. This research was part of the 2nd Comprehensive NHI Plan, announced earlier this year. According to industry sources on May 29th, a policy initiative reporting session was held to announce the start of the res
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