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  • Will 'Bylvay' be listed in the second half the year?
  • by Eo, Yun-Ho | translator Hong, Ji Yeon | Sep 18, 2025 06:04am
The 1st drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program
Has passed the Drug Reimbursement Evaluation Committee (DREC) in July and is currently undergoing drug price negotiation
Attention has been drawn to establishing the success of expedited review pilot program
Attention has been drawn to whether Bylvay, the first drug in the Concurrent Approval-Evaluation-Negotiation Pilot Program, will be approved for the reimbursement listing.

Ipsen Korea is currently in negotiations with the National Health Insurance Service (NHIS) over the drug price for Bylvay (odevixibat), a treatment for pruritus in patients aged 3 months and older with Progressive Familial Intrahepatic Cholestasis (PFIC).

Bylvay recently passed the Health Insurance Review & Assessment Service's (HIRA) Drug Reimbursement Evaluation Committee (DREC) in July after a second review. It had previously been sent back for re-deliberation at the DREC in April.

The government initiated the first phase of the Concurr
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