Odevixibat (Bylvay®)

Odevixibat (Bylvay®) for the treatment of progressive familial intrahepatic cholestasis in patients aged six months or older is reimbursed on the High Tech Arrangement from 1st December 2024. A Managed Access Protocol (MAP) is in place for odevixibat. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of odevixibat under the High Tech Arrangement.

Applications for reimbursement approval for odevixibat under the High Tech Arrangement will only be considered from consultant hepatologists and gastroenterologists registered with the Irish Medical Council, who are experienced in the management of progressive familial intrahepatic cholestasis, and who have agreed to the terms of this MAP and have been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient.

A copy of the MAP for odevixibat for the treatment of progressive familial intrahepatic cholestasis, and the application form for individual reimbursement approval, can be found in the Related Files section below.

For further information, please contact mmp@hse.ie