Obeticholic acid (Ocaliva®)
Obeticholic acid (Ocaliva®) was added to the High Tech Arrangement on 1st November 2022. A Managed Access Protocol (MAP) is in place for obeticholic acid. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of obeticholic acid under the High Tech Arrangement.
The prescribing of obeticholic acid under the High Tech Arrangement is confined to consultant hepatologists and gastroenterologists registered with the Irish Medical Council, who have agreed to the terms of this MAP and who have been approved by the HSE.
The clinician must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved clinicians.
A copy of the HSE-Managed Access Protocol for obeticholic acid and the application form for individual reimbursement approval can be found in the Related Files section below.
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