Iptacopan (FABHALTA®)
Iptacopan (FABHALTA®) as monotherapy for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) is reimbursed on the High Tech Arrangement from 1st December 2025. A Managed Access Protocol (MAP) is in place for iptacopan. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of iptacopan on the High Tech Arrangement.
Applications for reimbursement approval for iptacopan on the High Tech Arrangement, will only be considered from consultants with specialist registration in haematology with the Irish Medical Council and who have agreed to the terms of this MAP and been approved by the HSE (‘approved consultants’). The approved consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval or transferring reimbursement approval will only be considered from approved consultants.
A copy of the MAP for iptacopan as monotherapy in the treatment of adult patients with PNH 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