Bulevirtide (Hepcludex®)
Bulevirtide (Hepcludex®) for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV- RNA positive adult patients with compensated liver disease, is reimbursed on the High Tech Arrangement from 1 May 2025. A Managed Access Protocol (MAP) is in place for bulevirtide. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of bulevirtide under the High Tech Arrangement.
Applications for reimbursement approval for bulevirtide under the High Tech Arrangement, will only be considered from consultants in infectious diseases or consultant hepatologists and gastroenterologists registered with the Irish Medical Council, who are experienced in the treatment of patients with HDV infection, 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 bulevirtide for the treatment of chronic HDV infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease 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