Lanadelumab (TAKHZYRO®) was added to the High Tech Arrangement on 1 September 2021. A Managed Access Protocol is in place for Lanadelumab. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of Lanadelumab under the High Tech Arrangement.
The prescribing of Lanadelumab under the High Tech Arrangement is confined to designated consultant immunologists who have agreed to the terms of the HSE-Managed Access Protocol and have been approved by the HSE-Medicines Management Programme. 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 Lanadelumab and the application form for individual reimbursement approval can be found in the Related Files section below.