Berotralstat (Orladeyo®)
Berotralstat (Orladeyo®) and Lanadelumab (TAKHYRO®) are used for routine prevention of recurrent attacks of hereditary angioedema. A Managed Access Protocol is in place for these medicines. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of berotralstat or lanadelumab under the High Tech Arrangement.
The prescribing of berotralstat or 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 consultant must submit an application for individual reimbursement approval for each patient. Applications for individual reimbursement approval will only be considered from approved consultants.
A copy of the HSE-Managed Access Protocol for medicines for routine prevention of recurrent attacks of hereditary angioedema 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.