PCSK9 Inhibitors

The PCSK9 inhibitors alirocumab (Praluent®) and evolocumab (Repatha®) are available under the High Tech Arrangement. A Managed Access Protocol is in place for the PCSK9 inhibitors. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of alirocumab or evolocumab under the High Tech Arrangement.

The prescribing of alirocumab (Praluent®) and evolocumab (Repatha®) under the High Tech Arrangement is confined to designated clinicians 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 online 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 PCSK9 inhibitors can be found in the Related Files section below.

At the end of August 2023, the HSE had approved 71 prescribers for PCSK9 inhibitors under this protocol. Two hundred patients were accessing PCSK9 inhibitors under this protocol. Click here for more information.