Onasemnogene abeparvovec (Zolgensma®)

Onasemnogene abeparvovec (Zolgensma®) was approved for reimbursement through the Hospital Arrangement in October 2021. Pricing approval in Ireland was granted from the 8th October 2021 following joint assessment and negotiations under the Beneluxa Initiative.

A Managed Access Protocol (MAP) is in place for Onasemnogene abeparvovec. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of Onasemnogene abeparvovec under the Hospital Arrangement.

The prescribing of Onasemnogene abeparvovec under the Hospital Arrangement is confined to consultant neurologists with experience in the diagnosis and management of Spinal Muscular Atrophy (SMA) in specialist centre(s) in Ireland, who have agreed to the terms of the MAP and have been approved by the HSE.

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 Onasemnogene abeparvovec approval can be found in the Related Files section below.

For further information, please contact mmp@hse.ie.