Tafamidis (Vyndaqel®)

Tafamidis (Vyndaqel®) was added to the High Tech Arrangement on 1st March 2022. A Managed Access Protocol (MAP) is in place for Tafamidis. This outlines the criteria that must be satisfied in order for a patient to be recommended for reimbursement of Tafamidis under the High Tech Arrangement.

The prescribing of Tafamidis under the High Tech Arrangement is confined to consultants with experience in the diagnosis and management of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM), 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 Tafamidis 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

At the end of February 2023, the HSE had approved 33 prescribers for tafamidis under this protocol. In March 2023, 80 patients accessed tafamidis under the High Tech arrangement. More information available in the Tafamidis snapshot (PDF, 493 KB, 1 page)