Dáil Éireann Debate, Wednesday - 22 April 2026
241. Deputy Ken O'Flynn asked the Minister for Health whether any interim access schemes, compassionate use programmes, or early access pathways are currently available in the State for patients with Friedreich’s ataxia; and whether consideration is being given to enabling access to skyclarys pending a full reimbursement decision. [29080/26]
Amharc ar fhreagraThe Government is committed to investing in new medicines. Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. 72 of these were for rare diseases.
Budget 2026 allocated €30 million of funding available for new drugs to be allocated from the overall additional €217 million in funding allocated for medicines.
This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.
The Programme for Government contains a suite of measures on medicines, which the State aims to progress over its lifetime. Access to medicines for patients with rare diseases is the focus of a number of workstreams across the Department.
The HSE is the statutory decision maker on the pricing and reimbursement of new medicines. The HSE advise the following regarding an update on omaveloxolone (Skyclarys®). The NCPE HTA Report was received by the HSE on the 16th December 2025, including submissions made by patient organisations. These submissions will form part of the data that the HSE considers.
The HSE invited the marketing authorisation holder, Biogen (Idec) Ireland Limited, to commence price negotiations and offered a range of dates to the company. The HSE have advised this meeting took place on the 12th February 2026, and as of April 16th a commercial proposal from the company remains outstanding.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
Two new Framework Agreements have been reached with the Irish Pharmaceutical Healthcare Association (IPHA) and Medicines for Ireland (MFI) on the pricing and supply of medicines.
As part of these Agreements, the State and MFI and IPHA have agreed to develop a future strategic partnership. This partnership will support the Department of Health in its development of proof of concept for a pilot early access programme focused on rare diseases, in line with the commitments in the Programme for Government.
