Dáil Éireann Debate, Wednesday - 15 April 2026
332. Deputy Emer Currie asked the Minister for Health the latest update on the accessibility of skyclarys for the treatment of Friedreich’s ataxia; the timeline as to when the HSE senior leadership team will make a decision; and if she will make a statement on the matter. [27367/26]
Amharc ar fhreagra339. Deputy Peter 'Chap' Cleere asked the Minister for Health if she will intervene to ensure that the HSE urgently prioritises a conclusion to the skyclarys reimbursement negotiations, given that it is the only available treatment for this progressive disease, which currently can be classed as having an 'unmet need' as outlined in the National Rare Disease Strategy 2025-2030. [27404/26]
Amharc ar fhreagra340. Deputy Peter 'Chap' Cleere asked the Minister for Health her views on way in which the current delay with the skyclarys reimbursement negotiations aligns with the equitable access promised in the newly launched National Rare Disease Strategy 2025-2030. [27405/26]
Amharc ar fhreagraI propose to take Questions Nos. 332, 339 and 340 together.
The Government is committed to investing in medicines. Budgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Budget 2026 allocated €217 million in additional funding for drugs, with €30 million of this allocated for new drugs funding.
A central component of pharmaceutical expenditure is the HSE’s pricing and reimbursement process for medicines.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices. The Minister has no role in decisions on pricing and reimbursement.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
As the HSE is the statutory decision maker, I have asked them for 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 have advised that they have met with the applicant and await a commercial proposal from the applicant at this juncture. These negotiations are commercially confidential.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
