1130. Deputy Eamon Scanlon asked the Minister for Health if she will ensure that the HSE urgently prioritises a conclusion to the skyclarys (omaveloxolone) reimbursement negotiations, given that it is the only available treatment for Friedreich’s ataxia, which currently can be classed as having an ‘unmet need’ as outlined in the National Rare Disease Strategy 2025-2030; her views on whether the current delay aligns with the "equitable access" promised in the newly launched National Rare Disease Strategy 2025-2030; and if she will make a statement on the matter. [37136/26]

1241. Deputy Niamh Smyth asked the Minister for Health if she will urgently provide an update on the HSE's decision regarding the reimbursement of skyclarys for the treatment of Friedreich's ataxia; the timeline for a final decision; and if she will make a statement on the matter. [37786/26]

I propose to take Questions Nos. 1130 and 1241 together.

The 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 new medicines 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.

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.

This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines.

The National Rare Disease Strategy 2025–2030, was launched last year. The strategy outlines a comprehensive framework designed to enhance diagnosis, treatment, and support for people living with rare diseases, aiming to improve quality of life, promote equitable access to healthcare, and foster innovation in rare disease research and treatment. It also emphasises the importance of access to orphan medicines among its key recommendations. An Implementation Oversight Group has been launched and met in February to begin work planning for the 11 recommendations.

There is a suite of measures, that have been implemented and are to be implemented to shorten the timeframe from the issue of a Marketing Authorisation on foot of a positive opinion by the European Medicines Agency to a decision on whether to reimburse the medicine by the HSE's Senior Leadership Team.

These measures include:

• Funding by the Government to an almost doubling of capacity in the HSE’s pricing and reimbursement system with 34 additional staff.

• New Framework Agreements on the Supply and Pricing of Medicines with Medicines for Ireland (MFI) and the Irish Pharmaceutical Healthcare Association (IPHA) which provide commitments towards achieving a 180-day timeline for completing health technology assessments (HTA) and reimbursement decisions following application by the Marketing Authorisation Holder. The Agreements outline a structured process towards achieving the 180-day timeline for reimbursement decisions by Q1 2029, accelerating patient access to new treatments.

• A commitment from IPHA member companies to aim to shorten the timeline to submit reimbursement applications in Ireland to within six months of marketing authorisation of medicines by the European Commission.

• An Agreement between the State and IPHA and MFI to establish a strategic partnership on the development of a sandboxed early access programme for rare diseases. This will be a proof-of-concept initiative, aligned with the commitments in the Programme for Government and recommendations in the National Rare Disease Strategy 2025–2030. The Department of Health are examining early access mechanisms across the EU for the Minister for Health’s further consideration.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed. The HSE is the statutory decision maker for the pricing and reimbursement of new medicines under the Health (Pricing and Supply of Medical Goods) Act 2013. The HSE considers the criteria set out in the Act.

As the HSE is the statutory decision maker for the pricing and reimbursement of new medicines I have asked them for an update on omaveloxolone (Skyclarys®).

A HTA Report from the National Centre for Pharmacoeconomics 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 May 15th a commercial proposal from the company remains outstanding.

This application remains under consideration with the HSE and cannot proceed until a commercial proposal is received from Biogen (Idec) Ireland Limited.

The HSE cannot make any comment on possible outcomes from the ongoing process.