3101. Deputy Michael Cahill asked the Minister for Health if she will give consideration to correspondence (details supplied) and allow for skyclarys treatment for the progressive neurological condition Friedreich's ataxia; and if she will make a statement on the matter. [54785/26]

3127. Deputy Niamh Smyth asked the Minister for Health if she will review correspondence (details supplied); if she will address the concerns raised therein; if she will provide an update on the matter; and if she will make a statement on the matter. [54910/26]

3200. Deputy Barry Ward asked the Minister for Health the position regarding the approval process for skyclarys as a treatment for Friedrich's ataxia; and if she will make a statement on the matter. [55213/26]

3201. Deputy Barry Ward asked the Minister for Health the position regarding the commercial proposal in relation to the approval process for skyclarys as a treatment for Friedrich's ataxia; and if she will make a statement on the matter. [55214/26]

3202. Deputy Barry Ward asked the Minister for Health the position regarding a timeline for the approval of skyclarys as a treatment for Friedrich's ataxia; and if she will make a statement on the matter. [55215/26]

3203. Deputy Barry Ward asked the Minister for Health the position regarding meetings held between the HSE or her Department officials with the manufacturers of skyclarys in relation to it's approval process for the treatment for Friedrich's ataxia; and if she will make a statement on the matter. [55216/26]

3204. Deputy Barry Ward asked the Minister for Health her views on whether delays in the approval of skyclarys as a treatment for Friedrich's ataxia aligns with the 'equitable access' as outlined in the National Rare Disease Strategy 2025-2030; and if she will make a statement on the matter. [55217/26]

3205. Deputy Barry Ward asked the Minister for Health her views on whether the treatment for Friedrich's ataxia falls under an 'unmet need' as set out in the National Rare Diseases Strategy 2025-2030; and if she will make a statement on the matter. [55218/26]

3206. Deputy Barry Ward asked the Minister for Health if her attention has been drawn to a protest held outside Leinster House by the families and supporters of people suffering from Friedrich's ataxia in relation to the delays in the approval of skyclarys as a treatment for the disease; and if she will make a statement on the matter. [55219/26]

3207. Deputy Barry Ward asked the Minister for Health the position regarding the engagement that she has had with families and supporters of people suffering from Friedrich's ataxia in relation to the delays in the approval of skyclarys as a treatment for the disease; and if she will make a statement on the matter. [55220/26]

3220. Deputy Eoghan Kenny asked the Minister for Health if as of July 2026, her Department has further considered the inclusion of skyclarys (omaveloxolone) which is a treatment for Friedreich's ataxia in a reimbursement scheme given the cost of the drug and the fact that other European countries provide this scheme to patients; and if she will make a statement on the matter. [55273/26]

3348. Deputy Michael Cahill asked the Minister for Health if she will urgently intervene in the case of a person (details supplied); and if she will make a statement on the matter. [55883/26]

3654. Deputy Naoise Ó Cearúil asked the Minister for Health the progress that has been made in considering skyclarys (omaveloxolone) for reimbursement for patients with Friedreich's ataxia; the engagement that has taken place between the HSE and the manufacturer since April 2026; the expected timeline for a decision; and if she will make a statement on the matter. [57259/26]

3785. Deputy Keira Keogh asked the Minister for Health the position regarding the availability of skyclarys (omaveloxolone) for those who are living with Friedreich's ataxia following the most recent HSE Drugs Group monthly meeting; and if she will make a statement on the matter. [57697/26]

I propose to take Questions Nos. 3101, 3127, 3200, 3201, 3202, 3203, 3204, 3205, 3206, 3207, 3220, 3348, 3654 and 3785 together.

The State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly those living with rare diseases such as Friedreich’s ataxia. I attended a briefing in Leinster House where I met patients and their families and heard directly about their experiences through regular engagements. The Taoiseach has also engaged with families affected by this disease.

Skyclarys® received marketing authorisation from the European Medicines Agency in 2024 for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE), through its Senior Leadership Team has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices.

The HSE is assessing this medicine for reimbursement in line with the criteria detailed in legislation. Following consideration by the HSE’s Drugs Group on the 14th of July, the HSE Drugs Group has decided to seek additional advice from the Rare Diseases Technology Review Committee (RDTRC) to ensure that every aspect of the application is fully considered.

The HSE moved immediately to convene the Committee and is seeking to complete its input in one month. The review process will include engagement with national clinical experts in Friedreich’s Ataxia and with patient representatives, ensuring that lived experience and specialist expertise inform the assessment. This input is about the HSE giving every opportunity to make the case for a particular drug.

The Drugs Group will consider this application again when the statement of the RDTRC is returned, and will make a recommendation to the HSE Senior Management Team who have final decision making authority on whether to reimburse a medicine.

This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.