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This is a cruel, fast-moving disease and every month that passes Emma loses more of her independence. There is a treatment called Skyclarys which is approved across Europe and in the USA. Patients elsewhere are already benefitting but in Ireland Emma and others cannot access it despite … decline. I am asking for two simple things. Will the Minister of State intervene to ensure the HSE concludes reimbursement talks for Skyclarys? Do these delays reflect the access promised in the new rare diseases strategy? Emma and the FA community cannot be left behind while the rest

Deputy Johnny Guirke asked the Minister for Health regarding the reimbursement of Skyclarys (omaveloxolone), the only approved treatment for Friedreich’s Ataxia (details supplied), the specific steps being taken to ensure the HSE considers the "time-critical" nature of FA during the current price negotiations for Skyclarys

Willie O'Dea asked the Minister for Health if she will provide an update on the process to allow for the reimbursement of Skyclarys, the only approved treatment for Friedreich’s Ataxia (FA); the specific steps being taken to ensure the HSE considers the "time-critical" nature … during the current price negotiations for Skyclarys; the way in which the commitments in the National Rare Disease Strategy 2025-2030 and the 2026 IPHA Framework Agreement (which aims for a 180-day decision timeline) are being applied to this specific case, to prevent further delays in addressing

steps are being taken to ensure the HSE recognises the “time-critical” nature of Friedreich’s ataxia during the current price negotiations for skyclarys; and if she will make a statement on the matter. [22549/26

Michael Collins asked the Minister for Health if she will intervene to ensure the HSE prioritises a conclusion to the reimbursement negotiations for skyclarys, given it is the only available treatment for Friedreich’s ataxia and the unmet clinical need recognised in the national rare disease strategy

Deputy Michael Collins asked the Minister for Health her views on whether current delays in providing skyclarys are compatible with the commitment to “equitable access” outlined in the new National Rare Disease Strategy, particularly when patients across Europe already have access to this therapy; and if she will

specific steps being taken to ensure the HSE considers the time-critical nature of Friedreich’s ataxia during the current price negotiations for skyclarys; and the way in which the commitments in the National Rare Disease Strategy 2025-2030 and the 2026 IPHA Framework Agreement (which aims

Deputy Jennifer Whitmore asked the Minister for Health whether she will consider funding the medication skyclarys for people living with Friedreich’s ataxia; and if she will make a statement on the matter. [22147/26

Muirí asked the Minister for Health if she will intervene to ensure that the HSE prioritises the conclusion of reimbursement negotiations for skyclarys, given that it is currently the only available treatment for Friedreich’s ataxia and is identified as addressing an unmet need under the National Rare

Deputy John Clendennen asked the Minister for Health for an update on the accessibility of Omaveloxolone (brand name Skyclarys) for the treatment of Friedreich’s ataxia; and if she will make a statement on the matter. [21312/26

Deputy John Brady asked the Minister for Health for an update on the application for reimbursement for the drug Skyclarys (omaveloxalone); and if she will make a statement on the matter. [18485/26

Deputy Pádraig Mac Lochlainn asked the Minister for Health the current status of the assessment, pricing negotiations and potential reimbursement approval for Skyclarys (omaveloxolone) for the treatment of Friedreich's Ataxia (FA) in Ireland; when patients can expect a decision on access to this medicine

steps being taken to ensure the HSE considers the "time-critical" nature of Friedreich's Ataxia during the current price negotiations for Skyclarys; the way in which the commitments in the National Rare Disease Strategy 2025-2030 and the 2026 IPHA Framework Agreement, which aims

Deputy Rose Conway-Walsh asked the Minister for Health when she expects an outcome from the application for pricing and reimbursement of omaveloxolone (Skyclarys) for the treatment of Friedreich’s Ataxia in adults and adolescents aged 16 years and older; if not yet known, the efforts that will

specific steps being taken to ensure the HSE recognises the time-critical nature of Friedreich’s Ataxia during the current price negotiations for Skyclarys; how the commitments in the National Rare Disease Strategy 2025–2030 and the 2026 IPHA Framework Agreement are being applied to this case

Deputy Seán Canney asked the Minister for Health when the drug Skyclarys will be reimbursed for patients with Friedreich’s Ataxia (details supplied); and if she will make a statement on the matter. [18731/26

Deputy Albert Dolan asked the Minister for Health the status of the HSE and Department of Health assessment of Omaveloxolone (Skyclarys) for the treatment of Friedreich’s Ataxia; the timeline for completing the reimbursement process; the engagement that has taken place with patient representatives and clinical experts

that the time-critical nature of Friedreich’s Ataxia is fully recognised and reflected in the ongoing price negotiations for the reimbursement of Skyclarys; and if she will make a statement on the matter. [18745/26

Strategy 2025–2030, particularly regarding timely access to approved therapies for rare disease patients, are being applied to the current reimbursement process for Skyclarys for the treatment of Friedreich’s Ataxia; and if she will make a statement on the matter. [18746/26

which the 180-day decision timeline contained within the 2026 IPHA Framework Agreement is being implemented in the case of Skyclarys, given that over 570 days have now elapsed since the reimbursement application was submitted; and if she will make a statement on the matter. [18747/26

Deputy Louis O'Hara asked the Minister for Health if the drug Skyclarys (omaveloxolone), used for the treatment of Friedreich’s ataxia, will be made available under licence in Ireland; and if she will make a statement on the matter. [18769/26

that are being taken to ensure the HSE recognises the time-critical nature of Friedreich’s ataxia during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [18770/26

reimbursement decision timeline mandated under the Health (Pricing and Supply of Medical Goods) Act 2013 was applied to the drug skyclarys (omaveloxolone); and if she will make a statement on the matter. [18771/26

Deputy Sorca Clarke asked the Minister for Health to outline the current status of the reimbursement application for skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia; if she will provide a detailed update of ongoing engagement between the HSE and the manufacturer; and the way in which

IPHA Framework Agreement 2026, including the stated 180-day decision target for reimbursement applications are being adhered to in the case of skyclarys, given that more than 570 days have elapsed since the initial application was submitted in August 2024. [18961/26

ensure that the HSE recognises and responds to the time-critical nature of Friedreich’s ataxia during the current price negotiations for skyclarys; the way in which the commitments, which are outlined in the National Rare Disease Strategy 2025–2030, and the 2026 IPHA Framework Agreement (which aims