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will be a proof-of-concept initiative aligned with the commitments in the programme for Government and the national rare disease strategy. Regarding Skyclarys, I will provide some background for our colleagues and then address the Deputy's question. Omaveloxolone, sold under the brand name Skyclarys … right medicines are chosen and that approval is at a sustainable price. The HSE received an application for pricing and reimbursement for Skyclarys from the applicant, Biogen Idec (Ireland) Limited, on 1 August 2024. After receiving a completed rapid review assessment report from the National Centre for Pharmacoeconomics

drugs, specifically drugs for rare diseases. When I submitted this question, I specifically wanted to talk about Friedreich's ataxia and the drug Skyclarys, which is currently under consideration by the National Centre for Pharmacoeconomics, NCPE, and the drugs group. It is a degenerative disease. I know … would like to see in the reply that the Minister has finally embarked on the task of starting that work, specifically on Skyclarys, which is currently under consideration

Friedreich's ataxia and their second child is now in a wheelchair due to the same disease, which is advancing. A treatment called SkyClarys is clinically approved and has been shown to slow the progress and the State refuses to reimburse it. Let me be clear: this … withheld? I want to ask him a direct question. Will he instruct the Minister for Health to fast-track a reimbursement decision for SkyClarys and define the timeframe

symptoms had deteriorated over time. Every day brings her a loss. It is a relentless and progressive disease. The reimbursement of Skyclarys would slow the progression of this disease and give her the chance to maintain her strength and independence for as long as possible. She is just

rank 23rd out of 27 EU countries with regard to reimbursement for rare disease drugs. That is a fact. Whether it is Skyclarys or some other drug for some other ailment, the fact of the matter is that Ireland is a laggard among our EU counterparts in terms

died as a result of Friedreich's ataxia. Their second son Paudie, who is 15 years old, is dying of the same disease. Skyclarys is not a perfect medicine. It is not a cure, but it has been shown repeatedly to have clinical benefits in slowing the disease

Deputy Thomas Gould asked the Minister for Health whether 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 Frederich's ataxia which currently can be classed as having an 'unmet need

Deputy Thomas Gould asked the Minister for Health her views on whether the current delay in the reimbursement of skyclarys aligns with the equitable access promised in the newly launched National Rare Disease Strategy 2025-2030. [31102/26

Deputy Paul Donnelly asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations (details supplied); and her views on whether the current delay aligns with the equitable access promised in the newly launched National Rare Disease

Minister for Health if she will intervene to ensure that the Health Service Executive urgently prioritises the conclusion of reimbursement negotiations for skyclarys for the treatment of Friedreich’s ataxia, given that it is currently the only available treatment for this progressive and life-limiting rare disease

Deputy Martin Daly asked the Minister for Health her views on whether the ongoing delay in concluding reimbursement negotiations for skyclarys for patients with Friedreich’s ataxia is consistent with the commitment to “equitable access” set out in the recently launched National Rare Disease Strategy

Deputy Eoghan Kenny asked the Minister for Health if her Department has 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

will review matters raised in correspondence (details supplied); if she will provide an update on the HSE's decision regarding the reimbursement of skyclarys for the treatment of Friedreich's ataxia; if she will note that 619 days have elapsed since the application for reimbursement was submitted

Deputy Ken O'Flynn asked the Minister for Health whether an application has been received for the reimbursement of the drug skyclarys for the treatment of Friedreich’s ataxia; if so, the current status of that application; the date on which it was submitted to the National Centre

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

Deputy Ken O'Flynn asked the Minister for Health whether skyclarys has been approved or reimbursed in other EU Member States or comparable jurisdictions; and whether such decisions are considered in Ireland’s reimbursement process. [29083/26

Deputy Catherine Callaghan asked the Minister for Health for an update on the measures being taken to provide treatments such as skyclarys (omaveloxolone) to patients with Friedrich's ataxia in Carlow and Kilkenny, and across the country; and if she will make a statement on the matter. [28381/26

Deputy Micheál Carrigy asked the Minister for Health for an update on the price negotiations regarding Skyclarys; the steps being taken to support those with Friedrich’s ataxia in the time critical interim; and if she will make a statement on the matter. [28226/26

Deputy James Geoghegan 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. [28209/26

Deputy Natasha Newsome Drennan asked the Minister for Health 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

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

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

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

Deputy Denise Mitchell asked the Minister for Health if consideration will be given to adding the drug skyclarys which is used in the treatment of Friedreich's ataxia to the drugs payment scheme; and if she will make a statement on the matter. [25182/26

Deputy Tom Brabazon asked the Minister for Health if the HSE will fund the skyclarys drug for those suffering from Friedreich's ataxia. [26084/26

Deputy Holly Cairns asked the Minister for Health if a decision not to reimburse a treatment Omaveloxolone sold under the brand name Skyclarys will be reviewed given it is the only pharmaceutical treatment available for treating Friedreich's Ataxia; and if she will make a statement

Deputy Pat Buckley asked the Minister for Health if she will ensure that the HSE urgently prioritizes a conclusion to the skyclarys 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

Deputy Ruth Coppinger asked the Minister for Health if she will take steps to ensure that skyclarys (omaveloxolone) is made available for those with Fredericks ataxia who require it; and if she will make a statement on the matter. [26512/26

Parliamentary Question No.1818 of 18 March 2026, 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

being taken to ensure the HSE considers the time-critical nature of the 2026 IPHA Framework Agreement 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 Robert O'Donoghue asked the Minister for Health if she will intervene to ensure that the HSE urgently concludes reimbursement negotiations for skyclarys given that it is currently the only available treatment for Friedreich’s ataxia and that the condition may be considered an unmet need under