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what Independent Ireland believes should be delivered. I wish to ask the Minister of State about Friedreich's ataxia and the medication Skyclarys. Where are we in relation to getting patients access to Skyclarys? The brother of Emma O'Shea in west Cork died from this disease … weeks ago. One was a young lady who was devastated by what the disease was doing to her. Every second without Skyclarys medication is a death sentence. I ask the Minister of State, how can we in opposition help the Government? We are not here to blame

ataxia and Duchenne muscular dystrophy and to recognise the very brave patients and their advocates who have made this case in Leinster House. Skyclarys is the first and only approved treatment for Friedreich's ataxia which around 200 people live with in Ireland. This medication can slow … progression of their condition. The company that makes Skyclarys has put the official pricing proposal to the CPU and now the situation is fully in the hands of the HSE. Patients do not know how long it will take for the HSE to make its final decision

Skyclarys was approved for reimbursement on 25 August. It has been a very challenging period for our patients with Friedreich’s ataxia, FA, and their families. If services in Tallaght University Hospital remain unchanged, some FA patients could have to wait until June 2028 to get the Skyclarys … half years. What work has been done since 25 August to ensure there is a timely rollout of the drug, Skyclarys? How many patients with FA will have the medication, Skyclarys, in their hands on Thursday, 1 October? There seems to be a lack of information forthcoming from

going to regain any of the abilities we've lost, but Skyclarys will give us time. Time when you're dealing with our progressive relentless disease is everything. We all deserve time with our loved ones." Those are the words of Emily Felix, a 28-year-old trainee … future, but the disease continues to progress. Yesterday, as the Taoiseach knows, the HSE drugs group met to consider reimbursement of Skyclarys, the first approved treatment that can slow the progression of Friedreich's ataxia. Patients hoped for a positive decision. This process has been ongoing for years

clinical trials. It is important to note that going out from here today. I want to raise the urgent need for access to Skyclarys. It has been raised many times in the Chamber. I was watching on the screens. There are over 200 people living with Friedrich … Every month that passes means a loss of function that can never be regained. Time matters enormously for people with progressive degenerative conditions. Skyclarys was approved by the European Medicines Agency in February 2024 and is available to patients in the US, UK, France, Germany, Austria and other

sufferers with the Taoiseach on numerous occasions in this Chamber for well over a year. There is a need to approve the drug Skyclarys for people like Emily Felix, Paudie Coady and Emma O'Shea - the latter of whom the Taoiseach visited when he was in west Cork … convey her thanks to the Taoiseach for doing this. The huge fight these sufferers have had to go through to have the drug Skyclarys approved by the State leaves many unanswered questions on how the rare drugs review group works in Ireland but, more alarmingly, Skyclarys has been

briefing. I was very glad to have the opportunity to meet those patients, as I have had the opportunity to meet other patients. Skyclarys has been authorised at European level for Friedreich’s ataxia. In Ireland, as with other medicines, any decision on reimbursement must follow the statutory … Deputies are familiar with. They are informed by clinical, economic, budgetary and other relevant considerations. No reimbursement decision has yet been made on Skyclarys. I really understand that for families this sort of process language can feel very distant from the reality of living with a progressive condition

must apply in this jurisdiction. At the same time, people living with Freidrich's ataxia, FA, are still waiting for a decision on Skyclarys. This is the first and only treatment for around 200 people in Ireland living with this progressive and life shortening disease. It is those … living with rare diseases and their loved ones who are forced to fight for access to treatment. Skyclarys has been shown to markedly improve neurological function in those with FA and they are still waiting for access. Their illness is not waiting; it is progressing every

weaker while waiting for access. I hope access is granted for whoever needs it as soon possible. On Friedreich's ataxia Skyclarys is the only drug that has been shown to slow the disease. It was approved by the EMA and is available in other European countries … will quote from a constituent: The NCPE issued a harsh verdict for Skyclarys on 17 December 2025. While I understand the HSE is still in discussions with the manufacturer, the delay is costing my niece time to slow this cruel disease. It is already heartbreaking watching her fade

answered a question on this already. Perhaps he would give us a timeline. Will he urgently intervene to ensure that the drug, Skyclarys, is included in the HSE's drugs group agenda for tomorrow, 10 June? I raised this issue in the Dáil a number of months … ataxia, a cruel and relentlessly progressive disease where every single month lost means a permanent loss of mobility and quality of life. Skyclarys is the first treatment proven to slow the condition. It is already approved and being provided in countries across Europe and the United States

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

This is a progressive degenerative neurological disease. They were here at the Dáil because they have been waiting two years for access to Skyclarys, a drug that can slow down the relentless progression of their condition. Their hopes were very high that the HSE drugs committee would finally … approve Skyclarys, but those hopes were to be dashed. The committee decided against approving the drug. Instead, it referred it to a rare disease review group. In other words, one committee passing the buck to another committee. That means more delay and more time wasting - time that these

want to read an excerpt from an email I got today in relation to Skyclarys for people with Friedreich's ataxia: At 19 years old, I should be excited about my future. I should be looking forward to building a career, travelling, making memories with friends and planning … deteriorate while a treatment exists that could slow the decline. The Friedreich's ataxia community in Ireland has been fighting for reimbursement of Skyclarys for a long time. We have shared our stories, met with politicians, engaged with decision makers and done everything asked of us. The postponement

group of individuals who have Friedreich’s ataxia and their families here in Leinster House. They are calling for urgent access to Skyclarys, the life-changing drug for those living with this rare, degenerative neurological condition. I offered them my full support and that of the Labour Party … communication with the group. I ask that this be addressed. Clearly, the most substantive issue is the delay in providing approval for reimbursements. Skyclarys is already being reimbursed in other EU countries. We need to work with other EU member states to reduce costs in line with

ourselves at what cost. Unfortunately, in this case it is at the cost of lives. I made a comment about the Skyclarys campaign. I know the Minister of State has to be careful what she says because it is due before the drugs group. I again make … from the United States and a few other countries internationally. When are we going to step up to the plate with drugs like Skyclarys for Friedreich's ataxia patients? I know the Minister of State has constituents of her own and it is close to her heart

Deputy said, it is important. The next HSE drugs group is meeting on Tuesday, 14 July and that will be discussed. Skyclarys is on the agenda for that meeting. It is important because I have met with so many families in Carlow-Kilkenny and with constituents who need … important that we know we have the date for it. The meeting is on Tuesday, 14 July with the drugs group and Skyclarys is on the agenda for that group meeting. I will bring all of the Deputy's important issues and concerns on timing to the Minister

family in Kilkenny, Oisín Pollard and his family in Carlow and many others have campaigned with huge dignity and courage for access to Skyclarys, the first treatment approved for this condition but unfortunately they continue to face delay and uncertainty while the disease continues to progress. Will … Taoiseach update the House on what the Government's position is on reimbursing Skyclarys? What message does he have for the young people and families who feel they are being asked to wait while an irreversible disease takes more and more from them every

been done; I am not sure of the timelines - and when these families can expect this medicine. I will raise, as others have, Skyclarys and the treatment of Friedreich's ataxia, a rare neurodegenerative disorder that progresses very quickly, resulting in neurological decline, the loss of bodily function … ultimately death. Approximately 200 people in Ireland have Friedreich's ataxia. I know the Minister met some of them earlier this year. Skyclarys is the only approved treatment for this condition. It was approved by the EMA in February 2024 and is available in many states across

recently in the context of heartbreaking battles to get people care and treatment. The drugs highlighted in the media recently are givinostat and Skyclarys. I congratulate my colleagues Deputy Pádraig O'Sullivan and Senator Teresa Costello on the strong and diligent work that they have done in relation … these two drugs. Thankfully, givinostat has been approved but people with Friedreich's ataxia are waiting for Skyclarys to be approved. This inequity is to be found across the entire healthcare sector, including in the areas of rare diseases and cancer. We have effectively developed a two-tier

with advanced Huntington's disease. Paudie's father, Craig, has said that he is in a race against time to secure access to Skyclarys, the first treatment shown to slow progression of this devastating illness. He has rightly stated that if there is a price tag on every … facing rare diseases cannot afford bureaucratic delays while conditions continue to progress. Will the Government commit to expediting the decision-making process on Skyclarys? Can the Minister give a clear timeline on when patients like Paudie will finally have access to this life-changing treatment

degenerative disease for which there is no cure. Until recently there was no effective treatment either but now there is. It is called Skyclarys and it is available elsewhere in Europe but not here in Ireland. People with Friedreich’s ataxia have been waiting since 1 August … days, for the HSE to make this drug available. Why is Skyclarys not on the agenda for the HSE drugs group meeting that will happen tomorrow? Further delay is intolerable and cruel because there is no pause in this disease. Every day lost has consequences. Emily Felix told

showed in meeting Paudie's father, Craig, in recent days and his commitment to do everything he can to help secure access to Skyclarys for Paudie and other patients who may benefit from it. I also acknowledge the strong advocacy of the Taoiseach's colleague, Deputy Pádraig … lost as a condition progresses. Will the Taoiseach exhaust all efforts to try to bring forward the HSE drugs group discussion on Skyclarys from July to June so that Paudie and his family are not waiting unnecessarily any longer

gone through is quite shocking. I have spoken to the Minister about this. We will do everything we can to accelerate consideration of Skyclarys provision. It was never scheduled for tomorrow but I think Givinostat is. However, we are hoping we can bring forward consideration of Skyclarys

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

Deputy Robert Troy asked the Minister for Health if she will provide an update on the approval of Skyclarys for the treatment of Friedreich's ataxia; the cause for the delay in completing the final administrative arrangements between the HSE and an organisation (details supplied); and when will … hospital neurologists be given the formal, logistical clearance to begin prescribing and dispensing Skyclarys to eligible patients. [65199/26

Deputy Albert Dolan asked the Minister for Health the reason skyclarys has not been included on the agenda for the recent HSE Drugs Group meeting held in June 2026; when the drug will be considered by the Drugs Group; the timeline for a decision on its prioritisation within … reimbursement process; and the measures being taken to ensure there are no further avoidable delays in progressing access to skyclarys for patients living with Friedreich’s ataxia; and if she will make a statement on the matter. [48540/26

Deputy Louis O'Hara asked the Minister for Health whether the reimbursement of the drug skyclarys was included in the agenda for the June meeting of the HSE's Drugs Groups; if not, the rationale for its exclusion; to provide an update on the process of adjudicating whether … cost of skyclarys will be reimbursed; and if she will make a statement on the matter. [46002/26

given that persons in the Friedreich’s ataxia community in Ireland are being left behind waiting for a decision regarding the skyclarys reimbursement, while patients across Europe gain access to skyclarys (details supplied). [43947/26

Deputy John Connolly asked the Minister for Health further to Parliamentary Question No. 1964 of 18 March 2026, relating to omaveloxolone skyclarys®, whether any interim arrangements are available or under consideration whereby, in circumstances where a family is willing to travel abroad, a patient could be facilitated … assessment by the HSE; whether the National Treatment Purchase Fund, or any other State mechanism, can be used to enable access to omaveloxolone (skyclarys®) in another jurisdiction pending completion of the assessment and reimbursement process; and if she will make a statement on the matter. [33553/26

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

Minister for Health if she is aware of concerns that some people living with Friedreich’s ataxia may face significant delays in accessing skyclarys (omaveloxolone) despite its reimbursement from 1 October 2026 due to capacity constraints at the combined ataxia clinic at Tallaght University Hospital; the estimated timeframe

Minister for Health if she is aware of concerns that some people living with Friedreich’s ataxia may face significant delays in accessing skyclarys (omaveloxolone) despite its reimbursement from 1 October 2026 due to capacity constraints at the Combined Ataxia Clinic at Tallaght University Hospital; the estimated timeframe

Minister for Health if she is aware of concerns that some people living with Friedreich’s ataxia may face significant delays in accessing skyclarys (omaveloxolone) despite its reimbursement from 1 October 2026 due to capacity constraints at the combined ataxia clinic at Tallaght University Hospital; the estimated timeframe

Minister for Health if she is aware of concerns that some people living with Friedreich’s ataxia may face significant delays in accessing skyclarys (omaveloxolone) despite its reimbursement from 1 October 2026 (details supplied); the estimated timeframe within which all eligible patients will have commenced treatment; if additional

asked the Minister for Health if her Department intends to review the current medicines reimbursement process following concerns raised during the consideration of skyclarys for patients with Friedreich's ataxia; and if lessons have been identified regarding the assessment of treatments for rare diseases. [64548/26

Deputy Michael Cahill asked the Minister for Health the status of the roll out of Skyclarys (omaveloxolone) for patients with Friedreich's ataxia; the reason for delays following re-imbursement approval; when eligible patients can expect to access the treatment; and if she will make a statement

Deputy Matt Carthy asked the Minister for Health the number of patients estimated to be eligible for treatment with skyclarys (omaveloxolone); if additional clinical appointments or resources are being provided to the National Ataxia Clinic at Tallaght University Hospital or other relevant services to facilitate the assessment

Department or the HSE has engaged with a company (details supplied) and the relevant neurology and ataxia services regarding the roll-out of skyclarys (omaveloxolone) following its approval for reimbursement; if a national implementation or treatment pathway has been agreed; the arrangements being made to ensure eligible patients

Deputy Matt Carthy asked the Minister for Health for an update on the implementation and availability of skyclarys (omaveloxolone) for patients with Friedreich’s ataxia following its approval for reimbursement; the date on which it is expected that the first patients in Ireland to commence treatment; the steps

Deputy Niamh Smyth asked the Minister for Health if she will provide an update on the HSE's consideration of Skyclarys for the treatment of Friedreich's ataxia; the reason the drug was not included on the agenda of the HSE Drugs Group meeting of 14 July

Deputy Eoin Ó Broin asked the Minister for Health if she will confirm that Skyclarys will be on the agenda for the upcoming HSE Drugs Group meeting in July; and if she will make a statement on the matter. [52634/26

Deputy Ryan O'Meara asked the Minister for Health for an update on the pricing and reimbursement application for omaveloxolone (skyclarys); if the commercial proposal has yet been received from the company; and if she will make a statement on the matter. [51756/26

Deputy John McGuinness asked the Minister for Health if she will provide an update on the approval of the drug skyclarys in the reimbursement scheme; if all of the information and costings have been submitted by the supplier; and the indicative date for approval. [50630/26

Deputy Niamh Smyth asked the Minister for Health if she will provide an update on the reimbursement process for skyclarys for the treatment of Friedreich's Ataxia; the meetings that have taken place to date regarding the application; when a final decision is expected; and if she will

Deputy John Brady asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations; if she will commit to the inclusion of the drug on the agenda of the next HSE drugs group meeting

Deputy Natasha Newsome Drennan asked the Minister for Health when the commercial proposal request to include skyclarys on the agenda for the June HSE Drugs Group meeting was received by the HSE; and if she will make a statement on the matter. [46675/26

Deputy Pádraig Rice asked the Minister for Health if the consideration of skyclarys for the treatment of Friedreich's ataxia will be prioritised; the date on which the drug will be on the agenda for a meeting of the HSE Drugs Group; and if she will make

Deputy Réada Cronin asked the Minister for Health the reason skyclarys is not included on the agenda for the upcoming HSE Drugs Group meeting; and if she will make a statement on the matter. [46373/26