enough either. The process clearly needs to be improved, but I welcome the progress made and I encourage the approval of givinostat and skyclarys
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In debates
That tells you how painful this disease is.
There is some hope, however, and that hope is in the form of the medication Skyclarys. It was approved by the European Medicines Agency in 2024. While it is not a full cure, the clinical guidelines show that it will
patients can access new, potentially life-altering treatments in a timely fashion.
In recent weeks, I have met with Biogen, the producer of Skyclarys, on a number of occasions to urge efficiency and urgency in its negotiations with the HSE. I have also engaged with
point of order, will the Minister of State give us some direction on the situation regarding Skyclarys
senior leadership group, which will now consider it. Hopefully we can get this progressed as quickly as possible. There are other drugs. Skyclarys is on the agenda, among others. In fact, we are increasing the number of approvals on a year-by-year basis. The recent pharmaceutical agreement
There is a campaign currently under way by parents whose children primarily suffer from Friedreich's ataxia and who urgently require the drug Skyclarys. I understand that matter is at a sensitive stage of negotiations with the HSE and I do not expect the Minister to comment
have discussed this with the Minister for Health. We want all those living with Friedreich's ataxia to have access to Skyclarys as fast as we possibly can. The company made its commercial proposal
because I think he is looking for clarification. Basically, the HSE received an application for pricing and reimbursement on 1 August 2024 for Skyclarys, for adults and adolescents aged 16 years and older. On foot of a rapid review of the application by the National Centre for Pharmacoeconomics
recent weeks. It is now nearly 700 days and the HSE has still not made a decision on the reimbursement for the drug Skyclarys. Other EU citizens are receiving this transformational drug thanks to support from their governments. Why are the HSE and Irish Government not supporting Irish
fully accept the urgency and seriousness of this for those who require Skyclarys. The engagement between the HSE and the company has perhaps at times been problematic. When I saw "problematic", delays have taken place, but meetings did happen. I will talk to the Minister again
battled on. For most of those 18 years, he was told there was no treatment. Now, for the first time, there is hope. Skyclarys has been rolled out by other EU states with great effect. It is life-changing. However, little progress has been made here
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
In parliamentary questions
Ken O'Flynn
Written
National Centre for Pharmacoeconomics, the HSE medicines management programme, or any external body estimated the likely eligible patient cohort for omaveloxolone (skyclarys) prior to reimbursement consideration. [38850/26
Ken O'Flynn
Written
Deputy Ken O'Flynn asked the Minister for Health if any hospitals, hospital groups, or specialist neurology centres currently facilitate access to omaveloxolone (skyclarys) through named-patient arrangements, manufacturer-supported supply, or exceptional approval mechanisms outside PCRS reimbursement pathways. [38854/26
Ken O'Flynn
Written
Deputy Ken O'Flynn asked the Minister for Health whether the HSE formally reviewed reimbursement, managed access, or pricing decisions relating to omaveloxolone (skyclarys) in France, Germany, Italy, Spain, Belgium, the Netherlands or the United Kingdom as part of the Irish reimbursement assessment process; and if she will
Ken O'Flynn
Written
Pharmacoeconomics considered any international managed access agreements, risk-sharing agreements, conditional reimbursement models or outcomes-based reimbursement arrangements in respect of omaveloxolone (Skyclarys); and if she will provide details of the jurisdictions and models reviewed. [39832/26
Ken O'Flynn
Written
orphan-drug specific weighting, modified cost-effectiveness threshold, severity adjustment or rare disease reimbursement framework was applied in the assessment of omaveloxolone (skyclarys); and if she will make a statement on the matter. [39833/26
Ken O'Flynn
Written
Deputy Ken O'Flynn asked the Minister for Health whether the assessment of omaveloxolone (skyclarys) included analysis of indirect societal costs associated with Friedreich's ataxia, including disability supports, caregiver burden, loss of educational participation, workforce impacts and long-term health service utilisation; and if she will provide
Ken O'Flynn
Written
Health whether patient organisations or rare disease advocacy groups were consulted or invited to make submissions during the reimbursement assessment process for omaveloxolone (skyclarys); and if she will provide details of the process involved. [39839/26
Ken O'Flynn
Written
Group considered the progressive and degenerative nature of Friedreich's ataxia, including irreversible disease progression during reimbursement delays, in its consideration of omaveloxolone (Skyclarys); and if she will make a statement on the matter. [39840/26
Michael Cahill
Written
Deputy Michael Cahill asked the Minister for Health if she will intervene to ensure that the HSE urgently prioritises a conclusion to the skyclarys reimbursement negotiations (details supplied); her views on whether the current delay aligns with the 'equitable access' promised in the newly launched National Rare Disease
Michael Cahill
Written
Deputy Michael Cahill asked the Minister for Health if she will intervene to ensure that the HSE urgently prioritises a conclusion to the skyclarys reimbursement negotiations (details supplied); her views on whether the current delay aligns with the "equitable access" promised in the newly launched National Rare Disease
Eamon Scanlon
Written
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
Niamh Smyth
Written
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
John Lahart
Written
specific steps being taken to ensure the HSE considers the "time-critical" nature of Friederichs 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
Ken O'Flynn
Written
Deputy Ken O'Flynn asked the Minister for Health whether any patients in the State currently have access to omaveloxolone, marketed as Skyclarys, for Friedreich’s ataxia through compassionate use, named patient access, hospital-level approval, exceptional funding, or any other interim access mechanism pending a final
Ken O'Flynn
Written
patients in the State known to the HSE or the Department of Health who are clinically eligible for treatment with omaveloxolone, marketed as Skyclarys, for Friedreich’s ataxia; and if this number has informed any budget impact assessment. [32772/26
Ken O'Flynn
Written
Flynn asked the Minister for Health whether the HSE has considered international reimbursement or access decisions in respect of omaveloxolone, marketed as Skyclarys, including decisions in France, Italy, Germany or other comparable European countries, as part of the Irish reimbursement process. [32775/26
Ken O'Flynn
Written
Flynn asked the Minister for Health whether the Department or HSE has examined the favourable reimbursement opinion issued in France for Skyclarys in Friedreich’s ataxia, and whether such international assessments are considered in Irish rare disease reimbursement decisions. [32776/26
Ken O'Flynn
Written
Flynn asked the Minister for Health whether the Department or HSE is aware that Italy’s medicines authority approved reimbursement of Skyclarys for Friedreich’s ataxia in December 2025, and whether this decision has been considered in the Irish process. [32777/26
Ken O'Flynn
Written
Minister for Health whether the HSE has received a commercial proposal from Biogen Idec Ireland Limited in respect of omaveloxolone, marketed as Skyclarys, since 16 April 2026; and if not, what steps the HSE is taking to progress the matter. [32778/26
Barry Ward
Written
Deputy Barry Ward asked the Minister for Health the position regarding the approval process for skyclarys as a treatment for Friedrichs ataxia; and if she will make a statement on the matter. [32794/26
Barry Ward
Written
Deputy Barry Ward asked the Minister for Health her views on whether the delays in the approval of skyclarys as a treatment for Friedrichs ataxia aligns with the "equitable access" as outlined in the National Rare Disease Strategy 2025-2030; and if she will make a statement
Thomas Gould
Written
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
Thomas Gould
Written
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
Paul Donnelly
Written
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
Martin Daly
Written
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
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