Search the record

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

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

Health if any budget impact assessment, cost projection, prevalence estimate, or epidemiological model was prepared in advance of reimbursement consideration for omaveloxolone (skyclarys); and the details of same. [38847/26

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

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

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

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

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

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