HSE Rejects Funding for Friedreich's Ataxia Drug Skyclarys, Sparking Political Backlash
Published on 08/14/2026 at 19:17 | Redaktion boerse-global.de
The Health Service Executive (HSE) Drugs Group has recommended against public funding for Skyclarys (omaveloxolone), a treatment for the rare genetic disorder Friedreich's ataxia. The decision has triggered significant political opposition, with dozens of Irish politicians calling on the government to intervene before senior health leadership makes a final determination later this month.
Politicians Demand Government Intervention
More than 60 Fianna Fáil politicians, including junior minister Catherine Ardagh, several TDs, senators, and three MEPs, have signed an open letter to the Taoiseach, Tánaiste, and the Minister for Health rejecting the HSE recommendation. The group includes Carlow-Kilkenny representatives John McGuinness and Peter 'Chap' Cleere, along with MEP Cynthia Nà Mhurchú.
John McGuinness, whose nephew is affected by the condition, expressed shock at the recommendation and called for government support for the approximately 200 people in Ireland living with the disease. Sinn FĂ©in leader Mary Lou McDonald has also sought transparency regarding the decision-making process and requested a meeting with the Taoiseach to discuss the matter.
The dissenting politicians pointed to the 2019 precedent involving the drug Spinraza, where political pressure eventually led to reimbursement of a high-cost treatment for spinal muscular atrophy.
Cost and Efficacy at the Centre of Dispute
Skyclarys carries an annual cost of approximately €280,000 per patient. The National Centre for Pharmacoeconomics (NCPE) initially recommended against reimbursement in December 2025, a position the HSE Drugs Group recently upheld. The health service cited limitations in clinical efficacy data and a price point exceeding established cost-effectiveness levels as the primary reasons for the refusal.
Despite these concerns, advocates for the drug's approval highlighted that seven other EU nations—Germany, France, Italy, Spain, Portugal, Greece, and the Czech Republic—have already approved reimbursement for the treatment. The HSE senior leadership team is scheduled to discuss the recommendation and reach a final determination on August 25.
Broader Financial Pressures on Health Services
The dispute over Skyclarys coincides with other financial challenges facing the state's healthcare system. Figures provided in response to a parliamentary question by Sinn Féin TD John Brady revealed that the state has spent more than €23 million on legal costs related to Assessment of Need (AON) challenges since 2021. So far in 2026, these costs have reached €5.6 million, following a peak of €7.2 million in 2025.
Internal reports from the HSE West and North West regions indicate that a decision to end an insourcing initiative could lead to an increase of 4,000 patients per month on waiting lists for endoscopies and breast assessments. The health service also struggled to meet homecare assessment targets last year, completing only 4,656 of the expected 18,100 assessments, which officials attributed to ongoing carer shortages.
Research Developments in Friedreich's Ataxia
While the funding debate continues in Ireland, new research published in the journal Nature has identified potential new therapeutic targets for the condition. The study found that mutations in certain proteins, FDX2 and NFS1, could potentially bypass the frataxin deficiency that characterises Friedreich's ataxia.
In mouse models, the reduction of FDX2 was shown to improve neurological symptoms, offering a possible avenue for future drug development beyond existing treatments.
