Campaigners in final push for Skyclarys approval

Campaigners in Dublin are making a final push to secure approval for Skyclarys, a medication aimed at treating Friedreich's Ataxia, a rare and progressive neuromuscular condition. The demonstration took place in Dublin city centre, with a march from the Garden of Remembrance to Custom House Quay. Around 200 people in Ireland are believed to be affected by this condition, which causes nerve damage, muscle weakness, and mobility loss.

Earlier this month, the HSE Drugs Group recommended against covering Skyclarys under the HSE. A final decision will be made at a meeting of HSE senior management on Tuesday. While Skyclarys does not cure the condition, it has been shown to slow its progression. However, the HSE has concerns about the drug's efficacy and cost, finding that while Skyclarys may slow disease progression, there are uncertainties associated with the clinical efficacy data.

The drug costs around €280,000 per patient per year, with a projected five-year budget impact of approximately €130 million. Skyclarys was first approved by the European Medicines Agency in 2024, and Ireland's evaluation for reimbursement began over two years ago. There is strong support for the campaign across Leinster House, with opposition parties also calling for the drug's approval. However, the decision rests with the HSE, which will announce its decision on Tuesday following the senior management meeting.