Skyclarys reimbursement and access
Deputy Collins presses for Skyclarys access for people with Friedreich’s ataxia and questions the rare-drugs process. The Taoiseach confirms HSE reimbursement for eligible patients aged 16 and over, expected through the high-tech scheme from 1 October.
I have raised the issue of Friedreich's ataxia 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. She has asked me to 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 cleared to be rolled by the State 23 days ago. To this day, no Friedreich's ataxia sufferer has been contacted by the HSE or otherwise as to when or how the drug is to be administered. Twenty-three days of these people's lives is like five years. In God's earthly name, is it not time to bring this suffering at an end? Will the HSE announce immediately a clear timeline for all 199 patients to be contacted with timelines for the roll-out of a life-changing drug for them? Can the Taoiseach tell us today when this will happen?
Comment on this
I appreciate the Deputy's interest in this issue. I was very pleased with the decision of the HSE senior management to approve the reimbursement of Skyclarys for patients over 16 years of age with Friedreich's ataxia following substantive engagement and negotiations with the company. The company did come to the table with a significant new offer in respect of the drug itself. The HSE has advised that it is working to have reimbursement under the high tech arrangements in place from 1 October. For the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older, the prescribing will be restricted to designated approved consultants with experience of treating patients with Friedreich's ataxia. Biogen - the product supplier - has confirmed that it expects to have commercial stock available in Ireland from late September 2026.