Dáil Éireann Debate, Thursday - 9 July 2026
109. Deputy Pádraig O'Sullivan asked the Minister for Health for an update in relation to reimbursement of the drug skyclarys for patients with Frederich's ataxia; and if she will make a statement on the matter. [51848/26]
View answerI wish to thank the Deputy for raising this matter.
The State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly those living with rare diseases such as Friedreich’s ataxia. I attended a briefing in Leinster House where I met patients and their families and heard directly about their experiences through regular engagements. The Taoiseach has also engaged with families affected by this disease.
Skyclarys® received marketing authorisation from the European Medicines Agency in 2024 for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
Following authorisation, a company must submit an application for pricing and reimbursement to the HSE’s Corporate Pharmaceutical Unit, as reimbursement applies only to licensed indications. Applicants are required to engage fully throughout the process to support timely consideration.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on pricing and reimbursement. I have requested an update from the HSE on the Skyclarys® application. The HSE has advised that the Health Technology Assessment report from the National Centre for Pharmacoeconomics was received on 16 December 2025.
The HSE invited the marketing authorisation holder, Biogen (Idec) Ireland Limited, to enter commercial negotiations, with an initial meeting held on 12 February 2026. A further meeting took place on 18 May 2026, followed by submission of a commercial proposal on 27 May 2026.
Once a commercial offer is received by the HSE and given the potential high budget impact from all new medicines, the HSE must undertake its due diligence on offers ahead of bringing the material to the Drugs Group for its consideration.
Medicines are brought forward for consideration in line with the progression of commercial engagements and the receipt of finalised materials, ensuring an orderly and fair process for all applications.
The application, along with all evidence, commercial negotiation output, and pharmacoeconomic evaluation, will proceed to the HSE’s Drugs Group. On the 14th July 2026, the Drugs Group will consider all the evidence and make a recommendation to the HSE Senior Management Team, who make the final decision.
The HSE will continue to progress the application as efficiently as possible. As the process is ongoing, it cannot comment on the outcome.
