Dáil Éireann Debate, Tuesday - 21 April 2026
149. Deputy Catherine Callaghan asked the Minister for Health for an update on the measures being taken to provide treatments such as skyclarys (omaveloxolone) to patients with Friedrich's ataxia in Carlow and Kilkenny, and across the country; and if she will make a statement on the matter. [28381/26]
Amharc ar fhreagraI propose to take Questions Nos. 149 and 207 together.
I wish to thank the Deputies for raising this matter. I propose to take oral parliamentary questions 30 and 90 together.
The State recognises the importance of timely access to innovative medicines for patients in Ireland, particularly those living with rare diseases like Friedreich’s ataxia. I recently attended a briefing in Leinster House on Friedreich’s ataxia, where I met patients and their family members, and heard directly about their experiences.
Skyclarys® was granted marketing authorisation in the EU by the European Medicines Agency in 2024 for treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
A pharmaceutical company must submit an application for pricing and reimbursement to the HSE’s Corporate Pharmaceutical Unit once marketing authorisation is granted, as reimbursement applies only to licensed indications. Applicants must engage fully throughout the process to enable timely consideration.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. Therefore, I have asked them for an update on the Skyclarys® pricing and reimbursement application. They have advised that the report of the Health Technology Assessment conducted by the National Centre for Pharmacoeconomics was received by the HSE on the 16th December 2025.
The HSE invited the marketing authorisation holder, Biogen (Idec) Ireland Limited, to commence price negotiations and offered a range of dates to the company. The HSE have advised this meeting took place on the 12th February 2026, and as of April 16th a commercial proposal from the company remains outstanding.
The negotiations are commercially confidential and the HSE cannot make any comment on possible outcomes from the ongoing process.
It is important to note that the negotiation process cannot recommence until a commercial proposal is received by the HSE.
