Dáil Éireann Debate, Tuesday - 23 June 2026
802. Deputy Niamh Smyth asked the Minister for Health if she will provide an update on the reimbursement process for skyclarys for the treatment of Friedreich's Ataxia; the meetings that have taken place to date regarding the application; when a final decision is expected; and if she will make a statement on the matter. [47506/26]
Amharc ar fhreagra805. Deputy John Brady asked the Minister for Health if she will intervene to ensure that the HSE prioritises a conclusion to the skyclarys reimbursement negotiations; if she will commit to the inclusion of the drug on the agenda of the next HSE drugs group meeting; and if she will make a statement on the matter. [47509/26]
Amharc ar fhreagraI propose to take Questions Nos. 802 and 805 together.
Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE) has statutory responsibility for decisions on the pricing and reimbursement of medicines. The HSE is assessing the pricing and reimbursement application for omaveloxolone (Skyclarys®) in line with the criteria detailed in legislation.
The HSE received a commercial proposal on the 27th May 2026 from the company Biogen(Idec)Ireland Limited.
Following the conclusion of commercial negotiations, applications are progressed via the Drugs Group who will make a recommendation to the HSE Senior Leadership Team who have final decision making authority on whether to reimburse a medicine.
No decision has been made by the HSE Senior Leadership Team, which has final statutory decision making authority for the reimbursement of medicines in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
Medicines are brought forward for consideration at Drugs Group in line with the progression of commercial engagements and the receipt of finalised proposals, ensuring an orderly and fair process for all applications. omaveloxolone (Skyclarys®) will be presented at the next meeting of the Drugs Group in July.
The HSE will continue to assess and progress the application as efficiently as possible. As this application remains under consideration with the HSE and the HSE cannot make any comment on possible outcomes from the ongoing process.
