Dáil Éireann Debate, Tuesday - 16 June 2026
821. Deputy Conor Sheehan asked the Minister for Health the reason Skyclarys is not included on the agenda for the upcoming HSE drugs group meeting; if this drug will be put on the agenda for this meeting; and if she will make a statement on the matter. [44885/26]
Amharc ar fhreagra830. Deputy Eoghan Kenny asked the Minister for Health if her Department has further considered the inclusion of Skyclarys (omaveloxolone) as of June 2026, which is a treatment for Friedreich's ataxia in a reimbursement scheme given the cost of the drug and the fact that other European countries provide this scheme to patients; and if she will make a statement on the matter. [44904/26]
Amharc ar fhreagra838. Deputy Claire Kerrane asked the Minister for Health the steps she will take to ensure that the HSE recognises and responds to the time-critical nature of Friedreich's ataxia during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [44928/26]
Amharc ar fhreagra857. Deputy James Geoghegan asked the Minister for Health to review correspondence (details supplied) [45010/26]
Amharc ar fhreagra877. Deputy Michael Cahill asked the Minister for Health if she will ensure Skyclarys is covered by the HSE as it is the only drug approved to treat Friedreich's ataxia; and if she will make a statement on the matter. [45121/26]
Amharc ar fhreagra929. Deputy Marie Sherlock asked the Minister for Health for an update on the reimbursement process for Skyclarys for persons living with Friedreich’s ataxia; and if she will make a statement on the matter. [45289/26]
Amharc ar fhreagraI propose to take Questions Nos. 821, 830, 838, 857, 877 and 929 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.
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.
