3142. Deputy Danny Healy-Rae asked the Minister for Health the position regarding approval of skyclarys for people with Friedreich’s Ataxia by the HSE; to review the decision by the HSE to not cover the cost of this drug (details supplied); and if she will make a statement on the matter. [59693/26]

3277. Deputy Michael Cahill asked the Minister for Health if she will intervene to ensure all options, including further price negotiations with the manufacturer of skyclarys are explored before a final reimbursement decision is made (details supplied); and if she will make a statement on the matter. [60940/26]

3302. Deputy Michael Cahill asked the Minister for Health to make the lifesaving drug skyclarys available as a matter of urgency (details supplied); and if she will make a statement on the matter. [59827/26]

3303. Deputy Michael Cahill asked the Minister for Health to make the lifesaving drug skyclarys available as a matter of urgency (details supplied); and if she will make a statement on the matter. [59831/26]

3304. Deputy Michael Cahill asked the Minister for Health further to previous Parliamentary Questions, if she will make skyclarys available as a matter of urgency (details supplied); and if she will make a statement on the matter. [59834/26]

3307. Deputy Michael Cahill asked the Minister for Health to make the lifesaving drug skyclarys available as a matter of urgency, the only approved treatment for patients for the progressive neurological condition Friedreich’s ataxia (details supplied); and if she will make a statement on the matter. [59848/26]

3341. Deputy Pa Daly asked the Minister for Health if her attention has been drawn to concerns of the HSE’s decision not to approve the Friedreich’s ataxia drug for reimbursement; if she has met with the HSE to discuss the matter; if so, to report on those meetings and the dates on which they took place (details supplied); if her attention has been drawn to that it is publicly funded and / or accessible in other European countries having been approved since February 2024; if she is satisfied that this is not the case in Ireland; and if she will make a statement on the matter. [61173/26]

3346. Deputy Michael Cahill asked the Minister for Health to urgently intervene and request the HSE drugs group to recommend reimbursing skyclarys for people living with Friedreich's ataxia in Ireland (details supplied); and if she will make a statement on the matter. [61208/26]

3421. Deputy Ruth Coppinger asked the Minister for Health her current plans to provide access to drug (details supplied) for those diagnosed with Friedreich's Ataxia; and if she will make a statement on the matter. [60821/26]

3454. Deputy Cian O'Callaghan asked the Minister for Health if she recognises the clinical necessity of a drug (details supplied) for a community that currently has no other therapeutic options; if the HSE have considered working with the European Union to ensure that this treatment is made available to the approximately 200 people in Ireland living with Friedreich’s ataxia; and if she will make a statement on the matter. [61401/26]

3703. Deputy Barry Ward asked the Minister for Health the position regarding any engagement she has had with the HSE in relation to their decision to refuse reimbursement for skyclarys in the treatment of Friedreich's ataxia; and if she will make a statement on the matter. [62389/26]

3704. Deputy Barry Ward asked the Minister for Health the actions she will take to engage with the HSE in relation to the reimbursement for skyclarys in the treatment of Friedreich's ataxia; and if she will make a statement on the matter. [62391/26]

3705. Deputy Barry Ward asked the Minister for Health the position regarding any engagement she has had with the campaign organisers in relation to the reimbursement for skyclarys in the treatment of Friedreich's ataxia; and if she will make a statement on the matter. [62390/26]

3707. Deputy Shónagh Ní Raghallaigh asked the Minister for Health if she will intervene and use all powers available to her to ensure that the skyclarys treatment is approved for those patients living with Friedreich's ataxia; and if she will make a statement on the matter. [62404/26]

3742. Deputy Eoin Ó Broin asked the Minister for Health if she will intervene in relation to the provision of Skyclarys for people living with Friedreich’s ataxia, given further delays in providing the drug risks the deterioration of health of people living with the condition; and if she will make a statement on the matter. [62459/26]

3957. Deputy Brian Brennan asked the Minister for Health when the reimbursement of Skyclarys for patients with Friedreich’s Ataxia will commence. [63802/26]

I propose to take Questions Nos. 3142, 3277, 3302, 3303, 3304, 3307, 3341, 3346, 3421, 3454, 3703, 3704, 3705, 3707, 3742 and 3957 together.

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.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the Health Service Executive (HSE), through its Senior Leadership Team has statutory responsibility for decisions on the pricing and reimbursement of medicines and medical devices.

Following extensive engagement between the HSE and Biogen, the HSE’s SMT approved the reimbursement of Skyclarys for patients over 16 years of age with Friedreich’s Ataxia, on the 25th August 2026.

Engagements are ongoing with Biogen to finalise the administrative arrangements which will underpin reimbursement. The HSE will progress these engagements quickly, and understands that Biogen are also committed to finalising details at an early stage.