Written answer
Medicinal Products
Skyclarys reimbursement for Friedreich’s ataxia patients aged 16 and over was approved, with High Tech Hub arrangements expected by 1 October 2026.
1245. Deputy Michael Cahill asked the Minister for Health the status of the roll out of Skyclarys (omaveloxolone) for patients with Friedreich's ataxia; the reason for delays following re-imbursement approval; when eligible patients can expect to access the treatment; and if she will make a statement on the matter. [64785/26]
Comment on this
1324. Deputy Robert Troy asked the Minister for Health if she will provide an update on the approval of Skyclarys for the treatment of Friedreich's ataxia; the cause for the delay in completing the final administrative arrangements between the HSE and an organisation (details supplied); and when will hospital neurologists be given the formal, logistical clearance to begin prescribing and dispensing Skyclarys to eligible patients. [65199/26]
Comment on this
I propose to take Questions Nos. 1245 and 1324 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.
Following extensive engagement between the HSE and Biogen, the HSE’s Senior Management Team (SMT) approved the reimbursement of Skyclarys for patients over 16 years of age with Friedreich’s Ataxia, on the 25th August 2026. Reimbursement will be enabled in line with the approved European Medicines Agency market authorisation for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
The HSE has, since then, been progressing the administrative and logistic engagements necessary to enable reimbursement and to ensure that the manufacturer has supply processes in place.
Reimbursement will be subject to prescription under the supervision of a specialist with experience in the treatment of patients with Friedreich’s Ataxia and with that prescription to be processed via the HSE High Tech Hub. The HSE is working through the processes required to enable relevant specialists to register with the High Tech Hub so that their prescriptions can be processed via the Hub.
Subject to Biogen being able to supply product reimbursement under the high tech arrangements is expected to be in place from 1st October 2026.