Louis O'Hara
Ceist:812. Deputy Louis O'Hara asked the Minister for Health if the HSE has plans to reimburse omaveloxolone, a drug used to treat Friedrichs ataxia; and if she will make a statement on the matter. [16376/26]
Amharc ar fhreagraTuesday, 3 March 2026
Ceisteanna (812, 876, 899, 943, 951)
Richard Boyd Barrett
Ceist:876. Deputy Richard Boyd Barrett asked the Minister for Health if she will consider making the drug Omaveloxolone available to the approximately 200 people in Ireland currently living with Friedreich's Ataxia, given the life-changing impact this drug can have; if she will reconsider her position that the drug is not ‘economically viable’, in light of the relatively small number of people whose lives can be changed by making this drug available to them; if she will consider their quality of life above the cost of the drug; and if she will make a statement on the matter. [16678/26]
Amharc ar fhreagra
Denise Mitchell
Ceist:899. Deputy Denise Mitchell asked the Minister for Health if consideration will be given to making the medication Skyclarys (omaveloxolone) available to Irish Friedreich’s Ataxia patients under the current drugs reimbursement process; if she recognises the clinical necessity of this request as this drug is the only proven treatment to slow the progression of this debilitating condition; and if she will make a statement on the matter. [16880/26]
Amharc ar fhreagra
Barry Heneghan
Ceist:943. Deputy Barry Heneghan asked the Minister for Health when Skyclarys (omaveloxolone), the first approved treatment for Friedreich’s ataxia, will be made available to patients in Ireland through reimbursement; if she will prioritise the assessment and reimbursement process given the urgent clinical need for the approximately 200 people living with this progressive condition; and if she will make a statement on the matter. [17050/26]
Amharc ar fhreagra
Cian O'Callaghan
Ceist:951. Deputy Cian O'Callaghan asked the Minister for Health if she will commit to prioritising the reimbursement process for omaveloxolone to ensure that it is made available to the approximately 200 people in Ireland living with Friedreich’s ataxia; if she recognises the clinical necessity of this treatment for a community that currently has no other therapeutic options; and if she will make a statement on the matter. [17107/26]
Amharc ar fhreagraFreagraí scríofa
I propose to take Questions Nos. 812, 876, 899, 943 and 951 together.
The National Rare Disease Strategy 2025 – 2030 was launched on August 27th, 2025. The Department of Health will now ensure its implementation and vision to ensure that all people living with a rare disease have access to equitable, inclusive, safe and cross-sectoral care throughout their life journey. To enable them to reach their full potential and to live their best lives.
Since the launch of the Strategy, an Implementation Oversight Group has been launched and met in February to begin work planning for the 11 recommendations. As implementation of the Strategy progresses, it is intended that patient representation is a key feature and will be embedded in all structures.
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 and medical devices; therefore, I have asked the HSE for an update in this matter.
The HSE has advised that it is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available (provided) to it.
The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.
HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.
There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.
The HSE considers the following criteria prior to making any decision on pricing / reimbursement, in line with the Health (Pricing and Supply of Medical Goods) Act 2013:
(1) The health needs of the public,
(2) The cost effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,
(3) The availability and suitability of items for supply or reimbursement,
(4) The proposed costs, benefits, and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,
(5) The potential or actual budget impact of the item or listed item,
(6) The clinical need for the item or listed item,
(7) The appropriate level of clinical supervision required in relation to the item to ensure patient safety,
(8) The efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies) and,
(9) The resources available to the HSE.
In terms of the specific details of the application for pricing and reimbursement of omaveloxolone (Skyclarys®):
The HSE received an application for pricing and reimbursement of omaveloxolone (Skyclarys®) on the 1st August 2024 from Biogen Idec (Ireland) Limited (the applicant) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older. The first step in the process is the submission of a Rapid Review dossier (a clinical and economic dossier) to the National Centre for Pharmacoeconomics (NCPE) for assessment. The HSE commissioned the Rapid Review process on the 2nd August 2024.
• The NCPE Rapid Review assessment report was received by the HSE on the 29th August 2024. The NCPE advised the HSE that a full Health Technology Assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of omaveloxolone compared with the current standard of care.
• The HSE commissioned a full HTA on the 25th September 2024 as per agreed processes.
• The NCPE HTA Report was received by the HSE on the 16th December 2025. The NCPE recommends that omaveloxolone not be considered for reimbursement: [www.ncpe.ie/omaveloxolone-skyclarys-hta-id-24033/] .
• The HSE Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
• The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members. Pharmacoeconomic reports are reviewed by the HSE Drugs Group along with the outputs of commercial negotiations, and any patient group submission(s) received. The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team.
• The decision making authority in the HSE is the HSE Senior Leadership Team. The HSE Senior Leadership Team decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine, or new use of an existing medicine, from the resources that have been provided to it in line with the Health (Pricing and Supply of Medical Goods) Act 2013.
This application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process. 951. Deputy Cian O'Callaghan asked the Minister for Health if she will commit to prioritising the reimbursement process for omaveloxolone to ensure that it is made available to the approximately 200 people in Ireland living with Friedreich’s ataxia; if she recognises the clinical necessity of this treatment for a community that currently has no other therapeutic options; and if she will make a statement on the matter. [17107/26]