2073. Deputy Claire Kerrane asked the Minister for Health the steps being taken to ensure that the HSE recognises and responds to the time-critical nature of Friedreichs Ataxia during the current price negotiations for Skyclarys; and if she will make a statement on the matter. [20158/26]

2091. Deputy Michael Fitzmaurice asked the Minister for Health the steps being taken 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. [20251/26]

2177. Deputy Erin McGreehan asked the Minister for Health the specific steps the HSE is taking to ensure that the time critical and progressive nature of Friedreich's Ataxia is fully recognised and acted upon during the ongoing price and reimbursement negotiations for skyclarys, given the significant risk of irreversible decline for patients during prolonged delays. [20488/26]

2199. Deputy Maeve O'Connell asked the Minister for Health the position regarding the current reimbursement process for Omaveloxolone, considering the time-sensitive nature of the condition for those with Friedreich's ataxia; and if she will make a statement on the matter. [20597/26]

2221. Deputy Aengus Ó Snodaigh asked the Minister for Health the reason access to Friedreich's Ataxia is not available on the medical card or licenced for the drug reimbursement scheme for patients in the State; and if she will make a statement on the matter. [20816/26]

I propose to take Questions Nos. 2073, 2091, 2177, 2199 and 2221 together.

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 on 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 robustly assesses 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.

• A completed HTA was not submitted by the company until the 2nd July 2025.

• The NCPE HTA Report was received by the HSE on the 16th December 2025 which included Patient Organisation submissions from Friedreich’s Ataxia Research Alliance (FARA) Ireland and Neuroataxia CLG t/a Ataxia Foundation Ireland about omaveloxolone(Skyclarys®).These submissions will form part of the data that the HSE considers.

• 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 HSE have advised that they have met with the applicant and await a commercial proposal at this juncture.

• 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.