3160. Deputy Holly Cairns asked the Minister for Health if a decision not to reimburse a treatment Omaveloxolone sold under the brand name Skyclarys will be reviewed given it is the only pharmaceutical treatment available for treating Friedreich's Ataxia; and if she will make a statement on the matter. [26180/26]

3211. Deputy Ruth Coppinger asked the Minister for Health to prioritise the negotiations for reimbursement of a particular drug given that it is the only treatment for a specific disease (details supplied); and if she will make a statement on the matter. [26478/26]

3224. Deputy Ruth Coppinger asked the Minister for Health if she will take steps to ensure that skyclarys (omaveloxolone) is made available for those with Fredericks ataxia who require it; and if she will make a statement on the matter. [26512/26]

3359. Deputy Robert O'Donoghue asked the Minister for Health to provide a clear timeline for the conclusion of the reimbursement process for skyclarys given that more than 80 Parliamentary Questions have already been raised on this matter without any indication of when a decision may be reached; and if she will make a statement on the matter. [27038/26]

I propose to take Questions Nos. 3160, 3211, 3224 and 3359 together.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has sole 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. Decisions on pricing and reimbursement of medicines are not made by the Minister or the Department.

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 recommended that omaveloxolone not be considered for reimbursement: [Omaveloxolone (Skyclarys®). HTA ID: 24033 | National Centre for Pharmacoeconomics].

• 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 CPU recently met with the company marketing Skyclarys® and commercial engagements are ongoing. These negotiations are commercially confidential.

• 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.