528. Deputy John McGuinness asked the Minister for Health if she will provide an update on the approval of the drug skyclarys in the reimbursement scheme; if all of the information and costings have been submitted by the supplier; and the indicative date for approval. [50630/26]

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.

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.

To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine, that has been granted European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation, to the HSE’s Corporate Pharmaceutical Unit.

Applicants must continue to engage through-out the process to ensure that the necessary evidence is available for the HSE to carry out its statutory role as a decision-maker with respect to the reimbursement of new medicines, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

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 the1st 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: [https://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.

• Upon receipt of the HTA report on the 16th December 2025 the HSE immediately offered the company a suite of dates to attend a commercial meeting. The first commercial meeting was held on 12th February 2026 with a further meeting on the 18th May 2026.

• The HSE received a commercial proposal on the 27th May 2026 from the company Biogen(Idec)Ireland Limited. Following the conclusion of commercial negotiations the application will be progressed via the Drugs Group who will make a recommendation to the HSE Senior Leadership Team who have final decision making authority on whether to reimburse a medicine.

• 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.

• Skyclarys® is scheduled for consideration at the next Drugs Group meeting in July.

• 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.

While the HSE cannot comment on commercial negotiations as these are commercially confidential, it will continue to process and assess the application as efficiently as possible. This application remains under consideration with the HSE.