Dáil Éireann Debate, Tuesday - 20 January 2026
1047. Deputy Darren O'Rourke asked the Minister for Health an update on the approval status of the drug givinostat; if officials from her Department have been in contact with their counterparts in the North to examine the possibility of children with Duchenne muscular dystrophy accessing treatment in the North as an interim measure; and if she will make a statement on the matter. [4348/26]
View answerUnder 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 givinostat (Duvyzat®):
On the 6th June 2025, the European Commission granted EU conditional marketing authorisation for givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
The HSE received a complete application for pricing and reimbursement of givinostat (Duvyzat®) on the 6th August 2025 from Italfarmaco Pharma (the applicant) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.
• 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 5th August 2025.
• The NCPE Rapid Review assessment report was received by the HSE on the 14th August 2025. A full health technology assessment (HTA) was recommended to assess the clinical effectiveness and cost effectiveness of givinostat compared with the current standard of care.
• The HSE commissioned a full HTA on the 26th August 2025 as per agreed processes.
• A completed HTA dossier was received from the company on the 15th January 2026.
• The NCPE publishes details of medicines where the HSE has commissioned a Rapid Review assessment and / or a full health technology assessment on their website. The website is updated at regular intervals and includes assessment outcomes and updates on reimbursement for each individual medicine and indication listed. Details of the assessment(s) of givinostat (Duvyzat®) are available at: www.ncpe.ie/givinostat-duvyzat-hta-id-25048-2/.[]
• 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.
Further information on the progress of givinostat (Duvyzat®) through the HSE assessment and approval processes is available via the Pricing and Reimbursement Application tracker available at www.hse.ie/eng/about/who/cpu/. HSE application ID HSE100060 has been assigned to this application. As per the processes outlined above, the HSE will process and assess the pricing and reimbursement application received as efficiently as possible within the resources available to the HSE.
The application remains under consideration with the HSE. The HSE cannot make any comment on possible outcomes from the ongoing process.
In terms of any cross-border initiatives, such as the Northern Ireland Planned Healthcare Scheme or Treatment Abroad Scheme a drug or treatment must be approved for reimbursement in the State by the HSE in order for it to be funded outside the State.
