Dáil Éireann Debate, Thursday - 11 June 2026
314. Deputy Naoise Ó Cearúil asked the Minister for Health the status of the reimbursement process for givinostat for the treatment of Duchenne muscular dystrophy; the timeline for a decision following consideration by the HSE Drugs Group; the steps being taken to ensure timely access for eligible patients once a decision is made; and if she will make a statement on the matter. [44665/26]
View answer349. Deputy Cathal Crowe asked the Minister for Health the status of the reimbursement process for the medication givinostat (duvyzat) for patients living with Duchenne muscular dystrophy (DMD); if she will provide an update on the outcome of the HSE Drugs Group meeting scheduled for 10 June 2026; the timeline for a final decision by the HSE leadership; if she will ensure that the clinical eligibility criteria will be aligned with the National Institute for Health and Care Excellence (NICE) guidelines to include children who can walk or stand with or without support so that patients in Ireland are not disadvantaged compared to those in Northern Ireland; the proactive steps being taken to plan the immediate clinical rollout to prevent administrative delays post-approval; and if she will make a statement on the matter. [44830/26]
View answer350. Deputy Michael Cahill asked the Minister for Health to ensure that all children within the State receive urgent access to givinostat (duvyzat) for Duchenne muscular dystrophy (details supplied); and if she will make a statement on the matter. [44837/26]
View answer357. Deputy Colm Burke asked the Minister for Health to provide an update on the availability of the drug givinostat for patients with Duchenne muscular dystrophy; and if she will make a statement on the matter. [44851/26]
View answer360. Deputy Michael Cahill asked the Minister for Health to ensure that all children within the State receive urgent access to givinostat (duvyzat) for Duchenne muscular dystrophy (details supplied); and if she will make a statement on the matter. [44860/26]
View answer361. Deputy Michael Cahill asked the Minister for Health to ensure that all children within the State receive urgent access to givinostat (duvyzat) for Duchenne muscular dystrophy (details supplied); and if she will make a statement on the matter. [44861/26]
View answer362. Deputy Michael Cahill asked the Minister for Health to ensure that all children within the State receive urgent access to givinostat (duvyzat) for Duchenne muscular dystrophy (details supplied); and if she will make a statement on the matter. [44863/26]
View answer363. Deputy Paula Butterly asked the Minister for Health the steps being taken to expedite access and reimbursement for givinostat for children living with Duchenne muscular dystrophy here (details supplied) [44870/26]
View answerI propose to take Questions Nos. 314, 349, 350, 357, 360, 361, 362 and 363 together.
The Government recognises the importance of timely access for patients to new medicines and supporting those living with rare diseases in Ireland. Budgets 2021-2025 allocated €158 million for new drugs, and Budget 2026 allocated an additional €30 million. Since 2021, this funding has facilitated the introduction of 270 new medicines, including 74 medicines for rare diseases and more than 100 for treating cancer.
The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Ireland is among the highest spenders on health across the EU (OECD), with the third-highest rate of State coverage of pharmaceutical expenditure in Europe.
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. The Minister has no role in decisions on pricing and reimbursement.
There is no hierarchy of disease and pricing and reimbursement applications are considered in order of application.
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 to the HSE’s Corporate Pharmaceutical Unit. European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation is required for the medicine prior to submission to the HSE for reimbursement as reimbursement only applies to licensed uses (indications) of the medicine.
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.
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.
With respect to givinostat, the HSE received a commercial proposal from Italfarmaco, the marketing authorisation holder, on 08 May 2026.
Italfarmaco's application for givinostat was considered at a meeting of the Drugs Group on 09 June 2026. The Drugs Group will make a recommendation to the HSE Senior Leadership Team who have final decision making authority on whether to reimburse a medicine.
The application remains under consideration and the HSE cannot make any comment on possible outcomes from the ongoing process.
