Dáil Éireann Debate, Wednesday - 11 June 2025
300. Deputy Eoin Ó Broin asked the Minister for Health the reason a type of medication (details supplied) is not currently available in Ireland; if consideration will be given to approving the medication urgently in light of the reported benefits to people living with a specific progressive neuromuscular disease; and if she will make a statement on the matter. [30839/25]
Amharc ar fhreagraIn 2023 a record €3.2 billion, nearly €1 in every 8 of public funding spent on health, was spent on medicines. This is an unprecedented level of investment in supporting patients through the availability of the latest and wide range of medicines.
From January 2021 up to December 2024 the State made an additional €128 million available for new drugs which has seen 194 new medicines or new uses for existing medicines approved for reimbursement by the HSE. This includes 74 medicines for oncology and 49 new drugs for rare diseases. .Budget 2025 includes an allocation of €30m for new medicines, to be generated from efficiencies.
Duchenne Muscular Dystrophy (DMD) is a rare disease affecting fewer than 200 people in Ireland. The State acknowledges the importance of access to medicines and is aware of the plight of patients with Duchenne Muscular Dystrophy (DMD).
Givinostat, sold under the brand name Duvyzat®, is a medication used to treat Duchenne muscular dystrophy (DMD) in patients aged 6 years and older. Conditional marketing authorisation was granted on the 6th June 2025 by the European Commission for this medicine as a treatment for Duchenne muscular dystrophy (DMD) in patients from the age of six who are able to walk.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
The National Centre for Pharmacoeconomics (NCPE) conducts the Health Technology Assessment (HTA) of drugs for the health service in Ireland in collaboration with the HSE's Corporate Pharmaceutical Unit (CPU). They assess comparative clinical effectiveness and cost-effectiveness of drugs compared to current standard of care. The NCPE engages with stakeholders, including patients and clinicians, throughout the assessment process.
The HSE’s CPU is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications.
As conditional marketing authorisation has now been granted to the marketing authorisation holder for Givinostat(Duvyzat®) the company must now apply to the HSE for the treatment to be reimbursed through the public health system.
If the company chooses to submit a pricing and reimbursement application, the HSE will give fair consideration to the application with consideration for the criteria detailed in the 2013 Act.
The State encourages all marketing authorisation holders of new medicines to apply to the HSE for reimbursement once marketing authorisation is granted by the European Medicines Agency.
