Conor McGuinness (Waterford, Sinn Fein)
Link to this: Individually | In context

70. To ask the Minister for Health if she will implement a plan to support individuals with Duchenne muscular dystrophy, including the development of specialist multidisciplinary teams, and ensuring enhanced and immediate access to givinostat and similar treatments. [34818/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines is the focus of a number of workstreams across my Department.

I recognise the importance of providing the best care possible to patients with Duchenne. In terms of givinostat (Duvyzat®) my Department is closely following the developments in relation to the medicine which was authorised by the European Commission for the treatment of Duchenne Muscular Dystrophy on the 6^th of June 2025.

The HSE has statutory responsibility for decisions on the pricing and reimbursement of medicines. This arises from the Health (Pricing and Supply of Medical Goods) Act 2013. The Act provides a rigorous process for the assessment of new medicines for reimbursement. The Act specifies nine criteria which must be considered. These include the health needs of the public and the clinical need for the medicine. All these factors, taken together, allow the HSE to make an informed decision on new medicines.

As of the 23^rd of June 2025, the HSE has advised that it has not yet received a pricing and reimbursement application for givinostat (Duvyzat®) from Italfarmaco S.p.A., the Marketing Authorisation Holder. The national assessment and decision process for the medicine cannot commence in the absence of this application.

I encourage the company to submit a pricing and reimbursement application to the HSE, in early course, to allow the national assessment and decision process to commence.