Darren O'Rourke (Meath East, Sinn Fein)
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102. To ask the Minister for Health when Givinostat will be available to people with Duchenne muscular dystrophy; if cross-border and early access programmes have been considered; and if she will make a statement on the matter. [51163/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I recognise the importance of providing the best care possible to patients with Duchenne muscular dystrophy (DMD). In terms of givinostat (Duvyzat®) my Department is closely following the developments in relation to this active pricing and reimbursement application.

I met with the families of children with DMD and their representative body, Muscular Dystrophy Ireland, in July to discuss their plight.

Under the Health (Pricing and Supply of Medical Goods) Act 2013 the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines.

Givinostat, sold under the brand name Duvyzat®, is a medication used to treat Duchenne muscular dystrophy (DMD) in ambulant patients aged 6 years and older. Conditional marketing authorisation was granted on the 6th June by the European Commission.

I met with my Italian counterpart at the EPSCO Council meeting in June in Luxembourg to ask him to encourage Italfarmaco to submit a pricing and reimbursement application to Ireland.

On the 6th August 2025 an application was received by the HSE.

The HSE and NCPE has proactively engaged with the company in relation to the application, to ensure it is processed as efficiently as possible. Following the conclusion of a Rapid Review by the NCPE on the 14th August 2025, a full Health Technology Assessment (HTA) was commissioned by the HSE on the 26th August 2025.

The company met with the National Centre for Pharmacoeconomics (NCPE) on the 30th September 2025 to assist the HTA process. The HSE has advised that the pricing and reimbursement assessment is ongoing.

In terms of any cross-border initiatives a drug or treatment must be approved for reimbursement by the HSE in order for it to be funded outside the State.

The Programme for Government gives a commitment to investigate new methods for faster reimbursement of certain treatments. The Department of Health is currently working on options to be considered by looking at various access schemes across Europe. This work is ongoing.