Cathal Crowe (Clare, Fianna Fail)
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118. To ask the Minister for Health for 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 of Ireland to examine the possibility of children with Duchenne muscular dystrophy accessing treatment in the North as an interim measure; if not, to outline the barriers to them doing so; and if she will make a statement on the matter. [62690/25]

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). My Department is closely following the developments in relation to the pricing and reimbursement application for givinostat (Duvyzat®).

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, marketed 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 for this indication 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, the marketing authorisation holder for givinostat, to submit a pricing and reimbursement application to Ireland.

On the 6th August 2025 a pricing and reimbursement application was received by the HSE.

The HSE and the National Centre for Pharmacoeconomics (NCPE) have proactively engaged with the company in relation to the application, to ensure it is processed as expeditiously 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 NCPE met with Italfarmaco on the 30th September 2025 to assist the HTA process.

Following enquiries from the Department, NCPE has advised that as of the 18th November 2025 a full HTA dossier is still awaited from the company.

In terms of any cross-border initiatives, 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.