Brian Brennan (Wicklow-Wexford, Fine Gael)
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775. To ask the Minister for Health for an update on the progress of a project (details supplied); and if she will make a statement on the matter. [31944/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Pearse Doherty (Donegal, Sinn Fein)
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776. To ask the Minister for Health if urgent help will be provided for a child (details supplied) in County Donegal to access CAMHS and other support services; and if she will make a statement on the matter. [31946/25]

Mary Butler (Waterford, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond directly to the Deputy as soon as possible.

Carol Nolan (Offaly, Independent)
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777. To ask the Minister for Health if consideration will be given to expediting the approval process for a medicine that assists in the treatment and progression of Duchenne muscular dystrophy (details supplied); and if she will make a statement on the matter. [31948/25]

Mark Ward (Dublin Mid West, Sinn Fein)
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860. To ask the Minister for Health if givinostat (details supplied) will be made available for children Duchenne muscular dystrophy; and if she will make a statement on the matter. [32395/25]

David Cullinane (Waterford, Sinn Fein)
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862. To ask the Minister for Health whether an application for reimbursement has been received for a medicine (details supplied); the status of the application; if funding is available to make this medicine available to patients; and if she will make a statement on the matter. [32416/25]

Cathal Crowe (Clare, Fianna Fail)
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880. To ask the Minister for Health if she and her Department will consider expediting the approval of givinostat to assist in the treatment of those who have Duchenne muscular dystrophy; and if she will make a statement on the matter. [32513/25]

Darren O'Rourke (Meath East, Sinn Fein)
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894. To ask the Minister for Health to provide an update on the approval of the givinostat (brand name duvyzat), for Duchenne muscular dystrophy in Ireland; if she will provide a timeline for implementation in Ireland; and the length of time the reimbursement process will take. [32595/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 777, 860, 862, 880 and 894 together.

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 devices; therefore, I have asked the HSE for an update in this matter.

The HSE has advised that there is a National Application, Assessment & Decision Process for new medicines which is underpinned by Primary Legislation (Health (Pricing and Supply of Medical Goods) Act 2013) put in place by the Oireachtas. The HSE must comply with the relevant legislation when considering investment decisions around new medicines.

The HSE must robustly assess applications for pricing and reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

There are formal processes which govern applications for the pricing and reimbursement of medicines, and new uses of existing medicines, to be funded and / or reimbursed.

Pharmaceutical companies are required to submit formal applications to the HSE if they wish for their medicines to be added to the list of reimbursable items / funded via hospitals. The decision of pharmaceutical companies to market licensed medicines i.e. whether or not to submit a formal application, is outside the control of the HSE.

In terms of the specific details of an application for pricing and reimbursement of Givinostat (Duvyzat®):

On 25th April 2025, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment. On the 6th June 2025 the European Commission granted EU conditional marketing authorisation for Givinostat (Duvyzat®) for the treatment of Duchenne muscular dystrophy (DMD).

A pricing and reimbursement application has not yet been received by the HSE for Givinostat (Duvyzat®).

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.