Aisling Dempsey (Meath West, Fianna Fail)
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388. To ask the Minister for Health the actions she will take to ensure that givinostat is available at the earliest opportunity to sufferers of Duchenne muscular dystrophy. [33245/25]

Albert Dolan (Galway East, Fianna Fail)
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402. To ask the Minister for Health if she will provide an update on the current status of the approval process for the drug givinostat for patients with Duchenne muscular dystrophy; if consideration is being given to its inclusion in an early access programme, similar to those operating in the United Kingdom and the United States; and if she will make a statement on the matter. [33312/25]

Ruth Coppinger (Dublin West, Solidarity)
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403. To ask the Minister for Health to outline her engagements with the HSE on access to givinostat for Duchenne muscular dystrophy; and if she will make a statement on the matter. [33325/25]

Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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412. To ask the Minister for Health if she will use her power to ensure a decision is made as a matter of urgency regarding an application for reimbursement of new medicines (details supplied) given lengthy reimbursement times and the detrimental impact delaying access to this medicine has on the medical condition to which it relates. [33380/25]

Barry Heneghan (Dublin Bay North, Independent)
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423. To ask the Minister for Health the steps she is taking to ensure that a drug (details supplied) will be assessed and made available as quickly as possible following its recent EU approval, given how important early access is for children with Duchenne muscular dystrophy; and if she will make a statement on the matter. [33451/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 388, 402, 403, 412 and 423 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.