Mairéad Farrell (Galway West, Sinn Fein)
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502. To ask the Minister for Health if the approval of a drug will be expedited considering its urgent need by a person (details supplied). [31405/25]

Conor Sheehan (Limerick City, Labour)
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534. To ask the Minister for Health if she will examine and expedite the approval of a new drug givinostat which has been approved in the UK and US for the treatment of Duchenne muscular dystrophy; and if she will make a statement on the matter. [31509/25]

Liam Quaide (Cork East, Social Democrats)
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542. To ask the Minister for Health her plans to expedite the national assessment and decision process for the use of duvyzat (givinostat) to treat patients with Duchenne muscular dystrophy; and if she will make a statement on the matter. [31557/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 502, 534 and 542 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.