Eoin Hayes (Dublin Bay South, Social Democrats)
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919. To ask the Minister for Health the measures she is taking to uphold the commitment as outlined in the Programme for Government to ensure patients have timely access to new and innovative treatments, and in particular the drug named givinostat (brand name duvyzat), which is crucial for children with Duchenne muscular dystrophy; and if she will make a statement on the matter. [34523/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Programme for Government contains a suite of measures on medicines, which we aim to progress over its lifetime. Access to medicines is the focus of a number of workstreams across my Department.

Budgets 2021 to 2024 allocated €128 million for new drugs which has allowed the HSE to approve 194 new medicines. Seventy-four (74) of these were for cancer and forty-nine (49) of these are for rare diseases.

Budget 2025 allocated 30 million euro for new drugs to come from efficiencies to be identified by the HSE.

On foot of the recommendations of the Mazars Review, a pricing and reimbursement application tracker was launched in December 2024 to improve transparency.

In late 2024 an additional 34 staff, an increase of over 80% in staffing across the pricing and reimbursement system, were recruited to enhance capacity across the pricing and reimbursement system. Given the unique technical skill set required for these roles it is expected that the impact of these staff will be seen as we continue through 2025.

This enhanced capacity has been allocated by Government to enhance the pricing and reimbursement process but industry must also play its part by submitting pricing and reimbursement applications as soon as marketing authorisation is granted by the European Medicines Agency.

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.