Alan Kelly (Tipperary North, Labour)
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970. To ask the Minister for Health if all persons diagnosed with Duchenne muscular dystrophy will be entitled to access the drug Givinostat. [39474/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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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) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.

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 for this indication cannot commence in the absence of a pricing and reimbursement application submission to the HSE.

In terms of Givinostat (Duzyvat®) for the treatment of DMD for non-ambulant patients, neither the EMA nor the HPRA have granted marketing authorisation for Givinostat (Duzyvat®) in this indication to date. A national assessment and decision process cannot commence in the absence of a marketing authorisation for this indication.

Alan Kelly (Tipperary North, Labour)
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971. To ask the Minister for Health if an early access program or a compassionate use-managed access program will be established to allow quicker access to Givinostat for people with Duchenne muscular dystrophy. [39475/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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The Government recognises the importance of timely access for patients to new medicines.

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 2021-2024 allocated an additional €128 million for new drugs, which has facilitated the introduction of 219 new medicines. Fifty-five (55) of these are orphan drugs for rare diseases. Budget 2025 allocated €30 million for new drugs to come from efficiencies to be identified by the HSE.

In 2023 a review of the drug reimbursement process was published. It found that the process was operating as intended and within international norms. Recommendations from the review have now been implemented. A pricing and reimbursement application tracker has been launched to improve transparency. In 2024 an additional 34 staff were recruited to enhance capacity across the pricing and reimbursement system.

Access to medicines requires industry and the State to work together, through timely assessment, and reasonable pricing with fully completed HTAs (Health Technology Assessments). The Government encourages pharmaceutical companies to submit timely applications for reimbursement.

My Department is looking at reimbursement systems across the European Union and working closely on access to medicines with Beneluxa partners, where we have had previous success.

As outlined in the Programme for Government, consideration will be given to early access mechanisms for medicines. These mechanisms and their effects are complex and must be evaluated carefully.

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 on the matter of givinostat (Duvyzat®).

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) in ambulant patients, aged 6 years and older, and with concomitant corticosteroid treatment.

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.