Ruth Coppinger (Dublin West, Solidarity)
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1758. To ask the Minister for Health the timeline for the approval of linzagolix by the National Centre for Pharmacoeconomics for the public prescription of this particular drug; and if she will make a statement on the matter. [58304/25]

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 medical 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 robustly assesses 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.

As of the 31st October 2025, a pricing and reimbursement application has not been received by the HSE for linzagolix choline(Yselty®) from the marketing authorisation holder.

As per the processes outlined above, the HSE will process and assess any pricing and reimbursement application received from a company as efficiently as possible within the resources available to the HSE.