Shane Moynihan
Ceist:728. Deputy Shane Moynihan asked the Minister for Health when a drug treatment for neurofibromatosis (details supplied) will be made available for patients by the HSE. [47110/26]
Amharc ar fhreagraTuesday, 23 June 2026
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Freagraí scríofa
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, the HSE has been asked to provide 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 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. 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 mirdametinib (Ezmekly®):
Mirdametinib (Ezmekly®), marketed by Merck Europe B.V., was granted conditional marketing authorisation in the EU in July 2025.
As of the 18th June 2026, a pricing and reimbursement application has not been received by the HSE for mirdametinib (Ezmekly®).
As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.