Ryan O'Meara
Question:1137. Deputy Ryan O'Meara asked the Minister for Health if a pricing and reimbursement application has been received by the HSE for zolbetuximab (Vyloy); and if she will make a statement on the matter. [6494/26]
View answerTuesday, 27 January 2026
Questions (1137)
Written answers
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 the 2013 Act. 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.
The HSE have advised as of 22 January 2026, a pricing and reimbursement application has not been received for Zolbetuximab (Vyloy®).
As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.
Question No. 1138 answered with Question No. 1128.