Pádraig O'Sullivan (Cork North-Central, Fianna Fail)
Link to this: Individually | In context

769. To ask the Minister for Health if she will consider for reimbursement the new treatment VYLOY (zolbetuximab), which is used for certain types of gastric and gastroesophageal junction cancers; and if she will make a statement on the matter. [27585/25]

Pádraig Rice (Cork South-Central, Social Democrats)
Link to this: Individually | In context

800. To ask the Minister for Health if a drug will be made available to patients for certain types of gastric and gastroesophageal junction cancers under the HSE reimbursement scheme (details supplied); and if she will make a statement on the matter. [27684/25]

Holly Cairns (Cork South-West, Social Democrats)
Link to this: Individually | In context

802. To ask the Minister for Health the reason vyloy, also called zolbetuximab, (details supplied) is not currently reimbursed by the HSE under the drug payment scheme despite being approved by the European Medicines Agency; and if she will make a statement on the matter. [27689/25]

Pat Buckley (Cork East, Sinn Fein)
Link to this: Individually | In context

805. To ask the Minister for Health for a fast-tracked review of vyloy (zolbetuximab), which is used for certain types of gastric and gastroesophageal junction cancers, for inclusion in the HSE reimbursement scheme. [27703/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
Link to this: Individually | In context

I propose to take Questions Nos. 769, 800, 802 and 805 together.

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 therefore I have reached out to the HSE 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 zolbetuximab (Vyloy®):

As of the 22nd May 2025, a pricing and reimbursement application has not been received by the HSE for zolbetuximab (Vyloy®) from the Marketing Authorisation Holder.

As outlined above, the national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE.