Written answer
Health Service Executive
1062. Deputy Michael Lowry asked the Minister for Health the approval and reimbursement status of the targeted immunotherapy zolbetuximab (Vyloy®) for the treatment of metastatic gastric adenocarcinoma (detail supplied). [6213/26]
Comment on this
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.
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 Department of Health, the Minister for Health and the HSE. The national assessment and decision process cannot commence in the absence of a pricing and reimbursement application submission to the HSE by the pharmaceutical company.
The HSE have advised as of 22 January 2026, a pricing and reimbursement application has not been received for Zolbetuximab (Vyloy®).
The State has successfully negotiated a new Agreement in Principle on the Supply and Pricing of Medicines with IPHA, which will commence from this year and last until the end of 2029. The agreement provides a commitment and a structured process towards achieving a 180-day timeline, for completing health technology assessments (HTA) and reimbursement decisions. The structured process will be implemented over the lifetime of the Agreement.