Dáil Éireann Debate, Tuesday - 21 April 2026
190. Deputy Shay Brennan asked the Minister for Health if her Department has assessed the potential national cost savings associated with weight based dosing of pembrolizumab (keytruda), in light of the Cork University Hospital study indicating a saving of €635,417.50 for 28 patients over two years. [28352/26]
Amharc ar fhreagraBudgets 2021-2025 allocated an additional €158 million for new drugs, which has facilitated the introduction of 263 new medicines, to date. The Year 1 cost of a new drug comes from the allocation for new medicines, but it should be noted that once these medicines are approved for reimbursement the full cost of providing them can reach multiples of this initial cost as their uptake increases.
Budget 2026 allocated €217 million in additional funding for drugs, with €30 million of this allocated for new drugs funding.
A central component of pharmaceutical expenditure is the HSE’s pricing and reimbursement process for medicines.
To commence the pricing and reimbursement process, a pharmaceutical company must submit an application for a new medicine or a new use of an existing medicine, that has been granted European Medicines Agency (EMA) or Health Products Regulatory Authority (HPRA) authorisation, to the HSE’s Corporate Pharmaceutical Unit.
I understand for the HSE that Pembrolizumab is currently licensed by the EMA for a number of cancer indications. The current license is for fixed dosing for adult indications.
Currently, weight-based dosing for adult indications would therefore represent an unlicensed dosing posology for pembrolizumab in Ireland.
The pricing and reimbursement process is for licenced indications of a medicine.
While clinicians may choose to prescribe based on weight, patients should be informed of this and consented to treatment in line with the hospital’s policy on the use of unlicensed medication and unlicensed or “off label” indications. Cost savings from weight-based dosing would likely require cohorting of patients to reduce wastage from part vials (which can result from weight- based dosing).
