Dáil Éireann Debate, Wednesday - 1 July 2026
309. Deputy Erin McGreehan asked the Minister for Health the current status of the health technology assessment and reimbursement decision for pluvicto (lutetium-177 PSMA therapy) for the treatment of metastatic castration-resistant prostate cancer; the timeline for a final determination; and if she will make a statement on the matter. [50111/26]
Amharc ar fhreagraThe Government recognises the importance of timely access for patients to new medicines. Budgets 2021 to 2025 have included dedicated funding for new medicines of 158 million euros. Budget 2026 allocated an additional 30 million euros of funding for new drugs out of 217 million euros in additional funding for drugs. This has enabled the HSE to approve reimbursement for 276 new medicines or new uses for existing medicines, including 110 for treating cancer and 75 for treating rare diseases.
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.
The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines and medical items, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.
In line with the Act a company must submit an application to the HSE to have a new medicine added to the formal Reimbursement list.
Pluvicto® (lutetium (¹77Lu) vipivotide tetraxetan) is a medicine used to treat prostate cancer. It is indicated, in combination with androgen deprivation therapy (ADT), with or without androgen receptor (AR) pathway inhibition, for adult patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have previously been treated with AR pathway inhibition and taxane-based chemotherapy. The medicine was granted marketing authorisation by the European Medicines Agency (EMA) in September 2022.
On the 9th January 2023, the HSE received an application from Advanced Accelerator Applications, a Novartis Company, for pricing and reimbursement of Pluvicto®.
The Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes clinical experts and public interest members.
The HSE Drugs Group considers all of the evidence and makes a recommendation to the HSE Senior Leadership Team. The totality of clinical and economic evidence for this treatment was comprehensively and extensively reviewed by the Drugs Group at the April 2025 meeting.
Evidence considered included a HTA report from the NCPE, a patient interest group submission, two additional clinical representations, and advice from the National Cancer Control Programme Technology Review Committee, an expert group whose membership includes clinicians specialising in oncology.
The decision-making authority in the HSE is the HSE Senior Management Team (SMT). The HSE SMT decides on the basis of all the demands it is faced with (across all services) whether it can fund a new medicine. The SMT supported the Drugs Group recommendation not to reimburse this treatment.
The HSE Corporate Pharmaceutical Unit (CPU) issued a formal written Notice of Proposal to the applicant on Tuesday 5th May 2026.
The applicant has since met with the CPU and they have submitted a commercial offer which remains under consideration.
