Since I have known him, the Deputy has consistently come to the Dáil and raised issues relating to rare diseases. He has worked so hard not just in respect of this particular drug but also in respect of several others. I thank him for his commitment and his hard work on this. I know he is constantly meeting the Minister, Deputy Carroll MacNeill. The State acknowledges the importance of access to medicines. This Government is committed to providing timely access to new and innovative medicines and has made considerable investments in recent years, with annual expenditure on medicines now almost €4 billion. This means that nearly €1 in every €8 of public funding is being spent on health. This level of investment is unprecedented in supporting patients through the availability of new and innovative medicines. The budgets for the period between 2021 to 2025 included dedicated funding of €158 million for new medicines. Budget 2026 allocated an additional €30 million of funding for new drugs out of €217 million 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 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. I know the Deputy is aware of this. Pluvicto is a medicine used to treat prostate cancer. It is indicated for certain adult patients with prostate cancer who have previously been treated with AR pathway inhibition and taxane-based chemotherapy. The medicine was granted marketing authorisation by the European Medicines Agency in September 2022, following a positive opinion from the Committee for Medicinal Products for Human Use. The centralised procedure results in a single EU-wide marketing authorisation valid across all EU member states. On 9 January 2023, the HSE received an application from Advanced Accelerator Applications, a Novartis company, for pricing and reimbursement of the drug. The drugs group is the national committee 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 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, which decides whether it can fund a new medicine. The senior management team supported the drugs group recommendation not to reimburse this treatment. The HSE corporate pharmaceutical unit issued a formal written notice of proposal to the applicant on Tuesday, 5 May 2026. The applicant has since met with the CPU, and it has submitted a commercial offer that remains under consideration. The HSE cannot comment on potential outcomes of this application. That information is important.

Sentiment score: 0.06

Two new frameworks are agreed with Medicines for Ireland. This is the Irish pharmaceutical healthcare association on the supply and pricing of medicines. These have been successfully reached following extensive negotiation with the pharmaceutical sector. These two new framework agreements will change things. A tender for conducting this review was published on Monday, 15 June. Once commenced, the project timeline is between six and nine months. Together these measures will enable faster access to medicines for patients in Ireland. I thank the Deputy for this. I will talk about my own constituency. I have met with a lot of families in Carlow affected by Friedreich's ataxia, particularly Emily and Oisín. As the Deputy said, it is important. The next HSE drugs group is meeting on Tuesday, 14 July and that will be discussed. Skyclarys is on the agenda for that meeting. It is important because I have met with so many families in Carlow-Kilkenny and with constituents who need this drug. These families are waiting to get it urgently. Like everything, there is due diligence and funding is always spoken about. It is important that we know we have the date for it. The meeting is on Tuesday, 14 July with the drugs group and Skyclarys is on the agenda for that group meeting. I will bring all of the Deputy's important issues and concerns on timing to the Minister, Deputy Jennifer Carroll MacNeill. Unfortunately, she could not take this Topical Issue.

Sentiment score: 0.11