2026-07-01

I thank the Minister of State, Deputy Murnane O'Connor, for coming in to take this matter, which relates to the drug Pluvicto. This drug is for men suffering with prostate cancer. It was granted European Medical Agency, EMA, approval back in 2022. The HSE received an application for reimbursement on 9 January 2023. A rapid review was commenced shortly thereafter, on 10 February 2023. It was decided in March 2023 that a full higher technical assessment, HTA, was required in order to assess the efficacy of the drug. That assessment took the best part of 15 months to complete. A final HTA was completed in August 2024, when it was recommended that Pluvicto not to be reimbursed. That recommendation went forward to the drugs group, which followed through with its decision on the basis that it believed the therapy does not represent optimal use of limited HSE resources. That negative recommendation went forward to the HSE senior management team, which, as one would expect following a negative recommendation from the two subcommittees under it, followed through with its own refusal. In the period that followed, 40 specialist consultants in oncology and radiology wrote a letter to the then chief executive of the HSE, Bernard Gloster, pleading with him to make the drug available to men suffering with prostate cancer. It has the potential to prolong their lives and has been described as a significant breakthrough. The consultants in question also highlighted that similar drugs are available to other men with similar prostate cancer conditions, which just deepened the inequitable situation whereby some people were able to avail of drugs while others were prevented from doing so. The Minister of State is probably fed up with me coming in here looking for various drugs to be reimbursed. In that context, this drug is available in ten other European countries. I just checked my phone and discovered that it is available in France, Italy, Belgium, Switzerland, Austria, Czechia, Slovenia, Greece, Spain, Germany and Great Britain. It is not just big countries, because Switzerland, Austria, Belgium and Slovenia have made it available. I am here again beating the same drug. I commend the Minister for Health, Deputy Carroll MacNeill, regarding the review she instigated. To be fair, she put her money where her mouth is. I look forward to that review being completed. I believe it has gone out to tender and will happen by the end of this year. Nevertheless, here we are again. I do not want to hear that what is happening in this instance is the fault of the drug company involved, the HSE or the National Centre for Pharmacoeconomics, NCPE. That drug was approved by the EMA in 2022 and an application in respect of it was made in January 2023. Fast forward three and a half years, and people still do not have access to a cancer drug that could save their lives and that is widely available in other European countries. Here we are again, talking about Ireland being behind the curve. There will be a litany of reasons given as to why it has taken this long to get to this point. Ultimately, the drugs group and the HSE senior management team have decided not to reimburse the drug. Over the past few years, this Government and that which preceded it have approved more of these rare disease drugs than was the case over the previous decade. In the past three years, more of them have been approved than ever before. That is down to money. I am not asking for extra money. I am not trying to bankrupt the HSE, blow its budget or to do any of the other things I am being accused of. What I am asking for is a fairer apportionment of the existing drugs budget in this country. The Leas-Cheann Comhairle and the Minister of State will know that we are working with Friedreich’s ataxia patients who are undergoing a similar process regarding reimbursement of the drug Skyclarys, which, I understand, will be deal with by the drugs group shortly. Still, here we are again. How many more patients' groups or cohorts of people will have to plead for much-needed access to quality drugs?

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.

I have asked many parliamentary questions on this over the past few years. Very little has changed. The only thing that gives me hope is that the company has since met the CPU and submitted a commercial offer that remains under consideration. I am not asking for special treatment for any drug. These are all subject to commercial sensitivity. I am asking for fairness. This process started in January 2023, so we are here three and a half years later. They should be given a final response one way or another. That is all I ask for, good, bad or indifferent at this stage. People need to be put out of their misery. We can go on about the savings achieved in that timeline because this drug was not made available. That is probably because people have died because of the lack of access to it, truth be told. Those are the facts. I am not asking for special treatment. I have spoken consistently in the House about systems change. I hope to God the review the Minister commissioned brings the systems change I would like to see. Dozens of other countries do this in a better way than we do. We can continue to put up the front that we are one of the best at negotiating and we get the best price and the best value for drugs, but ultimately as a society we have to ask ourselves at what cost. Unfortunately, in this case it is at the cost of lives. I made a comment about the Skyclarys campaign. I know the Minister of State has to be careful what she says because it is due before the drugs group. I again make the case that these people just want a hearing as expeditiously as possible. Like I said, nine other European countries have approved that drug apart from the United States and a few other countries internationally. When are we going to step up to the plate with drugs like Skyclarys for Friedreich's ataxia patients? I know the Minister of State has constituents of her own and it is close to her heart.

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.