Robert Troy (Longford-Westmeath, Fianna Fail)
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I thank the office of the Ceann Comhairle for selecting this extremely important topic. It is fair to say that access to appropriate healthcare is a fundamental right of all our citizens. I want to take this opportunity to acknowledge the huge progress being made by the Minister, Deputy Stephen Donnelly, and his team in ensuring that we improve our health service in the face of the global pandemic. Despite significant increases in investment there still remain challenges and problems. In an ever-evolving world there always will be. This is why we need the Government to respond to these challenges. It is important that this response is done in an efficient and timely fashion.

Most of us are aware of someone who suffers from cystic fibrosis and the debilitating disease it is. I compliment Cystic Fibrosis Ireland for the work it does in advocacy, supporting families and fundraising. Most of us remember that a number of years ago there was a very comprehensive campaign for the licensing of Orkambi and the huge difference that drug made to the quality of lives of so many people. I am told by the CEO of Cystic Fibrosis Ireland that a new drug, Kaftrio, is much better and makes even more of a difference to people's lives, improving their quality of life. Unfortunately there is a cohort of approximately 35 children aged between six and 12 years who are excluded from this drug because of their genotype. This is despite medical people knowing that the drug will work and greatly enhance the quality of their lives.

I am aware the National Centre for Pharmacoeconomics, NCPE, is in the process of carrying out a health technology assessment, HTA, and that the HSE has prioritised this. I thank the Minister for ensuring this was prioritised. Through the Minister of State, Deputy Collins, I ask that the Minister encourage the HSE to have this process brought to a conclusion as soon as possible and for the HSE to give a commitment not to procrastinate thereafter but to come forward with a positive decision. Every delay is causing irreparable damage to these children and potentially reducing their life expectancy.

A young boy in my constituency, Ciarán Kilmurray, whose family know I am raising this issue, spoke to Joe Duffy before Christmas. Ciarán was in hospital right up until Christmas. I compliment his classmates from St. Kenny National School. They were precluded from visiting him because of his vulnerability. They did not want to put him at any greater risk so they made Ciarán a lovely video to show he was very much missed by the school. I am glad to say he is now back at school but he is sitting on his own with a mask on and cannot participate freely in school activities with his classmates. However, if he had access to this life-changing drug, he could participate. I am sharing this story with the Minister of State in the hope he will bring it back to the Minster to ensure this process is concluded without delay, that we have a positive outcome and that the 34 other children who are in a position similar to Ciarán can get access to this life-changing drug and go on to live their lives normally.

Niall Collins (Limerick County, Fianna Fail)
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I am taking this matter on behalf of the Minister for Health. I thank Deputy Troy for raising this important issue.

Kaftrio has been a life-changing drug for cystic fibrosis sufferers. Access to drugs like this was what we expected when the HSE signed its agreement with the manufacturer, Vertex Pharmaceuticals, in 2017. The deal stipulated our patients would have access to Vertex's whole portfolio of cystic fibrosis drugs for a capped yearly cost. We made a ten-year commitment that has already seen us pay hundreds of millions of euro to Vertex. We entered this agreement in good faith expecting that as new licences were approved for Kaftrio's medicines, the HSE would receive access at no additional cost. This has been the case previously when new indications were licensed. The agreement was amended in 2019 and 2020 to include these patient groups at no additional cost. However, for this particular sub-type that affects a small group of children, Vertex is requesting additional funds to provide access.

The HSE has statutory responsibility for the community drug schemes. It has structures in place to ensure our health service is able to provide the right care sustainably. Given the substantial budgetary impact of the additional funds sought by Vertex, it must complete the pricing and reimbursement process that is required of all other medicines. This requires the NCPE to complete a HTA of Kaftrio for this patient group. Until recently, Vertex did not engage with this process. Following extensive efforts from the HSE's corporate pharmaceutical unit, Vertex supplied its HTA dossier to the NCPE last month. The NCPE has agreed to treat this HTA as a priority case. The Minister is pushing to have the HTA completed as soon as possible. In the meantime, the HSE's corporate pharmaceutical unit continues its open dialogue with Vertex and met the company a couple of times in January.

The Government is committed to providing access to innovative new medicines for Irish patients. Budgets 2021 and 2022 saw €80 million of funding dedicated to new medicines. Some 112 new medicines, or expanded uses of existing medicines, of which 34 were for the treatment of rare diseases, have been provided since 2021. I thank Cystic Fibrosis Ireland for its efforts in bringing attention to this situation. The organisation provided valuable insight to the Minister during their meetings late last year. The voices of parents and of these children have also been heard and the Minister fully appreciates their concern. He and I are hopeful this situation will be brought to a satisfactory conclusion for everyone shortly.

Robert Troy (Longford-Westmeath, Fianna Fail)
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I thank the Minister of State. What is the difference for this particular sub-type? We have 35 children in this situation. I gave a personal example of one of them whose quality of life has been severely impacted by this decision. What is the rationale for this drug company not honouring a deal made a number of years ago? I welcome that a process has commenced and that the HTA will conclude very quickly. I ask that this happen within the next number of weeks, if not days, and that when that process is concluded the HSE proceeds at speed to make this drug available to this cohort of children. As I said, any delay is doing irreparable damage. If the children move onto the drug in a number of weeks, it will not be able to undo the damage that is already done, so time is of the essence. These children, like everyone else availing of this life-changing drug, deserve it. I ask the Minister of State to use his good offices to ensure the Minister continues to keep this as a priority so we can get a satisfactory conclusion in the next number of weeks, if not days.

Niall Collins (Limerick County, Fianna Fail)
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We fully appreciate the severity of cystic fibrosis and acknowledge the fears and frustrations of the families affected by this situation. I also acknowledge the circumstances the Deputy's constituents, Ciarán and his family, whom the Deputy spoke about in his initial remarks, find themselves in. The Minister is working on resolving this issue as a matter of high priority. He has been very clear in telling me that and it is his position and the position of the Government. It is a matter of extreme regret that Vertex has behaved in the manner it has. That being said, we are pursuing every avenue to try to remedy the situation.

The HSE has a statutory responsibility for medicine pricing and reimbursement decisions given under the Health (Pricing and Supply of Medical Goods) Act 2013. This requires the executive to ensure medicines are reimbursed in a cost-effective manner. The HSE is making an effort to fulfil its responsibility. Following extensive efforts by the HSE's corporate pharmaceutical unit, we are now beginning to see progress in this matter. The Minister, the clinical community and, most important, the families affected are all eager to see progress towards making this drug available to these children as soon as possible.