Seanad debates
Thursday, 2 February 2023
Nithe i dtosach suíonna - Commencement Matters
Medicinal Products
9:30 am
Jerry Buttimer (Fine Gael)
Link to this: Individually | In context | Oireachtas source
The next Commencement matter is an issue I too as a Member have raised on a number of occasions on the floor of the Seanad and I commend the Senator on raising it today.
Pauline O'Reilly (Green Party)
Link to this: Individually | In context | Oireachtas source
I thank the Cathaoirleach. I thank the Minister of State for coming to the Chamber today. As the Cathaoirleach has said, a number of Members have raised this issue, and Senator Buttimer has indeed been at the forefront on the issues around cystic fibrosis.
I am here for an update from the Minister of State. He will be aware that Cystic Fibrosis Ireland had called for a health technology assessment to be completed by the end of January. We are now into February. I submitted this Commencement matter at the end of January to get an update. There are 35 children and their families awaiting news. They had been denied the drug Kaftrio. I have been contacted by a former senior psychologist at the adult unit for cystic fibrosis in St. Vincent's University Hospital. She outlined to me the real psychological challenges for people when they are dealing with a long-term condition such as cystic fibrosis. We in Ireland have a particular propensity for cystic fibrosis. There is no cure and people are reliant on these drugs. It is immoral not to ensure every person who needs the drug can get access to it. I look forward to hearing the Minister of State's response. I would like to hear that the HSE had been in contact with the Minister for Health, Deputy Donnelly, and some confirmation that the health technology assessment is either completed or nearing completion. The families were disappointed to hear it needed to go through this step, albeit a step in the right direction.
Niall Collins (Limerick County, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
I am taking this matter on behalf of the Minister for Health. I thank Senator O'Reilly for raising this issue. Cystic fibrosis is a devastating disease for patients and their families. With Ireland having one of highest per capitarates of cystic fibrosis in the world, many of us will have been affected by the sadness it can cause for families. Access to effective treatments offers hope to those suffering from this disease, and the Minister aims to make this possible for every patient who needs it.
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 drug's manufacturer, Vertex, in 2017. That deal stipulated that 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 which 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 their medicines, the HSE would receive access at no additional cost. This had 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 subtype affecting 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 services are available 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 in respect of all other medicines. This requires the National Centre for Pharmacoeconomics, NCPE to complete a health technology assessment, 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, CPU, Vertex supplied its HTA dossier to the NCPE in January 2023. The NCPE has agreed to treat this HTA as a priority. The Minister is pushing to have the HTA completed as soon as possible. In the meantime, the HSE's CPU continues its open dialogue with Vertex and met its representatives on a couple of occasions 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 and 112 new medicines, or expanded uses of existing medicines, 34 of which were for the treatment of rare diseases, were provided since 2021.
I thank Cystic Fibrosis Ireland for its efforts in bringing attention to this situation. It provided valuable insight to the Minister during the meeting late last year. The voices of the parents of these children have also been heard and the Minister fully appreciates their concern. He and I are hopeful that this matter can be brought to a satisfactory conclusion for everyone involved.
Pauline O'Reilly (Green Party)
Link to this: Individually | In context | Oireachtas source
I will not get into a long discussion on the stranglehold that pharma companies have when it comes to providing treatment. As the Minister of State indicated, a huge amount of money was given to Vertex. I am disappointed that we have no update on the HTA. I ask the Minister of State to go back to the Minister and ask him to, as soon as possible, give me a date by which he thinks it will be completed. Cystic Fibrosis Ireland wanted this done by the end of January.
We have a new group in Leinster House of Senators and Deputies who are interested in rare diseases. It can be incredibly difficult to advocate for yourself when you have a rare illness. It is really important that we have this group in order that we can advocated more effectively on people's behalf.
Niall Collins (Limerick County, Fianna Fail)
Link to this: Individually | In context | Oireachtas source
We fully appreciate the severity of cystic fibrosis and acknowledge the fears and frustrations of the families affected by this situation. The HSE has statutory responsibility for medicine pricing and reimbursement decisions as given to it in the Health (Pricing and Supply of Medical Goods) Act 2013. This requires that the HSE ensures that medicines are reimbursed in a cost-effective manner. The HSE is making every effort to fulfil its responsibility. Following extensive efforts by the HSE's corporate pharmaceutical unit we are now seeing progress with this situation. The Minister, the clinical community and, most importantly, the families affected are all eager to see progress towards making this drug available to these children. I will certainly convey the Senator's concerns and comments to the Minister directly.