Seanad debates

Wednesday, 18 May 2022

Nithe i dtosach suíonna - Commencement Matters

Medicinal Products

10:30 am

Photo of Jerry ButtimerJerry Buttimer (Fine Gael)
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I welcome the Minister of State to the House. I raise this on behalf of the 36 children excluded, particularly Eimear and her mom Julie. This is about the availability and accessibility of a life-changing cystic fibrosis drug. A total of 36 children between the ages of six and 11 are being excluded. It makes no sense, as the treatment prevents damage to the lungs. Cystic fibrosis diminishes the quality of life and left expectancy of young children who have it. This new medication Kaftrio allows cystic fibrosis patients to live a fairly normal life. I know of a number of young children who have it and have benefited enormously from this drug therapy. Their quality of life has been enhanced beyond words. It is a vexing issue for the families in question, that is, Eimear, her mom Julie and the 35 other children.

There is the issue of gene mutation not being covered by the HSE. Cystic Fibrosis Ireland, which has done an extraordinary amount of work and advocacy, including on this matter, has asked the HSE and the pharmaceutical company to return to the negotiating table to allow the 35 children to access this life-saving drug. It is a pricing dispute, from what I can gather. More important, this is about enhancing the quality of life of young people, ensuring we do not allow further damage to their lungs and pancreas and, as the Minister of State said, the postcode lottery is eliminated and we allow for accessibility.Cystic Fibrosis Ireland asks that the children in this case are not used as pawns in a pricing dispute between a pharmaceutical company and the HSE.

We are discussing a difficult issue. If we have learned nothing else from Covid-19, we have learned that we can change how we do business at the flick of a switch. I urge that we do something similar in this case. We should not allow young children and their families to be used a part of a negotiation between the HSE and a pharmaceutical company.

A press release from Cystic Fibrosis Ireland states:

Cystic Fibrosis Ireland understands that Vertex is currently seeking an enhanced price for the 35 children concerned, which is different to the price charged for all other children and adults under the Portfolio Agreement. As a result, we understand that the HSE has been unwilling to accept this price and has instead referred the matter to the National Centre for Pharmaco-Economics (NCPE).

I am sure Professor Barry has a role to play in that as well.

On behalf of the children, their families and Cystic Fibrosis Ireland, I implore those concerned to find a resolution to this matter and to allow access to the Kaftrio drug therapy. This is about quality of life and enhancement of life, and about saying to these children that they can live a life free from worry and concern.

I thank the Minister of State for coming to the House to represent the Minister for Health. I know this is not her area of responsibility. I ask her to convey to the Minister my concerns and those of the families.

Photo of Mary ButlerMary Butler (Waterford, Fianna Fail)
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I thank the Senator for raising this important issue. For Eimear, her mum Julie and the 35 other children he referred to, this is a very important issue, especially for families with children who suffer from debilitating conditions.

As the Senator will know, the HSE has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes and for the administration of the community drug schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority. In line with the 2013 Health Act and the national framework agreed with industry, a company must submit an application to the HSE to have a new medicine added to the reimbursement list. The HSE robustly assesses applications for pricing and reimbursement to make sure it can deliver the best value in terms of each medicine and ultimately make more medicines available to Irish citizens who need them.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds on the advice of the National Centre for Pharmacoeconomics. The NCPE conducts health technology assessments for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess a drug's clinical and cost-effectiveness as a health intervention.

The HSE has advised that on 7 January 2022, the European Medicines Agency approved a change to the marketing authorisation for the medicinal product Kaftrio. This change expanded the group of cystic fibrosis patients for which this medicine is now licensed and that is good news. On 21 March 2022, the HSE received a rapid review dossier from the manufacturer for a pricing and reimbursement application for Kaftrio to treat a group of patients aged between six and 11 years covered by the EMA's expanded marketing authorisation. Following assessment by the HSE, and in line with agreed processes, reimbursement is in place from May for these children under the high-tech drug arrangements. The HSE has also advised that another pricing and reimbursement application with respect to Kaftrio for a further group of patients of the same age was received on 11 April 2022 and is currently undergoing assessment in line with the 2013 Act.

The HSE has, to date, engaged in five commercial meetings with the manufacturer between 6 January 2022 and 14 April 2022 to discuss this application. The NCPE rapid review assessment report for the application was received by the HSE on 10 May 2022. The NCPE advised that a full health technology assessment was recommended to assess the clinical effectiveness and cost-effectiveness of this indication compared with the current standard of care. The HSE advises that it commissioned a full health technology assessment on 16 May as per standard process.

The HSE executive management team is the decision-making body for the reimbursement of medicines under the Health Act 2013. It will, following the NCPE's assessment and receipt of the outcome of the drugs group's deliberations, make the decision on whether Kaftrio will be reimbursed for this indication.

To sum up, the Senator was quite right that this all about enhancing the quality of life of these children. A lot of work is under way behind the scenes. Four meetings have taken place, one of which was held as recently as 16 May. I am hopeful and confident that because this drug has been made available to some children who have cystic fibrosis, more progress will be made for the families to whom he referred.

Photo of Jerry ButtimerJerry Buttimer (Fine Gael)
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I thank the Minister of State for the encouraging words at the end of her contribution. She is right that the drug has been made available to some people. I believe that others should not be excluded from receiving the drug and hope that progress will be made. As the Minister of State said, there is work under way behind the scenes. I ask her to ask the Minister for Health, Deputy Stephen Donnelly, to meet representatives of Cystic Fibrosis Ireland. The organisation asked to meet him and I hope such a meeting will take place.

As the Minister of State said, we need an outcome that ensures progress continues and all of the affected children can avail of this life-changing, fantastic drug, Kaftrio. As I keep saying, the pandemic has taught us how to change the way we operate and do things differently. I am sure we can apply a pandemic-style approach to this matter to ensure the progress made continues and that access is opened to all.

Photo of Mary ButlerMary Butler (Waterford, Fianna Fail)
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The Minister for Health appreciates the desire of families to see their children who suffer from this debilitating condition access all potential treatments as soon as possible. However, section 6 of the Health Service Executive (Governance) Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or personal service to any individual or to confer eligibility on any individual.

As the Senator will be aware, the Oireachtas put in place a robust legal framework in the 2013 Health Act which gives full statutory powers to the HSE to assess and make decisions on the reimbursement of medicines. An allocation of €30 million in budget 2022 has enabled the HSE to approve 24 new medicines to date this year. That is very good news. The Senator will appreciate that given the ongoing assessment process with respect to Kaftrio, the HSE is not in a position to comment further on this application. I will convey to the Minister his view that speed is of the utmost importance to these children and his request, on behalf of Cystic Fibrosis Ireland, for a meeting with the Minister.