Bernard Durkan (Kildare North, Fine Gael)
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327. To ask the Minister for Health the extent to which efforts have been successful towards resolving the difficulties in providing the appropriate new medicine kaftrio for the 35 children who directly greatly benefit from its use and whose parents are extremely concerned at the long, drawn-out nature of the discussions with the drug firm (details supplied); if immediate steps will be taken to resolve the impasse in early date; and if he will make a statement on the matter. [2563/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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Kaftrio has been a life changing drug for Cystic Fibrosis sufferers, and I want to see it made available to everyone who needs it. This Government wants to ensure greater access to new and innovative medicines and has allocated significant additional funding for new medicines in recent Budgets. Since the beginning of 2021, 99 new medicines, or expanded uses of existing medicines, have been funded. This has included 27 for the treatment of rare diseases, including Cystic Fibrosis.

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

I am grateful to Cystic Fibrosis Ireland (CFI) for meeting with me recently, and outlining the concerns of the Cystic Fibrosis community. We discussed the recent statement from the Consultants providing care for these children, with all parties aligning in the view that the approach taken by the manufacturer, Vertex, is unfair to these children. I reassured CFI of the urgency with which the Government and the HSE are approaching the current situation.

As Vertex are seeking additional funds to cover this group, a Health Technology Assessment (HTA) must be completed by the National Centre for Pharmacoeconomics (NCPE). Vertex has now submitted the required materials to the NCPE. The assessment is underway in accordance with the commitments made jointly by the HSE and NCPE to undertake a priority assessment of this application.

I am glad to see progress on this issue, and hope that it can be quickly brought to a satisfactory conclusion for everyone.