Joe Carey (Clare, Fine Gael)
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1382. To ask the Minister for Health if he will ensure that the health technology assessment dossier covering kaftrio in combination with ivacaftor for the cohort of 35 children aged 6 to 11 years with certain mutations in the cystic fibrosis transmembrane conductance regulator gene which was submitted to the National Centre for Pharmacoeconomics on 21 December 2022 moves as expeditiously as possible, with appropriate input from the patient community thereby giving access to this life changing drug for these vulnerable children at the earliest opportunity; and if he will make a statement on the matter. [1024/23]

Paul Kehoe (Wexford, Fine Gael)
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1404. To ask the Minister for Health if he will provide an update on the position of access to kaftrio for the 35 excluded children with cystic fibrosis; and if he will make a statement on the matter. [1134/23]

Johnny Guirke (Meath West, Sinn Fein)
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1624. To ask the Minister for Health if he will provide an update in relation to drug reimbursement for the lifesaving cystic fibrosis drug kaftrio; the reason that some young patients aged six to 11 years are still excluded from the reimbursement scheme; if he will intervene at this stage to ensure that the drug is made available to all cystic fibrosis patients currently in urgent need of it; and if he will make a statement on the matter. [1867/23]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 1382, 1404 and 1624 together.

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.