Medicinal Products

Dáil Éireann Debate, Thursday - 16 February 2023

Thursday, 16 February 2023

Ceisteanna (114, 171, 372)

Gino Kenny

Ceist:

114. Deputy Gino Kenny asked the Minister for Health if the HSE has made kaftrio available to all adults and children who need the treatment; and if he will make a statement on the matter. [7664/23]

Joe Carey

Ceist:

171. Deputy Joe Carey asked the Minister for Health if he will provide an update in relation to the health technology assessment which is underway since the 21 December 2022 on the drug kaftrio for the cohort of 35 children aged 6 to 11 years with certain mutations in the cystic fibrosis transmembrane conductance regulator gene; and if he will make a statement on the matter. [7271/23]

James Browne

Ceist:

372. Deputy James Browne asked the Minister for Health the position regarding the NCPE’s assessment of the HTA in respect of securing the drug kaftrio for 35 children who benefit from its use and the HSE’s ongoing discussions with the drug producer; and if he will make a statement on the matter. [7802/23]

Freagraí scríofa

Minister for Health

I propose to take Questions Nos. 114, 171 and 372 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, 112 new medicines, or expanded uses of existing medicines, have been funded. This has included 35 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) had to be completed by the National Centre for Pharmacoeconomics (NCPE). The NCPE has now completed a full assessment and their report has been received by the HSE. The HSE's Corporate Pharmaceutical Unit (CPU) is the interface between the HSE and the Pharmaceutical Industry in relation to medicine pricing and reimbursement applications. CPU have scheduled a meeting with Vertex to discuss their application and recommendation(s) received from the NCPE for Kaftrio.

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