Mark Ward (Dublin Mid West, Sinn Fein)
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244. To ask the Minister for Health if he will clarify that the cost of cariban, the treatment for hyperemesis gravidarum, can only be reimbursed if prescribed by a consultant; if reimbursement can also be given if prescribed by the person’s GP; if this is not the case, if it can be considered; and if he will make a statement on the matter. [62378/22]

Eoin Ó Broin (Dublin Mid West, Sinn Fein)
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249. To ask the Minister for Health the reason that only consultant prescriptions for cariban for patients with hyperemesis gravidarium are reimbursable; and if this will be reviewed given that most pregnant persons present to their GP with symptoms in advance of appointments with their maternity consultants. [62395/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 244 and 249 together.

As part of Budget 2023, I announced €32.2 million in funding for Women’s Health Initiatives in 2023, to include dedicated funding for Cariban® (doxylamine/pyridoxine). Cariban® is an Exempt Medicinal Product i.e. not licensed with the Health Products Regulatory Authority (HPRA) in Ireland. Following the recommendations of the HSE Medicines Management Programme, this product will be made available on an individual patient basis for those patients who meet the criteria under Community Drug Schemes (GMS, DPS) from January 2023 where Consultant Obstetrician initiated.

Under Community Drug Schemes, Exempt Medicinal Products must be Consultant initiated. However, whilst the original prescriber is a Consultant and specialist in the relevant field, the HSE will accept a GP prescription further to the initial hospital prescription for approved patients.

Paul Kehoe (Wexford, Fine Gael)
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245. To ask the Minister for Health whether he is considering fast-tracking the HTA process to enable access to Kaftrio for the 35 excluded children with Cystic Fibrosis; and if he will make a statement on the matter. [62381/22]

Duncan Smith (Dublin Fingal, Labour)
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262. To ask the Minister for Health if he will provide an update on when the cystic fibrosis drug kaftrio will be available for all children, with specific regard to the 35 children in Ireland who are waiting on the drug; and if he will make a statement on the matter. [62444/22]

Róisín Shortall (Dublin North West, Social Democrats)
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266. To ask the Minister for Health the status of negotiations in respect of a therapy (details supplied) for 35 children living with cystic fibrosis who are excluded from the 2017 agreement; the steps that are being taken to progress this matter; and if he will make a statement on the matter. [62496/22]

Neale Richmond (Dublin Rathdown, Fine Gael)
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272. To ask the Minister for Health if he will provide an update on access to the drug kaftrio for children with cystic fibrosis; and if he will make a statement on the matter. [62551/22]

Patrick Costello (Dublin South Central, Green Party)
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278. To ask the Minister for Health the progress to date in providing kaftrio to the 35 children suffering from cystic fibrous who are currently excluded from accessing it due to a dispute between the manufacturers and the HSE; and if he will make a statement on the matter. [62614/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 245, 262, 266, 272 and 278 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.

I have been advised by the HSE that engagement with Vertex Pharmaceuticals is ongoing, which I hope can be quickly brought to a satisfactory conclusion for everyone.