Aengus Ó Snodaigh (Dublin South Central, Sinn Fein)
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794. To ask the Minister for Health if the drug Kaftrio has been rolled out for cystic fibrosis patients in Ireland; and if not, the reason. [37935/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.

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.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

The HSE has advised that reimbursement was approved in October 2020 for Ivacaftor/ Tezacaftor/ Elexacaftor (Kaftrio®) in a combination regimen with ivacaftor 150 mg tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation.

This reimbursement approval is fully aligned with the EMA market authorisation which issued on 21 August 2020. Irish patients aged 12 years and older with CF and the above specified mutations, for which Kaftrio is licensed, will have reimbursement approval.

HSE reimbursement of Kaftrio is administered under the High Tech Drug Arrangements. The High Tech Drug Arrangements provide for the supply of high-tech medicines through Community Pharmacies. The reimbursement of High Tech medicines is administered by the HSE through the Primary Care Eligibility & Reimbursement Service (PCERS).

Seán Sherlock (Cork East, Labour)
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795. To ask the Minister for Health his views on an issue raised in correspondence (details supplied); and the steps he will take to retain service levels. [37936/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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I have been informed by the HSE that there are currently no plans to change the provision of services at the treatment centre concerned. Any changes to the provision of services would be subject to discussions with and approval by the HSE.

In relation to the issue raised in the correspondence, as GP out-of-hours providers are private organisations, the rostering of GPs is an operational matter for the service provider and the HSE has no role in this regard.