Written answers

Tuesday, 8 September 2020

Department of Health

Medicinal Products

Photo of Peter FitzpatrickPeter Fitzpatrick (Louth, Independent)
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1204. To ask the Minister for Health when the drug kalydeco will be made be available to patients for the treatment of cystic fibrosis in view of the fact the clinical trial for same has finished; and if he will make a statement on the matter. [21578/20]

Photo of Stephen DonnellyStephen Donnelly (Wicklow, Fianna Fail)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

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

Ivacaftor (Kalydeco®) has received marketing authorisation from the EMA for a number of indications. I am advised by the HSE that reimbursement has been approved for all ivacaftor monotherapy indications for which the EMA has granted market authorisations and that there is no market-authorised indication or cohort of cystic fibrosis patients eligible for ivacaftor monotherapy for which reimbursement is not in place.

The HSE advises that it has also approved reimbursement for the combination regimen with tezacaftor. The HSE expects that cystic fibrosis patients in Ireland will be able to avail of the combination regimen with ivacaftor75mg/tezacaftor50mg/elexacaftor100mg tablets in Q4 of 2020.

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