Medicinal Products

Dáil Éireann Debate, Wednesday - 14 September 2022

Wednesday, 14 September 2022

Questions (469, 505, 530)

Denis Naughten

Question:

469. Deputy Denis Naughten asked the Minister for Health further to Parliamentary Question No. 258 of 11 May 2022, when the HSE will approve the reimbursement under the high-tech drug arrangements for kaftrio for children under 12 years of age; the reason for the delay in approval in view of the fact that it has already been approved for children aged 12 years and over; the steps taken by the HSE to consider this dossier; the dates on which these steps were taken; if all outstanding queries have been addressed by the applicant company; if so, when; and if he will make a statement on the matter. [44404/22]

David Cullinane

Question:

505. Deputy David Cullinane asked the Minister for Health the status of the reimbursement pricing negotiations for the cystic fibrosis medication kaftrio for children aged six to 11 years; and if he will make a statement on the matter. [44492/22]

Denis Naughten

Question:

530. Deputy Denis Naughten asked the Minister for Health further to Parliamentary Question No. 258 of 11 May 2022, the reason that the HSE is seeking a health technology appraisal for kaftrio for children under 12 years of age; the reason for the delay in approval in view of the fact that it has already been approved for children aged 12 years and over; and if he will make a statement on the matter. [44561/22]

Written answers

Minister for Health

I propose to take Questions Nos. 469, 505 and 530 together.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply to the Deputy.