Back in 2017 Orkambi was reimbursed for market distribution here in Ireland and it was a great boost for the cystic fibrosis, CF, community after a long campaign. A new drug, Kaftrio, has been approved in the USA and by the European Medicines Agency, EMA, in April of this year. I tabled a question to the Minister for Health in early May and I was told the applicants had put in the rapid review dossier for the drug. I flagged this with the Tánaiste yesterday because I hope the CF community will get some clarity today on when the Health Products Regulatory Authority, HPRA, will reimburse the drug and market it.

I thank the Deputy for raising this issue. I know how important it is to the CF community. As a country, we should endeavour to be among the first to approve and reimburse new medicines. It makes sense from a health point of view and it also makes sense from an economic point of view. If we are asking pharmaceutical companies to invest and employ people here, we should be among the first to approve and reimburse their products. At the very least, we should not fall behind our nearest neighbour, the United Kingdom. As a country, we invest heavily in medicines to the tune of €2 billion annually and additional funding of €50 million provided for new medicines this year will support the introduction of a significant number of new medicines. To date this year, 26 approvals for new drugs and new indications for existing drugs have been made.

On Kaftrio, the HSE advises me that, on 26 April, the European Commission approved the EMA’s recommended licence for the extension of Kaftrio to patients aged 12 years or older with CF who have at least one F508del mutation. In line with the agreed formal process governing the reimbursement of new medicines or new indications for existing medicines, the assessment process commences when the applicant submits a rapid review dossier of evidence to the HSE. The HSE has confirmed that it has received the rapid review dossier for the extended indication from the applicant company. It is not possible at this time for the HSE to commit to a precise date for commencement but it advises that the reimbursement is expected to be in place in the coming months for the cohort covered by the EMA decision.