HSE approves Kaftrio®

The HSE today (Tuesday, 21st March 2023) has approved the Cystic Fibrosis drug Kaftrio® for use by children aged 6-11 who previously fell outside the eligibility criteria, following robust and lengthy engagements with the drug manufacturer Vertex.

Kaftrio® is used for the treatment of Cystic Fibrosis and we are now extending it for the use in patients aged 6 to 11 years who are heterozygous for the F508del mutation and either a minimal function (MF) mutation, or an unknown mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The HSE is committed to providing access to as many medicines as possible, in as timely a fashion as possible, from the resources available and provided by Government. HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds.

The HSE robustly assesses applications for reimbursement to make sure that it can stretch available resources as far as possible and to deliver the best value in relation to each medicine and ultimately more medicines to Irish citizens and patients.

According to Dr Colm Henry, HSE Chief Clinical Officer, “We are delighted today to announce that Kaftrio® is now to be made available to those children previously ineligible.  We have finalised the negotiated agreement with the manufacturer and are pleased to announce that the HSE has now approved this drug which will improve the lives of the children who can now avail of it.”

Health Minister Stephen Donnelly said: “This is a very welcome development. Kaftrio® has been a life-changing drug for Cystic Fibrosis sufferers and I wanted it made available to everyone who needs it. I would like to commend the HSE and the National Centre for Pharmacoeconomics for working so hard to conclude this agreement with the manufacturer. This is good news for the young children with Cystic Fibrosis who can now access this therapy. It is another important milestone that will help us to continue to improve outcomes for patients with Cystic Fibrosis in this country.”


Last updated on: 21 / 03 / 2023