Friday, December 13th 2019

The first drug to treat the underlying cause of cystic fibrosis (CF) for around 80 per cent of the CF population in Ireland has been approved by the Health Service Executive (HSE).

Philip Watt, CEO, Cystic Fibrosis Ireland, comments:
“This is a most wonderful Christmas present for all those with cystic fibrosis in Ireland. The drug therapy ‘Trikafta’ is what many scientists and patients have been waiting for since the basic genetic cause of CF became understood in 1989.”

Trikafta is the first approved treatment that is effective for CF patients age 12 years and over with at least one F508del mutation, which affects 90 per cent of the population with CF worldwide and 80 per cent of the CF population in Ireland, or about 1,000 people.

Trikafta was approved in the United States of America on 21 October 2019, some five months ahead of schedule. Because of the HSE’s announcement today, all patients in Ireland with CF who are age 12 years and over and who have at least one copy of the F508del gene mutation will get access to Trikafta as soon as it is approved by the European Medicines Agency (decision expected in the first quarter of 2020).

Philip Watt adds:
“This means that all those who can benefit from Trikafta aged 12 and over will have access to this drug. It is likely that most of those on existing CF drugs such as Orkambi will transfer over to Trikafta depending on the advice of their clinician. One clinical trial showed that Trikafta increased lung function by a mean of 14 per cent. Research also shows a decrease in exacerbations by up to 60 per cent. This is a new dawn for CF care in Ireland and we thank Minister for Health Simon Harris and the Irish Government for their care and compassion. The decision today effectively means Ireland will be the first country in Europe to receive this drug for its patients. We have great hope now that the life expectancy of people with cystic fibrosis in Ireland will increase steadily over the next few years and, indeed, Ireland may overtake other countries.”

ENDS

Further information: Philip Watt, CEO, Cystic Fibrosis Ireland, tel.: 087 6370557

Read the statement from the HSE below.

Friday, 13th December 2019

HSE Statement

The Health Service Executive in Ireland would like to confirm that after recent collaborative discussions with Vertex, we have expanded our existing reimbursement agreement with Vertex so that all cystic fibrosis patients eligible to be prescribed VX-455 (Elexacaftor), Tezacaftor and Ivacaftor Triple Combination treatment i.e. patients 12 years or older, will have access subject to receipt of EMA approval.  

VX-445 (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is not currently licenced or approved for use in Ireland - Vertex submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) on October 31st 2019.

Ends

Issued by HSE National Press Office

01-92 139 12 / press@hse.ie