Further to the great news on Friday re Trikafta, please see the HSE press statement issued on Friday 13th December 2019  below, which makes clear that all CF patients eligible to be prescribed Trikafta [Triple Combination] will have access, subject to receipt of European Medicines Agency (EMA) approval. This was made clear in all CFI statements and in most media reports, but was slightly mis-reported in one newspaper report (hence some confusion among our members). 

CFI understands that EMA approval is likely to be given in the first 3-4 months of 2020 and perhaps even sooner if approval is fast-tracked by the EMA. CFI further notes that the FDA (Food and Drug Administration) in America approved Trikafta in October 2019, 5 months ahead of schedule and it is already available for many people with CF in the USA, so CFI seen no reason at this point why the EMA will not make a similar decision. 

This is of course remains excellent news!

Philip Watt
CEO
Cystic Fibrosis Ireland 

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