Orkambi now available to children aged between 6 and 11 with Cystic Fibrosis
The availability of the drug Orkambi has been extended to eligible children with Cystic Fibrosis aged between six and 11.
This comes following EMA approval in January of this year.
The 2017 agreement between the manufacturer, Vertex Pharmaceuticals, and the HSE included the extension to other age groups, subject to market authorisation in Europe.
"It’s very positive news that Orkambi is now licenced and available for reimbursement in Ireland for CF patients aged 6 to 11," said Minister for Health Simon Harris.
"Orkambi was already licenced and available for reimbursement for children aged 12 years and over. The extension to the younger children became possible following EMA approval in January of this year.
"This quick turnaround between approval and availability was possible because we ensured the younger age group was included in the agreement with the company Vertex last year, subject to market authorisation in Europe."
I am very pleased that Ireland is one of the first countries in the European Union to provide access to Orkambi for children in this age category.
The manufacturer of the drug, Vertex, has welcomed the decision.
"The announcement that Orkambi (lumacaftor/ ivacaftor) can be offered to eligible children with cystic fibrosis from age six demonstrates what can be achieved through an innovative approach to funding.
We are pleased that in Ireland all parties were able to get together and find a solution that now means that only seven weeks after European Commission approval children can be initiated on the medicine.
"This process usually takes in excess of a year.
"“For people with cystic fibrosis every day counts and there is a growing body of evidence that suggests that using medicines early to treat the underlying cause of cystic fibrosis could modify the course of the disease."
