People with cystic fibrosis (CF) living in Wales should get speedy access to Vertex’ new therapy following its approval by Europe regulators.
The company has agreed a letter of intent with NHS Wales to expand its reimbursement agreement for CF medicines to include Kaftrio (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with ivacaftor 150 mg, upon the medicine’s anticipated marketing clearance by the European Commission.
Once finalised, the expanded agreement will include reimbursed access for eligible patients to Kaftrio in a combination regimen with ivacaftor, as well as Vertex’ currently licensed medicines Kalydeco (ivacaftor), Orkambi (lumacaftor/ivacaftor) and Symkevi (ivacaftor/tezacaftor).
The move is in line with the recently announced agreement between Vertex and NHS England, and follows a recommendation for approval by the European Medicines Agency’s human medicines committee for the Kaftrio/ivacaftor combination to treat CF in people aged 12 and older with one F508del mutation and one minimal function mutation (F/MF) or two F508del mutations (F/F) in the CF transmembrane conductance regulator (CFTR) gene.
“I’m pleased that we have been able to work quickly and in partnership with the authorities in Wales to come to the terms of an agreement that, once finalised, would provide patients in Wales access to Kaftrio in a combination regimen with ivacaftor, upon anticipated approval from the European Commission.”
The company said it is still working closing with authorities in Scotland and Northern Ireland to secure equivalent agreements “as soon as possible”.
