EU grants marketing authorisation of ivacaftor/tezacaftor/elexacaftor (Kaftrio) for cystic fibrosis

Approval is for treatment of cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation or heterozygous for the F508del in the cystic fibrosis transmembrane conductance regulator gene with a minimal function mutation.

SPS commentary:

NHS England has negotiated a four-year deal so that eligible patients will now have access to the treatment. The criteria are defined in the urgent commissioning policy.

PharmaTimes

Resource links:

NHS England press release:

Clinical Commissioning Urgent Policy Statement: Cystic fibrosis modulator therapies access agreement for licensed mutations:

Clinical Commissioning Urgent Policy Statement