Product meets AWMSG exclusion criteria due to NICE appraisal TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis

NICE has recommended tezacaftor–ivacaftor (Symkevi) within its marketing authorisation, and so it is available on the NHS in Wales as follows:

• In a combination regimen with ivacaftor (Kalydeco) alone for the treatment of people aged 6 years and older with cystic fibrosis (CF) who have 2 copies of the CFTR gene with F508del mutations, or who have a copy of the CFTR gene with an F508del mutation and a copy of the CFTR gene with one of the following mutations: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T

This recommendation applies only in circumstances where the approved commercial arrangement price is utilised.