| Status: Excluded due to NICE appraisal |
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 ivacaftor (Kalydeco), within it marketing authorisation, and so it is available on the NHS in Wales as follows:
- In a combination regimen with tezacaftor/ivacaftor (Symkevi) 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
- In a combination regimen with ivacaftor/tezacaftor/elexacaftor (Kaftrio) for the treatment of people aged 2 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene.
This recommendation applies only in circumstances where the approved commercial arrangement price is utilised. |
Medicine details
|
| Medicine name |
ivacaftor (Kalydeco®) |
| Formulation |
Film-coated tablets; granules |
| Reference number |
772 |
| Indication |
Kalydeco tablets are indicated:
- In a combination regimen with tezacaftor/ivacaftor tablets for the treatment of adults and children aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del mutation or who are heterozygous for the F508del mutation and have one of the following mutations in the CFTR gene: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
- In a combination regimen with ivacaftor/tezacaftor/elexacaftor tablets for the treatment of adults, adolescents and children aged 6 years and older with cystic fibrosis (CF) who have at least one F508del mutation in the CFTR gene.
Kalydeco granules are indicated in a combination regimen with ivacaftor/tezacaftor/elexacaftor for the treatment of cystic fibrosis (CF) in paediatric patients aged 2 to less than 6 years who have at least one F508del mutation in the CFTR gene. |
| Company |
Vertex Pharmaceuticals UK Ltd |
| BNF chapter |
Respiratory system |
| Submission type |
N/A |
| Status |
Excluded due to NICE appraisal |
| Date of issue |
24/07/2024 |
| NICE guidance |
TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis |
| Commercial arrangement |
CAA |
Further information
See also:
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