| 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 lumacaftor/ivacaftor (Orkambi), within its marketing authorisation, and so it is available on the NHS in Wales for treating cystic fibrosis in people 1 year and over who have 2 copies of the CFTR gene with F508del mutations. This recommendation applies only in circumstances where the approved commercial arrangement price is utilised. |
|
Medicine details |
|
| Medicine name | lumacaftor/ivacaftor (Orkambi®) |
| Formulation | Film-coated tablets; granules |
| Reference number | 2734 |
| Indication | Orkambi tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Orkambi granules are indicated for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (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 | |
| Commercial arrangement | CAA |
| Further information See also: |
|