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ivacaftor (Kalydeco)

Advice

Following a resubmission:

ivacaftor (Kalydeco®) is not recommended for use within NHS Scotland.

Indication under review: treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Ivacaftor has demonstrated superiority over placebo measured by absolute change in forced expiratory volume in one second (FEV1) % predicted in two phase III, double-blind randomised studies.

The submitting company’s justification of the treatment’s cost in relation to its health benefits was not sufficient and in addition the company did not present a sufficiently robust economic assessment to gain acceptance by SMC.

Drug Details

Drug Name: ivacaftor (Kalydeco)
SMC Drug ID: 827/12
Manufacturer: Vertex Pharmaceuticals Ltd
Indication: For the treatment of cystic fibrosis (CF) in patients age 6 years and older who have a G551D mutation in the CFTR (cystic fibrosis transmembrane conductance regulator) gene.
BNF Category:
Sub Category: 3.7 Mucolytics
Submission Type: Resubmission
Status: Not Recommended
Date Advice Published: 10 June 2013

Archived Advice

Full submission 14 January 2013

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