awmsg logo



ivacaftor (Kalydeco®)


Reference No. 2294

Publication date:
05/01/2016


Appraisal information

ivacaftor (Kalydeco®) 150 mg film-coated tablet


Company: Vertex Pharmaceuticals UK Ltd
BNF category: Respiratory system
NMG meeting date: 09/09/2015
AWMSG meeting date: 09/12/2015
   
   
Submission Type: Full Submission
Status: Recommended
Advice No: 4415
Ministerial ratification: 30/12/2015

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Ivacaftor (Kalydeco®) is recommended for use within NHS Wales for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene: G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme is utilised.
Final Appraisal Recommendation (FAR)
Download
AWMSG Secretariat Appraisal Report (ASAR)
Download
Clinical Expert (CE) Summary
Download
Clinician and Patient Involvement Group (CAPIG) Meeting Summary
Download