awmsg logo



ivacaftor (Kalydeco®)


Reference No. 2680

Publication date:
10/10/2017


Appraisal information

ivacaftor (Kalydeco®) 150mg film-coated tablet


Company: Vertex Pharmaceuticals UK Ltd
BNF category: Respiratory system
NMG meeting date: 08/02/2017
AWMSG meeting date: 15/03/2017
   
   
Submission Type: Full Submission
Status: Recommended with restrictions
Advice No: 1017
Ministerial ratification: 06/10/2017

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Ivacaftor (Kalydeco®) is recommended for restricted use within NHS Wales for the treatment of patients with cystic fibrosis (CF) aged 18 years and older who have an R117H mutation in the CF transmembrane conductance regulator (CFTR) gene. This recommendation will apply only when people are treated in line with the relevant Welsh clinical access policy. This recommendation applies only in circumstances where the approved Wales Patient Access Scheme (WPAS) is utilised or where the list/contract price is equivalent or lower than the WPAS price.
Final Appraisal Recommendation (FAR)
Download
AWMSG Secretariat Appraisal Report (ASAR)
Download
Clinician and Patient Involvement Group (CAPIG) Meeting Summary
Download
Clinical Expert (CE) Summary
Download