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ivacaftor (Kalydeco®)


Reference No. 2770

Publication date:
04/01/2017


Appraisal information

ivacaftor (Kalydeco®) 50 mg granules
ivacaftor (Kalydeco®) 75 mg granules


Company: Vertex Pharmaceuticals UK Ltd
BNF category: Respiratory system
NMG meeting date: 02/11/2016
AWMSG meeting date: 07/12/2016
   
   
Submission Type: Limited Submission
Status: Recommended
Advice No: 3716
Ministerial ratification: 22/12/2016

Current Progress


Submission
received
NMG
meeting
AWMSG
meeting
Ministerial
Ratification

AWMSG advice

Ivacaftor (Kalydeco®) granules are recommended as an option for use within NHS Wales for the treatment of children with cystic fibrosis (CF) aged 2 years to less than 6 years and weighing less than 25 kg who have one of the following gating (class III) mutations in the CF transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. 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)
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AWMSG Secretariat Appraisal Report (ASAR)
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Clinical Expert (CE) Summary
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