lumacaftor/ivacaftor

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Generic Name:
lumacaftor/ivacaftor
Project Status:
Complete
Therapeutic Area:
Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older
Manufacturer:
Vertex Pharmaceuticals (Canada) Incorporated
Call for patient/clinician input open:
Brand Name:
Orkambi
Project Line:
Reimbursement Review
Project Number:
SR0559-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of cystic fibrosis (CF) in patients 6 years of age and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older
Date NOC Issued:
Recommendation Type:
Do not reimburse
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input posted January 24, 2018
Patient group input closed March 15, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups March 26, 2018
Patient group comments on input summary closed April 03, 2018
Clarification:

- Patient input summary feedback received

Submission received February 22, 2018
Submission accepted for review March 08, 2018
Review initiated March 09, 2018
Draft CDR review report(s) sent to applicant May 29, 2018
Comments from applicant on draft CDR review report(s) received June 07, 2018
Redaction requests from applicant on draft CDR review report(s) received June 14, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans August 01, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 16, 2018
Clarification:

- Request for Clarification received from CDR Participating Drug Plans

Drug plans' request for clarification placed on CDEC agenda September 19, 2018
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans September 26, 2018
CDEC Final Recommendation posted October 04, 2018
Clarification:

- Target posting of CDEC Final Recommendation October 4, 2018

Final CDR review report(s) posted October 12, 2018