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lumacaftor/ivacaftor

Last Updated: November 5, 2018
Result type: Reports
Project Number: SR0559-000
Product Line: Common Drug Review

Generic Name: lumacaftor/ivacaftor

Brand Name: Orkambi

Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated

Indications: Cystic Fibrosis, F508del CFTR mutation in patients 6 years and older

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: New Indication

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: September 26, 2018

Recommendation Type: Do not reimburse

Fee Schedule: Schedule B

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedJanuary 24, 2018
Patient group input closedMarch 15, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsMarch 26, 2018
Patient group comments on input summary closedApril 03, 2018
Clarification:

- Patient input summary feedback received

Submission receivedFebruary 22, 2018
Submission accepted for reviewMarch 08, 2018
Review initiatedMarch 09, 2018
Draft CDR review report(s) sent to applicantMay 29, 2018
Comments from applicant on draft CDR review report(s) receivedJune 07, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJune 14, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansAugust 01, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedAugust 16, 2018
Clarification:

- Request for Clarification received from CDR Participating Drug Plans

Drug plans' request for clarification placed on CDEC agendaSeptember 19, 2018
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plansSeptember 26, 2018
CDEC Final Recommendation postedOctober 04, 2018
Clarification:

- Target posting of CDEC Final Recommendation October 4, 2018

Final CDR review report(s) postedOctober 12, 2018