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elexacaftor/tezacaftor/ivacaftor and ivacaftor

Last Updated: February 17, 2021
Result type: Reports
Project Number: SR0673-000
Product Line: Reimbursement Review

Generic Name: elexacaftor/tezacaftor/ivacaftor and ivacaftor

Brand Name: TBC

Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated

Therapeutic Area: Cystic fibrosis, F508del CFTR mutation

Indications: Triple Combination Therapy (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Manufacturer Requested Reimbursement Criteria1: Triple Combination Therapy (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Submission Type: Initial

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

  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/clinician input open December 17, 2020
Call for patient/clinician input closed February 12, 2021
Clarification:

- Patient input submission received from the Canadian Cystic Fibrosis Treatment Society, Cystic Fibrosis Canada and CF Get Loud

Submission received January 22, 2021
Submission accepted February 05, 2021
Review initiated February 08, 2021
Draft CADTH review report(s) provided to sponsor for comment April 23, 2021
Deadline for sponsors comments May 04, 2021
CADTH responses on draft review report(s) provided to sponsor June 04, 2021
Expert committee meeting (initial) June 16, 2021
Draft recommendation issued to sponsor June 28, 2021
To
June 30, 2021
Draft recommendation posted for stakeholder feedback -