elexacaftor/tezacaftor/ivacaftor and ivacaftor


( Last Updated : November 29, 2021)
Generic Name:
elexacaftor/tezacaftor/ivacaftor and ivacaftor
Project Status:
Active
Therapeutic Area:
Cystic fibrosis, F508del CFTR mutation, 6 years and older
Manufacturer:
Vertex Pharmaceuticals (Canada) Inc.
Call for patient/clinician input open:
Brand Name:
Trikafta
Project Line:
Reimbursement Review
Project Number:
SR0710-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
​​Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
"​Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene."
  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 Milestones

Call for patient/clinician input open October 28, 2021
Call for patient/clinician input closed December 16, 2021
Submission received November 05, 2021
Submission accepted November 19, 2021
Review initiated November 22, 2021
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment February 10, 2022
Deadline for sponsors comments February 22, 2022
CADTH review report(s) and responses to comments provided to sponsor April 14, 2022
Expert committee meeting (initial) April 27, 2022
Draft recommendation issued to sponsor May 09, 2022
To
May 11, 2022
Draft recommendation posted for stakeholder feedback May 19, 2022
End of feedback period June 03, 2022