Canada’s Drug Agency | Drugs, Health Technologies and Systems.

elexacaftor/tezacaftor/ivacaftor and ivacaftor

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Generic Name:
elexacaftor/tezacaftor/ivacaftor and ivacaftor
Project Status:
Complete
Therapeutic Area:
Cystic fibrosis, F508del or responsive CFTR mutation, 2 years and older
Manufacturer:
Vertex Pharmaceuticals (Canada) Incorporated
Call for patient/clinician input open:
Brand Name:
Trikafta
Project Line:
Reimbursement Review
Project Number:
SR0837-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Confirmed diagnosis of CF (with or without a F508del mutation) Age 2 years of age or older
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in patients aged 2 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on in vitro and/or clinical data.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation/Report:
  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/clinician input open22-Jan-24
Call for patient/clinician input closed19-Mar-24
Clarification:

- Patient input submission received from Cystic Fibrosis Canada

Submission received05-Mar-24
Submission accepted20-Mar-24
Review initiated21-Mar-24
Draft CADTH review report(s) provided to sponsor for comment06-Jun-24
Deadline for sponsors comments17-Jun-24
CDA-AMC review report(s) and responses to comments provided to sponsor16-Aug-24
Expert committee meeting (initial)28-Aug-24
Draft recommendation issued to sponsor10-Sep-24
Draft recommendation posted for stakeholder feedback19-Sep-24
End of feedback period04-Oct-24
Final recommendation issued to sponsor and drug plans17-Oct-24
Final recommendation posted04-Nov-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)31-Oct-24
CDA-AMC review report(s) posted17-Mar-25

Files

Recommendation and Reason View PDF
Clinical and Pharmacoeconomic Combined Report View PDF
Feedback on Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : March 17, 2025