elexacaftor/tezacaftor/ivacaftor and ivacaftor

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Generic Name:
elexacaftor/tezacaftor/ivacaftor and ivacaftor
Project Status:
Complete
Therapeutic Area:
Cystic fibrosis, F508del 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:
SR0776-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Confirmed diagnosis with CF with at least one F508del mutation in the CFTR gene 2-5 years of age
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) is indicated 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.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
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/clinician input openMarch 28, 2023
Call for patient/clinician input closedMay 23, 2023
Clarification:

- Patient input submission received from Cystic Fibrosis Canada

Submission receivedMay 10, 2023
Submission acceptedMay 25, 2023
Review initiatedMay 26, 2023
Draft CADTH review report(s) provided to sponsor for commentAugust 10, 2023
Deadline for sponsors commentsAugust 21, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 18, 2023
Draft recommendation posted for stakeholder feedbackOctober 26, 2023
End of feedback periodNovember 09, 2023
Final recommendation issued to sponsor and drug plansNovember 24, 2023
Final recommendation postedDecember 12, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 08, 2023
CADTH review report(s) postedFebruary 09, 2024