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:
  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 openJanuary 22, 2024
Call for patient/clinician input closedMarch 19, 2024
Clarification:

- Patient input submission received from Cystic Fibrosis Canada

Submission receivedMarch 05, 2024
Submission acceptedMarch 20, 2024
Review initiatedMarch 21, 2024
Draft CADTH review report(s) provided to sponsor for commentJune 06, 2024
Deadline for sponsors commentsJune 17, 2024
CADTH review report(s) and responses to comments provided to sponsorAugust 16, 2024
Expert committee meeting (initial)August 28, 2024
Draft recommendation issued to sponsorSeptember 10, 2024
Draft recommendation posted for stakeholder feedbackSeptember 19, 2024
End of feedback periodOctober 04, 2024
Final recommendation issued to sponsor and drug plansOctober 17, 2024
Final recommendation postedNovember 04, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 31, 2024
CADTH review report(s) postedMarch 17, 2025