Last Updated : February 9, 2024
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | March 28, 2023 |
|---|---|
| Call for patient/clinician input closed | May 23, 2023 |
| Clarification: - Patient input submission received from Cystic Fibrosis Canada | |
| Submission received | May 10, 2023 |
| Submission accepted | May 25, 2023 |
| Review initiated | May 26, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | August 10, 2023 |
| Deadline for sponsors comments | August 21, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | September 15, 2023 |
| Expert committee meeting (initial) | September 27, 2023 |
| Draft recommendation issued to sponsor | October 18, 2023 |
| Draft recommendation posted for stakeholder feedback | October 26, 2023 |
| End of feedback period | November 09, 2023 |
| Final recommendation issued to sponsor and drug plans | November 24, 2023 |
| Final recommendation posted | December 12, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 08, 2023 |
| CADTH review report(s) posted | February 09, 2024 |
Files
Last Updated : February 9, 2024