Last Updated : March 21, 2024
Details
Generic Name:
elexacaftor/tezacaftor/ivacaftor and ivacaftor
Project Status:
Active
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
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.
- 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.
| Call for patient/clinician input open | 22-Jan-24 |
|---|---|
| Call for patient/clinician input closed | 19-Mar-24 |
| Clarification: - Patient input submission received from Cystic Fibrosis Canada | |
| Submission received | 05-Mar-24 |
| Submission accepted | - |
| Review initiated | 21-Mar-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 06-Jun-24 |
| Deadline for sponsors comments | 17-Jun-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 12-Jul-24 |
| Expert committee meeting (initial) | 24-Jul-24 |
| Draft recommendation issued to sponsor | August 06, 2024 To August 08, 2024 |
| Draft recommendation posted for stakeholder feedback | 15-Aug-24 |
| End of feedback period | 29-Aug-24 |
Last Updated : March 21, 2024