Last Updated : November 4, 2021
Details
FilesGeneric Name:
elexacaftor / tezacaftor / ivacaftor and ivacaftor
Project Status:
Complete
Therapeutic Area:
Cystic fibrosis, F508del CFTR mutation
Manufacturer:
Vertex Pharmaceuticals (Canada) Incorporated
Brand Name:
Trikafta
Project Line:
Reimbursement Review
Project Number:
SR0673-000
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Triple Combination Therapy (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Triple Combination Therapy (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets for the treatment of cystic fibrosis (CF) in patients aged 12 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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones |
|
|---|---|
| Call for patient/clinician input open | 17-Dec-20 |
| Call for patient/clinician input closed | 12-Feb-21 |
| Clarification:
- Patient input submission received from the Canadian Cystic Fibrosis Treatment Society, Cystic Fibrosis Canada and CF Get Loud |
|
| Submission received | 22-Jan-21 |
| Submission accepted | 05-Feb-21 |
| Review initiated | 08-Feb-21 |
| Clarification:
- Selected for CADTH/INESSS Joint Clinician Engagement |
|
| Draft CADTH review report(s) provided to sponsor for comment | 04-May-21 |
| Deadline for sponsors comments | 13-May-21 |
| CADTH responses on draft review report(s) provided to sponsor | 04-Jun-21 |
| Expert committee meeting (initial) | 16-Jun-21 |
| Draft recommendation issued to sponsor | 28-Jun-21 |
| Draft recommendation posted for stakeholder feedback | 08-Jul-21 |
| End of feedback period | 22-Jul-21 |
| Clarification:
- Reconsideration: major revisions requested by sponsor - Reconsideration: minor revisions requested by drug programs |
|
| Expert committee meeting | 18-Aug-21 |
| Final recommendation issued to sponsor and drug plans | 30-Aug-21 |
| Final recommendation posted | 16-Sep-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 14-Sep-21 |
| CADTH review report(s) posted | 03-Nov-21 |
Files
Last Updated : November 4, 2021