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, 6 years and older
Manufacturer:
Vertex Pharmaceuticals (Canada) Inc.
Brand Name:
Trikafta
Project Line:
Reimbursement Review
Project Number:
SR0710-000
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
​​Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 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:
"​Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) tablets are indicated for the treatment of cystic fibrosis (CF) in patients aged 6 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 open28-Oct-21
Call for patient/clinician input closed16-Dec-21
Clarification:

- Patient input submission received from Cystic Fibrosis Canada and CF Get Loud x

Submission received05-Nov-21
Submission accepted19-Nov-21
Review initiated22-Nov-21
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment22-Feb-22
Deadline for sponsors comments03-Mar-22
CADTH review report(s) and responses to comments provided to sponsor14-Apr-22
Expert committee meeting (initial)27-Apr-22
Draft recommendation issued to sponsor11-May-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Final recommendation issued to sponsor and drug plans17-Jun-22
Final recommendation posted06-Jul-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-Jul-22
CADTH review report(s) posted23-Sep-22