elexacaftor / tezacaftor / ivacaftor and ivacaftor


( Last Updated : November 4, 2021)
Generic 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

Details


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:
  1. 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