elexacaftor / tezacaftor / ivacaftor and ivacaftor


( Last Updated : September 16, 2021)
Generic Name:
elexacaftor / tezacaftor / ivacaftor and ivacaftor
Project Status:
Active
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 Milestones2

Call for patient/clinician input open17-Dec-20
Call for patient/clinician input closed12-Feb-21
Clarification:

- Patient input submission received from the Canadian Cystic Fibrosis Treatment Society, Cystic Fibrosis Canada and CF Get Loud

Submission received22-Jan-21
Submission accepted05-Feb-21
Review initiated08-Feb-21
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment04-May-21
Deadline for sponsors comments13-May-21
CADTH responses on draft review report(s) provided to sponsor04-Jun-21
Expert committee meeting (initial)16-Jun-21
Draft recommendation issued to sponsor28-Jun-21
Draft recommendation posted for stakeholder feedback08-Jul-21
End of feedback period22-Jul-21
Clarification:

- Reconsideration: major revisions requested by sponsor

- Reconsideration: minor revisions requested by drug programs

Expert committee meeting18-Aug-21
Final recommendation issued to sponsor and drug plans30-Aug-21
Final recommendation posted16-Sep-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)14-Sep-21
CADTH review report(s) posted