elexacaftor/tezacaftor/ivacaftor and ivacaftor


( Last Updated : July 29, 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.
  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 openDecember 17, 2020
Call for patient/clinician input closedFebruary 12, 2021
Clarification:

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

Submission receivedJanuary 22, 2021
Submission acceptedFebruary 05, 2021
Review initiatedFebruary 08, 2021
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentMay 04, 2021
Deadline for sponsors commentsMay 13, 2021
CADTH responses on draft review report(s) provided to sponsorJune 04, 2021
Expert committee meeting (initial)June 16, 2021
Draft recommendation issued to sponsorJune 28, 2021
Draft recommendation posted for stakeholder feedbackJuly 08, 2021
End of feedback periodJuly 22, 2021
Clarification:

- Reconsideration: major revisions requested by sponsor

- Reconsideration: minor revisions requested by drug programs

Expert committee meetingAugust 18, 2021