elexacaftor / tezacaftor / ivacaftor and ivacaftor

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Generic Name:

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

Performance Metric:

Achieved

Biosimilar:

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:

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

September 16, 2021

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 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