Generic Name: elexacaftor/tezacaftor/ivacaftor and ivacaftor
Brand Name: TBC
Manufacturer: Vertex Pharmaceuticals (Canada) Incorporated
Therapeutic Area: Cystic fibrosis, F508del CFTR mutation
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.
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
NOC Status at Filing: Pre NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule A
- 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 open | December 17, 2020 |
| Call for patient/clinician input closed | February 12, 2021 |
| Clarification:
- Patient input submission received from the Canadian Cystic Fibrosis Treatment Society, Cystic Fibrosis Canada and CF Get Loud |
|
| Submission received | January 22, 2021 |
| Submission accepted | February 05, 2021 |
| Review initiated | February 08, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | April 23, 2021 |
| Deadline for sponsors comments | May 04, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | June 04, 2021 |
| Expert committee meeting (initial) | June 16, 2021 |
| Draft recommendation issued to sponsor | June 28, 2021 To June 30, 2021 |
| Draft recommendation posted for stakeholder feedback | - |