Last Updated : September 15, 2021
Details
FilesGeneric Name:
encorafenib and binimetinib
Project Status:
Complete
Therapeutic Area:
Advanced Melanoma
Manufacturer:
Pfizer Canada ULC
Brand Name:
Braftovi and Mektovi
Project Line:
Reimbursement Review
Project Number:
PC0232-000
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Braftovi (encorafenib): In combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. Mektovi (binimetinib): In combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Braftovi (encorafenib): In combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test. Mektovi (binimetinib): In combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600 mutation, as detected by a validated test.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 Milestones2 | |
|---|---|
| Call for patient/clinician input open | 17-Nov-20 |
| Call for patient/clinician input closed | 15-Jan-21 |
| Clarification: - Patient input submission received from Melanoma Network of Canada and Save Your Skin Foundation | |
| Submission received | 16-Dec-20 |
| Submission accepted | 07-Jan-21 |
| Review initiated | 08-Jan-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 31-Mar-21 |
| Deadline for sponsors comments | 12-Apr-21 |
| CADTH responses on draft review report(s) provided to sponsor | 03-May-21 |
| Expert committee meeting (initial) | 14-May-21 |
| Draft recommendation issued to sponsor | 31-May-21 |
| Draft recommendation posted for stakeholder feedback | 10-Jun-21 |
| End of feedback period | 24-Jun-21 |
| Final recommendation issued to sponsor and drug plans | 08-Jul-21 |
| Final recommendation posted | 26-Jul-21 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 22-Jul-21 |
| CADTH review report(s) posted | 15-Sep-21 |
Files
Last Updated : September 15, 2021