encorafenib and binimetinib


( Last Updated : September 15, 2021)
Generic 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

Details


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:
  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-Nov-20
Call for patient/clinician input closed15-Jan-21
Clarification:

- Patient input submission received from Melanoma Network of Canada and Save Your Skin Foundation

Submission received16-Dec-20
Submission accepted07-Jan-21
Review initiated08-Jan-21
Draft CADTH review report(s) provided to sponsor for comment31-Mar-21
Deadline for sponsors comments12-Apr-21
CADTH responses on draft review report(s) provided to sponsor03-May-21
Expert committee meeting (initial)14-May-21
Draft recommendation issued to sponsor31-May-21
Draft recommendation posted for stakeholder feedback10-Jun-21
End of feedback period24-Jun-21
Final recommendation issued to sponsor and drug plans08-Jul-21
Final recommendation posted26-Jul-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)22-Jul-21
CADTH review report(s) posted15-Sep-21