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encorafenib and binimetinib

Last Updated: December 21, 2020
Result type: Reports
Project Number: PC0232-000
Product Line: Reimbursement Review

Generic Name: encorafenib and binimetinib

Brand Name: Braftovi and Mektovi

Manufacturer: Pfizer Canada ULC

Therapeutic Area: Advanced Melanoma

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.

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

Tumour Type: Skin & Melanoma

NOC Status at Filing: Pre NOC

Project Status: Active

Companion Diagnostics: Yes

Fee Schedule1: Schedule A

  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 openNovember 17, 2020
Call for patient/clinician input closedJanuary 15, 2021
Clarification:

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

Submission receivedDecember 16, 2020
Submission acceptedJanuary 07, 2021
Review initiatedJanuary 08, 2021
Draft CADTH review report(s) provided to sponsor for commentMarch 31, 2021
Deadline for sponsors commentsApril 12, 2021
CADTH responses on draft review report(s) provided to sponsorMay 03, 2021
Expert committee meeting (initial)May 13, 2021
Draft recommendation issued to sponsorMay 26, 2021
To
May 28, 2021
Draft recommendation posted for stakeholder feedback-