encorafenib

Details

Files

Generic Name:

encorafenib

Project Status:

Complete

Therapeutic Area:

Metastatic colorectal cancer

Manufacturer:

Pfizer Canada ULC

Brand Name:

Braftovi

Project Line:

Reimbursement Review

Project Number:

PC0233-000

Tumour Type:

Gastrointestinal

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

In combination with cetuximab, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test, after prior therapy.

Submission Type:

Initial

Companion Diagnostics:

Yes

Fee Schedule:

Schedule A

Indications:

In combination with cetuximab, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by a validated test, after prior therapy.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

July 26, 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 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 Colorectal Cancer Canada and Colorectal Cancer Resource & Action Network
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	24-Mar-21
Deadline for sponsors comments	05-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	16-Sep-21