pembrolizumab

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Generic Name:

pembrolizumab

Project Status:

Complete

Therapeutic Area:

Colorectal cancer

Manufacturer:

Merck Canada Inc.

Call for patient/clinician input open:

November 2, 2020

Brand Name:

Keytruda

Project Line:

Reimbursement Review

Project Number:

PC0235-000

Call for patient/clinician input closed:

December 24, 2020

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the first line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC)

Submission Type:

Initial

Companion Diagnostics:

Yes

Fee Schedule:

Schedule A

Indications:

For the first line treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC)

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

July 27, 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	02-Nov-20
Call for patient/clinician input closed	24-Dec-20
Clarification: - Patient input submission received from Colorectal Cancer Canada and Colorectal Cancer Resource & Action Network
Submission received	30-Nov-20
Submission accepted	14-Dec-20
Review initiated	15-Dec-20
Draft CADTH review report(s) provided to sponsor for comment	08-Mar-21
Deadline for sponsors comments	17-Mar-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	09-Jul-21
Final recommendation posted	27-Jul-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	23-Jul-21
CADTH review report(s) posted	22-Sep-21