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:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0235-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
  1. 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