Canada’s Drug Agency | Drugs, Health Technologies and Systems.

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:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
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 openNovember 02, 2020
Call for patient/clinician input closedDecember 24, 2020
Clarification:

- Patient input submission received from Colorectal Cancer Canada and Colorectal Cancer Resource & Action Network

Submission receivedNovember 30, 2020
Submission acceptedDecember 14, 2020
Review initiatedDecember 15, 2020
Draft CADTH review report(s) provided to sponsor for commentMarch 08, 2021
Deadline for sponsors commentsMarch 17, 2021
CADTH responses on draft review report(s) provided to sponsorMay 03, 2021
Expert committee meeting (initial)May 14, 2021
Draft recommendation issued to sponsorMay 31, 2021
Draft recommendation posted for stakeholder feedbackJune 10, 2021
End of feedback periodJune 24, 2021
Final recommendation issued to sponsor and drug plansJuly 09, 2021
Final recommendation postedJuly 27, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 23, 2021
CADTH review report(s) postedSeptember 22, 2021

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submission View PDF
Clinician Input View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : January 29, 2025