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

pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Unresectable or metastatic MSI-H or dMMR solid tumors
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0377-000
Call for patient/clinician input closed:
Tumour Type:
Other
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Indications:
Pembrolizumab as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
  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 open05-Jun-24
Call for patient/clinician input closed26-Jul-24
Submission received16-Jul-24
Submission accepted30-Jul-24
Review initiated31-Jul-24
Draft CADTH review report(s) provided to sponsor for comment17-Oct-24
Deadline for sponsors comments28-Oct-24
CADTH review report(s) and responses to comments provided to sponsor22-Nov-24
Expert committee meeting (initial)04-Dec-24
Draft recommendation issued to sponsor17-Dec-24
Draft recommendation posted for stakeholder feedback02-Jan-25
End of feedback period16-Jan-25
Final recommendation issued to sponsor and drug plans31-Jan-25
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)14-Feb-25
CADTH review report(s) posted-

Files

Draft Recommendation View PDF
Patient and Clinician Group input View PDF
Last Updated : January 20, 2025