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:
Complete
Therapeutic Area:
Melanoma Adjuvant Treatment
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0286-000
Tumour Type:
Skin & Melanoma
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Skin & Melanoma
Indications:
Pembrolizumab is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection.
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 open28-Mar-22
Call for patient/clinician input closed20-May-22
Clarification:

- Patient input submission received from Melanoma Canada and Save Your Skin Foundation>

Submission received26-Apr-22
Submission accepted-
Review initiated11-May-22
Draft CADTH review report(s) provided to sponsor for comment26-Jul-22
Deadline for sponsors comments05-Aug-22
CADTH review report(s) and responses to comments provided to sponsor01-Sep-22
Expert committee meeting (initial)14-Sep-22
Draft recommendation issued to sponsor28-Sep-22
Draft recommendation posted for stakeholder feedback06-Oct-22
End of feedback period21-Oct-22
Final recommendation issued to sponsor and drug plans04-Nov-22
Final recommendation posted22-Nov-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Nov-22
CADTH review report(s) posted06-Feb-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : January 28, 2025