pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Triple-negative breast cancer
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0279-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda is indicated for the treatment of adult patients with early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
​Keytruda is indicated for the treatment of adult patients with early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
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 openJanuary 20, 2022
Call for patient/clinician input closedMarch 11, 2022
Clarification:

- Patient input submission received from Rethink Breast Cancer and Canadian Breast Cancer Network

Submission receivedFebruary 17, 2022
Submission acceptedMarch 04, 2022
Review initiatedMarch 07, 2022
Draft CADTH review report(s) provided to sponsor for commentMay 25, 2022
Deadline for sponsors commentsJune 03, 2022
CADTH review report(s) and responses to comments provided to sponsorJune 30, 2022
Expert committee meeting (initial)July 13, 2022
Draft recommendation issued to sponsorJuly 25, 2022
Draft recommendation posted for stakeholder feedbackAugust 04, 2022
End of feedback periodAugust 18, 2022
Final recommendation issued to sponsor and drug plansAugust 31, 2022
Final recommendation postedSeptember 19, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 15, 2022
CADTH review report(s) postedDecember 15, 2022