pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Triple-negative breast cancer
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0295-000
Tumour Type:
Breast
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab in combination with chemotherapy for the treatment of adult patients with locally recurrent unresectable or metastatic TNBC who have not received prior chemotherapy for metastatic disease and whose tumors express PDL1 (CPS 10) as determined by a validated test
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
​Pembrolizumab in combination with chemotherapy for the treatment of adult patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC), who have not received prior chemotherapy for metastatic disease and whose tumors express PD‐L1 (Combined Positive Score [CPS] ≥ 10) as determined by a validated test
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 openMay 20, 2022
Call for patient/clinician input closedJuly 15, 2022
Clarification:

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

Submission receivedJune 20, 2022
Submission acceptedJuly 05, 2022
Review initiatedJuly 06, 2022
Draft CADTH review report(s) provided to sponsor for commentSeptember 20, 2022
Deadline for sponsors commentsSeptember 29, 2022
CADTH review report(s) and responses to comments provided to sponsorOctober 28, 2022
Expert committee meeting (initial)November 09, 2022
Draft recommendation issued to sponsorNovember 22, 2022
Draft recommendation posted for stakeholder feedbackDecember 01, 2022
End of feedback periodDecember 15, 2022
Final recommendation issued to sponsor and drug plansJanuary 06, 2023
Final recommendation postedJanuary 24, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 20, 2023
CADTH review report(s) postedMarch 20, 2023