pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
recurrent, or metastatic cervical cancer
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0292-000
Tumour Type:
Gynecology
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda, indicated for treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PDL1 (CPS 1) as determined by a validated test, in combination with chemotherapy with or without bevacizumab.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Tumour Type:
Gynecology
Indications:
Keytruda, indicated for treatment of adult patients with persistent, recurrent, or metastatic cervical cancer whose tumours express PD‐L1 (CPS ≥ 1) as determined by a validated test, in combination with chemotherapy with or without bevacizumab.
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 openApril 22, 2022
Call for patient/clinician input closedJune 17, 2022
Clarification:

- Patient input submission received from HPV Global Action

Submission receivedMay 20, 2022
Submission acceptedJune 06, 2022
Review initiatedJune 07, 2022
Draft CADTH review report(s) provided to sponsor for commentAugust 22, 2022
Deadline for sponsors commentsAugust 31, 2022
CADTH review report(s) and responses to comments provided to sponsorSeptember 29, 2022
Expert committee meeting (initial)October 12, 2022
Draft recommendation issued to sponsorOctober 26, 2022
Draft recommendation posted for stakeholder feedbackNovember 03, 2022
End of feedback periodNovember 17, 2022
Final recommendation issued to sponsor and drug plansDecember 01, 2022
Final recommendation postedDecember 19, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)December 15, 2022
CADTH review report(s) postedMarch 10, 2023