pembrolizumab

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Generic Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Advanced endometrial cancer
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0280-000
Tumour Type:
Gynecology
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda (pembrolizumab), as monotherapy, for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial cancer whose tumours have progressed following prior therapy, or in combination with lenvatinib for the treatment of adult patients with advanced endometrial cancer who have disease progression following prior platinum-based systemic therapy in any setting and are not candidates for curative surgery or radiation.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Keytruda for Adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) endometrial cancer whose tumours have progressed following prior therapy and who have no satisfactory alternative treatment options, as monotherapy.
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 openNovember 10, 2021
Call for patient/clinician input closedJanuary 07, 2022
Clarification:

- Patient input submission received from Colorectal Cancer Resource & Action Network (CCRAN), in collaboration with Canadian Cancer Society (CCS) and Canadian Cancer Survivor Network (CCSN).

Submission receivedDecember 15, 2021
Submission acceptedJanuary 07, 2022
Clarification:

- Submission was not accepted for review on 6 Jan '22

Review initiatedJanuary 10, 2022
Draft CADTH review report(s) provided to sponsor for commentMarch 29, 2022
Deadline for sponsors commentsApril 07, 2022
CADTH review report(s) and responses to comments provided to sponsorApril 29, 2022
Expert committee meeting (initial)May 11, 2022
Draft recommendation issued to sponsorMay 25, 2022
Draft recommendation posted for stakeholder feedbackJune 02, 2022
End of feedback periodJune 16, 2022
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingDecember 07, 2022
Draft recommendation issued to sponsorDecember 21, 2022
Draft recommendation posted for stakeholder feedbackJanuary 05, 2023
End of feedback periodJanuary 19, 2023
Final recommendation issued to sponsor and drug plansFebruary 03, 2023
Final recommendation postedFebruary 22, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 17, 2023
CADTH review report(s) postedApril 25, 2023