Last Updated : April 25, 2023
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | November 10, 2021 |
|---|---|
| Call for patient/clinician input closed | January 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 received | December 15, 2021 |
| Submission accepted | January 07, 2022 |
| Clarification: - Submission was not accepted for review on 6 Jan '22 | |
| Review initiated | January 10, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | March 29, 2022 |
| Deadline for sponsors comments | April 07, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | April 29, 2022 |
| Expert committee meeting (initial) | May 11, 2022 |
| Draft recommendation issued to sponsor | May 25, 2022 |
| Draft recommendation posted for stakeholder feedback | June 02, 2022 |
| End of feedback period | June 16, 2022 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | December 07, 2022 |
| Draft recommendation issued to sponsor | December 21, 2022 |
| Draft recommendation posted for stakeholder feedback | January 05, 2023 |
| End of feedback period | January 19, 2023 |
| Final recommendation issued to sponsor and drug plans | February 03, 2023 |
| Final recommendation posted | February 22, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 17, 2023 |
| CADTH review report(s) posted | April 25, 2023 |
Files
Last Updated : April 25, 2023