Last Updated : February 19, 2025
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Unresectable or metastatic MSI-H or dMMR solid tumors
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0377-000
Call for patient/clinician input closed:
Tumour Type:
Other
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Pembrolizumab as
monotherapy for the treatment of adult and pediatric patients with unresectable
or metastatic microsatellite instability-high (MSI-H) or mismatch repair
deficient (dMMR) solid tumors, as determined by a validated test, that have
progressed following prior treatment and who have no
satisfactory alternative treatment options.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule E
Indications:
Pembrolizumab as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by a validated test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.
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 | June 05, 2024 |
|---|---|
| Call for patient/clinician input closed | July 26, 2024 |
| Submission received | July 16, 2024 |
| Submission accepted | July 30, 2024 |
| Review initiated | July 31, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | October 17, 2024 |
| Deadline for sponsors comments | October 28, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | November 22, 2024 |
| Expert committee meeting (initial) | December 04, 2024 |
| Draft recommendation issued to sponsor | December 17, 2024 |
| Draft recommendation posted for stakeholder feedback | January 02, 2025 |
| End of feedback period | January 16, 2025 |
| Final recommendation issued to sponsor and drug plans | January 31, 2025 |
| Final recommendation posted | February 19, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 14, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 19, 2025