Last Updated : March 20, 2023
Details
FilesGeneric 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
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | May 20, 2022 |
|---|---|
| Call for patient/clinician input closed | July 15, 2022 |
| Clarification: - Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | June 20, 2022 |
| Submission accepted | July 05, 2022 |
| Review initiated | July 06, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | September 20, 2022 |
| Deadline for sponsors comments | September 29, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | October 28, 2022 |
| Expert committee meeting (initial) | November 09, 2022 |
| Draft recommendation issued to sponsor | November 22, 2022 |
| Draft recommendation posted for stakeholder feedback | December 01, 2022 |
| End of feedback period | December 15, 2022 |
| Final recommendation issued to sponsor and drug plans | January 06, 2023 |
| Final recommendation posted | January 24, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 20, 2023 |
| CADTH review report(s) posted | March 20, 2023 |
Files
Last Updated : March 20, 2023