Last Updated : March 15, 2023
Details
FilesGeneric 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:
- 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 | April 22, 2022 |
|---|---|
| Call for patient/clinician input closed | June 17, 2022 |
| Clarification: - Patient input submission received from HPV Global Action | |
| Submission received | May 20, 2022 |
| Submission accepted | June 06, 2022 |
| Review initiated | June 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | August 22, 2022 |
| Deadline for sponsors comments | August 31, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | September 29, 2022 |
| Expert committee meeting (initial) | October 12, 2022 |
| Draft recommendation issued to sponsor | October 26, 2022 |
| Draft recommendation posted for stakeholder feedback | November 03, 2022 |
| End of feedback period | November 17, 2022 |
| Final recommendation issued to sponsor and drug plans | December 01, 2022 |
| Final recommendation posted | December 19, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | December 15, 2022 |
| CADTH review report(s) posted | March 10, 2023 |
Files
Last Updated : March 15, 2023