Last Updated : January 20, 2023
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Renal cell carcinoma, adjuvant
Manufacturer:
Merck Canada Inc.
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0273-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Adjuvant treatment of adult patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Genitourinary
Indications:
Adjuvant treatment of adult patients with RCC at intermediate-high or
high risk of recurrence following nephrectomy, or following nephrectomy and
resection of metastatic lesions.
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.
Key Milestones2 | |
|---|---|
| Call for patient/clinician input open | February 02, 2022 |
| Call for patient/clinician input closed | March 25, 2022 |
| Clarification: - Patient input submission received from Kidney Cancer Canada | |
| Submission received | March 03, 2022 |
| Submission accepted | March 17, 2022 |
| Review initiated | March 21, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 08, 2022 |
| Deadline for sponsors comments | June 17, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 28, 2022 |
| Expert committee meeting (initial) | August 10, 2022 |
| Draft recommendation issued to sponsor | August 24, 2022 |
| Draft recommendation posted for stakeholder feedback | September 01, 2022 |
| End of feedback period | September 16, 2022 |
| Final recommendation issued to sponsor and drug plans | September 29, 2022 |
| Final recommendation posted | October 18, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 14, 2022 |
| CADTH review report(s) posted | January 17, 2023 |
Files
Last Updated : January 20, 2023