Last Updated : December 17, 2022
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Complete
Therapeutic Area:
Triple-negative breast cancer
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0279-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda is indicated for the treatment of adult patients with early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
Keytruda is indicated for the treatment of adult patients with early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery.
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 | January 20, 2022 |
| Call for patient/clinician input closed | March 11, 2022 |
| Clarification: - Patient input submission received from Rethink Breast Cancer and Canadian Breast Cancer Network | |
| Submission received | February 17, 2022 |
| Submission accepted | March 04, 2022 |
| Review initiated | March 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | May 25, 2022 |
| Deadline for sponsors comments | June 03, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | June 30, 2022 |
| Expert committee meeting (initial) | July 13, 2022 |
| Draft recommendation issued to sponsor | July 25, 2022 |
| Draft recommendation posted for stakeholder feedback | August 04, 2022 |
| End of feedback period | August 18, 2022 |
| Final recommendation issued to sponsor and drug plans | August 31, 2022 |
| Final recommendation posted | September 19, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 15, 2022 |
| CADTH review report(s) posted | December 15, 2022 |
Files
Last Updated : December 17, 2022