Last Updated : February 26, 2025
Details
FilesGeneric Name:
pembrolizumab
Project Status:
Active
Therapeutic Area:
Non-small cell lung cancer (NSCLC)
Manufacturer:
Merck Canada
Call for patient/clinician input open:
Brand Name:
Keytruda
Project Line:
Reimbursement Review
Project Number:
PC0369-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Keytruda as monotherapy for the adjuvant treatment of adult patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC, and with PD-L1 tumor proportion score (TPS) less than 50% who have undergone complete resection and platinum-based chemotherapy.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Keytruda as monotherapy is indicated for the adjuvant treatment of adult patients with Stage IB (T2a greater than or equal to 4 cm), II, or IIIA NSCLC who have undergone complete resection and platinum-based chemotherapy.
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 03, 2024 |
|---|---|
| Call for patient/clinician input closed | July 26, 2024 |
| Submission received | July 15, 2024 |
| Submission accepted | July 29, 2024 |
| Review initiated | July 30, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | October 21, 2024 |
| Deadline for sponsors comments | October 30, 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 16, 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 30, 2025 |
| Final recommendation posted | February 18, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 13, 2025 |
| CADTH review report(s) posted | - |
Files
Last Updated : February 26, 2025