Last Updated : August 7, 2025
Details
Generic Name:
atezolizumab
Project Status:
Active
Therapeutic Area:
Metastatic non-small-cell lung cancer
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Tecentriq
Project Line:
Reimbursement Review
Project Number:
PC0419-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
TECENTRIQ as monotherapy, is indicated for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering greater than or equal to 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations.
Submission Type:
Initial
Submission Complexity:
Tailored Review
Companion Diagnostics:
Yes
Fee Schedule:
Schedule B
Indications:
TECENTRIQ as monotherapy, is indicated for the first-line treatment of patients with metastatic NSCLC whose tumours have high PD-L1 expression (PD-L1 stained greater than or equal to 50% of TCs or PD-L1 stained tumour-infiltrating immune cells [ICs] covering greater than or equal to 10% of the tumour area), as determined by a validated test and who do not have EGFR or ALK genomic tumour aberrations.
- 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 12, 2025 |
|---|---|
| Call for patient/clinician input closed | August 05, 2025 |
| Submission received | July 23, 2025 |
| Clarification: Eligible for review through the PACES process | |
| Submission accepted | August 07, 2025 |
| Review initiated | August 08, 2025 |
| Draft CADTH review report(s) provided to sponsor for comment | October 10, 2025 |
| Deadline for sponsors comments | October 20, 2025 |
| CDA-AMC review report(s) and responses to comments provided to sponsor | October 30, 2025 |
| Expert committee meeting (initial) | November 12, 2025 |
| Draft recommendation issued to sponsor | November 24, 2025 To November 26, 2025 |
| Draft recommendation posted for stakeholder feedback | December 04, 2025 |
| End of feedback period | December 18, 2025 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | November 12, 2025 |
Last Updated : August 7, 2025