Last Updated : January 30, 2025
Details
FilesGeneric Name:
osimertinib
Project Status:
Complete
Therapeutic Area:
Non-small cell lung cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Tagrisso
Project Line:
Reimbursement Review
Project Number:
PC0336-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic NSCLC whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
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 | October 30, 2023 |
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Call for patient/clinician input closed | December 22, 2023 |
Clarification: - Patient input submission received from Lung Cancer Canada and the Lung Health Foundation | |
Submission received | December 11, 2023 |
Submission accepted | January 02, 2024 |
Clarification: - Additional information has been received and the temporary suspension of the review has been lifted | |
Review initiated | January 03, 2024 |
Draft CADTH review report(s) provided to sponsor for comment | June 21, 2024 |
Deadline for sponsors comments | July 03, 2024 |
CADTH review report(s) and responses to comments provided to sponsor | August 01, 2024 |
Expert committee meeting (initial) | August 14, 2024 |
Draft recommendation issued to sponsor | August 26, 2024 |
Draft recommendation posted for stakeholder feedback | September 05, 2024 |
End of feedback period | September 19, 2024 |
Final recommendation issued to sponsor and drug plans | October 03, 2024 |
Final recommendation posted | October 22, 2024 |
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 18, 2024 |
CADTH review report(s) posted | January 29, 2025 |
Files
Last Updated : January 30, 2025