Last Updated : January 29, 2025
Details
FilesGeneric Name:
osimertinib
Project Status:
Complete
Therapeutic Area:
Non-small cell lung cancer
Manufacturer:
AstraZeneca Canada Inc.
Brand Name:
Tagrisso
Project Line:
Reimbursement Review
Project Number:
PC0246-000
Tumour Type:
Lung
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Tagrisso (osimertinib) is indicated as adjuvant therapy after tumour resection in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Tagrisso (osimertinib) is indicated as adjuvant therapy after tumour resection in patients with stage IB-IIIA non-small cell lung cancer (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 | February 24, 2021 |
|---|---|
| Call for patient/clinician input closed | April 16, 2021 |
| Clarification: - Patient input submission received from Lung Cancer Canada, Canadian Cancer Survivor Network (CCSN), CanCertainty, and Lung Health Foundation/The Ontario Lung Association. | |
| Submission received | March 24, 2021 |
| Submission accepted | - |
| Review initiated | April 09, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | June 23, 2021 |
| Deadline for sponsors comments | July 05, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | July 29, 2021 |
| Expert committee meeting (initial) | August 11, 2021 |
| Draft recommendation posted for stakeholder feedback | September 02, 2021 |
| End of feedback period | September 17, 2021 |
| Clarification: - Reconsideration: minor revisions requested by sponsor | |
| Final recommendation issued to sponsor and drug plans | January 10, 2022 |
| Final recommendation posted | January 28, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | January 24, 2022 |
| CADTH review report(s) posted | March 04, 2022 |
Files
Last Updated : January 29, 2025