Generic Name: osimertinib
Brand Name: Tagrisso
Manufacturer: AstraZeneca Canada Inc.
Therapeutic Area: Non-small cell lung cancer
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.
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
Tumour Type: Lung
NOC Status at Filing: Post NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule1: Schedule A
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
Key Milestones2 | |
|---|---|
| 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 issued to sponsor | August 23, 2021 To August 25, 2021 |
| Draft recommendation posted for stakeholder feedback | - |