Last Updated : March 11, 2024
Details
Generic Name:
osimertinib
Project Status:
Active
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 adult patients with locally advanced or metastatic non-small cell lung cancer whose tumours have EGFR exon 19 deletions or exon 21 L858R 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 adult patients with locally advanced or metastatic non-small cell lung cancer whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations.
- 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.
| Call for patient/clinician input open | 30-Oct-23 |
|---|---|
| Call for patient/clinician input closed | 22-Dec-23 |
| Clarification: - Patient input submission received from Lung Cancer Canada and the Lung Health Foundation | |
| Submission received | 11-Dec-23 |
| Submission accepted | 02-Jan-24 |
| Clarification: - Additional information has been received and the temporary suspension of the review has been lifted | |
| Review initiated | 03-Jan-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 21-Jun-24 |
| Deadline for sponsors comments | 03-Jul-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 01-Aug-24 |
| Expert committee meeting (initial) | 14-Aug-24 |
| Draft recommendation issued to sponsor | August 26, 2024 To August 28, 2024 |
| Draft recommendation posted for stakeholder feedback | 05-Sep-24 |
| End of feedback period | 19-Sep-24 |
Last Updated : March 11, 2024