Last Updated : October 23, 2024
Details
FilesGeneric 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
Performance Metric:
Achieved
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 | 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 | 26-Aug-24 |
| Draft recommendation posted for stakeholder feedback | 05-Sep-24 |
| End of feedback period | 19-Sep-24 |
| Final recommendation issued to sponsor and drug plans | 03-Oct-24 |
| Final recommendation posted | 22-Oct-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 18-Oct-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : October 23, 2024