osimertinib

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Generic 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:
  1. 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.
Key Milestones2
Call for patient/clinician input openOctober 30, 2023
Call for patient/clinician input closedDecember 22, 2023
Clarification:

- Patient input submission received from Lung Cancer Canada and the Lung Health Foundation

Submission receivedDecember 11, 2023
Submission acceptedJanuary 02, 2024
Clarification:

- Additional information has been received and the temporary suspension of the review has been lifted

Review initiatedJanuary 03, 2024
Draft CADTH review report(s) provided to sponsor for commentJune 21, 2024
Deadline for sponsors commentsJuly 03, 2024
CADTH review report(s) and responses to comments provided to sponsorAugust 01, 2024
Expert committee meeting (initial)August 14, 2024
Draft recommendation issued to sponsorAugust 26, 2024
Draft recommendation posted for stakeholder feedbackSeptember 05, 2024
End of feedback periodSeptember 19, 2024
Final recommendation issued to sponsor and drug plansOctober 03, 2024
Final recommendation postedOctober 22, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 18, 2024
CADTH review report(s) postedJanuary 29, 2025