CDA | Evidence Driven
CDA | Evidence Driven

osimertinib

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Generic 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
Performance Metric:
Achieved
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:
  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 Milestones

Call for patient/clinician input open24-Feb-21
Call for patient/clinician input closed16-Apr-21
Clarification:

- Patient input submission received from Lung Cancer Canada, Canadian Cancer Survivor Network (CCSN), CanCertainty, and Lung Health Foundation/The Ontario Lung Association.

Submission received24-Mar-21
Submission accepted
Review initiated09-Apr-21
Draft CADTH review report(s) provided to sponsor for comment23-Jun-21
Deadline for sponsors comments05-Jul-21
CADTH responses on draft review report(s) provided to sponsor29-Jul-21
Expert committee meeting (initial)11-Aug-21
Draft recommendation posted for stakeholder feedback02-Sep-21
End of feedback period17-Sep-21
Clarification:

- Reconsideration: minor revisions requested by sponsor

Final recommendation issued to sponsor and drug plans10-Jan-22
Final recommendation posted28-Jan-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)24-Jan-22
CADTH review report(s) posted04-Mar-22

Files

Recommendation and Reasons View PDF
Clinical and Pharmacoeconomic combined Report View PDF
Patient Group Input Submission View PDF
Clinician Input View PDF
Stakeholder feedback on Draft Recommendation View PDF
Last Updated : December 22, 2021