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osimertinib

Last Updated: April 8, 2021
Result type: Reports
Project Number: PC0246-000
Product Line: Reimbursement Review

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

  1. 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 openFebruary 24, 2021
Call for patient/clinician input closedApril 16, 2021
Submission receivedMarch 24, 2021
Submission accepted-
Review initiatedApril 09, 2021
Draft CADTH review report(s) provided to sponsor for commentJune 23, 2021
Deadline for sponsors commentsJuly 05, 2021
CADTH responses on draft review report(s) provided to sponsorJuly 29, 2021
Expert committee meeting (initial)August 11, 2021
Draft recommendation issued to sponsorAugust 25, 2021
Draft recommendation posted for stakeholder feedback-
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