osimertinib


( Last Updated : September 20, 2021)
Generic Name:
osimertinib
Project Status:
Active
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

Details


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.
  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 open February 24, 2021
Call for patient/clinician input closed April 16, 2021
Clarification:

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

Submission received March 24, 2021
Submission accepted -
Review initiated April 09, 2021
Draft CADTH review report(s) provided to sponsor for comment June 23, 2021
Deadline for sponsors comments July 05, 2021
CADTH responses on draft review report(s) provided to sponsor July 29, 2021
Expert committee meeting (initial) August 11, 2021
Draft recommendation issued to sponsor August 23, 2021
To
August 25, 2021
Draft recommendation posted for stakeholder feedback September 2, 2021
End of feedback period September 17, 2021