trastuzumab deruxtecan

Details

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Generic Name:
trastuzumab deruxtecan
Project Status:
Complete
Therapeutic Area:
Metastatic HER2 positive breast cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Enhertu
Project Line:
Reimbursement Review
Project Number:
PC0285-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
As per anticipated indication to be granted: for the treatment of adult patients with unresectable or metastatic HER2 (human epidermal growth factor receptor 2)-positive breast cancer who have received a prior treatment with an anti-HER2-based regimen in the metastatic setting or developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Breast
Indications:
Anticipated indication as filed with Health Canada: for the treatment of adult patients with unresectable or metastatic HER2 (human epidermal growth factor receptor 2)-positive breast cancer who have received a prior treatment with an anti-HER2-based regimen in the metastatic setting or developed disease recurrence during or within 6 months of completing neoadjuvant or adjuvant therapy
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 openFebruary 23, 2022
Call for patient/clinician input closedApril 14, 2022
Clarification:

- Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer

Submission receivedMarch 23, 2022
Submission acceptedApril 06, 2022
Review initiatedApril 07, 2022
Draft CADTH review report(s) provided to sponsor for commentJune 24, 2022
Deadline for sponsors commentsJuly 06, 2022
CADTH review report(s) and responses to comments provided to sponsorJuly 28, 2022
Expert committee meeting (initial)August 10, 2022
Draft recommendation issued to sponsorAugust 23, 2022
Draft recommendation posted for stakeholder feedbackSeptember 01, 2022
End of feedback periodSeptember 16, 2022
Final recommendation issued to sponsor and drug plansSeptember 28, 2022
Final recommendation postedOctober 17, 2022
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)October 13, 2022
CADTH review report(s) postedJanuary 23, 2023