trastuzumab deruxtecan

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Generic Name:
trastuzumab deruxtecan
Project Status:
Complete
Therapeutic Area:
unresectable or metastatic HER2-low breast cancer
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Enhertu
Project Line:
Reimbursement Review
Project Number:
PC0305-000
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 monotherapy, for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR-positive) breast cancer should have received at least one and be no longer considered eligible for endocrine therapy.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received at least one prior line of chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Patients with hormone receptor positive (HR+) breast cancer should have received at least one and be no longer considered eligible for endocrine 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 openOctober 28, 2022
Call for patient/clinician input closedDecember 22, 2022
Clarification:

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

Submission receivedDecember 13, 2022
Submission acceptedJanuary 04, 2023
Review initiatedJanuary 05, 2023
Draft CADTH review report(s) provided to sponsor for commentMarch 23, 2023
Deadline for sponsors commentsApril 03, 2023
CADTH review report(s) and responses to comments provided to sponsorApril 27, 2023
Expert committee meeting (initial)May 10, 2023
Draft recommendation issued to sponsorMay 24, 2023
Draft recommendation posted for stakeholder feedbackJune 01, 2023
End of feedback periodJune 15, 2023
Final recommendation issued to sponsor and drug plansJune 29, 2023
Final recommendation postedJuly 18, 2023
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)July 14, 2023
CADTH review report(s) postedSeptember 11, 2023