Last Updated : September 15, 2023
Details
FilesGeneric 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:
- 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.
| Call for patient/clinician input open | October 28, 2022 |
|---|---|
| Call for patient/clinician input closed | December 22, 2022 |
| Clarification: - Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | December 13, 2022 |
| Submission accepted | January 04, 2023 |
| Review initiated | January 05, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | March 23, 2023 |
| Deadline for sponsors comments | April 03, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | April 27, 2023 |
| Expert committee meeting (initial) | May 10, 2023 |
| Draft recommendation issued to sponsor | May 24, 2023 |
| Draft recommendation posted for stakeholder feedback | June 01, 2023 |
| End of feedback period | June 15, 2023 |
| Final recommendation issued to sponsor and drug plans | June 29, 2023 |
| Final recommendation posted | July 18, 2023 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | July 14, 2023 |
| CADTH review report(s) posted | September 11, 2023 |
Files
Last Updated : September 15, 2023