Last Updated : January 26, 2023
Details
FilesGeneric 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:
- 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 open | February 23, 2022 |
| Call for patient/clinician input closed | April 14, 2022 |
| Clarification: - Patient input submission received from Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | March 23, 2022 |
| Submission accepted | April 06, 2022 |
| Review initiated | April 07, 2022 |
| Draft CADTH review report(s) provided to sponsor for comment | June 24, 2022 |
| Deadline for sponsors comments | July 06, 2022 |
| CADTH review report(s) and responses to comments provided to sponsor | July 28, 2022 |
| Expert committee meeting (initial) | August 10, 2022 |
| Draft recommendation issued to sponsor | August 23, 2022 |
| Draft recommendation posted for stakeholder feedback | September 01, 2022 |
| End of feedback period | September 16, 2022 |
| Final recommendation issued to sponsor and drug plans | September 28, 2022 |
| Final recommendation posted | October 17, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | October 13, 2022 |
| CADTH review report(s) posted | January 23, 2023 |
Files
Last Updated : January 26, 2023