Last Updated : April 25, 2024
Details
FilesGeneric Name:
sacituzumab govitecan
Project Status:
Complete
Therapeutic Area:
HR+, HER2− advanced or metastatic breast cancer
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Trodelvy
Project Line:
Reimbursement Review
Project Number:
PC0323-000
Call for patient/clinician input closed:
Tumour Type:
Breast
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Trodelvy (sacituzumab govitecan) is indicated for: The treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Trodelvy (sacituzumab govitecan) is indicated for: • The treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | June 06, 2023 |
|---|---|
| Call for patient/clinician input closed | July 28, 2023 |
| Clarification: - Patient input submission received from Breast Cancer Canada and McPeak-Sirois Group for Clinical Research in Breast Cancer Research, Canadian Breast Cancer Network and Rethink Breast Cancer | |
| Submission received | July 18, 2023 |
| Submission accepted | August 01, 2023 |
| Review initiated | August 02, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | October 19, 2023 |
| Deadline for sponsors comments | October 30, 2023 |
| CADTH review report(s) and responses to comments provided to sponsor | November 24, 2023 |
| Expert committee meeting (initial) | December 06, 2023 |
| Draft recommendation issued to sponsor | December 19, 2023 |
| Draft recommendation posted for stakeholder feedback | January 04, 2024 |
| End of feedback period | January 18, 2024 |
| Final recommendation issued to sponsor and drug plans | February 01, 2024 |
| Final recommendation posted | February 20, 2024 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | February 15, 2024 |
| CADTH review report(s) posted | April 25, 2024 |
Files
Last Updated : April 25, 2024