sacituzumab govitecan

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Generic 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
Performance Metric:
Achieved
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:
  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 openJune 06, 2023
Call for patient/clinician input closedJuly 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 receivedJuly 18, 2023
Submission acceptedAugust 01, 2023
Review initiatedAugust 02, 2023
Draft CADTH review report(s) provided to sponsor for commentOctober 19, 2023
Deadline for sponsors commentsOctober 30, 2023
CADTH review report(s) and responses to comments provided to sponsorNovember 24, 2023
Expert committee meeting (initial)December 06, 2023
Draft recommendation issued to sponsorDecember 19, 2023
Draft recommendation posted for stakeholder feedbackJanuary 04, 2024
End of feedback periodJanuary 18, 2024
Final recommendation issued to sponsor and drug plansFebruary 01, 2024
Final recommendation postedFebruary 20, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)February 15, 2024
CADTH review report(s) postedApril 25, 2024