Canada’s Drug Agency | Drugs, Health Technologies and Systems.

trastuzumab deruxtecan

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Generic Name:
trastuzumab deruxtecan
Project Status:
Active
Therapeutic Area:
Gastric or gastroesophageal junction (GEJ) adenocarcinoma
Manufacturer:
AstraZeneca Canada Inc.
Call for patient/clinician input open:
Brand Name:
Enhertu
Project Line:
Reimbursement Review
Project Number:
PC0367-000
Call for patient/clinician input closed:
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Enhertu (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Enhertu (trastuzumab deruxtecan) as monotherapy is indicated for the treatment of adult patients with unresectable, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
Recommendation Type:
Time-limited reimbursement recommendation
Final Recommendation/Report:
  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 open06-Aug-24
Call for patient/clinician input closed27-Sep-24
Submission received16-Sep-24
Clarification:

Eligible for consideration as a time-limited recommendation

Submission accepted01-Oct-24
Review initiated02-Oct-24
Draft CADTH review report(s) provided to sponsor for comment17-Dec-24
Deadline for sponsors comments03-Jan-25
CDA-AMC review report(s) and responses to comments provided to sponsor31-Jan-25
Expert committee meeting (initial)12-Feb-25
Draft recommendation issued to sponsor25-Feb-25
Draft recommendation posted for stakeholder feedback06-Mar-25
End of feedback period21-Mar-25
Final recommendation issued to sponsor and drug plans03-Apr-25
Final recommendation posted23-Apr-25
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)17-Apr-25
CDA-AMC review report(s) posted-

Files

Recommendation and Reason View PDF
Patient and Clinician Group Input View PDF
Last Updated : April 23, 2025