enfortumab vedotin

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Generic Name:
enfortumab vedotin
Project Status:
Complete
Therapeutic Area:
Locally advanced or metastatic urothelial carcinoma
Manufacturer:
Seagen Canada Inc.
Brand Name:
Padcev
Project Line:
Reimbursement Review
Project Number:
PC0251-000
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who: have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting
Submission Type:
Initial
Fee Schedule:
Schedule A
Tumour Type:
Genitourinary
Indications:
For the treatment of patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who: have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting or are not eligible for cisplatin-containing chemotherapy
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 open26-May-21
Call for patient/clinician input closed16-Jul-21
Clarification:

- Patient input submission received from Bladder Cancer Canada

Submission received23-Jun-21
Submission accepted08-Jul-21
Review initiated09-Jul-21
Draft CADTH review report(s) provided to sponsor for comment23-Sep-21
Deadline for sponsors comments04-Oct-21
CADTH review report(s) and responses to comments provided to sponsor29-Oct-21
Expert committee meeting (initial)10-Nov-21
Draft recommendation issued to sponsor23-Nov-21
Draft recommendation posted for stakeholder feedback02-Dec-21
End of feedback period16-Dec-21
Final recommendation issued to sponsor and drug plans06-Jan-22
Final recommendation posted24-Jan-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)20-Jan-22
CADTH review report(s) posted26-May-22