Last Updated : May 26, 2022
Details
FilesGeneric 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:
- 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 | 26-May-21 |
| Call for patient/clinician input closed | 16-Jul-21 |
| Clarification: - Patient input submission received from Bladder Cancer Canada | |
| Submission received | 23-Jun-21 |
| Submission accepted | 08-Jul-21 |
| Review initiated | 09-Jul-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 23-Sep-21 |
| Deadline for sponsors comments | 04-Oct-21 |
| CADTH review report(s) and responses to comments provided to sponsor | 29-Oct-21 |
| Expert committee meeting (initial) | 10-Nov-21 |
| Draft recommendation issued to sponsor | 23-Nov-21 |
| Draft recommendation posted for stakeholder feedback | 02-Dec-21 |
| End of feedback period | 16-Dec-21 |
| Final recommendation issued to sponsor and drug plans | 06-Jan-22 |
| Final recommendation posted | 24-Jan-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 20-Jan-22 |
| CADTH review report(s) posted | 26-May-22 |
Files
Last Updated : May 26, 2022