Last Updated : February 7, 2025
Details
FilesGeneric Name:
belzutifan
Project Status:
Active
Therapeutic Area:
advanced renal cell carcinoma (RCC)
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Welireg
Project Line:
Reimbursement Review
Project Number:
PC0386-000
Call for patient/clinician input closed:
Tumour Type:
Genitourinary
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
WELIREG® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
WELIREG® is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
- 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.
| Call for patient/clinician input open | 11-Oct-24 |
|---|---|
| Call for patient/clinician input closed | 06-Dec-24 |
| Submission received | 25-Nov-24 |
| Submission accepted | 09-Dec-24 |
| Review initiated | 10-Dec-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 25-Mar-25 |
| Deadline for sponsors comments | 03-Apr-25 |
| CADTH review report(s) and responses to comments provided to sponsor | 02-May-25 |
| Expert committee meeting (initial) | 14-May-25 |
| Draft recommendation issued to sponsor | May 27, 2025 To May 29, 2025 |
| Draft recommendation posted for stakeholder feedback | 05-Jun-25 |
| End of feedback period | 19-Jun-25 |
Files
Last Updated : February 7, 2025