belzutifan

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Generic Name:

belzutifan

Project Status:

Active

Therapeutic Area:

advanced renal cell carcinoma (RCC)

Manufacturer:

Merck Canada Inc.

Call for patient/clinician input open:

October 17, 2024

Brand Name:

Welireg

Project Line:

Reimbursement Review

Project Number:

PC0386-000

Call for patient/clinician input closed:

December 6, 2024

Tumour Type:

Genitourinary

NOC Status at Filing:

Pre NOC

Biosimilar:

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:

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
Milestones title	Date
Call for patient/clinician input open	October 11, 2024
Call for patient/clinician input closed	December 06, 2024
Submission received	November 25, 2024
Submission accepted	December 09, 2024
Review initiated	December 10, 2024
Draft CADTH review report(s) provided to sponsor for comment	March 04, 2025
Deadline for sponsors comments	March 13, 2025
CADTH review report(s) and responses to comments provided to sponsor	May 02, 2025
Expert committee meeting (initial)	May 14, 2025
Draft recommendation issued to sponsor	May 27, 2025 To May 29, 2025
Draft recommendation posted for stakeholder feedback	June 05, 2025
End of feedback period	June 19, 2025

Files

Patient and Clinician Group Input View PDF

Last Updated : December 17, 2024