belzutifan


( Last Updated : January 24, 2023)
Generic Name:
belzutifan
Project Status:
Received
Therapeutic Area:
von Hippel-Lindau disease-associated tumours
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Welireg
Project Line:
Reimbursement Review
Project Number:
PC0309-000
Call for patient/clinician input closed:
Tumour Type:
Other
NOC Status at Filing:
Pre NOC

Details


Manufacturer Requested Reimbursement Criteria1:
The current reimbursement request is for the use of belzutifan for the treatment of patients with VHL disease-associated non-metastatic RCC, CNS hemangioblastomas or non-metastatic pNET, not requiring immediate surgery, consistent with the results of MK-6482-004 and in consideration of the high unmet need of these patients who have no options besides surgical resections.
Submission Type:
Initial
Fee Schedule:
N/A
Indications:
​WELIREG®, Belzutifan is a hypoxia-inducible factor inhibitor indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated non-metastatic renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, and non-metastatic pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery. (VHL-CNS and pNET tumors subject to Health Canada approval)
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input openDecember 16, 2022
Call for patient/clinician input closedFebruary 21, 2023
Submission receivedJanuary 23, 2023
Submission acceptedFebruary 07, 2023
Review initiatedFebruary 08, 2023
Draft CADTH review report(s) provided to sponsor for commentApril 26, 2023
Deadline for sponsors commentsMay 08, 2023
CADTH review report(s) and responses to comments provided to sponsorJune 02, 2023
Expert committee meeting (initial)June 14, 2023