CDA | Evidence Driven
CDA | Evidence Driven

belzutifan

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Generic Name:
belzutifan
Project Status:
Complete
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
Performance Metric:
Achieved
Biosimilar:
No
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:
Schedule E
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)
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 open16-Dec-22
Call for patient/clinician input closed21-Feb-23
Clarification:

- Patient input submission received from The Canadian VHL Alliance with: The Canadian Organization for Rare Disorders, Kidney Cancer Canada, Pancreatic Cancer Canada, and the Canadian Neuroendocrine Tumour Society

Submission received23-Jan-23
Submission accepted07-Feb-23
Review initiated08-Feb-23
Clarification:

- Submission temporarily suspended

- Additional information has been received and the temporary suspension of the review has been lifted

Draft CADTH review report(s) provided to sponsor for comment15-May-23
Deadline for sponsors comments26-May-23
CADTH review report(s) and responses to comments provided to sponsor29-Jun-23
Expert committee meeting (initial)12-Jul-23
Draft recommendation issued to sponsor26-Jul-23
Draft recommendation posted for stakeholder feedback03-Aug-23
End of feedback period18-Aug-23
Final recommendation issued to sponsor and drug plans01-Sep-23
Final recommendation posted20-Sep-23
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Sep-23
CADTH review report(s) posted15-Nov-23

Files

Recommendation and Reasons View PDF
Clinical, Pharmacoeconomic, Ethics, and Stakeholder Input Combined Report View PDF
Stakeholder Feedback on Draft Recommendation View PDF
Last Updated : November 16, 2023