Last Updated : November 16, 2023
Details
FilesGeneric 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
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:
- 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.
| Call for patient/clinician input open | 16-Dec-22 |
|---|---|
| Call for patient/clinician input closed | 21-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 received | 23-Jan-23 |
| Submission accepted | 07-Feb-23 |
| Review initiated | 08-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 comment | 15-May-23 |
| Deadline for sponsors comments | 26-May-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 29-Jun-23 |
| Expert committee meeting (initial) | 12-Jul-23 |
| Draft recommendation issued to sponsor | 26-Jul-23 |
| Draft recommendation posted for stakeholder feedback | 03-Aug-23 |
| End of feedback period | 18-Aug-23 |
| Final recommendation issued to sponsor and drug plans | 01-Sep-23 |
| Final recommendation posted | 20-Sep-23 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 18-Sep-23 |
| CADTH review report(s) posted | 15-Nov-23 |
Files
Last Updated : November 16, 2023