Welireg

Belzutifan

• Brand(s): Welireg
• Dosage Form/Strength: 40 mg Tablet
• Effective date: November 25, 2024

Initiation criteria:

For the treatment of patients with von Hippel-Lindau (VHL) disease meeting ALL the following criteria:

1. 18 years of age or older;
   AND
2. Documented confirmation of a germline mutation and/or deletion of the VHL gene;
   AND
3. Patient with VHL disease-associated tumours not requiring immediate surgery that is associated with one or more of the following conditions:
   a. non-metastatic renal cell carcinoma
   b. central nervous system (CNS) hemangioblastomas
   c. non-metastatic pancreatic neuroendocrine tumours (pNET);
   AND
4. Provides the baseline radiographic report prior to initiation of treatment with belzutifan;
   AND
5. Belzutifan will be used as monotherapy;
   AND
6. Patient must have a good performance status;
   AND
7. Initiated by a specialist with expertise in the management of VHL disease-associated tumours.

Discontinuation criteria:

Funding of Belzutifan will be discontinued upon meeting any of the following scenarios:

1. Clinical disease progression (i.e. worsening of symptoms)
2. Radiographic disease progression with clinical disease progression
3. Patient develops metastatic RCC or metastatic pNET or another metastatic cancer
4. Patient experiences intolerable side effects to belzutifan therapy (e.g., becoming transfusion dependent due to anemia)

Renewal Criteria:

Renewal of funding will be approved in those who continue to use belzutifan as monotherapy for vHL disease-associated tumours and who do not meet the discontinuation criteria.

Patients with tumours in multiple sites, who demonstrate radiographic progression without clinical disease progression may continue on treatment with belzutifan if the clinician deems that the patient is continuing benefit from treatment.

Approved dose: Up to 120 mg orally daily

Approval duration of initials and renewals: 1 year