Welireg®

Drug - Welireg® (belzufitan) [Merck Sharp & Dohme LLC.]

October 2022

Therapeutic area - Oncology, Oral - Renal Cell Carcinoma

Initial approval criteria

Patient is at least 18 years of age AND
Patient has a diagnosis of Von Hippel-Lindau Disease (VHL) based on a germline VHL-alteration AND
Patient has ≥ 1 of the following associated tumors:
- Renal cell carcinoma (RCC) [note: may be confirmed radiologically only] OR
- CNS hemangioblastomas OR
- Pancreatic neuroendocrine tumors (pNET) AND
Patient does not have an immediate need for surgical intervention for tumor treatment OR have evidence of metastatic disease AND
Patient has a serum hemoglobin level of at least 9 mg/dL AND
Patient oxygen saturation will be monitored prior to initiation of therapy and periodically throughout therapy AND
Patient has not received prior treatment with another HIF-2a inhibitor AND
Will not be used in combination with erythropoiesis stimulating agents (ESAs) AND
Patient will avoid coadministration with UGT2B17-inhibitors (e.g., green teas, quercetin, red wine) or cytochrome P450 pathway (CYP) CYP2C19 inhibitors (e.g., fluvoxamine, quercetin, ketoconazole), or if therapy is unavoidable, the patient will be monitored closely for adverse reaction and/or dose modifications will be implemented AND
Female of child-bearing age must have a confirmed negative pregnancy test prior to therapy AND
Female of child-bearing age must be using effective NON-hormonal contraception during treatment OR male with female partners of childbearing age must use effective contraception during treatment
Initial approval is for 6 months

Patient must continue to meet the above universal and other indicationspecific criteria (e.g., such as concomitant therapy requirements [not including prerequisite therapy], performance status) AND
Patient has not had unacceptable toxicity from the drug (e.g., severe anemia, severe hypoxia) AND
Treatment has resulted in disease response, as defined by stabilization of disease or decrease in size of tumor or tumor spread
Renewal approval is for 6 months

MHCP Provider Resource Center 651-431-2700 or 800-366-5411