Pharmacy Prior Authorization Criteria

Welireg (belzutifan)

Indications for Prior Authorization

Welireg (belzutifan)

• For diagnosis of Von Hippel-Lindau (VHL) disease
  Indicated for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), not requiring immediate surgery

• For diagnosis of Advanced Renal Cell Carcinoma (RCC)
  Indicated for treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

Criteria

Welireg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of von Hippel-Lindau (VHL) disease

• Diagnosis of von Hippel-Lindau (VHL) disease [A, 1]
AND
• Patient requires therapy for one of the following [A, 1] :
• Renal cell carcinoma (RCC)
• Central nervous system (CNS) hemangioblastoma
• Pancreatic neuroendocrine tumor (pNET)
AND
• Patient does not require immediate surgery [A,1]

Welireg

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of von Hippel-Lindau (VHL) disease

• Patient does not show evidence of progressive disease while on therapy [A, 1]

Welireg

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma (RCC)

• Diagnosis of advanced renal cell carcinoma
AND
• Disease has progressed after treatment with both of the following:
• One of the following:
• Programmed death receptor-1 (PD-1) inhibitor [e.g., Keytruda (pembrolizumab), Opdivo (nivolumab)]
• Programmed death-ligand 1 (PD-L1) inhibitor [e.g., Bavencio (avelumab), Imfinzi (durvalumab)]
AND
• Vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) [e.g., Votrient (pazopanib), Inlyta (axitinib)]

Welireg

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Advanced Renal Cell Carcinoma (RCC)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-10-01, 2024-01-26, 2023-09-11, 2023-07-03, 2022-09-11, 2021-10-09

References

1. Welireg [Prescribing Information]. Merck & Co, Inc. Rathway, NJ. December 2023.
2. NCCN Clinical Practice Guidelines in Oncology. Kidney Cancer V2.2025. Available at https://www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. Accessed October 1, 2024.

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End Notes

1. The efficacy of WELIREG was evaluated in Study 004 (NCT03401788), an open-label clinical trial in 61 patients with VHL-associated RCC diagnosed based on a VHL germline alteration and with at least one measurable solid tumor localized to the kidney as defined by response evaluation criteria in solid tumors (RECIST) v1.1. Enrolled patients had other VHL-associated tumors including CNS hemangioblastomas and pNET. CNS hemangioblastomas and pNET in these patients were diagnosed based on the presence of at least one measurable solid tumor in brain/spine or pancreas, respectively, as defined by RECIST v1.1 and identified by IRC. The study excluded patients with metastatic disease. Patients received WELIREG 120 mg once daily until progression of disease or unacceptable toxicity. The study population characteristics were: median age 41 years [range 19-66 years], 3.3% age 65 or older; 53% male; 90% were White, 3.3% were Black or AfricanAmerican, 1.6% were Asian, and 1.6% were Native Hawaiian or other Pacific Islander; 82% had an ECOG PS of 0, 16% had an ECOG PS of 1, and 1.6% had an ECOG PS of 2; and 84% had VHL Type I Disease. The median diameter of RCC target lesions per central independent review committee (IRC) was 2.2 cm (range 1-6.1). Median time from initial radiographic diagnosis of VHL-associated RCC tumors that led to enrollment on Study 004 to the time of treatment with WELIREG was 17.9 months (range 2.8-96.7). Seventy- seven percent of patients had prior surgical procedures for RCC. The major efficacy endpoint for the treatment of VHL-associated RCC was overall response rate (ORR) measured by radiology assessment using RECIST v1.1 as assessed by IRC. Additional efficacy endpoints included duration of response (DoR), and time to response (TTR).

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Revision History

• 2024-10-01: 2024 Annual Review. Background updates only.
• 2024-01-26: update guideline
• 2023-09-11: 2023 Annual Review
• 2023-07-03: Removed specialist requirement
• 2022-09-11: 2022 Annual Review
• 2021-10-09: New UM PA criteria

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