Welireg – NC Standard

Restricted Product(s)

• Welireg™ (belzutifan)

FDA Approved Use

• For the 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 the 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 for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is being managed by or in consultation with an oncologist; AND 
3. The patient is 18 years of age of older; AND 
4. ONE of the following: 
   1. The patient has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration [medical record documentation required]; AND 
      1. The patient has been diagnosed with ONE of the following [medical record documentation required]: 
         1. Renal cell carcinoma (RCC); OR 
         2. Central nervous system (CNS) hemangioblastoma; OR 
         3. Pancreatic neuroendocrine tumor (PNET); AND 
      2. The patient does not require immediate surgery; AND 
      3. The patient has not received prior treatment with belzutifan or another HIF-2α inhibitor; AND 
      4. The patient has not received prior treatment with any systemic anti-cancer therapy; AND 
      5. The patient does not have evidence of metastatic disease on screening imaging; OR 
   2. The patient has a diagnoses of advanced renal cell carcinoma (RCC) [medical record documentation required]; AND 
      1. The patient has had disease progression on or after receiving systemic treatment with 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); AND 
      2. The patient has received no more than 3 prior systemic regimens for advanced renal cell carcinoma (RCC); AND
5. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND 
6. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

December 2023: Criteria update: added new indication 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) to policy.
September 2023: Criteria update: Criteria review and formatting changes. Added duration of approval to quantity limit exception criteria.
September 2021: Original utilization management criteria issued.