CurrentUnitedHealthcarePolicy 2025 P 1370-6

Welireg (belzutifan) prior authorization and coverage criteria

Prior authorization and coverage criteria for Welireg (belzutifan) for UnitedHealthcare members, including indications, initial and reauthorization rules, and special notes about state mandates and automated approvals; applies to pharmacy benefit processing.

Policy Summary

PayerUnitedHealthcare

PolicyWelireg (belzutifan) prior authorization and coverage criteria

Policy CodePolicy 2025 P 1370-6

Change TypeAdded/updated clinical criteria

Effective Date10/1/2025

Next Review Date

Key ActionObtain prior authorization demonstrating diagnosis and required prior therapies (for advanced RCC: progression after both a PD‑1/PD‑L1 inhibitor and a VEGF‑TKI).

SourceLink

POLICY UPDATE CHANGES

Added criteria for pheochromocytoma/paraganglioma

Added criteria for advanced renal cell carcinoma

Updated examples of PD-1/PD-L1 checkpoint inhibitors and VEGF-TKIs within advanced RCC criteria

12 monthsauthorization duration for all approved indications

age <19auto-process for young members

3 groupsVHL indication groups

PD‑1 + VEGF‑TKIadvanced RCC requirement

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Coverage Criteria for Welireg (belzutifan)

Initial Therapy — VHL disease

Covered when ALL of the following are met

VHL initial criteria: 1) Diagnosis of von Hippel-Lindau (VHL) disease; 2) Patient requires therapy for one of: renal cell carcinoma (RCC), pancreatic neuroendocrine tumor (pNET), or central nervous system (CNS) hemangioblastoma; 3) Patient does not require immediate surgery

Authorization will be issued for 12 months

Reauthorization — VHL disease

Covered when ALL of the following are met

VHL reauthorization: Patient does not show evidence of disease progression while on Welireg

Authorization will be issued for 12 months

Initial Therapy — Advanced RCC

Covered when ALL of the following are met

Advanced RCC initial criteria: 1) Diagnosis of advanced renal cell carcinoma (RCC); 2) Disease has progressed after treatment with both: a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI

Authorization will be issued for 12 months

Reauthorization — Advanced RCC

Covered when ALL of the following are met

Advanced RCC reauthorization: Patient does not show evidence of disease progression while on Welireg

Authorization will be issued for 12 months

Initial Therapy — PPGL

Covered when ALL of the following are met

PPGL initial criteria: 1) Diagnosis of pheochromocytoma or paraganglioma (PPGL); 2) Disease is advanced, unresectable, or metastatic

Authorization will be issued for 12 months

Reauthorization — PPGL

Covered when ALL of the following are met

PPGL reauthorization: Patient does not show evidence of disease progression while on Welireg

Authorization will be issued for 12 months

For members under the age of 19, prescriptions for Welireg will automatically process without a coverage review. State-specific mandates may alter coverage requirements; where a state law or regulatory mandate applies (including mandated off‑label coverage or required compendia), that mandate supersedes the policy language. In addition, member benefit plan design or federal requirements may affect coverage determinations, and automated approval processes or supply limits may vary by claims logic.

Provider Actions, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization — VHL Indications

Prior authorization is required for all indicated Welireg (belzutifan) uses listed below. Submit documentation showing the specific diagnosis and supporting clinical evidence that the member meets the coverage criteria for the requested indication.

Required: completed prior authorization form and relevant clinical notes
Include ICD-10 diagnosis code corresponding to the approved indication
Automated approvals may be possible when claims/medication history and diagnosis codes demonstrate criteria are met

Prior Authorization

Prior Authorization — Advanced RCC

For advanced renal cell carcinoma (RCC), prior authorization requires documentation of the advanced RCC diagnosis and evidence that disease progressed after prior therapies.

Diagnosis: advanced RCC (provide relevant ICD-10 code and staging documentation)
Evidence of progression after treatment with a PD-1 or PD-L1 checkpoint inhibitor (e.g., pembrolizumab, nivolumab)

Initial Authorization Criteria (by Indication)

Initial authorization

Initial authorization criteria by indication

VHL initial: Diagnosis of VHL disease; requires therapy for RCC, pNET, or CNS hemangioblastoma; does not require immediate surgery

Authorization will be issued for 12 months

Advanced RCC initial: Diagnosis of advanced RCC; disease has progressed after treatment with both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI

Authorization will be issued for 12 months

PPGL initial: Diagnosis of pheochromocytoma or paraganglioma (PPGL); disease is advanced, unresectable, or metastatic

Authorization will be issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization

Reauthorization (continuation) criteria

VHL continuation: Patient does not show evidence of disease progression while on Welireg

Authorization will be issued for 12 months

Advanced RCC continuation: Patient does not show evidence of disease progression while on Welireg

Authorization will be issued for 12 months

PPGL continuation: Patient does not show evidence of disease progression while on Welireg

Authorization will be issued for 12 months

Step Therapy Requirements

Step	Requirement	Supporting details
1	Prior treatment with both a PD-1/PD-L1 checkpoint inhibitor and a VEGF-TKI is required before Welireg for advanced renal cell carcinoma (RCC)	Disease must have progressed after treatment with both: (a) a PD‑1 or PD‑L1 checkpoint inhibitor (e.g., pembrolizumab, nivolumab) and (b) a VEGF‑TKI (e.g., cabozantinib, axitinib, lenvatinib). Authorization issued for 12 months.

Background on Belzutifan (Welireg)

Belzutifan (Welireg) is a hypoxia-inducible factor (HIF) inhibitor indicated in the contexts described in this policy: for patients with von Hippel‑Lindau (VHL) disease who require therapy for associated tumors (renal cell carcinoma, pancreatic neuroendocrine tumor, or central nervous system hemangioblastoma); for advanced renal cell carcinoma (RCC) after disease progression on both a PD‑1/PD‑L1 checkpoint inhibitor and a VEGF‑tyrosine kinase inhibitor (VEGF‑TKI); and for locally advanced, unresectable, or metastatic pheochromocytoma/paraganglioma (PPGL) in appropriate patients. Authorization for approved indications is issued for 12 months where criteria are met.

Definitions and Disease Descriptions

VHL disease — definition and associated tumors

DefinitionVon Hippel-Lindau (VHL) disease is an inherited (hereditary) disorder associated with development of tumors including renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, and pancreatic neuroendocrine tumors (pNET).

Indications relevant to policyWelireg (belzutifan) is indicated for adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas, or pNET when immediate surgery is not required.

Authorization noteInitial authorization for VHL-associated tumors is issued for 12 months when criteria are met (diagnosis of VHL disease; patient requires therapy for RCC, pNET, or CNS hemangioblastoma; patient does not require immediate surgery).

Related tumor typesMajor VHL-associated tumor groups addressed in this policy: renal cell carcinoma (RCC), central nervous system hemangioblastomas, pancreatic neuroendocrine tumors (pNET).

Age considerationsWelireg indications in the document include adult patients with VHL disease; other indications in the policy cover pediatric patients 12 years and older for PPGL but VHL indication applies to adults per the source text.

Policy Revision History and Changes

2025-07annual_reviewLatest

Annual review — added criteria for pheochromocytoma/paraganglioma (PPGL).

2024-02addition

Added criteria for advanced renal cell carcinoma (RCC).

2024-07revision

Updated examples of PD-1/PD-L1 checkpoint inhibitors and VEGF-TKIs within the advanced RCC criteria.

Policy Summary

PayerUnitedHealthcare

PolicyWelireg (belzutifan) prior authorization and coverage criteria

Policy CodePolicy 2025 P 1370-6

Change TypeAdded/updated clinical criteria

Effective Date10/1/2025

Next Review Date

Key ActionObtain prior authorization demonstrating diagnosis and required prior therapies (for advanced RCC: progression after both a PD‑1/PD‑L1 inhibitor and a VEGF‑TKI).

SourceLink

On This Page

Evidence of progression after treatment with a VEGF tyrosine kinase inhibitor (e.g., cabozantinib, axitinib, lenvatinib)

Prior Authorization

Prior Authorization — PPGL

Prior authorization for pheochromocytoma or paraganglioma (PPGL) requires documentation of the diagnosis and that disease is advanced, unresectable, or metastatic.

Diagnosis: pheochromocytoma or paraganglioma (provide ICD-10 code and pathology/imaging as applicable)
Disease status: advanced, unresctable, or metastatic (documentation required)

Step Therapy

Step Therapy Requirement — Advanced RCC

Step therapy applies for advanced RCC: authorization will only be approved when the member has received prior therapy with both a PD-1/PD-L1 inhibitor and a VEGF-TKI and documented progression on those agents.

Step requirement: prior PD-1/PD-L1 and prior VEGF-TKI therapy documented in medical or pharmacy records
Progression: documentation of disease progression after each class is required

Documentation Required

Document Sources Accepted for Automated Approvals

UnitedHealthcare may approve initial or re-authorization requests using automated processes when the required documentation is present in claims or medication history. Accepted sources for automated approvals include prior claims, pharmacy fill history, and diagnosis codes (ICD-10); approval logic varies by program. Note that supply limits may apply.

Accepted sources for automated approval: previous claim records, pharmacy medication history, ICD-10 diagnosis codes, and claim-logic algorithms
Automated approvals depend on program-specific rules and may apply only when the claims history clearly demonstrates the coverage criteria
Supply limits or quantity limits may be enforced even when approved automatically

Denial Risk

Denial / Coverage Risk Factors

Denial or coverage risk may occur for reasons including state or federal mandate conflicts, member-specific benefit exclusions, missing or insufficient documentation, or when automated approval criteria are not met. Verify benefit design and state mandates before submitting.

State mandates or federal regulations may supersede or require different coverage — check state-specific requirements
Member-specific benefit limitations or exclusions may prevent coverage despite meeting clinical criteria
Incomplete documentation (missing prior therapy records, lack of ICD-10 codes, or absent progression evidence) will increase denial risk
Automated approvals are not guaranteed; if claims/medication history is insufficient, a manual review and additional documentation will be requested

2022-10annual_review

Annual review with no clinical coverage criteria changes; added state mandate footnote and updated references.

2021-10addition

Program created (new prior authorization/notification program for Welireg [belzutifan]).