CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Welireg (belzutifan) — Coverage Criteria (VHL and RCC)

Defines when Welireg (belzutifan) is authorized for treatment of von Hippel-Lindau (VHL) associated tumors and renal cell carcinoma (RCC), and lists exclusions and coding; applies to provider medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyWelireg (belzutifan) — Coverage Criteria (VHL and RCC)

Policy CodePolicy N/A

Change TypeRevised (March 2025)

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests using billing code J8999 and include supporting documentation per FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or peer‑reviewed literature.

SourceLink

POLICY UPDATE CHANGES

Updated verbiage in Renal Cell Carcinoma indication.

Updated exclusion criteria.

Converted to new Evolent guideline template and replaces prior UM ONC_1446 Welireg guideline.

J8999HCPCS code listed for belzutifan

90/moMaximum monthly quantity

120 mgSingle dose maximum

VHL tumorsFDA/accepted VHL indications

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Coverage Criteria

VHL-associated indications

Covered when ALL of the following are met for VHL-associated indications:

VHL indications: Member has VHL-associated non-metastatic RCC, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgical intervention

Monotherapy use allowed

Renal Cell Carcinoma

Covered when ALL of the following are met for RCC indication:

RCC indication: Adult member has unresectable, locally advanced or metastatic renal cell carcinoma AND belzutifan is being used following prior treatment with an immune checkpoint inhibitor AND a VEGF-TKI

Examples of ICIs and VEGF-TKIs are listed in policy (e.g., avelumab, pembrolizumab, nivolumab, ipilimumab; axitinib, pazopanib)

Continuation Therapy

Continuation authorization criteria:

Continuation: Member has not experienced disease progression on the requested medication AND the requested medication was used within the last year without a lapse of more than 30 days of having an active authorization AND additional medication(s) are not being added to the continuation request

Continuation requests for a not-approvable medication are exempt from initial-approval restrictions if these conditions are met

Exclusions for authorization of Welireg (belzutifan) include situations where the member has experienced disease progression while taking belzutifan; when the member has metastatic disease but the request is for a VHL-associated non‑metastatic indication (such as non‑metastatic RCC, CNS hemangioblastomas, or pNET that do not require immediate surgery); and when belzutifan is prescribed concurrently with other systemic therapies. Requests will also be excluded if dosing would exceed a single dose of 120 mg or a monthly supply beyond 90 (40 mg) tablets per month.

Use of belzutifan (Welireg) is considered not medically necessary for investigational or off‑label indications that lack adequate supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature. Abstracts or meeting summaries without a corresponding full article in an approved peer‑reviewed journal are specifically noted as insufficient evidence. The policy also emphasizes assessment of whether published evidence adequately represents the patient and cancer characteristics, the regimen studied, and clinically meaningful outcomes (e.g., ASCO‑recommended effect sizes such as hazard ratios and minimum survival benefit thresholds).

Covered Regimens

Regimen	Indication	Coverage status
Belzutifan monotherapy	Von‑Hippel Lindau (VHL)–associated non‑metastatic renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNET) that do not require immediate surgical intervention	Covered

Regimen	Indication / prior therapy requirement	Coverage status
Belzutifan monotherapy following specified prior therapies	Unresectable, locally advanced or metastatic renal cell carcinoma (RCC) in adults — belzutifan to be used after prior treatment with an immune checkpoint inhibitor (e.g., avelumab, pembrolizumab, nivolumab, ipilimumab) AND a VEGF‑TKI (e.g., axitinib, pazopanib)	Covered with criteria

Line of Therapy

second-line

Second-line (RCC): Belzutifan is authorized as second-line therapy for unresectable, locally advanced, or metastatic RCC after prior treatment with an immune checkpoint inhibitor AND a VEGF-TKI

Examples of agents provided in policy; applies to adult members

Coding

HCPCS codesHCPCS

J8999

belzutifan

Single dose and monthly maximum

Single dose maximum120 mg

Maximum monthly quantity90 (40 mg) tablets per month

Context for limitsDosing limits apply to Welireg (belzutifan) per exclusion criteria — doses above these limits are grounds for denial

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for belzutifan (Welireg) requests processed by Evolent.

Billing code: J8999

Step Therapy

Prior Therapy Requirement for RCC

For metastatic or unresectable renal cell carcinoma (RCC), belzutifan (Welireg) is authorized only after prior treatment with BOTH an immune checkpoint inhibitor (e.g., avelumab, pembrolizumab, nivolumab, ipilimumab) and a VEGF‑TKI (e.g., axitinib, pazopanib).

Documentation Required

Required Supporting Documentation

Definitions

VHL-associated tumors (definitions)

Covered VHL tumor typesVon-Hippel Lindau (VHL) associated non-metastatic renal cell carcinoma (RCC)

CNS tumorsCentral nervous system hemangioblastomas

Pancreatic tumorsPancreatic neuroendocrine tumors (pNET)

Use conditionMay be used as monotherapy when tumors do not require immediate surgical intervention

Examples of prior systemic therapies for RCC

Required prior systemic therapiesImmune checkpoint inhibitor (examples: avelumab, pembrolizumab, nivolumab, ipilimumab)

Required prior systemic therapies (cont.)

Background

Belzutifan (Welireg) is a HIF‑2α inhibitor indicated for treatment of tumors associated with von Hippel‑Lindau (VHL) disease, including VHL‑associated non‑metastatic renal cell carcinoma (RCC), central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors (pNET). It is also used for unresectable, locally advanced or metastatic RCC in adults who have been previously treated with an immune checkpoint inhibitor and a VEGF‑targeted tyrosine kinase inhibitor. Continued authorization may be considered when there has been no disease progression and prior authorization remained active without a lapse greater than 30 days.

Revision History

2025-03policy_revisionLatest

Converted to new Evolent guideline template and replaced prior UM ONC_1446 Welireg (belzutifan) guideline; operational wording for the Renal Cell Carcinoma indication was clarified and the exclusion criteria were expanded/clarified; references updated.

2024-03policy_update

Added Renal Cell Carcinoma indication and updated verbiage from NCH to Evolent; new reference added.