CurrentMass General Brigham Health PlanPolicy N/A

Welireg (belzutifan) — Coverage and Prior Authorization

Defines prior authorization, specialty dispensing, quantity/step limits, and medical necessity criteria for Welireg (belzutifan) for Mass General Brigham Health Plan members under pharmacy and medical benefits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyWelireg (belzutifan) — Coverage and Prior Authorization

Policy CodePolicy N/A

Change TypeAdded indicationrevised VHL eligibility

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation that member meets diagnosis-specific criteria or is within 90 days of plan enrollment and currently receiving therapy.

SourceLink

POLICY UPDATE CHANGES

Added supplemental indication of advanced renal cell carcinoma and updated criteria for von Hippel-Lindau disease to remove non‑metastatic and single‑agent requirements.

Updated criteria for von Hippel-Lindau disease to remove requirements that disease is not metastatic and that Welireg will be used as a single agent.

12 monthsapproval duration

Specialtydispensing channel

Advanced RCCsupplemental indication

PD-1 + VEGF-TKIprior therapy req

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Coverage Criteria for Welireg (belzutifan)

Von Hippel-Lindau (VHL) disease

Authorization may be granted if the member meets ALL of the following diagnosis-specific criteria for von Hippel-Lindau disease

VHL Indication: Member has a diagnosis of von Hippel-Lindau (VHL) disease; therapy is required for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET).

From policy VHL section

No Immediate Surgery: Member does not require immediate surgery for the VHL-related lesion.

Explicit condition in VHL criteria

Advanced Renal Cell Carcinoma

Authorization may be granted if the member meets ALL of the following for advanced renal cell carcinoma

Advanced RCC Indication: Member has a diagnosis of advanced renal cell carcinoma.

From policy Advanced RCC section

Prior Therapy: Member has had an inadequate response or adverse reaction to one, or has a contraindication to both, of the following: (a) a PD‑1 inhibitor; (b) a PD‑L1 inhibitor with a VEGF‑TKI.

From policy Advanced RCC section

Continuation of Therapy

Requests for reauthorization will be approved when ALL of the following are met

Safety and Efficacy: Prescriber submits documentation of no evidence of unacceptable toxicity or disease progression while on treatment.

From Continuation of Therapy section

Plan Requirements: Member meets any other applicable plan requirements (e.g., benefit, site-of-care, quantity limits, and program-specific rules).

Operational — refer to plan program constraints

Approval Duration: Reauthorizations (and initial approvals) will be granted for 12 months.

From Limitations section

For the von Hippel‑Lindau (VHL) disease indication, the member must not require immediate surgery. This is an explicit condition of the VHL coverage criteria and must be documented in the clinical record to support authorization.

Authorization is not granted when the diagnosis‑specific criteria are not met. Additionally, authorizations will not be approved for members who are new to the plan and are beyond the 90‑day review window unless they are currently receiving the requested medication at the time of request (exceptions include samples or manufacturer patient assistance programs, which are excluded).

Initial Therapy / Authorization

Initial Therapy/Authorization

Initial authorization may be reviewed or granted under the following pathways

Initial Authorization Pathways: Authorization may be reviewed for members new to the plan within the past 90 days who are currently receiving the medication, OR if the member meets the diagnosis‑specific criteria for von Hippel‑Lindau disease or for advanced renal cell carcinoma as specified in this policy.

Coverage Guidelines section

Continuation and Reauthorization Requirements

Continuation/Reauthorization

Reauthorization requests will be approved when ALL of the following are satisfied

Toxicity and Progression Documentation: Prescriber documents no evidence of unacceptable toxicity or disease progression while on belzutifan (Welireg).

Required documentation for reauthorization; Continuation of Therapy section

Compliance with Plan Rules: Member continues to meet applicable plan requirements including benefit-specific limits, specialty pharmacy dispensing rules, and any program constraints.

Operational — see plan benefit and site-of-care rules

Authorization Period: When criteria are met, reauthorization will be granted for 12 months.

From Limitations section

Provider Actions and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization may be reviewed for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication (excludes product obtained as samples or via manufacturer patient assistance programs). Authorization may also be granted when the member meets the diagnosis-specific criteria in the policy (e.g., VHL disease indications, advanced RCC criteria).

Authorization review window: within 90 days of plan enrollment if member is currently receiving medication
Excludes samples and manufacturer patient assistance program supplies

Step Therapy

Benefit / Program Constraints

Step therapy, quantity limits, pharmacy/medical benefit assignment, and specialty designation apply per the member's benefit. This product has program constraints: it may be subject to a Quantity Limit and/or Step Therapy under the pharmacy benefit, and specialty medication designation may require fill at a contracted specialty pharmacy.

Indications and Definitions

von Hippel‑Lindau (VHL) disease indication

IndicationTreatment 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).

Surgical requirementMember does not require immediate surgery for the VHL‑related lesion.

Diagnosis requirementMember has a documented diagnosis of von Hippel‑Lindau (VHL) disease.

Prior authorizationPrior authorization required and will be reviewed per plan criteria for VHL indication.

Advanced renal cell carcinoma indication

IndicationTreatment of adults with advanced renal cell carcinoma following prior therapy with a PD‑1 or PD‑L1 inhibitor and a VEGF‑TKI.

Step Therapy / Program Constraints

Program type	Step requirement details
Step Therapy	Policy lists Step Therapy as a program type; specific step requirements are not detailed in the document.

Quantity Limits and Benefit Details

Welireg (belzutifan) — See benefit-specific quantity limits

DrugWelireg (belzutifan)

Quantity limitsSee benefit-specific quantity limits (per plan/program).

Benefit channelsApplies to Pharmacy Benefit; program types include Quantity Limit and Step Therapy as specified by benefit.

Specialty designationDesignated as specialty; must be filled at a contracted specialty pharmacy.

Designated Dispensing Channel

Billing Rule

Specialty pharmacy dispensing required

Welireg is designated as a specialty medication and must be dispensed through a contracted specialty pharmacy as specified by the policy.

Must be filled at a contracted specialty pharmacy per policy
Contact numbers for specialty and non-specialty benefits are provided in the policy

Background

Belzutifan (Welireg) is indicated for 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) and who do not require immediate surgery. The policy also includes an indication for advanced renal cell carcinoma under specified prior‑therapy conditions.