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Colorado Rocky Mountain Health Plans Welireg Prior Auth | OpenPayer

CurrentColorado Rocky Mountain Health PlansPolicy N/A

Welireg (belzutifan) — Prior authorization and coverage criteria

Prior authorization and coverage criteria for Welireg (belzutifan) for Colorado Rocky Mountain Health Plans members, covering indications including VHL-associated tumors, advanced RCC after specific prior therapies, and PPGL; pediatric prescriptions (<19) auto-process without review. Affects providers prescribing Welireg and pharmacy prior authorization staff.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyWelireg (belzutifan) — Prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeMaterial additions for PPGL and advanced RCCexamples updated

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis and evidence of prior therapies or disease status as required by indication.

SourceLink

POLICY UPDATE CHANGES

Added criteria for pheochromocytoma/paraganglioma (PPGL).

Added criteria for advanced renal cell carcinoma after prior PD-1/PD-L1 and VEGF-TKI therapy.

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

12 monthsauthorization period for initial and reauthorization approvals

Age <19 auto-approvepediatric prescriptions process without coverage review

3 VHL tumor typesVHL indications requiring therapy (RCC, CNS hemangioblastoma, pNET)

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Coverage Criteria and Indications

Initial Therapy — VHL disease

Covered when ALL of the following are met

VHL initial: (1) Diagnosis of von Hippel-Lindau (VHL) disease; (2) Patient requires therapy for one of the following: renal cell carcinoma (RCC) OR central nervous system (CNS) hemangioblastoma OR pancreatic neuroendocrine tumor (pNET); (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: (1) Diagnosis of advanced renal cell carcinoma (RCC); (2) Disease has progressed after treatment with BOTH of the following classes: a PD-1 or PD-L1 checkpoint inhibitor (e.g., pembrolizumab, nivolumab) AND a VEGF tyrosine kinase inhibitor (e.g., cabozantinib, axitinib, lenvatinib)

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: (1) Diagnosis of pheochromocytoma or paraganglioma (PPGL); (2) Disease is advanced OR 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

Some states have mandates that require coverage for off-label medication uses or specify reliance on external compendium references. Where applicable, those state mandates or compendium requirements supersede the criteria and language in this policy document. Providers should follow state-specific benefit mandates when they conflict with the policy.

Initial Authorization Requirements by Indication

Initial Therapy

Initial authorization requirements by indication

VHL initial: Diagnosis of von Hippel-Lindau (VHL) disease; requires therapy for RCC OR CNS hemangioblastoma OR pNET; does not require immediate surgery

12-month authorization

Advanced RCC initial: Diagnosis of advanced RCC; disease progressed after treatment with BOTH a PD-1/PD-L1 checkpoint inhibitor and a VEGF-TKI (examples provided)

12-month authorization

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

12-month authorization

Reauthorization and Continuation Requirements

Reauthorization/Continuation Therapy

Reauthorization conditions

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

Authorization issued for 12 months

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

Authorization issued for 12 months

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

Authorization issued for 12 months

Prior Authorization Steps and Documentation

Prior Authorization

Prior authorization — VHL indications

Prior authorization required for von Hippel‑Lindau (VHL) indications. Provider must document diagnosis of VHL disease and that the patient requires therapy for an approved VHL-associated tumor (renal cell carcinoma, CNS hemangioblastoma, or pancreatic neuroendocrine tumor). Patient must not require immediate surgery. Authorization issued for 12 months.

Diagnosis: von Hippel‑Lindau (VHL) disease
Indication: RCC, CNS hemangioblastoma, or pNET
Clinical requirement: Patient does not require immediate surgery
Authorization length: 12 months

Step Therapy

Prior authorization — advanced RCC

Prior authorization required for advanced renal cell carcinoma (RCC). Provider must document diagnosis of advanced RCC and that disease has progressed after both a PD‑1/PD‑L1 checkpoint inhibitor and a VEGF‑TKI. Examples of agents may be provided in documentation. Authorization issued for 12 months.

Step Therapy Requirements

Requirement	Details
Step therapy requirement	Must have documented disease progression 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 period	Authorization will be issued for 12 months.
Program changes / references	Advanced RCC criteria and example agents updated in program change history (see references).

Supply and Quantity Limit Notes

Welireg (belzutifan) — Quantity limits

Quantity limit statusSupply limits may be in place for Welireg (belzutifan)

Basis for limitsAdditional clinical rules note that automated approval and re-approval processes vary by program and/or therapeutic class

ApplicabilitySupply limits apply in addition to coverage criteria and prior authorization requirements

Key Definitions

VHL disease (definition)

DefinitionVHL disease (von Hippel-Lindau) is a hereditary cancer syndrome associated with renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, and pancreatic neuroendocrine tumors (pNET)

Treatment contextWelireg indicated for adult patients with VHL disease who require therapy for associated RCC, CNS hemangioblastomas, or pNET not requiring immediate surgery

Authorization noteInitial authorization requires documented diagnosis of VHL disease and that the patient requires therapy for one of the listed tumor types

PPGL (definition)

DefinitionPPGL: pheochromocytoma or paraganglioma that is advanced, unresectable, or metastatic

Age indicationsWelireg is indicated for adult and pediatric patients 12 years and older with locally advanced, unresectable, or metastatic PPGL

Clinical Background and Indication Summary

Belzutifan (Welireg) is a hypoxia-inducible factor inhibitor indicated for adult patients with von Hippel‑Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors (pNETs) not requiring immediate surgery; for adult patients with advanced RCC after progression on both a PD‑1/PD‑L1 inhibitor and a VEGF‑targeted tyrosine kinase inhibitor; and for patients aged 12 years and older with locally advanced, unresectable, or metastatic pheochromocytoma/paraganglioma (PPGL).