CurrentCignaPolicy N/A

Oncology - Voranigo Prior Authorization Policy

This Cigna coverage policy governs prior authorization and medical necessity criteria for Voranigo (vorasidenib tablets) for eligible patients with IDH1- or IDH2-mutant Grade 2 (or higher) oligodendroglioma or astrocytoma following surgery; it applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicyOncology - Voranigo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded grade qualifieroverview clarified

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing patient is ≥12, has a susceptible IDH1/IDH2 mutation, Grade ≥2 astrocytoma or oligodendroglioma, and prior surgery.

SourceLink

POLICY UPDATE CHANGES

Added qualifier '≥' in front of Grade 2 oligodendroglioma and astrocytoma.

Updated guidelines in the overview section; no criteria changes.

≥12minimum patient age for coverage

1 yrinitial approval duration

IDH1/IDH2required susceptible mutation

Grade ≥2tumor grade required

Yesprior surgery required

Coverage Criteria for Voranigo (vorasidenib)

Initial FDA-Approved Indication

Covered when ALL of the following are met

FDA-Approved Indication for Voranigo: A) Patient is ≥ 12 years of age; AND B) Patient has a susceptible IDH1 or IDH2 mutation-positive disease; AND C) Patient meets ONE of the following: (i) Patient has ≥ Grade 2 oligodendroglioma OR (ii) Patient has ≥ Grade 2 astrocytoma; AND D) Patient has had prior surgery, including biopsy, sub-total resection, or gross total resection.

Approve for 1 year when all conditions met

Voranigo (vorasidenib) is covered only for the indication and clinical criteria described in this policy. The policy will be updated as new published data become available and coverage criteria are maintained accordingly.

Any use of Voranigo that does not meet the specific coverage criteria outlined in this document is considered not medically necessary and therefore not covered.

Covered Regimens and Dosing Context

Regimen	Indication / Setting	Key regimen details	Guideline reference	Coverage status
Voranigo (vorasidenib)	Adjuvant treatment after surgery for WHO Grade ≥2 IDH1- or IDH2‑mutant gliomas (astrocytoma or oligodendroglioma)	Oral IDH1/IDH2 inhibitor; indicated following surgery including biopsy, subtotal resection, or gross total resection; for patients ≥ 12 years of age.	NCCN CNS Cancers (v1.2025) — recommended as 'Preferred' regimen for adjuvant treatment after surgery/biopsy for WHO Grade 2 IDH‑mutant gliomas (KPS ≥ 60); also referenced for recurrent/progressive disease (various categories).	Covered with criteria

Policy Summary

PayerCigna

PolicyOncology - Voranigo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded grade qualifieroverview clarified

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing patient is ≥12, has a susceptible IDH1/IDH2 mutation, Grade ≥2 astrocytoma or oligodendroglioma, and prior surgery.

SourceLink

On This Page

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Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for prescription benefit coverage of Voranigo. Approvals are provided for the duration specified in the policy when criteria are met.

Prior authorization recommended for Voranigo (vorasidenib).
Approvals provided for the duration noted in the policy when all coverage criteria are met.

Step Therapy

No step therapy requirements are specified for Voranigo in this policy. Providers should not expect step edits or prerequisite therapies to be enforced under this coverage policy, but must follow any specific plan or benefit design that may impose different requirements.

Documentation Required

Required Documentation

Providers must submit documentation demonstrating the patient meets the plan terms and the specific coverage criteria listed in the policy (for example age, IDH1/IDH2 mutation status, tumor grade, and prior surgery). Include relevant medical records, pathology or molecular testing results confirming IDH mutation, operative reports or biopsy documentation, and any other clinical notes supporting the indication.

Include documentation of patient age.
Provide pathology/molecular testing confirming IDH1 or IDH2 mutation.
Provide documentation of tumor grade (≥ Grade 2 oligodendroglioma or ≥ Grade 2 astrocytoma).
Provide operative report, biopsy, or other documentation of prior surgery.

Denial Risk

Denial Risk for Unsupported Claims

Claims lacking documentation or billed with diagnoses/procedure codes that do not support the covered indication or meet the policy criteria will be denied as not covered. When billing, providers must use the most appropriate codes as of the date of service; services billed for conditions not covered under this policy will be denied.

Claims submitted without covered diagnosis/procedure codes or without supporting documentation of the policy criteria will be denied.
Use the most appropriate and current codes for the date of service.

Key Definitions

inv-11: Grade 2 diffuse gliomas — definition/label for Grade 2 diffuse gliomas

DefinitionGrade 2 diffuse gliomas are adult-type diffuse gliomas further sub‑divided into astrocytoma (IDH‑mutant), oligodendroglioma (IDH‑mutant and 1p/19q‑codeleted), and related WHO‑designated grades; nearly all Grade 2 diffuse gliomas in adults harbor IDH1 or IDH2 mutations.

WHO classification contextClassified by histologic and molecular features into tumor subtypes and grades

Common molecular featureHigh prevalence of IDH1/IDH2 mutations in Grade 2 diffuse gliomas

inv-12: Susceptible IDH mutation — Susceptible IDH1 or IDH2 mutation as detected by an FDA-approved test

Definition of susceptible mutationSusceptible IDH1 or IDH2 mutation as detected by an FDA‑approved test

Test requirementMutation must be identified by an FDA‑approved diagnostic test

Relevance to indicationPresence of a susceptible IDH1 or IDH2 mutation is required for coverage of Voranigo

OpenPayer

Oncology - Voranigo Prior Authorization Policy

Coverage Criteria for Voranigo (vorasidenib)

Covered Regimens and Dosing Context

Coding and Age Requirements

Provider Actions, Authorization, and Documentation

Key Definitions

Biomarker Requirements

Line of Therapy

Background