CurrentColorado Rocky Mountain Health PlansPolicy N/A

Voranigo (vorasidenib) prior authorization

Prior authorization and notification criteria for vorasidenib (Voranigo) for treatment of IDH1/2-mutant astrocytoma and oligodendroglioma in covered members; includes pediatric automatic processing for under-19. Affects prescribers and pharmacy reviewers for Colorado Rocky Mountain Health Plans implementing UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVoranigo (vorasidenib) prior authorization

Policy CodePolicy N/A

Change TypeClinical and operational updates

Effective DateMar 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of tumor histology, WHO grade, IDH1/2 mutation (and 1p19q codeletion for oligodendroglioma) and history of prior surgery.

SourceLink

POLICY UPDATE CHANGES

Separated criteria for astrocytoma and oligodendroglioma into two sections and added WHO grade requirements for both.

Added requirement of 1p19q codeletion for oligodendroglioma.

Removed Grade 2 disease requirement per NCCN Compendium.

12 monthsauthorization period for initial and reauthorization approvals

>=12 yrsage indication for Voranigo

IDH1/IDH2required molecular alteration for coverage

1p19q

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Coverage Criteria for Voranigo (vorasidenib)

Initial Authorization - Astrocytoma

Covered when ALL of the following are met:

Astrocytoma initial criteria: (1) Diagnosis of astrocytoma; (2) Presence of IDH1 or IDH2 mutation; (3) Disease is WHO Grade 2, 3, or 4; (4) History of prior surgery, including biopsy, sub-total resection, or gross total resection.

Authorization will be issued for 12 months.

Reauthorization - Astrocytoma

Reauthorization covered when the following is met:

Astrocytoma reauth: Patient does not show evidence of progressive disease while on Voranigo therapy.

Authorization will be issued for 12 months.

Initial Authorization - Oligodendroglioma

Covered when ALL of the following are met:

Oligodendroglioma initial criteria: (1) Diagnosis of oligodendroglioma; (2) Presence of IDH1 or IDH2 mutation with 1p19q codeletion; (3) Disease is WHO Grade 2 or 3; (4) History of prior surgery, including biopsy, sub-total resection, or gross total resection.

Authorization will be issued for 12 months.

Reauthorization - Oligodendroglioma

Reauthorization covered when the following is met:

Oligodendroglioma reauth: Patient does not show evidence of progressive disease while on Voranigo therapy.

Authorization will be issued for 12 months.

Members under 19 years

Pediatric processing: Member is less than 19 years of age; prescription will automatically process without a coverage review.

Authorization will be issued for 12 months when approved under pediatric criteria.

Coverage for Voranigo (vorasidenib) is subject to the clinical criteria in this document and to member-specific benefit design. State-specific mandates or federal regulatory requirements that require coverage for certain off‑label uses or reference alternate compendia may supersede the criteria below. Reviewers should also confirm the member’s benefit plan terms when determining coverage.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Voranigo except for automatic processing of patients under 19 years of age. Requests should document the diagnosis and supporting clinical information; approvals are generally issued for 12 months when criteria are met.

Prior authorization required for adults and pediatric patients ≥19.
Patients <19: automatic approval pathway described below (see Pediatrics).
Authorization duration: 12 months when criteria met.

Note

Step Therapy

No explicit step therapy agents or required prior systemic therapies are listed in the policy. There are no specified prerequisite medications that must be tried before Voranigo.

Initial Therapy Criteria (by Histology)

Initial therapy

Initial authorization criteria by histology

Initial - Astrocytoma: See Initial Authorization - Astrocytoma: diagnosis of astrocytoma; IDH1 or IDH2 mutation; WHO Grade 2, 3, or 4; history of prior surgery.

Authorization will be issued for 12 months.

Initial - Oligodendroglioma: See Initial Authorization - Oligodendroglioma: diagnosis of oligodendroglioma; IDH1 or IDH2 mutation with 1p19q codeletion; WHO Grade 2 or 3; history of prior surgery.

Authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Continuation therapy

Reauthorization/continuation conditions

Continuation: Patient must not show evidence of progressive disease while on Voranigo therapy to qualify for reauthorization.

Authorizations issued for 12 months.

Definitions and Molecular Requirements

1p19q codeletion — definition and coverage requirement

DefinitionA combined chromosomal deletion status (loss of the short arm of chromosome 1 and the long arm of chromosome 19) used to molecularly classify oligodendroglioma.

Policy requirement1p19q codeletion is required for coverage of vorasidenib when the diagnosis is oligodendroglioma.

Supporting diagnostic evidenceMolecular testing demonstrating IDH1 or IDH2 mutation with concurrent 1p19q codeletion must be documented for oligodendroglioma cases.

Relevant tumor gradesWhen present with IDH mutation and 1p19q codeletion, eligible oligodendroglioma disease grades for coverage are WHO Grade 2 or 3.

AuthorizationApprovals for oligodendroglioma meeting the 1p19q requirement are issued for 12 months.

Step Therapy and Related Requirements

Step	Requirement
1	No step therapy requirements specified in this policy.

Quantity Limits

Vorasidenib — quantity limits and product-specific notes

Quantity limits — generalSupply limits may be in place; the document does not specify a product-specific numeric quantity limit for vorasidenib.

Automated approvalsUnitedHealthcare may approve initial and reauthorization based solely on prior claim/medication history, diagnosis codes, and/or claim logic — automated processes vary by program.

Authorization durationWhen approved, initial and reauthorization approvals are issued for 12 months.

Site of Care Restrictions

Note

No site‑of‑care restrictions specified

The policy contains no site‑of‑care limitations; no explicit infusion center or other site restrictions are provided.

Background

Voranigo (vorasidenib) is an oral inhibitor of mutant isocitrate dehydrogenase enzymes (IDH1 and IDH2) used to treat tumors harboring susceptible IDH mutations. The agent is indicated for adults and pediatric patients aged 12 years and older with Grade 2 astrocytoma or oligodendroglioma following surgical intervention, and is also recognized by NCCN for certain recurrent or progressive WHO grade 2–4 astrocytomas and grade 3 oligodendrogliomas with susceptible IDH mutations.