Subject: Voranigo SGM 6582-A P2025

Drug

VORANIGO  (vorasidenib)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications¹

Voranigo is indicated for the treatment of adult and pediatric patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection.

Compendial Uses²

• Recurrent or progressive IDH1 or IDH2 mutated astrocytoma or oligodendroglioma
• Adjuvant treatment of IDH1 or IDH2 mutated WHO grade 2 astrocytoma or oligodendroglioma
• IDH1 or IDH2 mutated high-grade glioma
  • H3-mutated high-grade glioma
  • High-grade astrocytoma with piloid features (HGAP)
  • Pleomorphic xanthoastrocytoma (PXA) WHO grade 3

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review: medical record documentation of isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation.

Coverage Criteria

Central Nervous System Cancers^1,2

Authorization of 12 months may be granted for the treatment of members 12 years of age and older with central nervous system (CNS) cancers with a susceptible IDH1 or IDH2 mutation when either of the following is met:

• Adjuvant treatment of WHO grade 2 astrocytoma or WHO grade 2 oligodendroglioma when used as a single agent.
• The member has progressive or recurrent disease and the requested medication will be used as a single agent for the treatment of the following types of CNS cancers:
  • H3-mutated high-grade glioma
  • High-grade astrocytoma with piloid features (HGAP)
  • WHO grade 3 Pleomorphic xanthoastrocytoma (PXA)
  • WHO grade 2 or 3 oligodendroglioma and Karnofsky Performance Status (KPS) greater than or equal to 60
  • WHO grade 2 astrocytoma and KPS greater than or equal to 60

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Voranigo [package insert]. Boston, MA: Servier Pharmaceuticals LLC; April 2025.
2. The The NCCN Drugs & Biologics Compendium^® © 2025 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed August 13, 2025.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

January 20, 2026