Pharmacy Prior Authorization Criteria

Voranigo (Vorasidenib)

Indications for Prior Authorization

Voranigo (Vorasidenib)

• For diagnosis of Astrocytoma or Oligodendroglioma
  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.

Criteria

Voranigo

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Grade 2 Astrocytoma or Oligodendroglioma

• One of the following diagnoses:
• Astrocytoma
OR
• Oligodendroglioma
AND
• Presence of a susceptible isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• History of one of the following:
• Biopsy
• Sub-total resection
• Gross total resection
AND
• Patient is 12 years of age or older

Voranigo

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Grade 2 Astrocytoma or Oligodendroglioma

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-11-15, 2024-10-11

References

1. Voranigo Prescribing Information. Servier Pharmaceuticals LLC, , Boston, MA 02210. August 2024.
2. Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF; INDIGO Trial Investigators. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. doi: 10.1056/NEJMoa2304194. Epub 2023 Jun 4. PMID: 37272516.
3. NCCN Clinical Practice Guidelines in Oncology. Central Nervous System Cancers Version 3.2024 Available at: https://www.nccn.org/professionals/physician_gls/pdf/cns.pdf Accessed October 11, 2024.

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Revision History

• 2024-11-15: Removal of non-formulary criteria. Attach EHB formulary
• 2024-10-11: New program

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