CurrentHealth NetPolicy CP PHAR.699

Vorasidenib (Voranigo) Coverage Criteria

Medical necessity criteria and utilization management for vorasidenib (Voranigo) for treatment of IDH1- or IDH2‑mutant grade 2–4 astrocytoma or oligodendroglioma in members aged ≥12 years; applies to Health Net lines of business listed in the policy.

Policy Summary

PayerHealth Net

PolicyVorasidenib (Voranigo) Coverage Criteria

Policy CodePolicy CP PHAR.699

Change TypeMaterial clinical & operational updates

Effective DateDec 1, 2024

Next Review Date

Key ActionSubmit prior authorization with documentation showing diagnosis, age ≥12, IDH1 or IDH2 mutation detected by an FDA‑approved test, evidence of surgery, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Updated FDA‑approved indication language to specify detection of IDH1 or IDH2 mutation by an FDA‑approved test and added Appendix D link for FDA‑approved tests.

Added coverage for additional uses including Grade 3 and Grade 4 (astrocytoma) disease per NCCN.

12minimum covered age

40 mg/daystandard adult max dose

6 moinitial authorization

12 mocontinuation authorization

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Coverage Criteria for Vorasidenib (Voranigo)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval Criteria: 1) Diagnosis of astrocytoma or oligodendroglioma; 2) Prescribed by or in consultation with an oncologist; 3) Age >= 12 years; 4) Disease is positive for an IDH1 or IDH2 mutation; 5) Member has received surgery including biopsy, sub‑total resection, or gross total resection; 6) Disease status meets one of the following: (a) WHO grade 2 (low‑grade glioma) and either recurrent/progressive after radiation and chemotherapy OR (b) WHO grade 3 (astrocytoma or oligodendroglioma) or WHO grade 4 (astrocytoma only) with appropriate performance status considerations (e.g., KPS); 7) Prescribed as a single agent; 8) Dosing within limits: adults and pediatric members >= 40 kg — 40 mg per day (1 tablet per day); pediatric members < 40 kg — 20 mg per day (1 tablet per day) OR dose supported by practice guidelines or peer‑reviewed literature; 9) Prescribed regimen is FDA‑approved or recommended by NCCN.

Approval duration: 6 months

Continuation Therapy

Continuation therapy covered when ALL of the following are met:

Continued Therapy Criteria: 1) Member is currently receiving vorasidenib via Centene benefit with documentation of at least 30 days of therapy; 2) Diagnosis of glioma; 3) Member is responding positively to therapy; 4) For dose increase requests, the new dose must either meet the specified dose limits (adults and pediatric >= 40 kg: 40 mg per day; pediatric < 40 kg: 20 mg per day) or be supported by practice guidelines or peer‑reviewed literature; 5) Prescribed regimen must be FDA‑approved or recommended by NCCN; 6) Member must use vorasidenib if available unless contraindicated or clinically significant adverse effects occur.

Approval duration: 12 months

Off‑Label / Non‑Formulary Pathways

Other allowable considerations:

Alternate coverage: Off‑label use may be considered if supported by practice guidelines or peer‑reviewed literature and in accordance with the applicable off‑label or non‑formulary review policies; prescribed regimen should be supported by submitted evidence.

See related policies for off‑label review pathways and Appendix D for FDA‑approved companion diagnostic information.

first-line | second-line

Post‑surgery adjuvant or recurrent therapy: Indicated following surgery (including biopsy, sub‑total resection, or gross total resection); disease may be recurrent or progressive after radiation and chemotherapy as specified; policy aligns some uses with NCCN recommendations for higher grade disease.

FDA indication covers Grade 2 disease; policy update expands coverage to select Grade 3–4 disease per NCCN.

Requests for use of vorasidenib for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the request is supported by sufficient documentation of efficacy and safety per the applicable off‑label use policy. Denials may be issued for indications outside the FDA‑approved labeling when adequate supporting evidence is not provided.

Off‑label or non‑formulary requests for vorasidenib will only be considered when there is robust supporting evidence such as relevant practice guidelines or peer‑reviewed literature and when submission follows the referenced off‑label review pathways (see CP.CPA.09, HIM.PA.154, and CP PMN.53 as applicable). Uses lacking adequate supporting evidence per those policies are considered not medically necessary.

Product Codes and Dosing Info

Product availability / NDCsNDC

NDC not specified

Product availability: oral tablets 10 mg and 40 mg listed in product availability section; exact NDCs not provided in document.

Body weight threshold for dosing

Body weight threshold>= 40 kg (pediatric and adult threshold for 40 mg/day dosing)

Pediatric <40 kg dosing20 mg per day for pediatric members under 40 kg

Dose limit for >=40 kg40 mg per day (maximum standard dose)

Regimen	Population	Dose / Frequency	Coverage Status
Vorasidenib (Voranigo)
Adults and pediatric patients ≥ 40 kg (age ≥ 12 years)
40 mg PO once daily
Covered with criteria
Vorasidenib (Voranigo)
Pediatric patients < 40 kg (age ≥ 12 years)
20 mg PO once daily
Covered with criteria

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Requirements

Prior authorization is required. Requests must demonstrate the diagnosis, age, molecular testing, treatment history, and prescriber specialty criteria outlined below. Voranigo (vorasidenib) is medically necessary only when all listed criteria are met.

Prior authorization required for Voranigo (CP PHAR.699).
Prescriber: oncologist or in consultation with an oncologist.
Approval duration: Initial 6 months; Continuation 12 months.

Prior Authorization

Use of Vorasidenib First / Initial Approval Criteria

For initial therapy, the following ALL must be met: diagnosis of astrocytoma or oligodendroglioma; patient is at least 12 years of age; disease is positive for an IDH1 or IDH2 mutation confirmed by an FDA‑approved test; disease is recurrent or progressive or meets the specified WHO grade criteria; prescribed by or in consultation with an oncologist; prescribed as a single agent; member has undergone surgery (biopsy, subtotal resection, or gross total resection) when applicable; for WHO grade 2 glioma one of the listed clinical conditions must be present (recurrent/progressive after radiation and chemotherapy, or poor performance status [KPS ≤ 60] as specified). Dose limits: adults and pediatric ≥40 kg — 40 mg per day (1 tablet per day); pediatric <40 kg — 20 mg per day (1 tablet per day) unless supported by guidelines or literature. Member must use vorasidenib first if available unless contraindicated or clinically significant adverse effects occur. Prescribed regimen must be FDA‑approved or recommended by NCCN.

Biomarker and Diagnostic Testing Requirements

IDH1 or IDH2 — biomarker requirement

Required biomarkerDetection of an IDH1 or IDH2 mutation by an FDA‑approved test is required for coverage

Indication linkageMutation must be present in Grade 2 astrocytoma or oligodendroglioma (per FDA label)

FDA companion diagnostic infoSee Appendix D for FDA‑approved tests for detection of IDH1 or IDH2 mutations

Background on Vorasidenib and Indications

Vorasidenib is an oral, small‑molecule inhibitor that targets mutant IDH1 and IDH2 enzymes implicated in certain gliomas. The agent is indicated for IDH‑mutant gliomas in patients meeting the clinical criteria described elsewhere in this policy, and its use outside FDA‑approved indications must meet the off‑label evidence requirements referenced above.

Key Definitions

isocitrate dehydrogenase

TermIDH

Definitionisocitrate dehydrogenase

ContextAbbreviation listed in Appendix A as used in this policy

Karnofsky Performance Status

AbbreviationKPS

DefinitionKarnofsky Performance Status

Usage in criteriaKPS >= 60 is referenced as a performance status threshold in disease condition descriptions

Policy Revision History

2024-12-01Material updateLatest

Policy updated to reference detection of IDH1 or IDH2 mutations by an FDA‑approved test and Appendix D link to FDA companion diagnostics; FDA‑approved indication language revised accordingly.

2024-08-26Policy creation

Policy created (initial coverage criteria established for vorasidenib including age ≥12 years, post‑surgery use, biomarker requirement, and dosing); original document creation recorded.

2024-11-24