CurrentmhnPolicy CP.PHAR.699

Vorasidenib (Voranigo)

Defines medical necessity criteria, dosing, and authorization requirements for Vorasidenib (Voranigo) for members aged ≥12 with IDH1- or IDH2‑mutant gliomas; applies to commercial, HIM, and Medicaid lines of business managed by the Health Plan.

Policy Summary

Payermhn

PolicyVorasidenib (Voranigo)

Policy CodePolicy CP.PHAR.699

Change TypeMaterial updates to indications, added grade 3/4 coverage, revised approval duration

Effective DateDec 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization documentation demonstrating the member meets all approval criteria, including age, diagnosis, IDH mutation detected by an FDA‑approved test, prescriber specialty, and dosing limits.

SourceLink

POLICY UPDATE CHANGES

Updated FDA Approved Indication(s) to specify 'as detected by an FDA‑approved test' for Grade 2 astrocytoma or oligodendroglioma.

Added coverage for additional uses including Grade 3 and Grade 4 disease and other high‑grade glioma per NCCN.

Revised initial approval duration to 12 months.

≥12minimum age for coverage

40 mg/daymaximum adult daily dose

12 moapproval duration

IDH1/IDH2required tumor biomarker

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Coverage Criteria for Vorasidenib (Voranigo)

Initial Therapy

Covered when ALL of the following are met for Initial Approval — Glioma:

Initial Approval — Glioma

Diagnosis and prescriber: Diagnosis of astrocytoma, oligodendroglioma, or other high-grade glioma; prescribed by or in consultation with an oncologist.
Age ≥ 12 years.>= 12 years
Biomarker: Disease is positive for an IDH1 or IDH2 mutation.
Detected by an FDA-approved test for Grade 2 disease per prescribing information.
Tumor grade and disease state
- Grade 2 options (any of i-iii): WHO grade 2 and one of: (i) prior surgery including biopsy, subtotal resection, or gross total resection; (ii) recurrent or progressive disease after radiation therapy and chemotherapy; or (iii) poor performance status (KPS < 60).
- Grade 3 or 4: WHO grade 3 (astrocytoma or oligodendroglioma) or WHO grade 4 (astrocytoma only) when prescribed as: (i) adjuvant therapy, or (ii) for recurrent or progressive disease.
- Other high-grade glioma (H3-mutated high-grade glioma, high-grade astrocytoma with piloid features [HGAP], or pleomorphic xanthoastrocytoma [PXA] WHO grade 3) with recurrent or progressive disease.
Monotherapy: Prescribed as a single agent.
Product availability preference: For Voranigo requests, member must use vorasidenib if available unless contraindicated or clinically significant adverse effects occur.
Dose limits
- Adults and pediatrics ≥ 40 kg: Dose does not exceed both: (i) 40 mg per day; and (ii) 1 tablet per day.<= 40 mg/day
- Pediatrics < 40 kg: Dose does not exceed both: (i) 20 mg per day; and (ii) 2 tablets per day.<= 20 mg/day
- Guideline-supported off-label dose: Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Continuation Therapy

Covered when ALL of the following are met for Continuation/Renewal — Glioma:

Continuation Therapy — Glioma

Current treatment: Member is currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Voranigo for a covered indication and has received this medication for at least 30 days.
Response: Member is responding positively to therapy.
Product availability preference: For Voranigo requests, member must use vorasidenib if available unless contraindicated or clinically significant adverse effects occur.
Dose increase

Requests for use of vorasidenib for indications that are not FDA‑approved and not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation demonstrating efficacy and safety. Such documentation must meet the Plan's off‑label use requirements per the referenced off‑label use policies (commercial, marketplace, or Medicaid) or other applicable evidence of coverage documents.

Requests for uses not listed in this policy that lack supporting clinical evidence will be considered not authorized (not medically necessary) in accordance with the Plan's off‑label use policies. Providers should submit peer‑reviewed literature, guideline support, or other clinical evidence per the off‑label policies cited to justify coverage for an off‑label indication.

Permitted Lines of Therapy

Required Tumor Biomarker Testing

IDH1 or IDH2 mutation — required (Grade 2)

Biomarker requirementIDH1 or IDH2 mutation required for Grade 2 disease as detected by an FDA‑approved test per prescribing information

Indication contextApplies to Grade 2 astrocytoma or oligodendroglioma following surgery (biopsy, sub‑total resection, or gross total resection)

Age requirementAdults and pediatric patients 12 years and older

Documentation sourcePer FDA Approved Indication(s) in prescribing information

Coding and Dosing Information

Codesmixed

N/A	No explicit CPT/HCPCS/ICD-10/NDC codes listed in policy.

Maximum daily dose (adult)

Maximum adult daily dose40 mg per day

Tablet limitNot to exceed 1 tablet per day for adults (per dosing rules)

Approval duration referenceApproval duration: 12 months (policy dosing section)

Pediatric dosing threshold by weight

Pediatric ≥ 40 kg40 mg per day (same as adult dosing)

Pediatric < 40 kg20 mg per day (may be up to 2 tablets/day per rules)

Age threshold

Provider Actions and Authorization Requirements

Prior Authorization

Prior authorization requirement — document all approval criteria

Prior authorization will only be approved when the request demonstrates that all initial or continuation approval criteria are met, including diagnosis (astrocytoma, oligodendroglioma, or other high‑grade glioma), patient age (≥12 years), presence of an IDH1 or IDH2 mutation as required by the criteria, prescriber specialty (prescribed by or in consultation with an oncologist), and that dosing limits or prior therapy/surgical history requirements are satisfied.

Diagnosis and prescriber specialty must be documented.
Age criterion (≥12 years) must be met.
Tumor must be positive for IDH1 or IDH2 mutation where required.
Dosing must meet the specified adult/pediatric limits or be supported by guidelines/literature.

Step Therapy

Product substitution preference — use vorasidenib when available

When requesting Voranigo, the member must use vorasidenib if that product/formulation is available unless it is contraindicated or the member experiences clinically significant adverse effects.

Background

Vorasidenib is an oral inhibitor of mutant IDH1 and IDH2 and is indicated for treatment of patients with IDH‑mutant gliomas as outlined in the prescribing information. Coverage under this policy applies to the indicated patient populations when the documented criteria are met; uses outside the FDA‑approved indication require satisfactory evidence per the Plan's off‑label policies to be considered for coverage.

Definitions and Abbreviations

KPS (Karnofsky Performance Status)

DefinitionKarnofsky Performance Status (KPS): a standard scale to quantify cancer patients' ability to perform ordinary tasks, referenced in appendices as 'KPS'

Use in criteriaKPS < 60 is used as an option for poor performance status in select Grade 2 criteria

Reference locationAppendix A: Abbreviation/Acronym Key in policy document

WHO — World Health Organization (tumor grading)

DefinitionWHO: World Health Organization tumor grading system (WHO grade classifications referenced in policy)

ApplicationUsed to define tumor grades (e.g., WHO grade 2, grade 3, grade 4) in coverage criteria

Policy Summary

Payermhn

PolicyVorasidenib (Voranigo)

Policy CodePolicy CP.PHAR.699

Change TypeMaterial updates to indications, added grade 3/4 coverage, revised approval duration

Effective DateDec 1, 2024

Next Review DateN/A

SourceLink

On This Page

Adults and pediatrics ≥ 40 kg: Dose does not exceed both: (i) 40 mg per day; and (ii) 1 tablet per day.<= 40 mg/day

Pediatrics < 40 kg: Dose does not exceed both: (i) 20 mg per day; and (ii) 2 tablets per day.<= 20 mg/day

Guideline-supported off-label dose: New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Applies to pediatric members ≥ 12 years (policy minimum age)

Population	Dosing regimen	Tablet strengths
Adults	40 mg PO once daily (maximum 40 mg/day)	10 mg, 40 mg
Pediatrics ≥ 12 years — body weight ≥ 40 kg	40 mg PO once daily	10 mg, 40 mg
Pediatrics ≥ 12 years — body weight < 40 kg	20 mg PO once daily	10 mg, 40 mg

This preference applies to both initial and continuation requests.
If a substitute is used for contraindication or adverse effects, document the reason.

Documentation Required

Required documentation — submit chart notes and labs

Providers must submit supporting clinical documentation with the authorization request (for example, office chart notes, laboratory results, or other clinical information) that verifies the member meets all approval criteria.

Include documentation of diagnosis, biomarker results (IDH1/IDH2), prescriber notes, and dosing rationale as applicable.

Denial Risk

Denial triggers — non‑FDA indications require strong evidence

Requests for non‑FDA‑approved indications that are not addressed in this policy may be denied unless sufficient documentation of efficacy and safety is provided in accordance with the off‑label use policies.

Provide supporting evidence per CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP.PMN.53 (Medicaid) as applicable to avoid denial.
If documentation does not demonstrate efficacy/safety for the off‑label use, the request may be considered not authorized or not medically necessary.

Reference locationAppendix A: Abbreviation/Acronym Key in policy document

FDA‑approved test — companion diagnostics for IDH1/IDH2

FDA companion diagnostics referenceInformation on FDA‑approved tests for detection of IDH1 or IDH2 mutations is available at: https://www.fda.gov/CompanionDiagnostics

PurposeThese tests are used to select patients with Grade 2 astrocytoma or oligodendroglioma for treatment with Voranigo per FDA labeling

Policy alignmentPolicy requires mutation detection by an FDA‑approved test for Grade 2 disease per prescribing information