CurrentCentenePolicy CP PHAR.699

Vorasidenib (Voranigo)

Defines Centene medical necessity criteria, authorization requirements, dosing, and continued therapy rules for vorasidenib (Voranigo) in patients with IDH1 or IDH2 mutated grade 2-4 astrocytoma or oligodendroglioma; applies to Centene-affiliated health plans and lines of business listed.

Policy Summary

PayerCentene

PolicyVorasidenib (Voranigo)

Policy CodePolicy CP PHAR.699

Change TypeRevised indication and appendix added

Effective Date12.01,.24

Next Review Date

Key ActionSubmit prior authorization with documentation confirming diagnosis, IDH1/2 mutation by an FDA-approved test, surgery history, prescriber specialty, age ≥12, and dosing within limits.

SourceLink

POLICY UPDATE CHANGES

Updated FDA Approved Indication(s) to include 'as detected by an FDA-approved test' per updated prescribing information and added Appendix D with link for FDA-approved tests for detection of IDH1 or IDH2 mutations.

12 yrsminimum eligible patient age

40 mgstandard dose

6 moinitial approval

12 mocontinued approval

Coverage Criteria for Vorasidenib (Voranigo)

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inv-01: Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Approval Criteria

Diagnosis of astrocytoma or oligodendroglioma
Age: Patient is >= 12 years>= 12 years
Prescriber: Prescribed by or in consultation with an oncologist
Mutation: Disease is positive for an IDH1 or IDH2 mutation detected by an FDA-approved test
See Appendix D for FDA-approved tests
Post-surgical status: Member has received surgery including biopsy, sub-total resection, or gross total resection
Included as post‑surgery adjuvant indication per FDA
WHO grade and disease course: Either: (a) WHO grade 2 low‑grade glioma with specified additional uses; OR (b) recurrent or progressive disease after radiation and chemotherapy; OR (c) WHO grade 3 (astrocytoma or oligodendroglioma) or grade 4 (astrocytoma only) with poor performance status
KPS referenced for some grade 3/4 conditions
Performance status: Karnofsky Performance Status (KPS) >= 60 as applicableKPS >= 60
Required for certain grade 3/4 coverage per policy
Single agent: Prescribed as a single agent
Dose limits: For adults and pediatric >=40 kg: dose does not exceed 40 mg per day; for pediatric <40 kg: dosing (e.g., 20 mg/day or 1 tablet/day) must be supported by guidelines or peer‑reviewed literature<= 40 mg/day for adults and pediatric >=40 kg
If off‑label pediatric dosing requested, prescriber must submit supporting evidence

inv-02: Continuation Therapy — Covered for continuation when ALL of the following are met

Covered for continuation when ALL of the following are met:

Continued Therapy Criteria

Current therapy: Member is currently receiving vorasidenib via the Centene benefit and has received the medication for at least 30 days>= 30 days
Documentation must support current use
Glioma indication: Continues to meet glioma coverage indication
Member must be receiving for a covered indication
Clinical response: Member is responding positively to therapy
Clinical documentation of benefit required

Requests for indications that are not FDA‑approved and that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with the referenced off‑label use policies. Supporting documentation should follow the requirements in the off‑label use policies cited by the plan.

Off‑label or non‑FDA approved uses are not authorized under this policy unless there is adequate evidence per the plan’s off‑label use policies (see CP.CPA.09, HIM.PA.154, CP.PMN.53). Requests for such uses will be denied in the absence of sufficient documentation supporting efficacy and safety.

Dosing and Regimens

Regimen	Indication / Age / Weight	Dose	Coverage status
Vorasidenib (Voranigo) 40 mg PO once daily
Adults and pediatric patients >= 12 years with body weight >= 40 kg
40 mg PO once daily
Covered with criteria

Regimen	Indication / Age / Weight	Dose / Notes	Coverage status
Vorasidenib (Voranigo) — pediatric dosing options
Pediatric patients < 40 kg or dosing scenarios not covered by standard adult/>=40 kg regimen; applicable to patients >=12 years per policy age threshold
Per policy: 20 mg per day (1 tablet) for certain weights; 40 mg per day (2 tablets) is maximum. Any off-label dosing must be supported by practice guidelines or peer-reviewed literature submitted by prescriber.
Covered with criteria (requires supporting evidence for off-label dosing)

Age and Dose Key Values

inv-05: Age

Minimum eligible age>= 12 years

Supporting FDA indicationVoranigo is indicated for patients 12 years and older with Grade 2 astrocytoma or oligodendroglioma

Age referenced in criteriaInitial approval criteria require patient is >= 12 years

inv-06: Dose (adults and pediatric >=40 kg)

Standard adult and pediatric >=40 kg dose40 mg per day (40 mg PO QD)

Dose listed in initial approval criteriaDose does not exceed 40 mg per day for adults and pediatric members with body weight >= 40 kg

Product dosing tableAstrocytoma or oligodendroglioma: Adults: 40 mg PO QD; Pediatric >=12 years & >40 kg: 40 mg PO QD

Prior Authorization, Documentation, and Agent Availability

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (e.g., office chart notes, pathology and lab results, imaging, mutation testing results, and other clinical information) that supports the member meets all approval criteria including diagnosis, IDH1 or IDH2 mutation status, prior surgeries, prior therapies, and that the drug is prescribed by or in consultation with an oncologist.

Ages and clinical history supporting diagnosis
IDH1 or IDH2 mutation test report
Operative or pathology reports documenting biopsy or resection when applicable
Records showing prior radiation and chemotherapy when required
Documentation of prescribing clinician specialty (oncologist)

Documentation Required

Documentation Required to Support Criteria

Provider must submit chart notes, lab results, imaging, pathology reports, and other clinical documentation demonstrating the member meets the policy criteria for initial or continued therapy (for continuation: documentation that member has been receiving the medication for at least 30 days and is responding positively to therapy).

Proof of current therapy and response (for continuation requests)
Supporting documentation for any requested dose changes, including guideline or peer‑reviewed evidence for off‑label dosing

Step Therapy

Agent Availability / Step Requirement

If vorasidenib is available to the member, the member must use vorasidenib unless it is contraindicated or the member experiences clinically significant adverse effects.

Applies to initial and continued therapy requests
If vorasidenib is not used, documentation of contraindication or intolerance must be provided

Denial Risk

Non‑FDA Approved Indications

Requests for non–FDA approved (off‑label) indications that are not specifically addressed in this policy will be denied unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policies (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, CP.PMN.53 for Medicaid) or other applicable evidence of coverage documents. For off‑label requests, the prescriber must submit supporting practice guideline or peer‑reviewed literature evidence.

Cited off‑label policy: CP.CPA.09 (Commercial)
Cited off‑label policy: HIM.PA.154 (Marketplace)
Cited off‑label policy: CP.PMN.53 (Medicaid)
Prescriber must submit supporting guideline or peer‑reviewed literature

IDH Mutation Testing Requirement

inv-16: IDH1 or IDH2 mutation

Biomarker requirementPresence of a susceptible IDH1 or IDH2 mutation detected by an FDA-approved test

FDA indication wordingIndicated for patients with a susceptible IDH1 or IDH2 mutation, as detected by an FDA-approved test

Appendix D resourceAppendix D provides link to FDA-approved tests for detection of IDH1 or IDH2 mutations (FDA companion diagnostics)

Permitted Lines of Therapy

inv-14: first-line

Post-surgery adjuvant or treatment: Indicated for patients following surgery (biopsy, subtotal resection, or gross total resection) as per FDA approval

Applies to Grade 2 astrocytoma or oligodendroglioma with susceptible IDH1/IDH2 mutation detected by an FDA‑approved test

inv-15: salvage

Recurrent or progressive disease: Covered if disease is recurrent or progressive after radiation therapy and chemotherapy

Includes recurrent/progressive WHO grade 2 low‑grade glioma scenario and other recurrent disease per policy

Key Definitions

inv-12: isocitrate dehydrogenase

TermIsocitrate dehydrogenase (IDH)

AbbreviationIDH

ContextReferenced in appendices and used as biomarker for Voranigo eligibility

inv-13: Karnofsky Performance Status

DefinitionKarnofsky Performance Status (KPS)

Usage in criteriaKPS >= 60 is required for certain grade 3/4 coverage conditions

AbbreviationKPS

Background on Vorasidenib

Vorasidenib (Voranigo) is an oral small‑molecule inhibitor that targets mutant IDH1 and IDH2 enzymes and is indicated for treatment of patients aged >= 12 years with grade 2 astrocytoma or oligodendroglioma harboring susceptible IDH1 or IDH2 mutations following surgery. The policy also provides coverage parameters for certain grade 3 and grade 4 gliomas per NCCN guidance, and dosing guidance specifies a standard adult (and pediatric ≥40 kg) dose of 40 mg once daily with pediatric dosing considerations for lower weights.

Policy Summary

PayerCentene

PolicyVorasidenib (Voranigo)

Policy CodePolicy CP PHAR.699

Change TypeRevised indication and appendix added

Effective Date12.01,.24

Next Review Date

Key ActionSubmit prior authorization with documentation confirming diagnosis, IDH1/2 mutation by an FDA-approved test, surgery history, prescriber specialty, age ≥12, and dosing within limits.

SourceLink

On This Page

Dose change requests: If request is for a dose increase, the new dose must meet dosing limits or be supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence)

Dose limits: adults and pediatric >=40 kg: <=40 mg/day; pediatric dosing per policy

Agent availability: Member must use vorasidenib if available unless contraindicated or clinically significant adverse effects are experienced

Step requirement per policy