CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1508

Voranigo (vorasidenib) — Coverage Criteria

Defines clinical indications, inclusion/exclusion and authorization rules for Voranigo (vorasidenib) for members of Neighborhood Health Plan of Rhode Island; applies to providers submitting medication requests processed by Evolent/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVoranigo (vorasidenib) — Coverage Criteria

Policy CodePolicy UM ONC_1508

Change TypeNo material changes

Effective DateSep 27, 2024

Next Review Date

Key ActionSubmit prior authorization requests to Evolent/UM with supporting documentation per FDA labeling, CMS compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

age ≥ 12minimum patient age for covered indication

Grade 2 glioma with IDH1/2covered tumor type & biomarker

≤ 40 mgadult single-dose limit

20–40 mgpediatric single-dose limit

2024-09-27policy effective date

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Coverage Criteria for Voranigo (vorasidenib)

Initial and Continuation Coverage Criteria

Covered when ALL of the following are met

Covered Indication: Member is age 12 years or older with Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery (biopsy, subtotal resection, or gross total resection)

Continuation criteria: For continuation requests: member has not experienced disease progression on vorasidenib; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request

Continuation exemption from initial criteria when met

Evidence requirement: Use must be supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 standards

Applies to initial and off‑label uses

Dose limits: Adult single dose must not exceed 40 mg; pediatric single dose limits: 40 mg for weight ≥40 kg, 20 mg for weight <40 kg

Exceeding single‑dose limits is an exclusion

Coverage requests will be excluded or denied when any of the following apply: disease progression while taking Voranigo (vorasidenib); concurrent use with other anticancer therapies; or dosing that exceeds the single‑dose limits. The single‑dose limits are 40 mg for adult members, and for pediatric members age ≥12 years, 40 mg if weight ≥40 kg or 20 mg if weight <40 kg.

Requests for investigational or off‑label uses of Voranigo (vorasidenib) that are not supported by CMS‑recognized compendia or acceptable peer‑reviewed literature will be excluded. The policy defines insufficient evidence to include lack of adequate representation of the patient or tumor characteristics in published studies, inadequate description of the concomitant therapy regimen, absence of clinically meaningful outcomes (generally at least 3 months), inappropriate study design for the question posed, reliance solely on uncontrolled case reports, or use of abstracts without a full peer‑reviewed article.

Initial Therapy

Initial approval requires documentation of diagnosis and supporting evidence

Age and diagnosis: Patient is ≥12 years with Grade 2 astrocytoma or oligodendroglioma and a susceptible IDH1 or IDH2 mutation after surgical intervention (biopsy, subtotal or gross total resection)

Evidence support: Use supported by FDA product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements

Documentation of supporting evidence required with request

Continuation Therapy

Continuation requests are permitted under specified conditions

Continuation allowed: Member has not experienced disease progression on vorasidenib; the medication was used within the last year without a lapse of more than 30 days of having an active authorization; and no additional medications are being added to the continuation request

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and processed by Evolent/UM. Continuation requests are allowable if the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of having an active authorization, and no additional medications are being added to the continuation request.

Prior authorization required and processed by Evolent/UM
Continuation requests allowed if no disease progression, used within last year with ≤30-day lapse, and no additional medications added

Note

Provider Highlight

Provider-facing highlights: ensure prior authorization is requested through Evolent/UM and that documentation meets supporting evidence standards (FDA labeling, CMS-recognized compendia, NCCN or ASCO guidelines, or peer-reviewed literature).

Quantity and Dosing Limits

Vorasidenib — Single Dose Limits

Adult single-dose limitMaximum single dose 40 mg for adult members

Pediatric single-dose limit (weight ≥40 kg)Maximum single dose 40 mg for pediatric members aged ≥12 years with weight ≥40 kg

Pediatric single-dose limit (weight <40 kg)Maximum single dose 20 mg for pediatric members aged ≥12 years with weight <40 kg

Dose-exceeding consequenceDosing that exceeds the stated single-dose limits is an exclusion and may lead to denial of the request

Definitions

IDH1/IDH2 Mutation — Definition and Related Requirements

DefinitionSusceptible IDH1 or IDH2 mutation: presence of tumor mutation in isocitrate dehydrogenase-1 (IDH1) or isocitrate dehydrogenase-2 (IDH2) determined by validated testing

Covered indication requirementMember must have Grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation

Age requirementApplicable to adult and pediatric members 12 years and older

Background

Voranigo (vorasidenib) is a targeted small‑molecule IDH inhibitor used in patients with IDH‑mutant low‑grade gliomas. The policy references the clinical evidence base and prescribing information when establishing coverage and exclusions; notable exclusion criteria include disease progression on therapy, concurrent anticancer treatment, dosing above specified single‑dose limits, and investigational/off‑label uses lacking sufficient supporting evidence.