CurrentCignaPolicy N/A

Oncology - Voranigo Prior Authorization Policy

Defines Cigna's prior authorization requirements and coverage criteria for Voranigo (vorasidenib) for treatment of Grade 2 or higher IDH1/IDH2‑mutant gliomas in eligible patients aged ≥12, and specifies noncovered uses.

Policy Summary

PayerCigna

PolicyOncology - Voranigo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 6, 2025

Next Review DateAug 6, 2025

Key ActionObtain prior authorization and submit documentation supporting age (≥12), a susceptible IDH1/IDH2 mutation, tumor grade (Grade ≥2), and prior surgery to request approval for up to 1 year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 yearapproval duration when criteria met

≥12minimum patient age for coverage

Grade 2+tumor grade requirement

IDH1/IDH2 mutbiomarker requirement

Prior surgerysurgery/biopsy requirement

Coverage Criteria for Voranigo (vorasidenib)

Policy Summary

PayerCigna

PolicyOncology - Voranigo Prior Authorization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 6, 2025

Next Review DateAug 6, 2025

SourceLink

On This Page

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Initial therapy — FDA‑approved indication

Covered when ALL of the following are met

FDA-Approved Indication Criteria: A) Patient is ≥ 12 years of age; AND B) Patient has a susceptible isocitrate dehydrogenase-1 (IDH1) or IDH2 mutation-positive disease; AND C) Patient meets ONE of the following: (i) Patient has ≥ Grade 2 oligodendroglioma; OR (ii) Patient has ≥ Grade 2 astrocytoma; AND D) Patient has had prior surgery, including biopsy, subtotal resection, or gross total resection.

Approve for 1 year when criteria met

Voranigo® (vorasidenib) is not medically necessary for any indications other than those specifically described in this policy. Coverage criteria will be updated as new published data and indications become available.

Any use of Voranigo that does not meet the FDA‑approved indication and the coverage criteria listed in this policy is considered not medically necessary and will be denied.

Provider Actions and Authorization

Prior Authorization

Prior authorization and approval duration

Prior authorization is recommended for Voranigo; when all coverage criteria are met, approvals are provided for up to 1 year.

Step Therapy

Step therapy not required

This policy does not require step therapy or prior systemic therapy before Voranigo; no step therapy requirement is specified.

Documentation Required

Required clinical documentation

Provide documentation that verifies the patient's age (≥ 12 years), presence of a susceptible IDH1 or IDH2 mutation, tumor grade (≥ Grade 2 oligodendroglioma or astrocytoma), and evidence of prior surgery (biopsy, subtotal resection, or gross total resection).

Age documented as ≥ 12 years
Laboratory/pathology report showing a susceptible IDH1 or IDH2 mutation detected by an FDA‑approved test
Pathology report or clinical record documenting tumor grade (≥ Grade 2)
Operative or procedure note confirming prior surgery (biopsy, subtotal resection, or gross total resection)

Denial Risk

Not covered uses — other indications will be denied

Requests for Voranigo for any indications other than the specified FDA‑approved glioma indication (Grade ≥2 IDH1/IDH2‑mutant gliomas after surgery in patients ≥12) are considered not medically necessary and will be denied.

Biomarker Requirement

inv-11: IDH1 or IDH2 mutation — Detected by an FDA‑approved test (susceptible mutation)

DefinitionIDH1 or IDH2 mutation detectable by an FDA-approved test as referenced in the Voranigo prescribing information.

Clinical relevanceRequired biomarker for coverage of Voranigo (vorasidenib) for Grade ≥2 IDH‑mutant gliomas.

Testing requirementMutation must be detected by an FDA‑approved test (susceptible mutation) per product labeling.

Indicated populationApplies to adult and pediatric patients aged ≥ 12 years with eligible gliomas.

Associated tumor typesGrade ≥2 astrocytoma or Grade ≥2 oligodendroglioma with the susceptible IDH1/IDH2 mutation.

Susceptible Mutation Definition

inv-09: Susceptible IDH1 or IDH2 mutation — detectable by an FDA‑approved test as referenced in prescribing information

Policy wordingSusceptible IDH1 or IDH2 mutation detectable by an FDA‑approved test as referenced in the Voranigo prescribing information.

Coverage implicationPresence of a susceptible IDH1 or IDH2 mutation is required for approval of Voranigo under the FDA‑approved indication.

Source of test standardMutation detection must be by an FDA‑approved diagnostic test as noted in the drug prescribing information.

Context in indicationMutation requirement is one of the ALL criteria for 1‑year approval for gliomas (along with age ≥12, tumor grade ≥2, and prior surgery).

Regimen	Indication	Coverage status
Voranigo (vorasidenib tablets)
Adjuvant treatment after surgery for WHO Grade 2 IDH1 or IDH2 mutation–positive gliomas (including biopsy, subtotal resection, or gross total resection) in patients aged ≥ 12 years, with a susceptible IDH1 or IDH2 mutation detected by an FDA‑approved test.
Covered with criteria (prior authorization recommended; approve for up to 1 year when criteria met).

OpenPayer

Oncology - Voranigo Prior Authorization Policy

Coverage Criteria for Voranigo (vorasidenib)

Provider Actions and Authorization

Definitions

Biomarker Requirement

Susceptible Mutation Definition

Line of Therapy

Covered Regimens and Dosing Forms