CurrentUnitedHealthcarePolicy 2025 P 1228-9

Idhifa (enasidenib) prior authorization

Prior authorization and coverage criteria for Idhifa (enasidenib) for UnitedHealthcare members, specifying clinical indications, age-based processing, and authorization durations.

Policy Summary

PayerUnitedHealthcare

PolicyIdhifa (enasidenib) prior authorization

Policy CodePolicy 2025 P 1228-9

Change TypeNo material change

Effective Date11/16/2025

Next Review Date

Key ActionObtain prior authorization documenting AML diagnosis and IDH2 mutation-positive status; approvals issued for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard authorization duration

IDH2 mutation-positiverequired biomarker for coverage

age <19pediatric auto-process

P&T 2017-2025policy review history

Coverage Criteria for Idhifa (enasidenib)

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Initial Authorization: (1) Diagnosis of acute myeloid leukemia (AML) AND (2) AML is IDH2 mutation-positive AND (3) one of: (a) disease is relapsed or refractory OR (b) used as low-intensity treatment induction when not a candidate for intensive induction therapy OR (c) used for consolidation therapy as continuation of low-intensity regimen used for induction OR (d) used as follow-up after induction therapy following response to previous lower intensity therapy with the same regimen

Authorization will be issued for 12 months.

inv-02: Reauthorization

Reauthorization covered when specified clinical benefit or disease stability criteria are met

Reauthorization: Patient does not show evidence of progressive disease while on Idhifa therapy

Authorization will be issued for 12 months.

inv-03: Patients less than 19 years of age

Members under 19 years of age — processed without coverage review

Pediatric auto-approval: Member is less than 19 years of age; prescription will automatically process without a coverage review

Authorization will be issued for 12 months.

inv-04: NCCN Recommended Regimens

Recognized regimens (single agent or with azacitidine) per NCCN

NCCN recognized: The drug is recognized by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Authorization will be issued for 12 months.

Use of Idhifa (enasidenib) outside of the scenarios listed in the coverage criteria is not supported. Specifically, coverage requires a diagnosis of acute myeloid leukemia (AML) that is IDH2 mutation-positive and meeting one of the enumerated clinical indications (for example, relapsed/refractory disease or the specified low‑intensity induction, consolidation, or follow‑up scenarios). Use in patients who do not have IDH2 mutation-positive AML or who do not meet one of the listed clinical scenarios is not covered.

Initial Therapy Criteria

inv-13: Initial therapy

Initial therapy coverage scenarios

Initial therapy: Diagnosis of AML AND IDH2 mutation-positive AND one of: relapsed/refractory disease OR low-intensity induction when not a candidate for intensive induction OR consolidation as continuation of low-intensity induction OR follow-up after induction following response to previous lower intensity therapy with same regimen

Authorization for 12 months.

Continuation / Maintenance Criteria

inv-14: Continuation therapy

Continuation/maintenance use recognized

Continuation therapy: Use for consolidation or follow-up after induction as continuation of low-intensity regimens is an approved scenario; reauthorization requires no evidence of progressive disease

Authorization issued for 12 months.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required per program 2025 P 1228-9. Initial approval requires documentation supporting a diagnosis of acute myeloid leukemia (AML), documented IDH2 mutation–positive status as detected by an FDA-approved test, and meeting one of the clinical scenarios listed in the policy (relapsed/refractory disease; low‑intensity induction when not a candidate for intensive induction; consolidation as continuation of a low‑intensity induction regimen; or follow‑up after induction following response to prior lower‑intensity therapy). Authorization will be issued for 12 months.

Program number: 2025 P 1228-9
Authorization duration: 12 months
Required: FDA-approved test documenting IDH2 mutation

Note

NCCN Alignment

Use of Idhifa (enasidenib) is recognized when consistent with NCCN-recommended regimens. NCCN recommends Idhifa as a single agent or in combination with azacitidine for IDH2‑mutated AML in the following contexts: treatment induction for patients not candidates for intensive induction therapy, follow‑up after induction following response to previous lower‑intensity therapy with the same regimen, or consolidation therapy as continuation of a low‑intensity induction regimen. No additional step‑therapy requirements are specified beyond alignment with NCCN recommendations.

NCCN recognition: Category 1, 2A, or 2B per NCCN Drugs & Biologics Compendium
Allowed regimens: single agent or with azacitidine as per NCCN guidance

Documentation Required

Required Clinical Documentation and Coverage Prerequisites

Clinical documentation must support the diagnosis of AML and confirm IDH2 mutation–positive status detected by an FDA‑approved test. Documentation should also indicate which of the policy’s covered clinical scenarios applies (relapsed/refractory disease; low‑intensity induction when not a candidate for intensive induction; consolidation as continuation of low‑intensity induction; or follow‑up after induction following response to prior lower‑intensity therapy). Lack of documentation of AML diagnosis or absence of documented IDH2 mutation positivity may result in denial of coverage.

Document: AML diagnosis
Document: IDH2 mutation positive via FDA‑approved test
Document: clinical scenario justifying use (one of the listed indications)

Step	Requirement
No explicit step therapy required	Use consistent with NCCN‑recommended regimens (single agent or combined with azacitidine) is recognized; drug recognized by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B. Authorization will be issued for 12 months.

Key Definitions

IDH2 mutation-positive — definition

DefinitionPresence of an isocitrate dehydrogenase-2 (IDH2) gene mutation as detected by an FDA-approved test.

Test requirementMutation must be identified using an FDA-approved diagnostic test for IDH2.

Associated indicationIDH2 mutation-positive status is required for Idhifa (enasidenib) use in relapsed or refractory AML in adults.

NCCN recognitionNCCN recommends Idhifa for IDH2‑mutated AML as single agent or with azacitidine for selected induction, follow-up, or consolidation scenarios.

Background

Idhifa (enasidenib) is an oral isocitrate dehydrogenase‑2 (IDH2) inhibitor used in the treatment of adult patients with acute myeloid leukemia (AML) that is IDH2 mutation‑positive. Coverage under this policy is limited to patients with a diagnosis of AML that is IDH2 mutation‑positive and where Idhifa is used in one of the covered clinical scenarios, such as relapsed or refractory disease or as part of low‑intensity induction, consolidation, or follow‑up per the listed criteria. For members under 19 years of age, prescriptions will automatically process without a coverage review, and applicable state mandates or compendia may supersede policy language.

Policy Summary

PayerUnitedHealthcare

PolicyIdhifa (enasidenib) prior authorization

Policy CodePolicy 2025 P 1228-9

Change TypeNo material change

Effective Date11/16/2025

Next Review Date

Key ActionObtain prior authorization documenting AML diagnosis and IDH2 mutation-positive status; approvals issued for 12 months.

SourceLink

On This Page

OpenPayer

Idhifa (enasidenib) prior authorization

Coverage Criteria for Idhifa (enasidenib)

Initial Therapy Criteria

Continuation / Maintenance Criteria

Provider Actions and Documentation Requirements

Step Therapy / Quantity Limits

Key Definitions

Background