CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Enasidenib (Idhifa) for IDH2‑mutated Acute Myeloid Leukemia — Coverage Criteria

Criteria and authorization requirements for coverage of Idhifa (enasidenib) for adult patients with IDH2‑mutated acute myeloid leukemia (AML), including FDA‑approved and specified compendial uses, for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnasidenib (Idhifa) for IDH2‑mutated Acute Myeloid Leukemia — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and submit medical record documentation confirming an IDH2 mutation to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

≥60age requirement for compendial covered uses

IDH2biomarker required for coverage

rel/ref AMLFDA‑approved indication

Coverage Criteria for Idhifa (enasidenib)

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Covered Indications and Criteria

Covered when ALL of the following are met for the specified indication:

FDA‑approved indication (relapsed/refractory): Patient is an adult with relapsed or refractory acute myeloid leukemia (AML) with an IDH2 mutation detected by an FDA‑approved test

based on FDA indication

Compendial single‑agent uses in patients ≥60: Single‑agent use in patients age ≥ 60 for either: (1) treatment induction when the patient is not a candidate for or declines intensive induction chemotherapy; OR (2) post‑induction therapy following response to prior lower intensity therapy with the same regimen

compendial uses

Authorization prerequisites: Medical record documentation of an IDH2 mutation is provided and member has no exclusions to therapy

prior authorization documentation required

Authorization Duration and Continuation

Continuation and duration criteria:

Initial and continuation authorization duration: Authorization of up to 12 months may be granted for initial treatment or continuation for indications listed in this policy when criteria are met and there is no evidence of unacceptable toxicity or disease progression12 months

See Section IV for continuation

All indications for Idhifa (enasidenib) that are not specifically listed as covered in this policy are considered experimental/investigational and are not covered. This includes uses outside the FDA‑approved relapsed/refractory IDH2‑mutated AML indication and the specified compendial single‑agent uses in older patients.

Use of Idhifa for indications other than the FDA‑approved relapsed/refractory AML with an IDH2 mutation or the specified compendial single‑agent uses in patients aged ≥ 60 is considered not medically necessary and is therefore not covered.

Covered Regimens

Regimen	Indication / Criteria	Authorization Duration
Idhifa (enasidenib) — single‑agent	Treatment induction in newly diagnosed AML with a susceptible IDH2 mutation when all of the following are met: (1) single‑agent use; (2) member age ≥ 60 years; (3) member has comorbidities that preclude or declines intensive induction chemotherapy.	Authorization of 12 months may be granted
Idhifa (enasidenib) — single‑agent	Post‑induction therapy for AML with a susceptible IDH2 mutation when all of the following are met: (1) single‑agent use; (2) member age ≥ 60 years; (3) member has experienced response to Idhifa therapy.	Authorization of 12 months may be granted
Idhifa (enasidenib) — single‑agent	Treatment of relapsed or refractory AML with a susceptible IDH2 mutation (FDA‑approved indication).	Authorization of 12 months may be granted

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Authorization of up to 12 months may be granted when the applicable coverage criteria are met.

Authorization of 12 months may be granted for treatment induction of newly diagnosed AML with a susceptible IDH2 mutation when criteria are met.
Authorization of 12 months may be granted for post‑induction therapy for AML with a susceptible IDH2 mutation when criteria are met.
Authorization of 12 months may be granted for treatment of relapsed or refractory AML with a susceptible IDH2 mutation.
Authorization of 12 months may be granted for continuation of therapy when there is no evidence of unacceptable toxicity or disease progression.

Step Therapy

No step therapy requirements specified.

Documentation Required

Required Documentation

Medical record documentation of an IDH2 mutation is required to initiate prior authorization review.

Denial Risk

Not Covered Indications

Use for indications other than the listed FDA‑approved or compendial uses (e.g., use outside the single‑agent IDH2‑mutated AML populations and settings described) is considered experimental/investigational and not medically necessary.

Compendial uses specified: as a single agent in patients ≥60 years with IDH2‑mutated AML for induction when not candidate for intensive induction or declines intensive therapy; post‑induction following response to prior lower intensity therapy; other indications not listed are not covered.

Line of Therapy

first-line | second-line | salvage

Line of therapy: Relapsed or refractory AML (FDA indication); OR single‑agent use in patients age ≥ 60 for induction when not a candidate for intensive therapy or declines intensive therapy, OR post‑induction therapy following response to prior lower intensity therapy (compendial)

Includes initial induction, post‑induction, and relapsed/refractory settings per FDA and compendia

Biomarker Requirements

inv-12: IDH2 — Detected by an FDA‑approved test

BiomarkerIsocitrate dehydrogenase‑2 (IDH2) mutation detected by an FDA‑approved test

Required documentationMedical record documentation of IDH2 mutation is required to initiate prior authorization review

Applicable indicationAdult patients with relapsed or refractory acute myeloid leukemia (AML)

inv-10: IDH2 mutation — IDH2 mutation defined as an isocitrate dehydrogenase‑2 gene alteration detected by an FDA‑approved test required for Idhifa use

DefinitionIDH2 mutation: an isocitrate dehydrogenase‑2 gene alteration detected by an FDA‑approved test

Clinical requirementPresence of an IDH2 mutation is required for coverage of Idhifa (enasidenib)

Authorization triggerMedical record documentation of the IDH2 mutation must be submitted to begin prior authorization review

Background

Idhifa (enasidenib) is indicated for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring an IDH2 mutation detected by an FDA‑approved test. Compendial single‑agent uses described in this policy include treatment induction or post‑induction therapy in patients aged 60 years or older who are not candidates for, or decline, intensive induction therapy.