CurrentNeighborhood Health Plan of Rhode IslandPolicy 2238-A

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

Covers enasidenib (Idhifa) for treatment of adult patients with IDH2‑mutated acute myeloid leukemia (AML), including FDA‑approved and compendial uses, when documented criteria are met and member has no exclusions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEnasidenib (Idhifa) for IDH2‑mutated AML — Coverage Criteria

Policy CodePolicy 2238-A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of an FDA‑approved IDH2 mutation test to support coverage for enasidenib.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

IDH2molecular test required

r/r AMLFDA‑approved indication

Coverage Criteria for enasidenib (Idhifa)

Coverage criteria

Covered when ALL of the following are met

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

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

Supports FDA indication; documentation of mutation required

Newly diagnosed induction/post‑induction uses (compendial): For newly diagnosed AML with a susceptible IDH2 mutation: Idhifa will be used as a single agent or in combination with azacitidine and the member is not a candidate for or declines intensive induction therapy (induction) OR the member has experienced response to Idhifa therapy (post‑induction)

Authorization of 12 months may be granted when criteria are met

Treatment duration: Authorization may be granted for up to 12 months for induction, post‑induction, or single‑agent relapsed/refractory settings; continuation requires evidence of benefit and acceptable toxicity12 months

Continuation allowed if no unacceptable toxicity or disease progression

Permitted Regimens and Settings

Regimen	Indication / Criteria	Coverage
Idhifa (enasidenib) as single agent or in combination with azacitidine	Induction or post‑induction therapy in newly diagnosed AML with a susceptible IDH2 mutation when ALL of the following are met: (1) requested medication will be used as a single agent or in combination with azacitidine; and (2) member is not a candidate for or declines intensive induction therapy (induction) — OR member has experienced response to Idhifa therapy (post‑induction)	Covered
Authorization duration	Authorization of 12 months may be granted when the above criteria are met

Regimen	Indication / Criteria	Coverage
Idhifa (enasidenib) as single agent	Treatment of relapsed or refractory AML with a susceptible IDH2 mutation — patient is an adult with relapsed or refractory AML and IDH2 mutation detected by an FDA‑approved test	Covered
Authorization duration	Authorization of 12 months may be granted for treatment as a single agent of relapsed or refractory AML with a susceptible IDH2 mutation

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests may be authorized for up to 12 months for treatment induction, post‑induction, or relapsed/refractory AML when the member has a susceptible IDH2 mutation and other clinical criteria below are met.

Authorization duration: up to 12 months
Settings: induction (newly diagnosed), post‑induction (maintenance), relapsed/refractory

Step Therapy

Step therapy is not structured as a multi‑step failure requirement. Therapy may be authorized as single‑agent ivosidenib (Idhifa) or in combination with azacitidine per the clinical criteria (e.g., induction or post‑induction) when the member meets the mutation and clinical response/candidate criteria.

No required prior trial of an alternative agent specified
Allowed regimens: single‑agent Idhifa or Idhifa + azacitidine

Documentation Required

Submit medical record documentation demonstrating the presence of an IDH2 mutation — for example, results from an FDA‑approved test — along with clinical notes showing treatment intent (induction, post‑induction maintenance, or relapsed/refractory therapy) and prior therapy status or response.

Required: documented IDH2 mutation test result (e.g., FDA‑approved assay)
Include: clinical indication (induction, post‑induction, relapsed/refractory), treatment history, and response status

Denial Risk

Non‑covered Indications

Requests for indications other than IDH2‑mutated AML or the compendial uses listed are considered experimental/investigational and are not medically necessary.

Non‑covered: any indication not supported by FDA approval or listed compendia

Key Definitions

Susceptible IDH2 mutation — definition and documentation

DefinitionAn isocitrate dehydrogenase‑2 (IDH2) mutation detected by an FDA‑approved test (documentation required).

Documentation requiredMedical record documentation of IDH2 mutation must be submitted (e.g., results from an FDA‑approved test).

Clinical contextThis defines the biomarker required to meet coverage criteria for enasidenib (Idhifa) in AML.

Biomarker Requirement for Coverage

IDH2 — Detected by an FDA‑approved test

Biomarker requirementIDH2 mutation must be detected by an FDA‑approved test.

Use for coverageDetection of IDH2 by an FDA‑approved test is required for covered indications of Idhifa (relapsed/refractory AML and specified compendial uses).

Evidence to submitProvide the FDA‑approved test result as part of prior authorization documentation.

Permitted Lines of Therapy

Line of therapy

Lines allowed: Relapsed or refractory AML (FDA‑approved); newly diagnosed induction or post‑induction when the patient is not a candidate for or declines intensive induction, or has responded to Idhifa

Authorization provided for these settings per criteria; single‑agent or combination with azacitidine permitted