CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Rezlidhia (olutasidenib) coverage criteria for IDH1‑mutated AML

Defines accepted indications, coverage criteria, and utilization management requirements for Rezlidhia (olutasidenib) for members, including FDA-approved and supported off-label uses; applies to providers submitting medication requests to Evolent on behalf of the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRezlidhia (olutasidenib) coverage criteria for IDH1‑mutated AML

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization via Evolent and document an IDH1 mutation detected by any FDA‑approved test.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1Covered indication (AML with IDH1 mutation)

Relapsed/Rfractorydisease setting specified

J8999billing code listed

150 mgsingle dose limit

60 caps/momaximum monthly limit

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Coverage Criteria for Rezlidhia (olutasidenib)

Initial therapy / Covered indication

Covered when ALL of the following are met

Rezlidhia coverage for AML: Member has relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation detected by any FDA-approved test; use consistent with FDA labeling or supported compendia/guidelines/literature.

Supported indications per policy purpose and references.

Coverage for Rezlidhia (olutasidenib) is excluded when any of the following apply: disease progression while taking Rezlidhia or while on any IDH1 inhibitor (for example, Tibsovo/ivosidenib), lack of documentation confirming an IDH1 mutation, a prescribed dose that exceeds the single dose limit of 150 mg, or treatment that exceeds the maximum limit of 60 (150 mg) capsules per month.

Use of Rezlidhia (olutasidenib) for investigational or off‑label indications is considered not acceptable for coverage when the indication is not supported by sufficient evidence or is not generally accepted by the medical community. Sufficient supporting evidence must include representation of the patient and cancer clinical characteristics in the published data, adequate representation of the administered regimen, and clinically meaningful outcomes (commonly a hazard ratio < 0.80 or survival benefits for OS/PFS of at least 3 months). Nonrandomized studies with substantial subject numbers may provide supportive evidence, whereas case reports and meeting abstracts without full peer‑reviewed publications generally do not.

Study (first author, year)	Phase / Population	Regimen (dose & schedule)	Key efficacy / outcome (as reported)
de Botton S, et al. (Blood Advances 2023)	Phase not specified in reference listing; relapsed or refractory IDH1‑mutated AML	Olutasidenib monotherapy per trial (dose/schedule as in publication) — see de Botton et al. for exact dosing regimen	Reported durable complete remissions in patients with relapsed or refractory IDH1‑mutated AML
Watts JM, et al. (Lancet Haematol. 2023)	Phase 1/2; IDH1‑mutated AML and myelodysplastic syndrome (relapsed/refractory and other eligible cohorts)	Olutasidenib alone or with azacitidine as evaluated in phase 1/2 trial — dosing per published trial and protocol	Phase results reported for olutasidenib monotherapy and combinations; see publication for response rates and durability
Rezlidhia (olutasidenib) prescribing information (Rigel) 2024	Indication: relapsed or refractory AML with IDH1 mutation	Olutasidenib monotherapy: recommended dosing and administration per FDA prescribing information (see full PI for specific mg and schedule)	Label and supporting trials summarize efficacy in IDH1‑mutated relapsed/refractory AML; consult PI for numeric outcomes and safety data

Billing and Coding

Drug HCPCS CodeHCPCS

J8999

olutasidenib

Single dose capsule strength — 150 mg

Single dose capsule strength150 mg

FormulationCapsule

DrugRezlidhia (olutasidenib)

Maximum monthly quantity — 60 (150 mg) capsules per month

Maximum monthly quantity60 (150 mg) capsules per month

Per-dose strength referenced150 mg capsules

Applies toRezlidhia (olutasidenib)

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Rezlidhia (olutasidenib). Submit requests using the appropriate prior authorization process; bill using J8999 for olutasidenib.

Prior authorization required
Bill using HCPCS code J8999

Note

Continuation Request Exemption

Continuation (renewal) requests are exempt from re-review under this policy when all conditions are met: the member has not had disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days from an active authorization, and no additional medications are being added to the continuation request.

Member has not experienced disease progression on the requested medication
Requested medication used within past 12 months with no lapse >30 days from active authorization
No additional medications added to the continuation request

Covered Regimens and Line of Therapy

second-line

Disease setting: Relapsed or refractory AML

Policy specifies relapsed or refractory setting for coverage (second-line).

Relapsed or refractory AML with IDH1 mutation — definition of disease setting

Disease settingRelapsed or refractory acute myeloid leukemia (AML)

Biomarker requirementPresence of an IDH1 mutation detected by any FDA-approved test

Coverage conditionUse consistent with FDA labeling or supported compendia/guidelines/literature

Biomarker Requirements for Therapy

IDH1 mutation — Detected by any FDA-approved test

IDH1 mutation detectionDetected by any FDA-approved test

Documentation requirementProvider must document presence of IDH1 mutation for coverage

Exclusion if undocumentedLack of documentation for detection of IDH1 mutation may trigger denial

Background

Olutasidenib (Rezlidhia) is indicated in the relapsed or refractory acute myeloid leukemia (AML) setting for patients with an IDH1 mutation. Coverage decisions require documentation that the clinical scenario and patient population are represented in the supporting evidence; absent adequate evidence and representation, use may be considered investigational and excluded from coverage.