CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1514

Revuforj (revumenib) drug coverage — Coverage Criteria and Authorization

Defines coverage criteria, exclusions, coding, and authorization workflow for Revuforj (revumenib) for Neighborhood Health Plan of Rhode Island members; applies to providers requesting medication authorization for covered members. Includes FDA‑labeled and supported off‑label uses per recognized compendia and guidelines.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRevuforj (revumenib) drug coverage — Coverage Criteria and Authorization

Policy CodePolicy UM ONC_1514

Change TypeNo material clinical or coverage changes

Effective DateDec 27, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of KMT2A translocation and evidence the member meets age and indication criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1 yrmin age

KMT2Arequired alteration

270 mgsingle dose max

90/120/60monthly tablet limits

J8999, C9399billing codes

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Coverage Criteria for Revuforj (revumenib)

Initial and Ongoing Therapy — Covered Indication

Covered when ALL of the following are met

Eligible diagnosis: Member has relapsed or refractory acute leukemia with a KMT2A translocation

Includes acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia

Age: Member is 1 year of age or older>=1 year

Applies to adult and pediatric members

Initial therapy coverage

Covered when diagnosis and age criteria are met and supported by FDA label or accepted evidence

Diagnosis: Relapsed or refractory acute leukemia with KMT2A translocation

Includes ALL, AML, mixed phenotype acute leukemia

Age >=1 year

Applies to adult and pediatric members

Supporting evidence: Use is supported by FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature

Refer to prescribing information and cited references

Requests for Revuforj (revumenib) will be excluded from coverage when any of the following apply: disease progression while taking Revuforj; diagnosis of an acute leukemia that does not have a KMT2A translocation; diagnosis of acute promyelocytic leukemia (APL); concurrent use with other anticancer therapies (combination or simultaneous anticancer agents); dosing that exceeds the single dose limit of 270 mg; or treatment that exceeds the monthly tablet limits of 90 tablets (25 mg), 120 tablets (110 mg), or 60 tablets (160 mg).

Use of Revuforj (revumenib) for investigational or off-label indications that are not supported by CMS‑recognized compendia or by acceptable peer‑reviewed literature is considered not medically necessary. Evidence considered insufficient includes reliance on abstracts without full articles, case reports alone, or other sources that do not adequately represent the patient population, regimen, or clinically meaningful outcomes as defined by accepted oncology standards.

Initial Therapy Specific Criteria

Initial therapy coverage

Covered when diagnosis and age criteria are met and supported by FDA label or accepted evidence

Diagnosis: Relapsed or refractory acute leukemia with KMT2A translocation

Includes ALL, AML, mixed phenotype acute leukemia

Age >=1 year

Applies to adult and pediatric members

Supporting evidence: Use is supported by FDA-approved labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature

Refer to prescribing information and cited references

Continuation Therapy Requirements

Continuation Therapy — Criteria

Continuation requests are approved when ALL of the following are met

No progression: Member has not experienced disease progression on the requested medication

Recent prior authorization: Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization<=30 days lapse

No additions: Additional medication(s) are not being added to the continuation request

Continuation therapy rules

Continuation requests meet criteria if all conditions are satisfied

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Revuforj (revumenib). Continuation requests may be approved only if the member has not experienced disease progression on revumenib, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the continuation request.

Continuation requests: member has not experienced disease progression on requested medication
Continuation requests: medication used within last year without >30-day lapse of active authorization
Continuation requests: no additional medications added to continuation request

Documentation Required

Supportive Documentation Required

Use must be supported by one of the following sources: FDA-approved product labeling, CMS‑recognized compendia, National Comprehensive Cancer Network (NCCN) or American Society of Clinical Oncology (ASCO) clinical guidelines, or acceptable peer‑reviewed literature that meets CMS evidentiary standards (see Medicare Benefit Policy Manual Chapter 15).

Billing and Coding

Billing HCPCS CodesHCPCS

J8999	revumenib
C9399	revumenib

inv-06: Single dose maximum — 270 mg

Single dose maximum270 mg

Source policy noteDosing exceeds single dose limit of 270 mg (exclusion)

Applies toAll age groups covered by policy (>= 1 year)

inv-07: Monthly tablet maximums — 90 tablets/month (25 mg), 120 tablets/month (110 mg), 60 tablets/month (160 mg)

25 mg tabletsMaximum 90 tablets per month

110 mg tabletsMaximum 120 tablets per month

160 mg tablets

Quantity Limits for Revumenib

inv-16: revumenib — Maximum single dose 270 mg; maximum tablets per month: 90 (25 mg), 120 (110 mg), 60 (160 mg)

Maximum single dose270 mg

Monthly tablet limits (25 mg)90 tablets/month

Monthly tablet limits (110 mg)120 tablets/month

Monthly tablet limits (160 mg)60 tablets/month

Definitions

inv-13: KMT2A translocation — defines molecular subgroup eligible for revumenib therapy

DefinitionA genetic rearrangement of the lysine methyltransferase 2A gene (KMT2A) that defines the molecular subgroup eligible for revumenib therapy.

Eligible diagnosesRelapsed or refractory acute leukemia with KMT2A translocation (includes ALL, AML, mixed phenotype acute leukemia)

Age criterionApplies to adult and pediatric members 1 year of age and older

Background

Revuforj (revumenib) is a menin inhibitor indicated for relapsed or refractory acute leukemias with a documented KMT2A (MLL) rearrangement in patients age >= 1 year. Coverage under this policy is limited to that molecularly defined population and must align with FDA labeling and accepted compendia or peer‑reviewed evidence.