CurrentNeighborhood Health Plan of Rhode IslandPolicy UM ONC_1514

Revuforj (revumenib) drug policy — coverage criteria and utilization management

Defines coverage, inclusion and exclusion criteria, coding, and utilization management procedures for Revuforj (revumenib) for Neighborhood Health Plan of Rhode Island members. Affects prescribers and UM staff processing authorization requests.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyRevuforj (revumenib) drug policy

Policy CodePolicy UM ONC_1514

Change TypeNo material change

Effective DateDec 27, 2024

Next Review Date

Key ActionObtain prior authorization and provide supporting documentation from FDA labeling, CMS compendia, NCCN/ASCO guidance, or acceptable peer-reviewed literature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

relapsed/refractory KMT2Aprimary covered indication

J8999, C9399billing codes listed

270 mgsingle dose limit

90 / 120 / 60monthly tablet limits

FDA PIprimary reference

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.

Coverage Criteria for Revuforj (revumenib)

Coverage criteria

Covered when ALL of the following are met

Indication and molecular requirement: Member has relapsed or refractory acute leukemia with a lysine methyltransferase 2A (KMT2A) gene translocation (includes acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia)

from inclusion criteria (II.B)

Evidence requirement: Use is supported by FDA labeling, a CMS-recognized compendium, NCCN or ASCO clinical guidance, or acceptable peer-reviewed literature

from Purpose section; required supporting documentation

Exclusion and safety checks: Member does not have disease progression while taking revumenib; member does not have acute promyelocytic leukemia (APL); requested use is not concurrent with other anticancer therapies; dosing does not exceed single dose limit of 270 mg; monthly tablet total does not exceed 90 (25 mg), 120 (110 mg), or 60 (160 mg) tablets per month; indication is not investigational/off-label without sufficient supporting evidence

from exclusion criteria (III)

Requests will be excluded when any of the following apply: disease progression while taking Revuforj (revumenib); the member’s acute leukemia does not have a documented KMT2A (lysine methyltransferase 2A) gene translocation; the diagnosis is acute promyelocytic leukemia (APL); concurrent use with other anticancer therapies; dosing that exceeds the single dose limit of 270 mg; or monthly dispensing that exceeds the maximum of 90 (25 mg), 120 (110 mg), or 60 (160 mg) tablets per month. Additionally, use for investigational or off‑label indications that lack sufficient evidence or acceptance in the medical community is excluded. Abstracts or meeting reports without the full peer‑reviewed article are not considered adequate supporting evidence.

Off‑label or investigational requests for Revuforj (revumenib) will be considered not medically necessary unless the use is supported by one or more of the following: FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidance, or acceptable peer‑reviewed literature. Evidence that does not meet these standards — including abstracts without the full published article, case reports, or other uncontrolled anecdotal reports — is insufficient to approve off‑label indications. The published evidence must adequately represent the patient and disease characteristics, the therapy regimen, and demonstrate clinically meaningful outcomes as defined by accepted oncology standards.

Billing and Coding

Billing HCPCS codesHCPCS

J8999	revumenib.
C9399	revumenib

Single dose limit — 270 mg

Single dose limit270 mg

Source sectionExclusion criteria - dosing exceeds single dose limit of 270 mg

Applies toAll members receiving Revuforj (revumenib)

Monthly tablet maximums

25 mg tabletsMaximum 90 tablets per month

110 mg tabletsMaximum 120 tablets per month

160 mg tabletsMaximum 60 tablets per month

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Revuforj (revumenib). Continuation (renewal) requests may be approved only when the member has not experienced 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.

Prior authorization required prior to initiation
Continuation criteria: no disease progression on therapy; active use within last 12 months with ≤30-day lapse; no added medications on continuation request

Documentation Required

Required Supporting Documentation

Prescribing clinicians must support requests with one or more of the following: FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets CMS standards (see Medicare Benefit Policy Manual Chapter 15). Refer to the FDA label/package insert for medication management details (dosing limits, monitoring, and safety information).

Key Definitions

KMT2A rearrangement definition

DefinitionKMT2A (lysine methyltransferase 2A) translocation

Included diagnosesRelapsed or refractory acute lymphoblastic leukemia, acute myeloid leukemia, or mixed phenotype acute leukemia with KMT2A translocation

Age rangeAdult and pediatric members (per indication language)

Initial Therapy Authorization Criteria

Initial therapy

Initial authorization allowed when supported by approved sources

Initial indication requirement: Member has relapsed or refractory acute leukemia with documented KMT2A translocation

from inclusion criteria (II.B)

Evidence requirement: Requested use is supported by one of: FDA approved product labeling, a CMS-recognized compendium, NCCN or ASCO clinical guidelines, or acceptable peer-reviewed literature that meets CMS criteria

from Purpose section

Continuation Therapy Authorization Criteria

Continuation therapy

Continuation requests exempt from policy when criteria met

Continuation request conditions: Member has not experienced disease progression on revumenib; medication was used within the last year without a lapse of more than 30 days of having an active authorization; no additional medications are being added to the continuation request

from continuation rules (II.A)

Step Therapy Requirements

Step	Requirement	Notes / Duration
1	No step-therapy fail-first medication is specified; prior authorization is required for Revuforj (revumenib)	Policy lists a single step (1) with no specified required prior agent or failure duration; authorization decisions follow coverage criteria and supporting documentation per the policy

Quantity Limits

Revumenib dosing limits

Single dose limitMust not exceed 270 mg per dose

Monthly tablet limitsMust not exceed 90 (25 mg), 120 (110 mg), or 60 (160 mg) tablets per month

Dosing non-compliance consequenceRequests exceeding limits are exclusionary per policy

Site of Care

Note

Infusion center — site of care

Site-of-care is noted as an infusion center per the drug policy site-of-care guidance.

Background

Revuforj (revumenib) is a targeted antineoplastic agent (a menin inhibitor) indicated for use in adult and pediatric members with relapsed or refractory acute leukemia who have a documented KMT2A (MLL) gene translocation. Coverage under this policy is limited to that molecularly defined population and is subject to the policy’s authorization, continuation, and dosing limits.