CurrentmhnPolicy CP.PHAR.707

REVUFORJ (PDF)

Defines medical necessity criteria, authorization duration, dosing guidance, contraindications/boxed warnings, and administrative references for Revumenib (Revuforj) for commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyREVUFORJ (PDF)

Policy CodePolicy CP.PHAR.707

Change TypeAdded indication; monotherapy requirement; approval duration extended

Effective DateMar 1, 2025

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria, including genetic test results confirming KMT2A translocation or NPM1 mutation (with AML).

SourceLink

POLICY UPDATE CHANGES

Added new FDA approved indication for AML with NPM1 mutation.

Added requirement for use as a single agent.

Extended initial approval duration from 6 months to 12 months.

2FDA Approved Indications

1 yearMinimum Age for Coverage

12 moApproval Duration (Initial/Cont.)

3Tablet Strengths

Coverage Summary

Coverage stance: covered_with_criteria for Revumenib (Revuforj). FDA-indicated populations include: relapsed or refractory acute leukemia with a KMT2A translocation and relapsed or refractory AML with a susceptible NPM1 mutation, in adult and pediatric patients aged ≥ 1 year. Scope includes Commercial, HIM, and Medicaid lines of business and the policy defines medical necessity criteria, authorization duration, dosing guidance, and administrative requirements consistent with FDA indications and Centene authorization practices.

Other Diagnoses / Exclusions

Other Diagnoses/Indications

If not meeting above criteria:

ANY of the following

Recent label change pathway: If drug label changed within last 6 months and policy not yet updated, follow specified formulary/no-coverage or non-formulary policies (CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16 as applicable).
Off-label pathway: If requested use is not listed under section III and label change condition does not apply, refer to off-label use policy (CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable).

Diagnoses/Indications NOT authorized

Not authorized note: Non-FDA approved indications not addressed in this policy, unless sufficient documentation of efficacy and safety per off-label policies or evidence of coverage documents.

Provider Actions

Documentation Required

Submit supporting documentation

Submit office chart notes, laboratory results, or other clinical information that documents the member meets all approval criteria for Revumenib (Revuforj). Examples include documentation of diagnosis, specialist consultation or prescribing, genetic test results, dosing rationale, and evidence supporting continuation or dose increases.

Office chart notes
Lab results
Other clinical information (e.g., imaging, pathology, genetic reports)

Prior Authorization

Specialist prescribing requirement

Prescriber must be an oncologist or hematologist, or the therapy must be prescribed in consultation with an oncologist or hematologist for coverage to be considered.

Prior Authorization

Genetic test requirement

Coverage requires documentation of a KMT2A gene translocation OR an NPM1 mutation (the latter only when the member has AML) as determined by an FDA-authorized test.

Billing Rule

Dose limits

Dose requests must not exceed the specified weight-based limits: for patients ≥ 40 kg, 540 mg per day (4 tablets per day); for patients < 40 kg, 160 mg/m2 (see Dosage and Administration). Any request to exceed these limits must be supported by practice guidelines or peer-reviewed literature and the prescriber must submit supporting evidence.

Weight ≥ 40 kg: 540 mg/day and 4 tablets/day
Weight < 40 kg: 160 mg/m2 (refer to Dosage and Administration table)
Exceeding dose requires guideline or peer-reviewed literature support and prescriber evidence submission

Documentation Required

Continuation documentation

For renewal/continuation, submit documentation showing the member has received Revuforj for at least 30 days via the Centene benefit (or equivalent documentation) and is responding positively to therapy. Include clinical evidence of response as part of the renewal request.

Documentation of ≥ 30 days on therapy via Centene benefit or equivalent
Clinical evidence of positive response to therapy

Background

Revumenib (Revuforj) is a menin inhibitor indicated for relapsed/refractory acute leukemia with a KMT2A translocation and for relapsed/refractory AML with an NPM1 mutation, aligned to the FDA-approved indications for patients aged ≥1 year. The policy requires prescribing by or in consultation with an oncologist or hematologist and documentation of genetic confirmation (KMT2A translocation or NPM1 mutation determined by an FDA-authorized test). Per the 1Q2026 policy revision, use is required as monotherapy (single agent) and dosing follows the weight- and BSA-based regimens in the label with specified tablet strengths available (25 mg, 110 mg, 160 mg).

Policy Summary

Payermhn

PolicyREVUFORJ (PDF)

Policy CodePolicy CP.PHAR.707

Change TypeAdded indication; monotherapy requirement; approval duration extended

Effective DateMar 1, 2025

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria, including genetic test results confirming KMT2A translocation or NPM1 mutation (with AML).

SourceLink

On This Page

25 mg tablet	Tablet strength available: 25 mg
110 mg tablet	Tablet strength available: 110 mg
160 mg tablet	Tablet strength available: 160 mg

OpenPayer

REVUFORJ (PDF)

Coverage Summary

Initial Therapy Criteria

Continuation (Renewal) Criteria

Other Diagnoses / Exclusions

Provider Actions

Applicable Codes

Clinical Evidence & References

Background

Revision History