CurrentUnitedHealthcarePolicy N/A

Revuforj (revumenib) prior authorization

Coverage and prior authorization criteria for Revuforj (revumenib) for treatment of relapsed or refractory acute leukemia with KMT2A translocation in adults and pediatric patients ≥1 year; applies to UnitedHealthcare pharmacy benefit prior authorization/notification programs.

Policy Summary

PayerUnitedHealthcare

PolicyRevuforj (revumenib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of relapsed or refractory acute leukemia and positive KMT2A translocation for approval (authorization issued for 12 months).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsStandard authorization duration

≥1 yrMinimum patient age

Prior Auth/NotificationProgram type

KMT2ARequired marker

Coverage Criteria for Revuforj (revumenib)

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Initial Authorization

Covered when ALL of the following are met

Initial Authorization for Revuforj: Diagnosis of acute leukemia

Initial Authorization for Revuforj: Disease is relapsed or refractory

Authorization will be issued for 12 months

Initial Authorization for Revuforj: Positive for lysine methyltransferase 2A gene (KMT2A) translocation

Provider Actions, Documentation & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved when the coverage criteria are met.

Initial and reauthorization approvals issued for up to 12 months where criteria are met.

Documentation Required

Pediatric Approval Note

Revuforj approvals for patients under 19 years will be issued when the pediatric-specific criterion is met.

Patient is less than 19 years of age.
Authorization duration: 12 months.

Note

Automated Approval and Limits

Automated approval and re-approval may be used in some cases; supply limits may apply.

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic.
Use of automated approval and re-approval processes varies by program and therapeutic class.
Supply limits may be in place.

Denial Risk

Required Documentation and Denial Triggers

Required documentation must be present in the medical record and submitted with the request; absence of required documentation or evidence of progression are triggers for denial.

Documentation of diagnosis of acute leukemia.
Documentation that disease is relapsed or refractory.
Documentation of positive KMT2A (lysine methyltransferase 2A) gene translocation.
For pediatric patients, documentation of age <19 years.
For reauthorization requests, documentation showing no evidence of progressive disease while on Revuforj therapy.
Absence of the above documentation or evidence of disease progression are grounds for denial.

Key Definitions

KMT2A translocation — definition and coverage relevance

DefinitionKMT2A translocation: a lysine methyltransferase 2A (KMT2A) gene rearrangement associated with certain acute leukemias.

Coverage requirementPresence of a documented KMT2A translocation is required for Revuforj (revumenib) coverage.

Associated indicationRevuforj is indicated for relapsed or refractory acute leukemia with KMT2A translocation in adults and pediatric patients 1 year and older.

Authorization effectPositive KMT2A translocation is one of the required criteria for initial authorization of Revuforj; authorization is issued for 12 months.

Exclusion if absentUse of Revuforj for acute leukemia without documented KMT2A translocation is not covered by these criteria.

Background

Revuforj (revumenib) is a menin inhibitor indicated for treatment of relapsed or refractory acute leukemia when the tumor is positive for a KMT2A translocation. Initial authorization requires documentation of acute leukemia that is relapsed or refractory and a positive KMT2A translocation; approvals are issued for 12 months when criteria are met.

Site of Care and Supply Limits

Billing Rule

Site‑of‑care and supply limits may apply for infusion center use

Supply limits and site‑of‑care or state mandates may affect coverage; federal regulatory requirements and the member’s specific benefit plan may also impact coverage determinations for infusion center administration.

Step-Therapy and Automated Approval Rules

Process	Triggering data	Notes / limits
Automated initial approval	Previous claims and medication history, diagnosis codes (e.g., ICD‑10)	UnitedHealthcare may approve initial requests based solely on prior claim/medication history and diagnosis codes; use of automated approval varies by program or therapeutic class; supply limits may apply.
Automated re‑approval	Prior claims/medication history and diagnosis codes; claim logic	Automated re‑approval processes may be used; program‑specific variation applies and supply limits may be enforced.