CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 1509-1

Komzifti (ziftomenib) — Prior Authorization and Coverage Criteria

Prior authorization and coverage criteria for Komzifti (ziftomenib) for treatment of relapsed or refractory acute myeloid leukemia with NPM1 mutation; affects pharmacy benefit management and prescribers for Colorado Rocky Mountain Health Plans members (note: underlying document is a UnitedHealthcare Pharmacy program).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKomzifti (ziftomenib) prior authorization and coverage criteria

Policy CodePolicy 2025 P 1509-1

Change TypeNew prior authorization program

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization for Komzifti; initial approval requires AML diagnosis, relapsed/refractory disease, and positive NPM1 mutation.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program established for Komzifti (ziftomenib).

2026-04-01policy effective date

P&T 01/2026P&T approval date

12 monthsauthorization period

Indication-limitedindication scope

Coverage Criteria for Komzifti (ziftomenib)

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inv-01: Initial Authorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Initial Authorization for Komzifti: Diagnosis of acute myeloid leukemia

AND (2) Disease is relapsed or refractory AND (3) Positive for nucleophosmin 1 (NPM1) mutation

inv-02: Reauthorization — Covered for reauthorization when the following is met

Covered for reauthorization when the following is met

Reauthorization for Komzifti: Patient does not show evidence of progressive disease while on Komzifti therapy

Authorization will be issued for 12 months

inv-03: Patients less than 19 years — Coverage for patients under 19 years of age

Coverage for patients under 19 years of age

Pediatric processing: Patient is less than 19 years of age

Prescription will automatically process without a coverage review; authorization will be issued for 12 months

inv-04: NCCN Recommended Regimens — Compendia recognition

Compendia recognition

NCCN recognition: Drug recognized by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B

Used as supportive recognition for the cancer indication

Some states have specific mandates that require coverage for off‑label medication use or the use of certain compendia. Where a state mandate applies, it supersedes the language in this policy and takes precedence over the criteria below. This may affect coverage determinations for off‑label uses of Komzifti.

Use of Komzifti that does not meet the initial authorization requirements — specifically, (1) a diagnosis of acute myeloid leukemia, (2) disease that is relapsed or refractory, and (3) documentation of a positive NPM1 mutation — will not meet coverage criteria. Additionally, at reauthorization, evidence of progressive disease while on Komzifti will preclude renewal. Initial and reauthorization approvals are managed through prior authorization and require supporting clinical documentation.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Komzifti except for members under age 19 where prescriptions automatically process without coverage review. Authorization requests should document the diagnosis, mutation status, and prior treatment history as applicable.

Applies to Komzifti (ziftomenib)
Policy Number: 2025 P 1509-1
Effective Date: 2026-04-01

Step Therapy

Step Therapy / Program Notes

No specific step therapy sequence is specified for Komzifti. State mandates, compendium requirements, and other utilization management programs may apply and supersede this policy where applicable.

No step therapy sequence required
State mandates and other UM programs may apply

Documentation Required

Required Clinical Documentation

Documentation must demonstrate diagnosis of acute myeloid leukemia (AML), relapsed or refractory disease status, and positive NPM1 mutation for initial authorization. Include relevant clinical records, diagnostic test results confirming NPM1 mutation, and prior treatment history when available.

Confirm diagnosis: acute myeloid leukemia (AML)
Confirm disease status: relapsed or refractory
Document positive NPM1 mutation (test results)
Provide prior treatment history and relevant clinical notes

Denial Risk

Initial Criteria Not Met

Failure to meet all initial authorization criteria (AML diagnosis, relapsed/refractory disease, and positive NPM1 mutation) will result in denial of the initial request.

Denial risk if any initial criteria not met
Provide missing documentation to avoid denial

Denial Risk

Progressive Disease at Reauthorization

Evidence of progressive disease while on Komzifti at the time of reauthorization will trigger denial. Reauthorizations will be approved only when there is no documented disease progression. Authorizations are issued for 12 months when approved.

Reauthorization denied if progressive disease documented
Approved reauthorizations issued for 12 months

Step	Requirement / Notes
1	No specific step therapy sequence is described in this program. State mandates, other utilization‑management programs, or automated approval processes may impose additional requirements; supply limits may also apply.

Definitions

Relapsed or refractory AML — definition

DefinitionRelapsed or refractory acute myeloid leukemia: AML that has returned after prior treatment or has not responded to standard therapy.

Context in policyInitial authorization requires diagnosis of acute myeloid leukemia and that disease is relapsed or refractory.

Age notePolicy provides separate automatic processing rules for patients under 19 years of age.

NPM1 mutation — definition

DefinitionSusceptible nucleophosmin 1 (NPM1) mutation: presence of an NPM1 mutation in tumor testing supporting use of Komzifti.

Coverage requirementInitial authorization requires the patient to be positive for NPM1 mutation.

IndicationKomzifti is indicated for adult patients with relapsed or refractory AML who have a susceptible NPM1 mutation and no satisfactory alternative options.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKomzifti (ziftomenib) prior authorization and coverage criteria

Policy CodePolicy 2025 P 1509-1

Change TypeNew prior authorization program

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization for Komzifti; initial approval requires AML diagnosis, relapsed/refractory disease, and positive NPM1 mutation.

SourceLink

On This Page

OpenPayer

Komzifti (ziftomenib) — Prior Authorization and Coverage Criteria

Coverage Criteria for Komzifti (ziftomenib)

Initial Therapy Requirements

Continuation / Reauthorization Criteria

Provider Actions and Documentation Requirements

Step Therapy / Utilization Management Notes

Quantity Limits

Site-of-Care Restrictions

Background

Definitions

Revision History