CurrentCignaPolicy N/A

Oncology (Oral - Menin Inhibitor) - Komzifti Prior Authorization Policy

Defines prior authorization coverage criteria for Komzifti (ziftomenib capsules) under Cigna benefit plans for the FDA-approved indication and states noncoverage for other uses. Approvals are for a duration of one year when criteria are met.

Policy Summary

PayerCigna

PolicyOncology (Oral - Menin Inhibitor) - Komzifti Prior Authorization Policy

Policy CodePolicy N/A

Change TypeOverview updated (NCCN v3.2026)

Effective Date

Next Review Date

Key ActionPrior Authorization is required; approvals provided for 1 year when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

Overview section updated to include updated guideline information (NCCN v3.2026).

New Policy created with review date 11/13/2025.

1Covered Indications

1 yrApproval Duration

≥18Age Requirement

Coverage Summary

FDA-Approved Indication (Acute Myeloid Leukemia)

A: Patient is ≥ 18 years of age
B: Patient has relapsed or refractory disease
C: Disease is positive for a susceptible nucleophosmin 1 (NPM1) mutation
Documentation of mutation status is required per policy

Conditions Not Covered

Komzifti is considered not medically necessary for any other use(s).

Any use not listed in the FDA-approved indication (acute myeloid leukemia with susceptible NPM1 mutation)

Coverage stance: covered_with_criteria — Komzifti is covered when the FDA‑approved criteria are met. Scope: Defines prior authorization coverage criteria for Komzifti (ziftomenib capsules) under Cigna benefit plans for the FDA‑approved indication and states noncoverage for other uses. Typical approval duration: 1 year when criteria are met. Age requirement: Age ≥18. Komzifti indicated for relapsed/refractory AML with susceptible NPM1 mutation; approvals for 1 year when criteria met; noncovered for other uses.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended/required for prescription benefit coverage of Komzifti. Approvals are provided for a duration of 1 year when the coverage criteria are met.

Documentation Required

Documentation of mutation status

Documentation that the disease is positive for a susceptible NPM1 mutation must be provided to meet coverage criteria (presence of a susceptible NPM1 mutation per FDA labeling/prescribing information).

Documentation Required

Age and disease status documentation

Documentation that the patient is ≥ 18 years of age and has relapsed or refractory disease must be provided to meet coverage criteria.

Clinical Evidence & Guidelines

Prescribing information: Komzifti capsules prescribing information, Kura Oncology, November 2025.

Guideline: NCCN Acute Myeloid Leukemia Clinical Practice Guidelines in Oncology (version 3.2026 November 24, 2025) — NCCN lists Komzifti as a category 2A option for relapsed/refractory AML with NPM1 mutation.

Background

Komzifti (ziftomenib) is a menin inhibitor indicated for the treatment of relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation in adult patients who have no satisfactory alternative treatment options. The FDA indication and NCCN placement support its use in this setting; NCCN lists Komzifti as a category 2A option for relapsed/refractory AML with NPM1 mutation.

Quick Facts

Covered Indications1 (relapsed/refractory AML with susceptible NPM1 mutation)

Typical Approval Duration1 year

Last Review2025-11-13

Definitions:

Susceptible NPM1 mutation — Presence of an NPM1 mutation considered susceptible per FDA labeling/prescribing information (documentation required).

Revision History

2025-11-26summary of changesLatest

Overview updated to include updated guideline information (NCCN v3.2026).

2025-11-13history/new policy