Ziftomenib (Komzifti) coverage
Customize your policy alerts
Sign up for QualChoice Policy CP.PHAR.765 alerts
Get alerted when Policy CP.PHAR.765 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity and prior authorization criteria for ziftomenib (Komzifti) for treatment of adult patients with relapsed or refractory NPM1‑mutated acute myeloid leukemia across QualChoice lines of business.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-03: Other Diagnoses/Indications
See referenced policies: CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53.
Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other approved evidence of coverage documents.
Uses of Komzifti for non‑FDA approved indications that lack adequate supporting evidence per the referenced off‑label policies are considered not medically necessary and will not be authorized.
Initial Therapy (AML) Requirements
Continuation Therapy (AML) Requirements
Coding and Dose Limits
Provider Actions and Requirements
Prior authorization required; 12-month approvals
Prior authorization is required for Komzifti (ziftomenib). When the member meets the initial or continued therapy criteria, approvals are issued for a duration of 12 months.
Preferred agent requirement — use ziftomenib when available
For Komzifti requests, the prescriber must use ziftomenib when it is available unless the member has a contraindication or experiences clinically significant adverse effects or intolerance.
Submit supportive clinical documentation
Providers must submit supporting clinical documentation (such as office chart notes, laboratory results, or other clinical information) showing the member meets all applicable approval criteria.
- Examples: office chart notes, lab results, other clinical information
Non‑FDA indications lacking sufficient evidence may be denied
Requests for non–FDA approved indications that are not addressed in this policy may be denied if there is insufficient documentation of efficacy and safety per the referenced off‑label use policies.
- Refer to off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), CP.PMN.53 (Medicaid).
Step Therapy / Substitution Rules
| Step | Requirement |
|---|---|
| 1 | Prescriber must use ziftomenib when available for Komzifti requests unless contraindicated or clinically significant adverse effects occur. |
Quantity Limits
Site of Care
Site of care: none specified
No site-of-care restrictions are specified in this policy.
Background
Ziftomenib (Komzifti) is a menin inhibitor indicated in this policy context for specific treatment of acute myeloid leukemia. Requests for indications outside the FDA‑approved labeling are subject to review and must include documentation demonstrating efficacy and safety per the off‑label use policies cited elsewhere in this document.
Definitions
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.