Naxitamab (Danyelza) (Medicaid Expansion)

Policy ID: ME-I-234-005-01

Section: Injections

Effective Date: December 09, 2024

Last Reviewed: November 19, 2024

Applies To: Medicaid Expansion Only

Description

Naxitamab (Danyelza®) is a recombinant humanized monoclonal IgG1 antibody that works by binding to glycolipid disialoganglioside (GD2) on the cell surface of neuroblastoma cells.

Policy Application

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

Naxitamab (Danyelza) may be considered medically necessary for the following:

Neuroblastoma

For the treatment of individuals one (1) year of age and older, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

The use of naxitamab (Danyelza) for any other indication than listed above is considered experimental/investigational and therefore, not covered. The safety and/or efficacy cannot be established by review of the available published peer-reviewed literature.

Procedure Code

J9348

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Codes

Covered diagnosis codes for J9348

C74.00

C74.10

C74.11

C74.12

C74.90

C74.91

C74.92

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 11-19-2024 Effective December 09, 2024

Adopted Medicaid Expansion specific policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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