Naxitamab (Danyelza) (ARCHIVED)

Policy ID: I-234-006

Section: Injections

Effective Date: March 15, 2021

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Applies To: Commercial Only

**This policy has been Archived effective December 08, 2024. Click the Archive tab above for more information.**

Policy ID: I-234-006

Section: Injections

Effective Date: March 15, 2021

Revised Date: October 24, 2024

Revision Effective Date: December 08, 2024

Last Reviewed: November 19, 2024

Archived Date: December 08, 2024

Applies To: Commercial 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.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

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 3-17-2021- Effective March 15, 2021

Adopted new pre-certification policy

Internal Medical Policy Committee 7-22-2021- Effective July 01, 2021

Added new code J9348 to policy

Internal Medical Policy Committee 7-21-2022 Annual review, no clinical content change

Internal Medical Policy Committee 7-26-2023 Annual review, no clinical content change

Internal Medical Policy Committee 7-16-2024 Effective September 01, 2024

Annual review no clinical content change

Internal Medical Policy Committee 11-19-2024 Effective December 08, 2024

Archived 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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