CurrentMass General Brigham Health PlanPolicy N/A

Danyelza (naxitamab-gqgk)

Policy defines prior authorization, coverage criteria, continuation, and limits for Danyelza (naxitamab-gqgk) under the medical benefit for treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow.

Policy Summary

PayerMass General Brigham Health Plan

PolicyDanyelza (naxitamab-gqgk)

Policy CodePolicy N/A

Change TypeBenefit alignment; formatting and reference updates

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization is required; submit claims to the medical benefit and ensure documentation supports diagnosis, prior response, use with GM-CSF, and appropriate dosing.

SourceLink

POLICY UPDATE CHANGES

Danyelza will be managed through the medical benefit only effective 6/1/25.

Reviewed and updated for P&T on 05/15/2025 with formatting and reference updates.

1Covered Indication

6 monthsApproval Duration

Coverage Summary

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with GM-CSF, for pediatric patients ≥1 year of age and adults with relapsed or refractory high-risk neuroblastoma in bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. Coverage stance: Covered with criteria. Scope summary: Policy defines prior authorization, coverage criteria, continuation, and limits for Danyelza (naxitamab-gqgk) under the medical benefit for treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow.

Initial Therapy Criteria

Authorization Criteria (Initial therapy)

Authorization may be granted when ALL of the following are met:

ALL of the following

Diagnosis of high-risk neuroblastoma of bone or bone marrow
Prescriber is an oncologist
Age: Member is 1 year of age or older>= 1 year
policy text lists 'The member is 2 1 year of age' — interpreted as ≥ 1 year
Dosing: Appropriate dosing per prescribing information
dosing specifics not provided in policy; must follow prescribing information
Tumor Risk: The member's tumor is high risk
Prior Response: Member has demonstrated a partial response, minor response, or stable disease to prior treatment (e.g., vincristine, cyclophosphamide, topotecan, doxorubicin, cisplatin, and etoposide)
Concomitant Therapy: Requested medication will be used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) agent

Continuation Therapy Criteria (Reauthorization)

Continuation of Therapy (Reauthorization)

Reauthorization requirement:

ALL of the following

Reauthorization by physician will infer a positive response to therapy

Limitations

Duration: Initial approvals and reauthorizations will be for 6 months6 months

New-to-Plan Exception

Authorization may be reviewed on a case by case basis for members new to the plan

New-to-Plan Exception: Members who are new to the plan and currently receiving treatment with the requested medication (excludes products obtained as samples or via manufacturer's patient assistance programs)

Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior authorization is required; authorizations may be granted when the listed criteria are met and may be reviewed case-by-case for members new to the plan currently receiving treatment.

Documentation Required

Clinical documentation to support response

For initial approval and reauthorization, documentation must support diagnosis of high-risk neuroblastoma in bone or bone marrow, prior response (partial, minor, or stable) to prior therapy, use in combination with a GM-CSF agent, and appropriate dosing consistent with the prescribing information.

Billing Rule

Benefit alignment

Danyelza will be managed through the medical benefit effective 2025-06-01; submit claims to the medical benefit accordingly.

Background & Definitions

Danyelza (naxitamab-gqgk) is indicated, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients ≥1 year of age and adult patients 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 policy will be managed through the medical benefit effective 06/01/2025 and defines prior authorization criteria, continuation requirements, and limitations including initial and reauthorization approvals for 6 months.

GM-CSF: Granulocyte-macrophage colony-stimulating factor