CurrentCareSourcePolicy N/A

Danyelza (naxitamab-gqgk) — Utilization Management Medical Policy (Oncology, Injectable)

Policy governs prior authorization and medical necessity criteria for Danyelza (naxitamab-gqgk) intravenous infusion for treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow in patients aged ≥1 year; applies to CareSource medical benefit coverage.

Policy Summary

PayerCareSource

PolicyDanyelza (naxitamab-gqgk) — Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 29, 2025

Key ActionObtain prior authorization and confirm patient meets criteria (age ≥1 year, subsequent therapy use, and oncology prescriber involvement).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥1minimum patient age for coverage

3 mg/kgrecommended dosing per day

Days 1,3,5dosing days per cycle

1 yearinitial authorization duration

Not recommendedcoverage outside criteria

Recommended Authorization Criteria

FDA‑Approved Indication

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

FDA-Approved Indication - Neuroblastoma: A) Patient is ≥ 1 year of age;

FDA-Approved Indication - Neuroblastoma: B) Danyelza is used as subsequent therapy (i.e., not first-line).

FDA-Approved Indication - Neuroblastoma: C) Danyelza is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 150 mg/day administered by intravenous infusion no more frequently than three times in each treatment cycle.

Coverage is not recommended for any use of Danyelza that is not explicitly listed in the Recommended Authorization Criteria. This policy will be updated if new published data expand or change the criteria.

Policy Summary

PayerCareSource

PolicyDanyelza (naxitamab-gqgk) — Utilization Management Medical Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateJan 29, 2025

Key ActionObtain prior authorization and confirm patient meets criteria (age ≥1 year, subsequent therapy use, and oncology prescriber involvement).

SourceLink

On This Page

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Regimen	Dose / Schedule	Cycle Frequency	Duration / Continuation Rules
Danyelza (naxitamab-gqgk) administered in combination with GM‑CSF
3 mg/kg/day (maximum 150 mg/day) on Days 1, 3, and 5 of each treatment cycle
Treatment cycles repeated every 4 weeks initially
Continue every 4 weeks until complete response (CR) or partial response (PR), then give five additional 4‑week cycles; subsequent cycles may be repeated every 8 weeks until disease progression or unacceptable toxicity.

Dose and Code Details

Maximum daily dose

Maximum daily dose150 mg/day

Recommended per-dose regimen3 mg/kg/day (up to 150 mg/day) on Days 1, 3, and 5 of each treatment cycle

Administration routeIntravenous infusion in combination with GM-CSF

Provider Requirements and Authorization Process

Prior Authorization

Prior authorization required

Prior Authorization is recommended for medical benefit coverage of Danyelza. Approval is recommended for patients who meet the policy's Recommended Authorization Criteria and Dosing; extended approvals allowed if criteria continue to be met. Requests for doses outside the established dosing will be considered case-by-case by a clinician (Medical Director or Pharmacist).

Approvals are provided for the duration noted in the policy.
Requests for non-standard dosing require clinician review.

Step Therapy

Subsequent-therapy requirement (not first-line)

Danyelza must be used as subsequent therapy (not first-line) to meet the FDA‑Approved Indication criteria for coverage; approval is for patients who meet all elements of the FDA‑Approved Indication.

Policy criteria A–C include B) Danyelza is used as subsequent therapy.

Documentation Required

Prescriber specialty and dosing consultation required

Danyelza must be prescribed by or in consultation with a physician who specializes in the condition being treated; because of required specialized evaluation and monitoring, clinician oversight is required. Requests for doses outside the established dosing documented in this policy will be reviewed case-by-case by a Medical Director or Pharmacist.

Prescribing or documented consultation with an oncologist is required per the FDA‑Approved Indication (criteria C).
Non-standard dosing requests require clinician (Medical Director or Pharmacist) review.

Denial Risk

Do not cover indications outside listed criteria

Coverage is not recommended for uses not listed in the Recommended Authorization Criteria; the policy explicitly states non‑specified indications are excluded and criteria will be updated as new data become available.

Coverage will only be considered for situations that meet the policy's Recommended Authorization Criteria.

Therapy Background

Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated in combination with GM-CSF for relapsed or refractory high‑risk neuroblastoma involving bone or bone marrow. The accelerated approval was granted based on overall response rate and duration of response; continued approval may depend on confirmatory trial results. Use is limited to the FDA‑approved indication and the Recommended Authorization Criteria described in this policy.

Key Definitions

Accelerated approval

DefinitionAccelerated approval: indication approved based on overall response rate and duration of response; continued approval may depend on confirmatory trial results.

Evidence basisApproval based on overall response rate and duration of response

Post‑approval requirementContinued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial

Treatment Line

second-line

Subsequent therapy requirement: Danyelza is used as subsequent therapy (i.e., not first-line).

Policy specifies use as subsequent therapy for the FDA‑Approved indication.

Covered Dosing Regimens and Schedules

Indication	Dosing Schedule	Cycle Repetition	Continuation / Stop Rules
Relapsed or refractory high‑risk neuroblastoma in bone or bone marrow
3 mg/kg/day (up to 150 mg/day) on Days 1, 3, and 5 administered IV in combination with GM‑CSF
Cycles repeated every 4 weeks until complete response (CR) or partial response (PR); after CR/PR, administer five additional 4‑week cycles
After the initial CR/PR and five additional cycles, subsequent cycles may be given every 8 weeks and continued until disease progression or unacceptable adverse events/toxicity.