CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Danyelza (naxitamab-gqgk) — Coverage Criteria for Relapsed/Refractory High‑Risk Neuroblastoma

Defines accepted indications, inclusion and exclusion criteria, and utilization management requirements for Danyelza (naxitamab-gqgk) requests for pediatric and adult members with relapsed or refractory high-risk neuroblastoma; applies to medication authorization and reimbursement decisions processed by Evolent for the payer.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDanyelza (naxitamab-gqgk) — Coverage Criteria for Relapsed/Refractory High‑Risk Neuroblastoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNovember 29, 2024

Next Review DateN/A

Key ActionSubmit prior authorization requests through Evolent with documentation supporting FDA label or recognized compendia/guidelines; Danyelza must be given with GM-CSF and meets age and disease response criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 mg/kgsingle dose maximum

1 yr+minimum pediatric age

Nov 13, 2024committee approval

Nov 29, 2024effective date

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Initial/authorized use

Covered when ALL of the following are met

Indication and patient factors: Member is one year of age or older (pediatric) or an adult with relapsed or refractory high-risk neuroblastoma involving bone or bone marrow

High‑risk neuroblastoma defined as >18 months with disseminated disease or localized disease with unfavorable markers such as MYCN amplification

Disease response to prior therapy: Disease demonstrates a partial response, minor response, or stable disease to prior therapy

Concomitant therapy: Danyelza (naxitamab‑gqgk) is administered in combination with GM‑CSF

Requests will be excluded when there is disease progression while taking Danyelza (naxitamab‑gqgk). Authorization will also be denied if dosing exceeds the stated single‑dose maximum of 3 mg/kg (up to 150 mg/day). Additionally, requests for Danyelza used for an off‑label or investigational indication will be excluded when the indication lacks sufficient supporting evidence or is not generally accepted by the medical community; the policy specifies criteria for what constitutes sufficient evidence (for example, adequate representation of the patient population and regimen in the published evidence, clinically meaningful outcomes, appropriate study design, and reliance on peer‑reviewed full‑text publications rather than abstracts or case reports).

Use of Danyelza for investigational or off‑label indications is considered not medically necessary when there is inadequate supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature. The policy details factors used to assess sufficiency of evidence, including whether the patient and regimen are represented in the literature, whether outcomes are clinically meaningful (for example, ASCO‑recommended thresholds such as a Hazard Ratio <0.80 or survival benefits of at least three months for OS or PFS), whether study design is appropriate, and that case reports or meeting abstracts without full peer‑reviewed articles generally do not provide adequate supportive evidence. Dosing that exceeds the single‑dose limit is also considered not medically necessary.

Regimen	Indication	Required concomitant therapy	Population / response to prior therapy	Coverage stance
Danyelza (naxitamab-gqgk)	Relapsed or refractory high-risk neuroblastoma involving bone or bone marrow	Granulocyte‑macrophage colony‑stimulating factor (GM‑CSF)	Pediatric members ≥ 1 year of age and adult members whose disease demonstrates a partial response, minor response, or stable disease to prior therapy	Covered with criteria

Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization required through Evolent for all requests for Danyelza (naxitamab‑gqgk). Continuation requests are eligible for exemption from initial-authorization requirements only when the medication was used within the last year, the member has not experienced disease progression or intolerance while on Danyelza, and no additional medications are being added to the continuation request. Evolent is responsible for processing and authorizing medication requests; medications not authorized by Evolent may be deemed not reimbursable.

All requests must be submitted to Evolent for prior authorization.
Continuation request exemption requires: use within last year; no disease progression or intolerance; no new medications added.

Documentation Required

Supporting Evidence Required

Use of Danyelza must be supported by one of the following sources: FDA-approved product labeling, CMS‑recognized compendia, NCCN or ASCO clinical guidelines, or peer‑reviewed literature that meets CMS standards (see CMS Medicare Benefit Policy Manual Chapter 15). Documentation submitted with the authorization request should reference the specific supporting source and relevant excerpts or citations to justify the requested indication.

Acceptable evidence: FDA label; CMS‑approved compendia; NCCN or ASCO guidelines; peer‑reviewed literature meeting CMS criteria.
Peer‑reviewed literature must address patient/cancer characteristics, regimen, clinically meaningful outcomes, and appropriate study design as described by CMS standards.

Documentation Required

Combination Therapy Requirement

Danyelza must be administered in combination with GM‑CSF for the indicated population. Specifically, therapy is indicated for pediatric members ≥1 year and adults with relapsed or refractory high‑risk neuroblastoma in bone or bone marrow who have achieved a partial response, minor response, or stable disease to prior therapy. High‑risk neuroblastoma is defined per the policy (e.g., >18 months with disseminated disease or localized disease with unfavorable markers such as MYCN amplification).

Danyelza must be given in combination with GM‑CSF.
Indicated population: pediatric ≥1 year and adults with relapsed/refractory high‑risk neuroblastoma in bone or bone marrow with PR/MR/stable disease to prior therapy.
High‑risk definition includes age and unfavorable markers (e.g., MYCN amplification).

Background

Danyelza (naxitamab‑gqgk) is a monoclonal antibody indicated for use in patients with relapsed or refractory high‑risk neuroblastoma involving bone or bone marrow. The policy requires that Danyelza be administered in combination with GM‑CSF for the indicated population and applies to pediatric members aged one year and older as well as adults with high‑risk disease. Utilization decisions are made in the context of FDA labeling and recognized oncology compendia or peer‑reviewed evidence, and the policy defines exclusions and evidence standards that guide authorization and denial decisions.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyDanyelza (naxitamab-gqgk) — Coverage Criteria for Relapsed/Refractory High‑Risk Neuroblastoma

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateNovember 29, 2024

Next Review DateN/A

SourceLink

On This Page

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Danyelza (naxitamab-gqgk) — Coverage Criteria for Relapsed/Refractory High‑Risk Neuroblastoma

Coverage Criteria for Danyelza (naxitamab-gqgk)

Key Coding & Dose Limits

Authorization, Documentation, and Denial Triggers

Intended Line of Therapy

Definitions and Eligibility

Biomarker Requirements

Background