CurrentCentenePolicy CP PHAR.523

Naxitamab-gqgk (Danyelza) Clinical Policy

Defines medical necessity and prior authorization criteria for coverage of Danyelza (naxitamab-gqgk) for treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow for Centene-affiliated lines of business.

Policy Summary

PayerCentene

PolicyNaxitamab-gqgk (Danyelza) Clinical Policy

Policy CodePolicy CP PHAR.523

Change TypeNo material change

Effective DateMar 1, 2021

Next Review DateFeb 25, 2025

Key ActionObtain prior authorization and document that the member meets all approval criteria, including diagnosis, disease location, response to prior therapy, and combination use with GM‑CSF.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age 1+FDA-indicated minimum patient age

150 mg/dayMaximum dose per day

40 mg/vialProduct vial strength

6–12 moApproval durations (init vs cont)

J9348Billing code

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Initial Therapy (Neuroblastoma)

Covered when ALL of the following are met

Initial approval - neuroblastoma: 1) Diagnosis of high‑risk neuroblastoma; 2) Disease is relapsed or refractory; 3) Disease involves bone or bone marrow; 4) Age >= 1 year; 5) Prescribed by or in consultation with an oncologist; 6) Prescribed in combination with GM‑CSF; 7) Member has demonstrated a partial response, minor response, or stable disease to prior therapy; 8) Dose does not exceed 150 mg (4 vials) per day for 3 days of each 4‑week treatment cycle; 9) Request meets one of the following: a) prescribed regimen is FDA‑approved or recommended by NCCN; OR b) dose/regimen is supported by practice guidelines or peer‑reviewed literature with prescriber submission of supporting evidence.

Approval duration: Medicaid/HIM 6 months; Commercial 6 months or to member renewal date.

Continuation Therapy (Neuroblastoma)

Covered when ALL of the following are met for continuation

Continued therapy - neuroblastoma: 1) Member is currently receiving Danyelza for a covered indication and has received treatment for at least 28 days; 2) Member is responding positively to therapy; 3) New dose does not exceed 150 mg (4 vials) per day for 3 days of each 4‑week treatment cycle; 4) Prescribed regimen must be FDA‑approved or recommended by NCCN, or the new dose/regimen is supported by practice guidelines or peer‑reviewed literature with prescriber submission of supporting evidence.

Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date.

Other Indications

Other indications

Other diagnoses/indications: 1) If the request is for a use that is on the formulary/PDL for the relevant line of business, follow the 'no coverage criteria' policy for that line of business (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255); OR 2) If the drug is not on the formulary/PDL for the relevant line of business, follow the non‑formulary policy for that line of business (e.g., CP.CPA.190, HIM.PA.103, CP.PMN.16); if the requested use is not specifically listed under exclusions and criterion 1 above does not apply, refer to the off‑label use policy for the relevant line of business (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53).

Prescriber may need to submit justification or supporting documentation per the referenced policies.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized for coverage unless the prescriber provides sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless the member’s evidence of coverage documents permit the use.

Coverage determinations under this clinical policy are subject to the member’s benefits and the plan contract. Use of Danyelza must comply with all terms, conditions, exclusions, and limitations contained in the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan administrative policies.

Requests for uses that are not FDA‑approved and that lack sufficient supporting evidence as required by the referenced off‑label use policies will be considered not medically necessary and are not eligible for coverage per this policy.

This clinical policy is a guide to assist in medical necessity determinations and prior authorization decisions; it does not guarantee payment and is not intended to prescribe or recommend treatment. Providers are expected to exercise their professional medical judgment when treating members and remain solely responsible for clinical decisions and for documenting medical necessity.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial and continuation approvals are provided when the documented clinical criteria in this policy are met. Initial approvals are typically granted for the durations specified under the Approval duration section (Medicaid/HIM 12 months; Commercial 6 months or to the member's renewal date, whichever is longer). Prior authorization may also be required for supporting agents used in combination (e.g., GM‑CSF/Leukine).

Prior authorization required for Danyelza for high‑risk neuroblastoma per policy criteria.
Initial and continuation requests must include documentation that all approval criteria are met.
Approval duration: Medicaid/HIM 12 months; Commercial 6 months or to member renewal date, whichever is longer.

Note

Prior Authorization Guidance

This clinical policy is a guide for medical necessity determinations and may be used in prior authorization decisions. For Medicaid members, applicable state Medicaid coverage provisions supersede this policy when conflicts exist. Coverage decisions remain subject to the member's benefit terms, exclusions, and limitations.

Clinical policy may be applied in prior authorization determinations.
State Medicaid provisions take precedence over this policy when conflicts exist.

Documentation Required

Required Clinical Documentation

Providers must document clinical information sufficient to demonstrate that the member meets all approval criteria. Required documentation includes, but is not limited to: diagnosis of high‑risk neuroblastoma, evidence of relapsed or refractory disease, disease location (bone or bone marrow), prior treatment history and response (e.g., partial response, minor response, or stable disease), dosing rationale if using off‑label regimens, and documentation of concomitant therapies (e.g., GM‑CSF).

Diagnosis and staging information supporting high‑risk neuroblastoma.
Evidence of relapsed or refractory disease and disease location (bone or bone marrow).
Treatment history and objective response documentation (e.g., prior response to therapy, duration).
Prescriber specialty: prescribed by or in consultation with an oncologist.
Dosing details: doses must not exceed 150 mg (4 vials) per day for 3 days of each 4‑week treatment cycle unless supported by practice guidelines or peer‑reviewed literature (submit supporting evidence).
If regimen is off‑label, include supporting literature per off‑label use policies.

Documentation Required

Provider Documentation & Contract Responsibilities

Providers are responsible for maintaining documentation that supports medical necessity and for complying with contractual obligations. This policy does not alter provider responsibilities to submit accurate claims, obtain prior authorization where required, or retain records for audit. The Health Plan may deny coverage if documentation is insufficient or if services are not authorized under the member's benefit plan.

Providers must adhere to their contract terms and are responsible for documentation supporting medical necessity.
Claims and services are subject to plan terms, conditions, exclusions, and limitations; insufficient documentation may result in denial.
Unauthorized copying or distribution of this policy is prohibited; providers agree to be bound by its terms when providing services or submitting claims.

Note

Therapeutic Alternatives Noted

Therapeutic alternatives are listed and may be preferred or require separate authorization; formulary status varies by line of business. Alternatives include cytotoxic multi‑agent regimens, dinutuximab (Unituxin), isotretinoin, and supportive agents such as GM‑CSF. Providers should consider preferred agents and formulary status when selecting therapy and may be required to provide rationale if requesting non‑preferred agents.

Therapeutic alternatives include multi‑agent cytotoxic regimens (e.g., cisplatin, etoposide, vincristine, cyclophosphamide, doxorubicin, topotecan).
Unituxin (dinutuximab) and isotretinoin are listed as alternatives.
GM‑CSF (colony‑stimulating factor) is commonly used in combination and may require separate prior authorization.

Definitions

High-risk neuroblastoma (COG/INRG criteria) — Appendix D

DefinitionHigh-risk neuroblastoma per COG/INRG criteria including staging and prognostic factors (MYCN amplification, age, histology, ploidy) as detailed in Appendix D.

COG examplesIncludes Stage 3 with MYCN amplification; Stage 2A/2B with MYCN amplification; Stage 3 in children ≥18 months with unfavorable histology and no MYCN amplification; certain Stage 4 presentations based on age, MYCN status, ploidy, and histology.

INRG useINRG classification uses INRGSS staging plus prognostic factors (age, histology, MYCN, 11q aberration, DNA ploidy) to assign pretreatment groups that map to overall risk including high risk.

Medical necessity — guidance

Role in coverage decisionsMedical necessity guidance: Component used to assist in making coverage decisions and administering benefits, not a guarantee of payment.

ScopeGuidance is intended to assist in determinations of medical necessity but does not constitute medical advice or a contract for payment.

LimitationsCoverage decisions remain subject to terms, conditions, exclusions, limitations of member coverage documents and applicable law.

Provider status

Provider relationship to Health PlanProviders are independent contractors who exercise independent judgment and are not agents or employees of the Health Plan.

ResponsibilityProviders are solely responsible for medical advice and treatment of members and must exercise professional judgment.

Policy ownershipThis clinical policy is the property of the Health Plan; unauthorized copying, use, or distribution is prohibited.

Therapeutic alternative	Notes
Unituxin (dinutuximab)
Listed as a therapeutic alternative; used in various combinations with GM-CSF per Appendix B; formulary status may vary and prior authorization may be required.
Isotretinoin
Listed as a therapeutic alternative; used in various combinations with GM-CSF per Appendix B; formulary status may vary and prior authorization may be required.
Cytotoxic regimens (e.g., cisplatin, etoposide, vincristine, cyclophosphamide, doxorubicin, topotecan)
Multiple cytotoxic agents are listed in Appendix B as alternative regimens; dosing and combinations vary by regimen and may require prior authorization.

Site of Care / Administration

Documentation Required

Administer in appropriate infusion setting with monitoring for infusion reactions and neurotoxicity

Infusion-related reactions and neurotoxicity are boxed warnings for naxitamab-gqgk; providers must ensure administration occurs in an appropriate infusion setting with monitoring for these risks.

Ensure the infusion setting and monitoring protocols can manage serious infusion‑related reactions and neurotoxicity.
Document site‑of‑care and monitoring plans in the prior authorization request if relevant.

Note

Confirm site‑of‑care and administration requirements per member coverage

Site-of-care or administration requirements are determined by the member's coverage documents and broader Health Plan policies; confirm allowable sites and any applicable requirements prior to scheduling administration.

Check line-of-business and state-specific coverage rules to determine whether an infusion center or alternate setting is authorized.
Document site-of-care authorization if required by the plan.

OpenPayer

Naxitamab-gqgk (Danyelza) Clinical Policy

Coverage Criteria

Coding

Provider Actions & Requirements

Background

Definitions

Initial Therapy Dosing & Criteria

Continuation Therapy

Step Therapy

Quantity Limits

Site of Care / Administration