CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Unituxin (dinutuximab) for high-risk neuroblastoma — Coverage Criteria

Defines indications, contraindications, coverage rules, and coding for use of Unituxin (dinutuximab) in members with high-risk neuroblastoma; applies to prior authorization and utilization management for Neighborhood Health Plan of Rhode Island members processed by Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyUnituxin (dinutuximab) for high-risk neuroblastoma — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrior authorization is required and Evolent will process medication requests; use must be supported by FDA labeling, CMS-recognized compendia, or accepted guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5maximum treatment duration

17.5 mg/m2single dose maximum

26%reported serious infusion reactions

J9999billing code

Commercial/Medicaidlines of business

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Unituxin (dinutuximab)

Initial therapy — high-risk neuroblastoma

Covered when ALL of the following are met

Neuroblastoma indication: Member has unresectable high-risk neuroblastoma

Supported by FDA labeling, compendia, or guidelines

Risk definition: High risk defined as age >18 months with disseminated disease, or localized disease with unfavorable markers such as MYCN amplification (see Attachment A)

Setting: Administration occurs in a hospital/acute care setting to mitigate and manage potential serious infusion reactions, capillary leak syndrome, and hypotension

Monitor patients closely during and for at least 4 hours after infusion; provide prehydration and premedication per prescribing information

Permitted regimens: Unituxin (dinutuximab) used in combination with chemotherapy or 13-cis-retinoic acid (isotretinoin), with or without granulocyte-macrophage colony-stimulating factor (sargramostim)

Includes regimens described in supporting trials and FDA labeling

Unituxin (dinutuximab) is covered for the treatment of unresectable high‑risk neuroblastoma when ALL of the following are documented: the member meets the high‑risk definition (typically age >18 months with disseminated disease or localized disease with unfavorable biologic markers such as MYCN amplification), the planned administration is consistent with approved or guideline‑supported regimens (dinutuximab combined with chemotherapy or 13‑cis‑retinoic acid ± sargramostim/GM‑CSF), and therapy will be delivered in an inpatient/acute care setting to monitor and manage serious infusion‑related adverse events. Prior authorization is required and requests must be supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature.

Requests for Unituxin will be excluded (and may be denied) when any of the following apply: use after disease progression on the same regimen or after prior anti‑GD2 antibody therapy (for example, naxitamab), dosing that exceeds the single dose limit of 17.5 mg/m2, treatment that exceeds the maximum of 5 cycles, or use for investigational/off‑label indications lacking sufficient supporting evidence per CMS‑recognized compendia or acceptable peer‑reviewed literature.

first-line

Intended use: Adjuvant or combination therapy for high-risk neuroblastoma as described in FDA labeling and supportive trials (e.g., COG ANBL0032)

Includes combination with isotretinoin and chemotherapy; GM-CSF optional

Regimen	Components / Notes	Coverage status
Dinutuximab (Unituxin) + chemotherapy
Dinutuximab administered in combination with cytotoxic chemotherapy as part of treatment for unresectable high-risk neuroblastoma; administration occurs in a hospital/acute care setting to mitigate infusion-related risks
Dinutuximab (Unituxin) + 13-cis-retinoic acid (isotretinoin)
Dinutuximab given with isotretinoin (13-cis-retinoic acid) for adjuvant or combination therapy for high-risk neuroblastoma; granulocyte-macrophage colony-stimulating factor (sargramostim) may be added or omitted

Billing and Coding

Drug HCPCSHCPCSCovered

J9999

dinutuximab

Single dose limit — 17.5 mg/m2

Single dose maximum17.5 mg/m2 per administration

RationaleDosing that exceeds 17.5 mg/m2 is listed as an exclusion trigger/not approvable

ApplicabilityApplies to all Unituxin (dinutuximab) administrations under this policy

Maximum number of treatment cycles — 5 cycles

Maximum treatment cycles5 cycles total

RationaleTreatment beyond 5 cycles is listed as an exclusion trigger/not approvable

Counting periods

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Evolent (on behalf of the plan) processes all medication requests from network ordering providers; medications not authorized by Evolent may be deemed not approvable and therefore not reimbursable. The use of Unituxin (dinutuximab) must be supported by FDA labeling, CMS‑recognized compendia, NCCN or ASCO guidelines, or peer‑reviewed literature meeting CMS standards.

Evolent processes all medication requests; unauthorized meds may be non‑reimbursable.
Acceptable evidentiary sources: FDA product labeling, CMS‑recognized compendia, NCCN, ASCO, or peer‑reviewed literature meeting CMS requirements.

Note

Continuation Request Conditions

Continuation (renewal) requests may be approved without full re‑evaluation when all conditions below are met.

No disease progression on the requested medication.
Requested medication was used within the last year without a lapse of more than 30 days of having an active authorization.

Background

High‑risk neuroblastoma refers to unresectable disease in patients typically older than 18 months who have disseminated disease or localized tumors with unfavorable biologic markers (for example, MYCN amplification). Dinutuximab (Unituxin) is an anti‑GD2 monoclonal antibody used as part of multimodal therapy (in combination with chemotherapy, isotretinoin, and optionally GM‑CSF) to reduce relapse risk; because infusions can cause serious reactions including severe infusion reactions, capillary leak, hypotension, and neuropathic pain, administration is recommended in a hospital/acute care setting with close monitoring during and after infusion.

Definitions

Definition of high-risk neuroblastoma

Age and stage criteriaPatients older than 18 months with disseminated (metastatic) disease

Localized high-risk featuresLocalized disease with unfavorable biologic markers (e.g., MYCN amplification)

Reference for risk strataChildren's Oncology Group risk strata (Attachment A) as referenced in policy and UpToDate

Biomarker Requirements

MYCN amplification (biomarker requirement)

Required biomarkerMYCN amplification

Role in risk classificationUsed to define unfavorable localized disease as high-risk

Covered Regimens and Combinations

Regimen	Details	Coverage status
Dinutuximab combined with chemotherapy
Use of dinutuximab (Unituxin) in combination with chemotherapy for treatment of unresectable high-risk neuroblastoma; administration in hospital/acute care setting recommended to manage serious infusion reactions, capillary leak, and hypotension
Dinutuximab combined with 13-cis-retinoic acid (isotretinoin) ± sargramostim (GM-CSF)
Dinutuximab given with isotretinoin; sargramostim (GM-CSF) may be used concomitantly or omitted per regimen — permitted as part of covered therapy for high-risk neuroblastoma