CurrentAvMedPolicy Pub. 100-2

Unituxin (dinutuximab) prior authorization / step-edit request

Form and criteria for medical prior authorization of Unituxin (dinutuximab) for members (pediatric focus) including required documentation, dosing limits, and combination therapy requirements; applies to AvMed-covered members and providers submitting requests.

Policy Summary

PayerAvMed

PolicyUnituxin (dinutuximab) prior authorization / step-edit request

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign and fax the prior authorization form to AvMed at 1-877-535-1391 to request a one-time approval for 5 cycles (20 doses) when all clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 cyclesauthorization duration offered

12 vials/24dquantity limit

52.5 mgmax daily dose

Prescriber signatureform requirement

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Initial Authorization: Member is less than 18 years of age

checkbox on form

Diagnosis: Member has a diagnosis of high-risk neuroblastoma with documentation of risk classification (age at diagnosis, INRG stage, tumor MYCN status, INPC histopathology)

provide risk classification documentation

Prior response: Member had at least partial response to first-line multiagent, multimodality therapy

examples: topotecan, cyclophosphamide, cisplatin, etoposide, vincristine

Policy Summary

PayerAvMed

PolicyUnituxin (dinutuximab) prior authorization / step-edit request

Policy CodePolicy Pub. 100-2

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrescriber must sign and fax the prior authorization form to AvMed at 1-877-535-1391 to request a one-time approval for 5 cycles (20 doses) when all clinical criteria are met.

SourceLink

On This Page

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No concurrent GD2 mAb:

Requested therapy will NOT be used in combination with other GD2-binding monoclonal antibodies (e.g., naxitamab)

Concomitant agents: Requested medication will be used in combination with a GM-CSF (e.g., sargramostim) AND a 13-cis-retinoic acid (e.g., isotretinoin) AND/OR an interleukin-2 (e.g., aldesleukin)

checkboxes on form; IL-2 may be excluded per provider due to toxicity concerns

Use of medication samples to initiate Unituxin therapy does not satisfy the policy's step-edit / prior authorization requirements. Documentation and verification of prior therapies will be performed through pharmacy paid claims or submitted chart notes, and samples alone cannot be used to meet those prior therapy prerequisites.

Requests that do not include the required clinical documentation or that fail to meet all listed clinical criteria may be denied as not medically necessary. To support each checked criterion, provide complete records such as risk-classification documentation (age at diagnosis, INRG stage, MYCN status, INPC histopathology), evidence of at least a partial response to first-line multiagent multimodality therapy, and any relevant lab results, diagnostics, or chart notes; missing documentation can lead to denial.

Coding & Quantity Limits

Requested drug HCPCSHCPCS

C9399	Unclassified biologics
J9999	Not otherwise classified, antineoplastic drugs

Quantity limit

Quantity limit (vials)12 vials every 24 days for Unituxin 17.5 mg/5 mL per vial

Product strengthUnituxin (dinutuximab) 17.5 mg/5 mL per vial

Measurement intervalLimit applies per 24-day cycle

Max daily dose

Maximum daily dose52.5 mg per day for four doses every 24-day cycle

Dosing frequency within cycleFour consecutive daily infusions per dosing block (see infusion schedule)

Cycle-based limitMax applies to 24-day cycles (cycles 1, 3, and 5) as specified

Provider Actions & Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — The prescribing physician must sign and clearly print their name on the request form (preprinted stamps not valid). Fax the completed form to AvMed at 1-877-535-1391. One-time approval may be granted for the full course (5 cycles, 20 doses) when all clinical criteria are met and supporting documentation is provided. Authorizations can be delayed or denied if information is incomplete, incorrect, or illegible.

Fax: 1-877-535-1391
Prescriber signature required (no preprinted stamps)
One-time approval for 5 cycles (20 doses) when criteria met

Step Therapy

Step-edit / Prior Therapy Verification

Step-edit / prior therapy verification — All listed clinical criteria must be met for approval. Prior therapies (e.g., first-line multiagent, multimodality regimens such as topotecan, cyclophosphamide, cisplatin, etoposide, vincristine) will be verified by review of medical record documentation and/or pharmacy/medical claims history. If prior therapy requirements are not met or cannot be verified, the request may be denied or delayed.

Verify prior multiagent, multimodality therapy (documentation or claims required)
Approval contingent on all clinical checklist items being met

Documentation Required

Clinical Supporting Documentation

Clinical supporting documentation — Provide documentation to support each checked clinical criterion. This includes risk classification (age at diagnosis, INRG stage, tumor MYCN amplification status, INPC histopathology), evidence of at least a partial response to first-line therapy, and treatment plan showing planned combination agents (GM-CSF, 13-cis-retinoic acid, and/or IL-2 if applicable). Laboratory results, diagnostic reports, and relevant chart notes must be included.

Risk classification: age at diagnosis, INRG stage, MYCN status, INPC histopathology
Evidence of response to first-line therapy (chart notes, imaging, pathology)
Planned combination agents (GM-CSF, 13-cis-retinoic acid, and/or IL-2) documentation
Relevant labs, diagnostic results, and clinic notes

Note

Administrative Information

Administrative information — Complete member and prescriber information in full. Authorization may be delayed if incomplete. Ensure inclusion of member name, AvMed ID number, date of birth, prescriber name, prescriber signature with date, office contact name, phone and fax numbers, DEA or NPI number, drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code (if applicable), weight, height, and date.

Member identifiers: name, AvMed #, DOB
Prescriber: name, signature, date, DEA or NPI #
Office contact name, phone number, fax number
Drug details: name/form/strength, dosing schedule, length of therapy, diagnosis, ICD code, weight, height, date

Denial Risk

Incomplete / Illegible Information

Incomplete/Illegible Information — Authorization can be delayed or denied if information on the request form is incomplete, incorrect, or illegible. No additional phone calls will be necessary if all contact information on the form is correct.

Incomplete, incorrect, or illegible forms may delay or result in denial of authorization
Ensure phone and fax numbers are accurate to avoid follow-up calls

Denial Risk

Missing Clinical Documentation

Missing Clinical Documentation — Requests may be denied if supporting documentation for each checked clinical criterion is not provided. To avoid denial, include all required evidence (risk classification details, prior therapy records, labs/diagnostics, and chart notes) that correspond to every checkbox selected on the clinical criteria checklist.

All documentation supporting each checked clinical criterion must be submitted
Missing labs, imaging, pathology, or prior therapy documentation can result in denial

Initial Therapy Dosing & Administration

Initial Therapy Dosing

Initial dosing, administration schedule, and limits

Dosing schedule: Recommended dose 17.5 mg/m2/day for 4 consecutive days for a maximum of 5 cycles

Infuse on days 4–7 for cycles 1, 3, and 5; infuse on days 8–11 for cycles 2 and 4 (cycles 1,3,5 = 24 days; cycles 2,4 = 32 days)

Quantity limits: Unituxin 17.5 mg/5 mL: 12 vials every 24 days

Max 52.5 mg per day for four doses every 24-day cycle

Continuation / Course Authorization

Authorization provided as a one-time approval for the full planned course when criteria met.

Course length: Approval is for 5 cycles (20 doses)

one-time approval

Step Therapy Requirements

Step	Requirement	Documentation / Verification
1	All prior required therapies must be completed before approval	Chart notes or records demonstrating at least a partial response to first-line multiagent, multimodality therapy (e.g., topotecan, cyclophosphamide, cisplatin, etoposide, vincristine)
2	Requested therapy will NOT be used in combination with other GD2-binding monoclonal antibodies (e.g., naxitamab)	Provider attestation on form that therapy will not be combined with other GD2 mAbs; cross-check with submitted regimen documentation
3	Concomitant use requirement: therapy will be given with GM-CSF and 13-cis-retinoic acid and/or IL-2 as indicated	Medication list, orders, or chart documentation confirming planned combination with GM-CSF (e.g., sargramostim) AND 13-cis-retinoic acid (e.g., isotretinoin) and/or IL-2 (e.g., aldesleukin)
4	Age and diagnosis criteria must be met (pediatric high‑risk neuroblastoma)	Documentation of member age (<18) and risk classification (age at diagnosis, INRG stage, tumor MYCN status, INPC histopathology)
5	Prior therapies and supporting documentation will be verified through pharmacy paid claims or submitted chart notes; use of samples does not meet step edit	Pharmacy paid-claim history or submitted chart notes; note that sample use is not acceptable evidence of prior therapy

Quantity Limits — Unituxin (dinutuximab)

Unituxin vial quantity

ProductUnituxin (dinutuximab) 17.5 mg/5 mL

Quantity per authorization unit12 vials

Associated limit intervalEvery 24 days (per applicable cycle)

Site of Care & Administration Location

Note

Specify site of administration and provide NPI/DEA or specialty pharmacy

Indicate the location/site of drug administration on the form and provide the NPI or DEA number of the administering location, or identify the specialty pharmacy if applicable.

Specify infusion center, office, or specialty pharmacy on the form.
Provide NPI or DEA number of the administering location or select Specialty Pharmacy - Proprium Rx.

Background

Unituxin (dinutuximab) is indicated in this policy for pediatric high-risk neuroblastoma as part of multimodality therapy. Authorization is intended for members less than 18 years of age and requires documented risk classification (examples: age at diagnosis, INRG Stage, tumor MYCN status, INPC histopathology). The drug is given in combination with supportive agents — specifically a GM-CSF (e.g., sargramostim) and a 13-cis-retinoic acid (isotretinoin) and may be used with IL-2 (aldesleukin) per provider judgment. The policy provides one-time approval for the planned course of therapy: 5 cycles (20 doses), with dosing recommended at 17.5 mg/m2/day for four consecutive days per cycle and specific infusion days defined by cycle number.

Definitions

High‑risk neuroblastoma risk classification (examples)

Age at diagnosisMember is less than 18 years of age (pediatric focus)

INRG stageInternational Neuroblastoma Risk Group (INRG) Stage (provide stage)

MYCN statusTumor MYCN status: presence or absence of MYCN amplification (report amplification if present)

INPC histopathologyHistopathology per International Neuroblastoma Pathology Classification (favorable or unfavorable)