By Counterforce Health Team in Gamifant (emapalumab-lzsg) —

How to Get Gamifant (Emapalumab-lzsg) Covered by UnitedHealthcare in New York: Prior Authorization, Appeals, and Medical Necessity Requirements

Quick Answer: To get Gamifant (emapalumab-lzsg) covered by UnitedHealthcare in New York, you need prior authorization showing: (1) confirmed primary HLH meeting HLH-2004 criteria, (2) failure/intolerance of conventional therapy (dexamethasone + etoposide), and (3) FDA-label dosing plan. Submit through the UnitedHealthcare Provider Portal with complete diagnostic documentation. If denied, file internal appeal within 60 days, then request New York State external review through DFS within 4 months for binding decision.

Table of Contents

  1. UnitedHealthcare's Gamifant Coverage Policy Overview
  2. Medical Necessity Requirements
  3. Step Therapy and Exception Pathways
  4. Required Diagnostic Documentation
  5. Prior Authorization Submission Process
  6. Appeals Process in New York
  7. Common Denial Reasons and Solutions
  8. Cost Assistance and Support Programs
  9. When to Escalate to State Regulators
  10. Frequently Asked Questions

UnitedHealthcare's Gamifant Coverage Policy Overview

UnitedHealthcare treats Gamifant (emapalumab-lzsg) as a specialty medical-benefit drug requiring prior authorization across commercial, Medicare Advantage, and Medicaid Community Plans. The drug is covered for primary hemophagocytic lymphohistiocytosis (HLH) that is refractory, recurrent, or progressive despite conventional therapy.

Coverage at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all plan types Complete PA form via provider portal
Formulary Status Medical benefit, specialty tier N/A
Step Therapy Must fail conventional HLH therapy first Treatment history with dates and outcomes
Age Limits None (pediatric and adult) Age-appropriate dosing per FDA label
Diagnosis Requirements Primary HLH meeting HLH-2004 criteria Lab values, imaging, pathology reports
Authorization Duration Up to 6 months initially Clinical response documentation for renewal

Medical Necessity Requirements

To meet UnitedHealthcare's medical necessity criteria, patients must have all of the following documented:

Primary HLH Diagnosis

  • ICD-10 code D76.1 (Primary hemophagocytic lymphohistiocytosis)
  • Must meet HLH-2004 diagnostic criteria with at least 5 of 8 criteria:
    • Fever
    • Splenomegaly
    • Cytopenias (≥2 lineages)
    • Hypertriglyceridemia (≥265 mg/dL) and/or hypofibrinogenemia (≤150 mg/dL)
    • Hemophagocytosis on tissue biopsy
    • Low/absent NK-cell activity
    • Ferritin ≥500 µg/L
    • Soluble IL-2 receptor ≥2400 U/mL

Disease Status

The HLH must be refractory, recurrent, or progressive despite appropriate conventional therapy, aligning with FDA labeling requirements.

Step Therapy and Exception Pathways

UnitedHealthcare requires documented trial and failure, intolerance, or contraindication to conventional HLH protocols before approving Gamifant.

Required Prior Treatments

Patients must have tried standard HLH therapy including:

  • Dexamethasone
  • Etoposide
  • Cyclosporine (depending on protocol used)

Medical Exception Criteria

Step therapy can be bypassed with documentation of:

  • Severe toxicity/intolerance (e.g., hepatic dysfunction, severe myelosuppression)
  • Medical contraindication (e.g., active uncontrolled infection, organ failure)
  • Life-threatening deterioration where conventional therapy poses excessive risk
Clinician Tip: Document specific adverse events with dates and severity scores rather than general statements like "patient did not tolerate." Include objective measures like lab values showing hepatotoxicity or infection complications.

Required Diagnostic Documentation

Your prior authorization must include comprehensive diagnostic evidence supporting the HLH diagnosis:

Essential Laboratory Values

  • Complete blood count showing cytopenias in ≥2 lineages
  • Ferritin levels with dates (typically >10,000 ng/mL in active HLH)
  • Triglycerides (fasting preferred) and fibrinogen levels
  • Soluble IL-2 receptor (sCD25) if available
  • NK-cell cytotoxicity results when performed

Imaging and Pathology

  • Spleen imaging (ultrasound, CT, or MRI) documenting splenomegaly
  • Bone marrow biopsy reports showing hemophagocytosis
  • Any additional tissue biopsies from liver, lymph nodes, or other sites

Timeline Documentation

Include dates for all diagnostic tests and clearly show the progression of disease despite conventional therapy.

Prior Authorization Submission Process

Step-by-Step Submission Guide

  1. Gather Required Documents
    • Complete diagnostic workup with HLH-2004 criteria documentation
    • Detailed treatment history with conventional therapy failures
    • FDA-label dosing plan for Gamifant
    • Infection screening results per FDA requirements
  2. Submit via UnitedHealthcare Provider Portal
    • Log into the UnitedHealthcare Provider Portal
    • Navigate to Prior Authorization & Notification tool
    • Complete medical drug PA form with comprehensive clinical narrative
  3. Alternative Submission Methods
  4. Expected Timeline
    • Standard review: 5-15 business days
    • Expedited review: 24-72 hours for life-threatening situations

Appeals Process in New York

If UnitedHealthcare denies your Gamifant prior authorization, New York offers robust appeal rights through multiple levels.

Internal Appeals (Required First Step)

Timeline: File within 60 days of denial notice How to Submit: Upload documents via UnitedHealthcare provider portal or mail to address on denial letter Decision Time: Up to 30 days (72 hours for expedited)

New York State External Review

After exhausting internal appeals, you can request binding external review through the New York State Department of Financial Services (DFS).

Key Details:

  • Timeline: File within 4 months of final adverse determination
  • Cost: $25 maximum per appeal (waived for Medicaid/financial hardship)
  • Expedited Options: 24-72 hours for urgent drug denials
  • Decision: Binding on UnitedHealthcare

How to File Expedited External Appeal:

  1. Complete DFS External Appeal Application
  2. Have physician complete attestation that delay threatens life/health
  3. Fax to DFS and call 888-990-3991 immediately
From Our Advocates: We've seen several HLH cases where external review overturned UnitedHealthcare denials, particularly when families provided comprehensive documentation showing conventional therapy failures and included peer-reviewed literature supporting Gamifant's use as standard of care for refractory primary HLH.

Common Denial Reasons and Solutions

Denial Reason How to Overturn
"HLH diagnosis not confirmed" Provide complete HLH-2004 criteria documentation with lab values and dates
"Insufficient conventional therapy trial" Submit detailed treatment timeline showing adequate doses and durations with objective failure measures
"Missing infection workup" Include TB screening, viral panels, and prophylaxis plan per FDA labeling
"Investigational use" Cite FDA approval for primary HLH and provide prescribing information
"Outpatient administration not covered" Justify hospital-based infusion due to patient acuity and monitoring needs

Cost Assistance and Support Programs

Manufacturer Support

  • Sobi Cares Patient Support Program provides coverage investigation and copay assistance
  • Contact: Visit manufacturer website for current enrollment information

Foundation Grants

  • National Organization for Rare Disorders (NORD) offers financial assistance for rare disease treatments
  • HealthWell Foundation provides copay assistance for eligible patients

New York State Programs

  • Medicaid covers Gamifant when medically necessary
  • Essential Plan for lower-income New Yorkers may provide coverage

When to Escalate to State Regulators

Contact the New York State Department of Financial Services if:

  • UnitedHealthcare fails to meet appeal deadlines
  • You believe the denial violates New York insurance law
  • There are procedural violations in the review process

What to Include:

  • Copy of denial letter and appeal submissions
  • Documentation of timeline violations
  • Evidence that treatment meets medical necessity standards

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals with evidence-backed documentation. Our platform analyzes denial reasons and drafts targeted rebuttals that align with payer-specific criteria, helping families get life-saving treatments like Gamifant approved faster. Learn more about our services.

Frequently Asked Questions

How long does UnitedHealthcare prior authorization take for Gamifant in New York? Standard review takes 5-15 business days. Expedited review for life-threatening cases can be completed in 24-72 hours.

What if Gamifant is non-formulary on my UnitedHealthcare plan? File for formulary exception with medical necessity documentation. New York allows expedited external review for non-formulary drug denials within 24 hours.

Can I request peer-to-peer review if denied? Yes, request peer-to-peer review between your hematologist and UnitedHealthcare medical director as part of the internal appeal process.

Does step therapy apply if I failed conventional therapy outside New York? Yes, document all prior treatments regardless of where they occurred. Include medical records showing specific failures or intolerances.

How much does Gamifant cost without insurance? Gamifant is a high-cost specialty biologic. Contact Sobi for current pricing information and patient assistance programs.

What happens if external review takes too long? For urgent cases, request expedited external review through DFS. Decisions are rendered within 24-72 hours for life-threatening situations.

This guide provides educational information and should not replace professional medical advice. Consult your healthcare provider for treatment decisions. For additional help with insurance appeals in New York, contact Community Health Advocates at 888-614-5400.

Sources & Further Reading:

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