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

The Requirements Checklist to Get Gamifant (emapalumab-lzsg) Covered by UnitedHealthcare in Washington: PA Forms, Appeal Deadlines & Documentation

Answer Box: Your Fastest Path to Gamifant Coverage

Who qualifies: Patients with primary hemophagocytic lymphohistiocytosis (HLH) who've failed conventional therapy (etoposide + steroids). Fastest approval: Submit prior authorization through UnitedHealthcare provider portal with complete HLH-2004 criteria documentation and step therapy failure records. Start today: Contact your hematologist to request a medical necessity letter and gather lab results showing ferritin >3000 μg/L plus four other HLH-2004 criteria. Washington residents have strong appeal rights through independent review if initially denied.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Five Common Denial Pitfalls
  10. Appeals Process in Washington
  11. Printable Checklist

Who Should Use This Checklist

This guide helps patients and healthcare teams navigate UnitedHealthcare's prior authorization process for Gamifant (emapalumab-lzsg) in Washington state. You'll need this if:

  • Your doctor has diagnosed primary HLH and recommended Gamifant
  • You've received a UnitedHealthcare denial for Gamifant coverage
  • You're preparing an initial prior authorization request
  • You need to appeal a coverage decision

Expected outcome: With complete documentation, initial approval rates improve significantly. Washington's independent review process provides additional protection if internal appeals fail.

Member & Plan Basics

Coverage Verification

Before starting, confirm these basics:

✓ Active UnitedHealthcare coverage - Check your member ID card and verify benefits through the UnitedHealthcare member portal

✓ Plan type matters:

  • Commercial plans: Standard PA process applies
  • Medicare Advantage: May have different formulary placement
  • Medicaid managed care: Separate criteria may apply

✓ Deductible status - Gamifant is a high-cost specialty drug; know your out-of-pocket responsibility

Note: UnitedHealthcare requires prior authorization for Gamifant across all plan types as a specialty medication.

Clinical Criteria Requirements

Primary HLH Diagnosis

UnitedHealthcare requires confirmation through either:

Option 1: Genetic confirmation

  • Documented gene mutation known to cause primary HLH (PRF1, UNC13D, RAB27A, STX11, STXBP2)

Option 2: HLH-2004 criteria (5 of 8 required):

  • Fever >38.5°C
  • Splenomegaly
  • Cytopenia (≥2 lineages): Hemoglobin <90 g/L, platelets <100 × 10⁹/L, neutrophils <1.0 × 10⁹/L
  • Hypertriglyceridemia and/or hypofibrinogenemia
  • Hyperferritinemia (>3000 μg/L shows 97.5% sensitivity)
  • Low/absent NK cell activity
  • High soluble IL-2 receptor levels
  • Hemophagocytosis in bone marrow/spleen/lymph nodes

Step Therapy Documentation

Required: Evidence of conventional therapy failure, including:

  • Etoposide-based regimen with specific outcomes and duration
  • Corticosteroids (dexamethasone) with response data
  • Cyclosporine (if tried) with tolerance/efficacy notes
  • Dates and objective measures for each therapy (not general statements)
Tip: Document specific clinical outcomes like "40% increase in ferritin levels and persistent fever despite 8 weeks of dexamethasone plus etoposide."

Coding & Billing Information

Code Type Code Description Units
HCPCS J9210 Injection, emapalumab-lzsg, 1 mg Per mg
Alternative C9050 May apply in certain circumstances Verify
ICD-10 D76.1 Hemophagocytic lymphohistiocytosis Primary
ICD-10 D76.2 HLH, infection-associated If applicable

Available vial strengths:

  • 10 mg/2 mL, 50 mg/2 mL, 50 mg/10 mL
  • 100 mg/4 mL, 100 mg/20 mL
  • 250 mg/10 mL, 500 mg/20 mL

Documentation Packet Essentials

Medical Necessity Letter Components

Provider note must include:

  1. Complete HLH diagnosis with ICD-10 code D76.1
  2. HLH-2004 criteria documentation - list all 8 with lab values/dates
  3. Genetic testing results (if available)
  4. Prior therapy history:
    • Specific medications tried
    • Duration of each treatment
    • Objective response measures
    • Reasons for discontinuation
  5. Clinical rationale for Gamifant specifically
  6. Dosing plan and monitoring schedule
  7. Supporting literature from peer-reviewed sources

Required Attachments Checklist

✓ Lab results showing HLH-2004 criteria
✓ Bone marrow biopsy (if hemophagocytosis documented)
✓ Genetic testing (if performed)
✓ Hospital records from HLH episodes
✓ Prior therapy documentation with dates and outcomes
✓ Current medication list
✓ Specialist consultation notes (hematology/oncology required)

Submission Process

Correct Forms and Portals

Primary method: UnitedHealthcare Provider Portal

  • Log in with provider credentials
  • Navigate to Prior Authorization section
  • Upload complete documentation packet

Alternative: Fax to 844-403-1027 (verify current number)

Required Fields That Cause Rejections

Common missing elements:

  • Patient demographics exactly matching insurance card
  • Prescriber NPI number and taxonomy code
  • Diagnosis codes with appropriate specificity
  • Drug strength and quantity calculations
  • Duration of therapy requested
  • Clinical trial history if applicable
Important: Gamifant requires coordination with Biologics, Inc. as the designated specialty pharmacy.

Specialty Pharmacy Requirements

Mandatory Routing

UnitedHealthcare requires Gamifant dispensing through Biologics, Inc. only.

Transfer steps:

  1. Prescriber writes prescription for Gamifant
  2. Prescription sent to Biologics, Inc. (not patient's usual pharmacy)
  3. PA approval must be in place before dispensing
  4. Patient coordinates delivery and administration site

Shipment verification:

  • Confirm cold chain handling for temperature-sensitive drug
  • Verify administration site can handle IV infusion
  • Coordinate with infusion center scheduling

After Submission: What to Expect

Timeline and Status Tracking

Step Timeline What to Record
Submission Day 0 Confirmation number, date submitted
Initial Review 3-5 business days Status check via portal
Decision 14 days standard Approval/denial notification
Expedited 72 hours For urgent medical situations

Status check schedule:

  • Day 3: Confirm receipt
  • Day 7: Check for additional information requests
  • Day 12: Follow up if no decision
  • Day 15: Escalate if past deadline

Five Common Denial Pitfalls

Denial Reason How to Fix
Incomplete HLH diagnosis Submit all 8 HLH-2004 criteria with lab values and dates
Missing step therapy Document specific conventional treatments tried with outcomes
Wrong specialty pharmacy Ensure prescription routed through Biologics, Inc. only
Insufficient clinical detail Replace general statements with specific measures and timelines
Missing genetic testing If no mutation found, emphasize clinical criteria fulfillment

Appeals Process in Washington

Washington state provides robust protection for insurance denials through a structured appeals process.

Internal Appeals (Required First Step)

Timeline: File within 60 days of denial notice
Decision: UnitedHealthcare has 30 days to respond (72 hours for urgent cases)
How to file: UnitedHealthcare member portal or written request

External Independent Review

After internal appeal denial, Washington residents can request Independent Review Organization (IRO) review:

Timeline: 180 days from final internal denial to file
Process: Submit request to Washington State Office of the Insurance Commissioner
Decision: 30 days for standard review, 72 hours for expedited
Binding: IRO decision is binding on UnitedHealthcare

Contact for help: Washington OIC Consumer Advocacy at 1-800-562-6900

From our advocates: "We've seen several Washington patients successfully overturn Gamifant denials through the IRO process. The key is submitting comprehensive clinical documentation that clearly demonstrates HLH diagnosis and conventional therapy failures. Having an independent specialist review the case often leads to approval when the insurance company's initial decision was too restrictive."

When to Escalate

Contact Washington State Insurance Commissioner if:

  • UnitedHealthcare misses appeal deadlines
  • Required information is ignored
  • Process seems unfair or discriminatory

File complaint: Washington OIC website or call 1-800-562-6900

Printable Checklist

Before You Start

  • Verify active UnitedHealthcare coverage
  • Confirm primary HLH diagnosis with hematologist
  • Gather all lab results showing HLH-2004 criteria
  • Document conventional therapy attempts and failures
  • Identify prescribing specialist (hematology/oncology required)

Documentation Packet

  • Medical necessity letter with clinical rationale
  • HLH-2004 criteria documentation (5 of 8 required)
  • Step therapy failure records with specific outcomes
  • Lab results: ferritin, triglycerides, fibrinogen, CBC
  • Bone marrow biopsy (if hemophagocytosis shown)
  • Genetic testing results (if available)
  • Hospital records from HLH episodes

Submission

  • Submit via UnitedHealthcare provider portal
  • Include all required attachments
  • Route prescription to Biologics, Inc. specialty pharmacy
  • Record confirmation number and submission date
  • Set calendar reminders for status checks

After Submission

  • Check status at 3, 7, and 12 days
  • Respond promptly to requests for additional information
  • If denied, file internal appeal within 60 days
  • If internal appeal fails, request IRO review within 180 days
  • Contact Washington OIC at 1-800-562-6900 for assistance

Cost Assistance Options

Manufacturer support: Sobi offers patient assistance programs for eligible patients. Check Gamifant.com for current offerings.

Foundation grants: Organizations like the HealthWell Foundation and Patient Advocate Foundation provide grants for rare disease treatments.

Washington state programs: Apple Health (Medicaid) may provide coverage for eligible low-income patients.

FAQ

Q: How long does UnitedHealthcare PA take in Washington?
A: Standard prior authorization decisions take up to 14 days. Urgent cases qualify for 72-hour expedited review.

Q: What if Gamifant is non-formulary on my plan?
A: Non-formulary drugs can still be covered through medical exception process. Strong clinical documentation is essential.

Q: Can I request an expedited appeal?
A: Yes, if delay could seriously jeopardize your health. Contact UnitedHealthcare to request expedited review.

Q: Does step therapy apply if I failed treatments in another state?
A: Yes, documented treatment failures from other states count toward step therapy requirements.

Q: What happens if UnitedHealthcare misses the appeal deadline?
A: Contact Washington State Insurance Commissioner at 1-800-562-6900. Missed deadlines may constitute a violation.

When navigating complex prior authorization requirements for rare disease treatments like Gamifant, having expert support can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance coverage processes and should not be considered medical advice. Always consult with your healthcare provider about treatment decisions and work with your clinical team for prior authorization submissions. Insurance policies and procedures may change; verify current requirements with UnitedHealthcare and Washington state regulators.

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