By Counterforce Health Team in Elfabrio (pegunigalsidase alfa-iwxj) —

Complete Requirements Checklist: Get Elfabrio (Pegunigalsidase Alfa) Covered by UnitedHealthcare in New Jersey

Answer Box: How to Get Elfabrio Covered by UnitedHealthcare in New Jersey

Eligibility: Adults with confirmed Fabry disease diagnosed by genetic testing or enzyme deficiency. Fastest path: Submit prior authorization with genetic confirmation, step therapy documentation (failed/contraindicated agalsidase beta), and specialist letter. First step today: Contact your prescriber to initiate PA through UnitedHealthcare Provider Portal or fax OptumRx at 1-844-403-1027. If denied, New Jersey's Independent Health Care Appeals Program (IHCAP) provides external review within 180 days.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Hygiene
  5. Documentation Packet Essentials
  6. Submission Mechanics
  7. Specialty Pharmacy Routing
  8. After Submission: Tracking & Follow-up
  9. Denial Prevention Tips
  10. Appeals Process in New Jersey
  11. Printable Requirements Checklist

Who Should Use This Checklist

This guide is for patients diagnosed with Fabry disease and their healthcare providers seeking UnitedHealthcare coverage for Elfabrio (pegunigalsidase alfa-iwxj) in New Jersey. You'll need this if:

  • Your doctor has prescribed Elfabrio for confirmed Fabry disease
  • You have UnitedHealthcare commercial, Medicare Advantage, or Medicaid managed care
  • You've received a denial and need to appeal
  • You want to prevent common submission errors that delay approval

Expected outcome: With complete documentation, initial approvals typically take 5-15 business days. Appeals through New Jersey's external review process succeed in approximately 50% of cases when medical necessity is properly documented.

Member & Plan Basics

Coverage Verification Checklist

✓ Active Coverage Requirements:

  • Valid UnitedHealthcare member ID and current benefits
  • Specialty drug coverage included (most plans cover under medical benefit)
  • Verify if prior authorization is required (it is for Elfabrio)

✓ Plan Type Considerations:

  • Commercial plans: Standard PA process through OptumRx
  • Medicare Advantage: May have additional step therapy requirements
  • Medicaid managed care: Follow state-specific criteria

✓ Deductible & Cost-sharing:

  • High-deductible plans may require meeting deductible first
  • Specialty tier copays typically $50-$200+ per infusion
  • Chiesi Total Care offers financial assistance programs

Clinical Criteria Requirements

Indication & Diagnosis

✓ FDA-Approved Use:

  • Adult patients (≥18 years) with confirmed Fabry disease
  • Not approved for pediatric use

✓ Diagnostic Confirmation Required:

  • Males: Alpha-galactosidase A enzyme deficiency (<5% normal activity) AND genetic confirmation
  • Females: GLA gene mutation analysis (enzyme testing unreliable in females)
  • ICD-10 code: E75.21 (Fabry disease)

Step Therapy Requirements

UnitedHealthcare requires documented trial and failure/intolerance of agalsidase beta (Fabrazyme) before approving Elfabrio. Acceptable documentation includes:

✓ Prior Therapy Documentation:

  • Prescription records showing agalsidase beta trial
  • Clinical notes documenting inadequate response, adverse reactions, or contraindications
  • Specific reasons why agalsidase beta is inappropriate (e.g., infusion reactions, antibody development)

Dosing & Duration

✓ Appropriate Dosing:

  • 1 mg/kg intravenously every 2 weeks
  • Weight-based dosing calculations documented
  • Initial authorization typically 6-12 months

✓ Prescriber Requirements:

  • Must be prescribed by or in consultation with appropriate specialist (geneticist, cardiologist, nephrologist, neurologist)

Coding & Billing Hygiene

Required Codes

Code Type Code Description Units
HCPCS J2508 Pegunigalsidase alfa, 1 mg Per mg administered
ICD-10 E75.21 Fabry disease Primary diagnosis
NDC 10122-160-01 20 mg/10 mL vial As dispensed
Modifier JA IV administration Required

✓ Billing Accuracy:

  • Match HCPCS units to exact mg administered (40mg dose = 40 units)
  • Include correct 11-digit NDC from vial used
  • JA modifier for intravenous infusion

Documentation Packet Essentials

Provider Note Requirements

✓ Clinical Documentation Must Include:

  • Confirmed Fabry disease diagnosis with supporting test results
  • Current symptoms and disease progression
  • Prior treatments tried and outcomes
  • Clinical rationale for Elfabrio specifically
  • Treatment goals and monitoring plan

Letter of Medical Necessity Components

✓ Essential Elements:

  • Patient demographics and insurance information
  • Detailed diagnosis with genetic/enzyme test results
  • Step therapy compliance or exception rationale
  • Specialist involvement and consultation notes
  • FDA labeling support for prescribed use
  • Expected clinical outcomes and monitoring plan
Tip: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing payer policies and crafting point-by-point rebuttals aligned to plan-specific requirements.

Required Attachments

✓ Documentation Checklist:

  • Genetic testing report (GLA gene analysis)
  • Enzyme activity test results (if applicable)
  • Specialist consultation notes
  • Prior therapy records and outcomes
  • Current clinical notes showing disease progression
  • Lab results supporting ongoing monitoring

Submission Mechanics

Prior Authorization Process

✓ Submission Methods:

✓ Required Fields That Commonly Cause Rejections:

  • Complete member demographic information
  • Accurate prescriber NPI and contact information
  • Specific strength and NDC number
  • Clear indication and ICD-10 code
  • Step therapy documentation

Form Requirements

✓ Current Forms:

  • Use most recent UnitedHealthcare PA form (verify version date)
  • Complete all required fields—incomplete forms cause automatic delays
  • Include all supporting documentation as attachments

Specialty Pharmacy Routing

Network Requirements

✓ UnitedHealthcare Preferred Vendors:

  • OptumRx specialty pharmacy network
  • Verify in-network status before prescribing
  • Home infusion available in most areas (verify eligibility)

✓ Site of Care Considerations:

  • UnitedHealthcare may restrict to home or outpatient clinic settings
  • Hospital outpatient departments require additional justification
  • Document medical necessity for specific infusion site

Transfer Process

✓ Prescription Transfer Steps:

  1. Obtain PA approval first
  2. Provider sends prescription to approved specialty pharmacy
  3. Pharmacy conducts benefits investigation
  4. Schedule initial infusion and monitoring
  5. Coordinate ongoing refills and administration

After Submission: Tracking & Follow-up

Timeline Expectations

✓ Standard Processing:

  • Initial review: 5-15 business days
  • Expedited requests: 72 hours (if criteria met)
  • Appeals: 30 days internal, 45 days external in New Jersey

✓ Status Monitoring:

  • Save confirmation numbers from all submissions
  • Check status weekly through provider portal
  • Document all phone conversations with reference numbers

What to Record

✓ Documentation Log:

  • Submission dates and confirmation numbers
  • Representative names and reference numbers
  • Status updates and next steps
  • Any additional information requested

Denial Prevention Tips

Five Common Pitfalls and Solutions

  1. Incomplete Diagnostic Documentation
    • Problem: Missing genetic testing or enzyme results
    • Solution: Include complete lab reports with normal ranges
  2. Insufficient Step Therapy Documentation
    • Problem: No evidence of agalsidase beta trial
    • Solution: Provide prescription records and clinical notes documenting failure/intolerance
  3. Wrong Prescriber Specialty
    • Problem: Primary care provider without specialist consultation
    • Solution: Ensure specialist involvement or referral documentation
  4. Coding Errors
    • Problem: Incorrect HCPCS codes or missing modifiers
    • Solution: Use J2508 with JA modifier and correct NDC
  5. Missing Medical Necessity Justification
    • Problem: No clear rationale for Elfabrio specifically
    • Solution: Include detailed clinical rationale addressing UnitedHealthcare criteria

Appeals Process in New Jersey

If your initial request is denied, New Jersey offers robust appeal rights through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals (Required First)

✓ Level 1 Internal Appeal:

  • File within 180 days of denial
  • Submit through UnitedHealthcare member/provider portal
  • Include additional clinical documentation addressing denial reasons
  • Decision within 30 days (expedited: 72 hours)

✓ Level 2 Internal Appeal:

  • Required for HMO/managed care plans
  • File within 60 days of Level 1 denial
  • Include peer-to-peer review request if available

External Review Through IHCAP

✓ New Jersey External Review Process:

  • File within 180 days of final internal denial
  • Submit directly to Maximus Federal Services (contracted by NJ DOBI)
  • Independent physician reviewers with specialty expertise
  • Decision within 45 days
  • No cost to patient

✓ Contact Information:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467
Note: Counterforce Health helps patients and providers navigate complex appeal processes by identifying specific denial reasons and crafting targeted responses with appropriate medical evidence and policy citations.

Required External Appeal Documentation

✓ Appeal Packet Must Include:

  • Completed external appeal form
  • Copy of all internal appeal decisions
  • Updated letter of medical necessity
  • Additional clinical evidence addressing denial reasons
  • Relevant medical literature supporting treatment

Printable Requirements Checklist

Pre-Submission Checklist

Patient Information:

  • Active UnitedHealthcare coverage verified
  • Member ID and group number confirmed
  • Specialty pharmacy benefits confirmed

Clinical Requirements:

  • Fabry disease diagnosis confirmed (genetic/enzyme testing)
  • Adult patient (≥18 years)
  • Step therapy documented (agalsidase beta trial/contraindication)
  • Specialist involvement documented
  • Appropriate dosing (1 mg/kg every 2 weeks)

Documentation:

  • Complete PA form with current version
  • Letter of medical necessity
  • Genetic testing report
  • Enzyme activity results (if applicable)
  • Prior therapy records
  • Clinical notes supporting medical necessity
  • Lab results for ongoing monitoring

Coding:

  • HCPCS J2508 (per mg)
  • ICD-10 E75.21 (Fabry disease)
  • Correct NDC number
  • JA modifier for IV administration

Submission:

  • Submit via UnitedHealthcare Provider Portal or fax 1-844-403-1027
  • Save confirmation numbers
  • Schedule follow-up for status check
  • Coordinate with specialty pharmacy

If Denied - Appeal Checklist

Internal Appeal:

  • File within 180 days
  • Address specific denial reasons
  • Include additional clinical evidence
  • Request peer-to-peer review if available

External Appeal (New Jersey IHCAP):

  • Complete internal appeals first
  • File within 180 days of final denial
  • Submit to Maximus Federal Services
  • Include comprehensive clinical documentation
  • Contact IHCAP hotline for assistance: 1-888-393-1062

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan benefits. Always verify current requirements with UnitedHealthcare and consult healthcare providers for medical decisions.

For additional support with insurance appeals and coverage challenges, Counterforce Health provides specialized assistance in converting insurance denials into successful appeals through targeted, evidence-based documentation that aligns with payer-specific requirements.

Sources & Further Reading

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.