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

How to Get Elfabrio (Pegunigalsidase Alfa-iwxj) Covered by Blue Cross Blue Shield in Texas: Complete Requirements Guide

Answer Box: Getting Elfabrio Covered by BCBS Texas

Blue Cross Blue Shield of Texas requires prior authorization for Elfabrio (pegunigalsidase alfa-iwxj) with confirmed Fabry disease diagnosis and specialist oversight. The fastest path to approval: (1) Submit PA through BCBS portal with genetic testing or enzyme deficiency results, (2) Include prescriber monitoring plan for infusion reactions, and (3) Route through Orsini Healthcare specialty pharmacy (800-410-8575). Texas law provides 180 days to appeal denials and external review through independent organizations if needed.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding & Billing Information
  5. Documentation Packet
  6. Submission Process
  7. Specialty Pharmacy Routing
  8. After Submission
  9. Common Denial Prevention Tips
  10. Appeals Process in Texas
  11. Printable Checklist

Who Should Use This Guide

This guide is for Texas patients with Fabry disease and their healthcare providers seeking Blue Cross Blue Shield of Texas (BCBSTX) coverage for Elfabrio. You'll find this most helpful if you:

  • Have a confirmed Fabry disease diagnosis
  • Are 18 years or older (FDA-approved age range)
  • Need enzyme replacement therapy
  • Have BCBSTX commercial coverage
  • Want to avoid common prior authorization pitfalls

Expected outcome: With proper documentation, most medically necessary Elfabrio requests receive approval within 2-3 business days for standard reviews.

Member & Plan Basics

Coverage Verification

Before starting, confirm your BCBSTX plan details:

Requirement What to Check Where to Find It
Active coverage Current member ID card BCBSTX member portal
Plan type Balanced, Performance, or Basic formulary Drug list PDFs on bcbstx.com
Prior authorization Required for specialty biologics Contact number on ID card
Deductible status Medical vs. pharmacy benefit Member services
Note: Elfabrio is not explicitly listed on 2024 BCBSTX formularies but requires prior authorization as a specialty medication under medical benefit coverage.

Clinical Criteria Requirements

Based on Federal Employee Program Blue Cross Blue Shield standards (which often align with BCBSTX policies), expect these requirements:

Primary Criteria

  • Age: 18 years or older
  • Diagnosis: Confirmed Fabry disease with documentation
  • Prescriber commitment: Monitor for hypersensitivity reactions during administration
  • Premedication plan: Antihistamines, antipyretics, and/or corticosteroids as needed

Diagnostic Confirmation Methods

For Males: α-galactosidase (α-Gal A) enzyme assay showing deficiency For Females: GLA gene sequencing (enzyme levels may be normal due to X-inactivation)

Clinician Corner: Testing is considered medically necessary when pathogenic variants are identified. Genetic testing may only be performed once per lifetime for a given condition.

Step Therapy Considerations

While not explicitly required, be prepared to document:

  • Previous enzyme replacement therapy trials (if any)
  • Treatment failures or intolerances
  • Contraindications to alternative therapies (Fabrazyme, Galafold)

Coding & Billing Information

Required Codes

Code Type Code Description Units
HCPCS J2508 Injection, pegunigalsidase alfa-iwxj, 1 mg 120 units per dose
ICD-10 E75.21 Fabry (-Anderson) disease Primary diagnosis
NDC 10122-0160-xx Elfabrio 20 mg/10 mL vial As applicable

Standard dosing: 120 mg (120 billable units) intravenously every 14 days

Tip: Prior to 2024, some payers used J3590 (unclassified biologics). Ensure your billing team uses the current J2508 code.

Documentation Packet

Provider Note Elements

Your specialist's documentation should include:

  1. Confirmed Fabry diagnosis with supporting lab results
  2. Baseline assessments: Gb3/lyso-Gb3 levels, kidney function (eGFR), neuropathic pain scores
  3. Treatment history: Previous ERTs tried, outcomes, reasons for discontinuation
  4. Monitoring plan: Infusion reaction prevention and management protocol
  5. Clinical rationale: Why Elfabrio is medically necessary for this patient

Letter of Medical Necessity Components

Chiesi provides an official appeal letter template that includes:

  • Patient demographics and insurance information
  • Detailed treatment rationale and medical history
  • Outline of FDA approval and clinical studies
  • Medical record highlights with key dates
  • Professional opinion on medical necessity

Required Attachments

  • Original prior authorization form
  • Complete medical records showing Fabry progression
  • Laboratory results (enzyme activity, genetic testing, kidney function)
  • Prescribing Information for Elfabrio
  • Any previous denial letters with EOB

Submission Process

Step-by-Step Submission

  1. Obtain current PA form from BCBSTX provider portal or Availity
  2. Complete all required fields - incomplete forms are a leading cause of delays
  3. Submit via preferred method:
    • Online: BCBSTX provider portal
    • Fax: Number provided on PA form (verify current number)
    • Portal submission recommended for faster processing
  4. Include all supporting documentation in single submission
  5. Request expedited review if clinically urgent (decision within 72 hours vs. 2 business days standard)
Important: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and plan policies to create point-by-point rebuttals with appropriate clinical citations.

Specialty Pharmacy Routing

BCBSTX Preferred Vendor

Orsini Healthcare is the designated specialty pharmacy for Elfabrio distribution:

  • Contact: 800-410-8575
  • Services: Direct delivery to provider office, injection supplies included
  • Coverage: IV medications for enzyme deficiencies

Transfer Process

  1. Once PA is approved, contact Orsini Healthcare
  2. Provide patient demographics and insurance information
  3. Coordinate delivery schedule with infusion center
  4. Verify shipment arrival before patient appointment
Note: Providers bill only for administration (not the medication) when using preferred specialty pharmacies.

After Submission

Tracking Your Request

Timeline Action What to Record
Day 1 Submit PA Confirmation number, submission date
Day 2-3 Check status Call provider services if no update
Day 5+ Follow up Request expedited review if delayed

Status check methods:

  • BCBSTX provider portal
  • Provider services phone line
  • Availity system updates

Common Denial Prevention Tips

Five Critical Pitfalls to Avoid

  1. Incomplete diagnostic documentation
    • Fix: Include both genetic testing results AND enzyme activity levels where available
  2. Missing prescriber monitoring plan
    • Fix: Detail infusion reaction prevention protocol in provider notes
  3. Inadequate medical necessity justification
    • Fix: Reference FDA labeling and peer-reviewed studies supporting use
  4. Wrong submission pathway
    • Fix: Verify medical vs. pharmacy benefit coverage before submitting
  5. Expired or incorrect forms
    • Fix: Download current PA forms from BCBSTX provider portal

Appeals Process in Texas

Internal Appeals

  • Deadline: 180 days from denial notice
  • Timeline: 30 days for pre-service requests, 60 days for services already received
  • Submission: Use form provided with denial letter

External Review (Independent Review Organization)

  • When available: Medical necessity denials after internal appeal failure
  • Deadline: 4 months from final internal denial
  • Timeline: 20 days for standard review, 5 days for urgent cases
  • Cost: Paid by insurer

Texas Resources for Help

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742
  • IRO Information Line: 1-866-554-4926

Counterforce Health's platform can help identify specific denial reasons and create targeted appeals that align with BCBSTX's own coverage policies.

Printable Checklist

Pre-Submission Checklist

  • Confirmed Fabry disease diagnosis with lab results
  • Patient age 18+ years
  • Specialist prescriber (geneticist, cardiologist, nephrologist)
  • Current BCBSTX PA form completed
  • Medical necessity letter with monitoring plan
  • Supporting documentation attached
  • Orsini Healthcare contacted for specialty pharmacy routing

Post-Submission Tracking

  • Confirmation number recorded: _______________
  • Submission date: _______________
  • Expected decision date: _______________
  • Status check scheduled for Day 3
  • Backup appeal strategy prepared if denied

From our advocates: We've seen Texas patients successfully obtain Elfabrio coverage by ensuring their genetic testing clearly documents a pathogenic GLA variant and their specialist explicitly addresses the FDA's boxed warning about infusion reactions in their monitoring plan. This attention to safety protocols often distinguishes approved requests from denied ones.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for plan-specific requirements. For personalized assistance with appeals, contact the Texas Department of Insurance or consider professional advocacy services.

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