By Counterforce Health Team in Fabrazyme (agalsidase beta) —

How to Get Fabrazyme (agalsidase beta) Covered by Cigna in Washington: Complete PA Guide and Appeal Scripts

Answer Box: Getting Fabrazyme Covered by Cigna in Washington

Cigna requires prior authorization for Fabrazyme (agalsidase beta) with genetic or biochemical confirmation of Fabry disease. The fastest path: (1) Have your specialist submit a PA through Accredo's provider portal with genetic testing results and medical necessity letter, (2) Include ICD-10 code E75.21 and HCPCS J0180, (3) If denied, file internal appeal within 180 days, then external review through Washington's Independent Review Organization. Start today: Call Cigna at 1-800-244-6224 to verify your plan's PA requirements and get the current forms.

Table of Contents

  1. Who Should Use This Guide
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Requirements
  5. Documentation Packet Checklist
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Reasons & Solutions
  10. Washington State Appeals Process
  11. Cost-Saving Programs
  12. FAQ

Who Should Use This Guide

This checklist is designed for Washington residents with confirmed or suspected Fabry disease who need Fabrazyme (agalsidase beta) covered by Cigna. You'll benefit most if you have:

  • A confirmed Fabry disease diagnosis with genetic or biochemical testing
  • Cigna commercial insurance, Medicare Advantage, or employer-sponsored plan
  • A specialist (geneticist, nephrologist, or cardiologist) managing your care
  • Prior authorization denial that needs appeal

Expected outcome: With complete documentation, most PA requests are approved within 72 hours to 14 days. If initially denied, appeals have approximately a 50% success rate when taken to external review with strong clinical evidence.

Member & Plan Basics

Coverage Requirements

✓ Active Cigna Coverage: Verify your plan is active and includes specialty pharmacy benefits ✓ Plan Type: Most Cigna plans require PA for Fabrazyme; check your formulary at Cigna.com ✓ Deductible Status: High-deductible plans may require meeting deductible before coverage begins ✓ Authorization Window: PAs are typically valid for 6-12 months before renewal required

Note: Self-funded employer plans may have different requirements. Contact your HR department to confirm if your plan follows Cigna's standard policies.

Clinical Criteria Requirements

Cigna requires meeting all of the following clinical criteria for Fabrazyme coverage:

Primary Requirements

Requirement Documentation Needed Where to Find
Confirmed Fabry Disease Genetic testing (GLA gene) OR enzyme assay (α-Gal A deficiency) Lab results from certified laboratory
Age ≥2 years Date of birth on prescription Medical record
Specialist Prescriber Geneticist, nephrologist, cardiologist, or metabolic specialist Provider credentials
Appropriate Dosing 1 mg/kg every 2 weeks IV Prescription and dosing calculation

Clinical Documentation

Genetic Testing: GLA gene sequencing showing pathogenic or likely pathogenic variant Biochemical Confirmation: α-Galactosidase A enzyme activity <1.2 nmol/hr/mg protein (males) or elevated lyso-Gb3 Clinical Symptoms: Document relevant symptoms like neuropathic pain, kidney disease, cardiac involvement, or stroke

Coding and Billing Requirements

Required Codes

  • ICD-10: E75.21 (Fabry disease)
  • HCPCS: J0180 (agalsidase beta, 1 mg)
  • NDC Codes:
    • 58468-0040-1 (35 mg vial)
    • 58468-0041-1 (5 mg vial)
  • Administration: 96365 (IV infusion, first hour), 96366 (additional hours)

Billing Requirements

Convert NDC to 11-digit format for claims submission. Include patient weight for dosing calculation (1 mg/kg every 2 weeks). Document infusion site and duration for administration codes.

Documentation Packet Checklist

Provider Note Elements

✓ Diagnosis: Confirmed Fabry disease with ICD-10 E75.21 ✓ Clinical History: Symptoms, family history, disease progression ✓ Test Results: Genetic testing report and/or enzyme assay ✓ Treatment Plan: Dosing schedule, monitoring plan, treatment goals ✓ Medical Necessity: Why Fabrazyme is appropriate for this patient

Medical Necessity Letter Components

Your specialist should include these elements in the medical necessity letter:

  1. Patient identification and confirmed Fabry disease diagnosis
  2. Diagnostic testing results (genetic and/or biochemical)
  3. Clinical symptoms and disease manifestations
  4. Treatment rationale citing FDA labeling
  5. Dosing justification based on patient weight
  6. Monitoring plan for treatment response and safety

Required Attachments

  • Genetic testing report or enzyme assay results
  • Recent clinic notes documenting symptoms
  • Laboratory results (kidney function, cardiac markers if applicable)
  • Prior treatment history (if any alternative therapies tried)

Submission Process

Step-by-Step Submission

1. Verify Coverage (Patient/Clinic Staff)

  • Call Cigna: 1-800-244-6224
  • Confirm PA requirement and current forms
  • Timeline: Same day

2. Complete Prior Authorization (Prescriber)

3. Track Submission (Clinic Staff)

  • Record confirmation number
  • Set follow-up reminder for 72 hours
  • Timeline: Ongoing

Submission Options

  • Electronic: Accredo provider portal (preferred)
  • CoverMyMeds: Integration with most EHR systems
  • Fax: Verify current fax number with Cigna (changes periodically)
Tip: Electronic submissions typically process faster and provide immediate confirmation numbers.

Specialty Pharmacy Requirements

Cigna's Preferred Specialty Pharmacy

Accredo Specialty Pharmacy is Cigna's preferred provider for Fabrazyme:

  • Phone: 1-800-803-2523
  • Website: Accredo.com
  • Services: PA assistance, copay program enrollment, delivery coordination

Transfer Process

If currently using another specialty pharmacy:

  1. Contact Accredo to initiate transfer
  2. Provide current prescription information
  3. Verify shipping address and delivery preferences
  4. Confirm insurance coverage transfer

Timeline: 3-5 business days for complete transfer

After Submission: What to Expect

Response Timeline

  • Urgent requests: 72 hours
  • Standard requests: 14 days
  • Complex cases: Up to 30 days with additional information requests

Status Tracking

✓ Confirmation Number: Record immediately upon submission ✓ Status Checks: Every 3 business days until decision ✓ Documentation: Save all correspondence and reference numbers

What to Record

  • Date and time of submission
  • Confirmation or reference number
  • Representative name (if submitted by phone)
  • Status check dates and outcomes
  • Any additional information requested

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Insufficient diagnostic proof Submit genetic testing or enzyme assay Lab report from certified laboratory
Non-specialist prescriber Transfer to appropriate specialist Credentials verification
Incomplete medical necessity Resubmit with comprehensive letter Detailed clinical justification
Dosing concerns Provide weight-based calculation Patient weight and dosing rationale
Step therapy requirement Document contraindications to alternatives Clinical notes explaining why alternatives inappropriate

Prevention Tips

  1. Complete initial submission with all required documents
  2. Use electronic portals to avoid processing delays
  3. Include genetic testing even if enzyme assay is normal (especially for females)
  4. Document clinical symptoms comprehensively
  5. Verify current forms before submission

Washington State Appeals Process

Internal Appeals (Required First Step)

Timeline: File within 180 days of denial Process: Submit written appeal with additional clinical documentation Decision: 14-30 days for standard appeals, 72 hours for urgent Contact: Use Cigna member portal or call customer service

External Review (Independent Review Organization)

After internal appeal denial, Washington residents can request external review:

Timeline: Request within 180 days of final internal denial Process: Independent medical experts review case Decision: Binding on Cigna if overturned Contact: Washington Office of the Insurance Commissioner at 1-800-562-6900

Washington State Resources

The OIC Appeals Guide provides step-by-step instructions and template letters. The OIC consumer advocacy team offers free assistance navigating the appeals process.

From our advocates: "We've seen Fabrazyme appeals succeed when families include both the genetic testing report and a detailed timeline of symptoms. One family in Washington had their denial overturned at external review after documenting how delayed treatment was affecting their child's kidney function. The key was having their nephrologist write a comprehensive letter explaining the urgency."

Cost-Saving Programs

Manufacturer Support

Sanofi CareConnect PSS

  • Copay assistance for eligible patients
  • Prior authorization support
  • Contact: 1-800-633-1610
  • Website: Fabrazyme.com

Foundation Assistance

  • National Organization for Rare Disorders (NORD): Patient assistance programs
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Access Network (PAN): Fabry disease fund

State Programs

Washington Apple Health (Medicaid) may cover Fabrazyme for eligible patients. Contact Washington Health Benefit Exchange at 1-855-923-4633.

FAQ

How long does Cigna PA take in Washington? Standard requests: 14 days. Urgent requests: 72 hours. Electronic submissions typically process faster than fax or mail.

What if Fabrazyme is non-formulary on my plan? Request a formulary exception with medical necessity documentation. Include clinical rationale for why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if delay could jeopardize your health. Provide supporting documentation from your physician about the urgency.

Does step therapy apply if I've tried alternatives outside Washington? Yes, document all prior therapies with dates, outcomes, and reasons for discontinuation. Out-of-state treatment history is valid.

What if my employer plan is self-funded? Self-funded plans may not follow standard Cigna policies. Contact your HR department and consider ERISA appeals through the Department of Labor if needed.

How much does Fabrazyme cost without insurance? Approximately $1,100 per 5mg vial and $7,600 per 35mg vial. Monthly costs can range from $15,000-$30,000+ depending on patient weight and dosing.

When navigating complex prior authorization and appeals processes for rare disease medications like Fabrazyme, having expert guidance can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft compelling rebuttals aligned with each payer's specific requirements.

For Washington residents facing Cigna denials, the combination of strong clinical documentation, understanding of state appeal rights, and persistence often leads to successful coverage. The key is thorough preparation and knowing your rights under Washington's robust consumer protection framework.

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance specialist. Always verify current requirements with your specific plan and consult with qualified professionals for your individual situation.

Sources & Further Reading:

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