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

How to Get Elfabrio (pegunigalsidase alfa-iwxj) Covered by Cigna in Texas: Complete Appeals Guide with Forms and Timelines

Answer Box: Getting Elfabrio Covered by Cigna in Texas

Elfabrio (pegunigalsidase alfa-iwxj) requires prior authorization through Cigna's Express Scripts/Accredo specialty pharmacy network. Start by calling Chiesi Total Care at 1-833-656-1056 for PA submission assistance. If denied, file internal appeals within 180 days, then request Texas Independent Review Organization (IRO) external review within 4 months using Form LHL009. The IRO decision is binding on Cigna and free to patients.

First step today: Contact Chiesi Total Care to download the Prior Authorization Guide and begin Accredo coordination.

Table of Contents

  1. Verify Your Cigna Plan Coverage
  2. Prior Authorization Forms and Submission
  3. Medical Necessity Documentation Requirements
  4. Common Denial Reasons and Solutions
  5. Internal Appeals Process with Cigna
  6. Texas External Review (IRO) Process
  7. Specialty Pharmacy Coordination
  8. Support Resources and Contact Information
  9. Cost Assistance Programs
  10. FAQ: Common Questions

Verify Your Cigna Plan Coverage

Before starting the prior authorization process, confirm your specific Cigna plan details and formulary status for Elfabrio.

Coverage at a Glance:

Requirement Details Where to Find It Timeline
Prior Authorization Required via Express Scripts/Accredo Cigna Provider Portal 72 hours standard, 24 hours expedited
Formulary Status Varies by plan; often non-preferred/tier 4 Member portal or call customer service Immediate
Step Therapy May require trial of other ERTs first Plan documents or formulary Varies
Site of Care Infusion center or home infusion Specialty pharmacy coordination N/A
Age Restriction FDA-approved for adults only FDA Label N/A

Check if your plan is ERISA self-funded: Look for "self-funded" in your plan documents or ask HR. Self-funded plans follow federal appeal rules instead of Texas state protections, though internal appeals and external review are still available.

Prior Authorization Forms and Submission

Primary Resource: Chiesi Total Care provides comprehensive PA support and should be your first contact.

Step-by-Step PA Submission

  1. Contact Chiesi Total Care at 1-833-656-1056
  2. Gather Required Documentation
    • Confirmed Fabry disease diagnosis (genetic testing or enzyme deficiency)
    • Prior therapy trials and outcomes
    • Clinical notes supporting medical necessity
    • Timeline: 1-3 business days
  3. Submit to Express Scripts/Accredo
    • Chiesi assists with submission to Cigna's specialty pharmacy network
    • Include all supporting documentation
    • Timeline: 2-3 business days for submission
  4. Await Initial Decision
    • Standard review: 72 hours
    • Expedited review: 24 hours (for urgent cases)
    • First submissions often denied—prepare for appeal
Tip: Chiesi Total Care reports high appeal success rates. Don't be discouraged by initial denials—they're common for specialty ERTs.

Medical Necessity Documentation Requirements

Essential Clinical Documentation:

Diagnosis Confirmation

  • Genetic testing: GLA gene mutation analysis
  • Enzyme activity: Alpha-galactosidase A activity <1-5% of normal
  • Clinical presentation: Organ involvement (kidney, heart, nervous system)
  • ICD-10 codes: E75.21 (Fabry disease)

Prior Therapy Documentation

  • Trials of other enzyme replacement therapies (if applicable)
  • Reasons for discontinuation or inadequate response
  • Contraindications to alternative treatments
  • Response to current therapy if switching from another plan

Clinical Rationale

  • Treatment goals (organ protection, symptom management)
  • Expected outcomes with Elfabrio therapy
  • Monitoring plan for efficacy and safety
  • Dosing justification (1 mg/kg every 2 weeks)

Clinician Corner: Medical Necessity Letter Checklist

Your letter should include:

  • Patient's confirmed Fabry disease diagnosis with supporting lab results
  • Previous ERT trials and clinical outcomes
  • Clinical rationale for Elfabrio specifically
  • Reference to FDA labeling and clinical trial data
  • Monitoring plan for treatment response

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Lack of confirmed diagnosis Submit genetic testing and enzyme activity results GLA gene analysis, alpha-Gal A enzyme levels
Inadequate prior therapy trials Document step therapy attempts and failures Medical records showing inadequate response or intolerance
Non-formulary status Request formulary exception Clinical justification for Elfabrio over formulary alternatives
Site of care restrictions Coordinate with approved infusion centers Accredo network provider list
Quantity/dose limits Justify weight-based dosing Patient weight, BSA calculations, dosing rationale

Most Effective Appeal Strategy: Work with Chiesi Total Care to prepare comprehensive rebuttals addressing each specific denial reason with clinical evidence and guideline references.

Internal Appeals Process with Cigna

Texas law requires completing internal appeals before requesting external review.

Level 1 Internal Appeal

Timeline: Submit within 180 calendar days of denial notice

Submission Methods:

Required Documents:

  • Completed appeal form
  • Copy of denial letter/EOB
  • Additional medical records
  • Updated clinical justification
  • Provider letter of support

Decision Timeline: 60 days for standard appeals, 30 days for pre-service requests

Level 2 Internal Appeal

Timeline: Submit within 60 days of Level 1 denial

Process: Reviewed by different personnel with authority to overturn previous decision

Enhancement Strategy: Include additional clinical evidence, peer-reviewed studies supporting Elfabrio use, and updated treatment response data.

Texas External Review (IRO) Process

If internal appeals are unsuccessful, Texas residents can request binding external review through an Independent Review Organization.

Eligibility Requirements

  • Completed both Level 1 and Level 2 internal appeals
  • Denial based on medical necessity, appropriateness, or experimental/investigational status
  • State-regulated plan (not ERISA self-funded)

Filing Process

  1. Complete Form LHL009 - Request for Review by an IRO
  2. Submit within 120 days of final internal denial
  3. Include supporting documentation:
    • All denial letters
    • Medical records
    • Clinical guidelines supporting Elfabrio use
    • Provider attestation

IRO Timeline

  • Standard review: 20 days
  • Expedited review: 5 days (life-threatening conditions)
  • Step therapy denials: 3 days (per Texas Insurance Code §1369.0546)

Contact for Assistance: Texas Department of Insurance Consumer Help Line at 800-252-3439

Note: IRO decisions are binding on Cigna and free to patients. Success rates are higher when comprehensive clinical evidence is provided.

Specialty Pharmacy Coordination

Elfabrio requires coordination through Cigna's specialty pharmacy network, typically Accredo.

Accredo Enrollment Process

  1. Physician orders Elfabrio with appropriate diagnosis codes
  2. Accredo contacts patient for enrollment and insurance verification
  3. Prior authorization submitted through Express Scripts
  4. Approval and scheduling for infusion center delivery
  5. Ongoing case management for refills and monitoring

Provider Contact: Accredo Physician Service Center for ordering coordination

Infusion Center Requirements

  • Must be in Cigna/Accredo network
  • Capable of handling specialty biologics
  • Emergency management protocols for infusion reactions
  • Cold chain storage capabilities

Support Resources and Contact Information

Primary Contacts

Resource Phone Number Purpose Hours
Chiesi Total Care 1-833-656-1056 PA assistance, appeals support Business hours
Cigna Customer Service Number on ID card General inquiries, appeal status 24/7
Cigna Specialty Pharmacy 1-800-351-3606 Specialty medication support Business hours
Texas Department of Insurance 800-252-3439 IRO assistance, consumer help Business hours

Online Resources

When to Escalate

Contact Texas Department of Insurance if:

  • Cigna fails to meet appeal deadlines
  • Procedural violations occur
  • IRO process is delayed beyond statutory timelines
  • You need assistance understanding your rights

Cost Assistance Programs

Manufacturer Support

Chiesi Total Care Patient Support:

  • Copay assistance for commercial insurance (excludes government plans)
  • Patient assistance program for uninsured/underinsured
  • Infusion supplies and support
  • Enrollment: 1-833-656-1056 or chiesitotalcare.com

Additional Resources

  • Fabry Support & Information Group: Patient advocacy and resources
  • National Organization for Rare Disorders (NORD): Financial assistance programs
  • State pharmaceutical assistance programs: Check Texas Health and Human Services for eligibility

FAQ: Common Questions

How long does Cigna prior authorization take for Elfabrio in Texas? Standard PA review is 72 hours; expedited review is 24 hours for urgent cases. First submissions are often denied, requiring appeals.

What if Elfabrio is not on my Cigna formulary? Request a formulary exception through your physician. Document medical necessity and why formulary alternatives are inappropriate.

Can I get expedited review for my Elfabrio appeal? Yes, if delay would seriously jeopardize your health. Request expedited internal appeal and concurrent expedited IRO review if needed.

Does step therapy apply if I've used other ERTs outside Texas? Document prior therapy trials from any state. Texas law requires consideration of previous treatment history regardless of location.

What happens if my employer plan is self-funded? Self-funded ERISA plans follow federal rules but still offer internal appeals and external review. Contact your plan administrator for specific procedures.

How can I strengthen my Elfabrio appeal? Work with Chiesi Total Care for comprehensive documentation. Include genetic testing, enzyme levels, prior therapy failures, and clinical guidelines supporting Elfabrio use.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex medications like Elfabrio. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals tailored to each payer's requirements. We help patients, clinicians, and specialty pharmacies navigate prior authorization challenges with targeted documentation and proven appeal strategies.

Getting Elfabrio covered requires persistence and proper documentation, but Texas residents have strong appeal rights and external review protections. With Chiesi Total Care's support and comprehensive clinical evidence, many initial denials can be successfully overturned. Counterforce Health provides additional resources for complex appeals when standard processes need enhancement.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance regarding your situation.

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