By Counterforce Health Team in Soliris (eculizumab) —

Do You Qualify for Soliris (Eculizumab) Coverage by Cigna in Florida? Decision Tree & Next Steps

Answer Box: Soliris (Eculizumab) Coverage by Cigna in Florida

Cigna requires prior authorization for Soliris (eculizumab) with 72-hour standard review (24 hours expedited). Key requirements: FDA-approved diagnosis confirmation, meningococcal vaccination ≥2 weeks before treatment, REMS enrollment, and prior therapy documentation. Submit via CoverMyMeds or provider portal. If denied, internal appeals within 180 days, then Florida external review through DFS (877-693-5236) with ~55-60% overturn rates for specialty drugs.

First step today: Contact your prescribing specialist to confirm diagnosis documentation and vaccination status.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible" - Your Approval Checklist
  4. If "Possibly Eligible" - Tests and Timeline
  5. If "Not Yet Eligible" - Alternative Paths
  6. If Denied - Appeal Path Chooser
  7. Coverage Requirements at a Glance
  8. Common Denial Reasons & Fixes
  9. FAQ: Soliris Coverage in Florida
  10. Sources & Further Reading

How to Use This Guide

This decision tree helps determine your path to Soliris (eculizumab) coverage through Cigna in Florida. Soliris treats rare conditions including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

Start here: Answer the eligibility questions below to find your specific pathway. Each section provides actionable next steps based on your situation.

Note: This guide reflects current Cigna policies and Florida regulations. Always verify requirements with your provider and insurer before starting treatment.

Eligibility Triage: Do You Qualify?

Step 1: Diagnosis Confirmation

Check your diagnosis against FDA-approved indications:

  • PNH: Flow cytometry showing >5% clone, elevated LDH, transfusion history
  • aHUS: Confirmed NOT Shiga toxin E. coli-related HUS, thrombocytopenia, hemolytic anemia
  • Generalized Myasthenia Gravis: MG-ADL score ≥6, anti-AChR antibody positive
  • NMOSD: AQP4 antibody positive, relapsing episodes

Result: ✅ Confirmed diagnosis = Continue to Step 2 Result: ❓ Unclear diagnosis = See "Possibly Eligible" section

Step 2: Safety Requirements Met

Required vaccinations (≥2 weeks before first dose):

  • MenACWY (Menactra, Menveo)
  • MenB (Bexsero, Trumenba)
  • Recommended: Pneumococcal, Hib

REMS enrollment: Your prescriber must be enrolled in the Soliris/Ultomiris REMS program

Result: ✅ Vaccinated and REMS enrolled = Continue to Step 3 Result: ❓ Need vaccinations = See timeline in "Possibly Eligible"

Step 3: Prior Therapy Documentation

Cigna removed the systematic requirement for prior rituximab/immunosuppression as of July 2024, but documentation of treatment history strengthens your case.

Document any previous treatments:

  • Specific drug names, doses, duration
  • Reasons for discontinuation (ineffective, adverse events, contraindications)
  • Current symptom severity despite treatments

Result: ✅ Clear treatment history = "Likely Eligible" Result: ❓ Limited prior therapy = "Possibly Eligible" Result: ❌ No prior therapy attempted = "Not Yet Eligible"

If "Likely Eligible" - Your Approval Checklist

Document Checklist

Clinical Documentation:

  • Specialist evaluation ≤30 days
  • FDA-approved diagnosis confirmation (flow cytometry, antibody testing)
  • Current labs ≤3 months (LDH, hemoglobin, platelets, creatinine as appropriate)
  • MG-ADL score for myasthenia gravis patients
  • Treatment history with specific failures/intolerances

Safety Requirements:

  • Meningococcal vaccination records (MenACWY + MenB, ≥2 weeks prior)
  • Prescriber REMS enrollment confirmation
  • Patient Safety Card issued

Submission Requirements:

  • Medical necessity letter from specialist
  • Prior authorization form completed
  • Insurance verification and formulary status check

Submission Path

Primary Route: Submit electronically via CoverMyMeds or Cigna provider portal

Timeline Expectations:

  • Standard review: 72 hours
  • Expedited review: 24 hours (if health jeopardized)
  • Approval duration: Typically 1 year

Contact for urgent cases: Call Cigna provider services (number on your member ID card) to request expedited review

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Soliris. Their platform can help identify denial reasons and draft point-by-point rebuttals aligned to Cigna's specific policies.

If "Possibly Eligible" - Tests and Timeline

Required Testing to Complete

Diagnostic Confirmation Needed:

  • PNH: Flow cytometry for GPI-anchored proteins
  • aHUS: Complement studies, STEC testing to rule out typical HUS
  • gMG: Anti-AChR antibody testing, MG-ADL assessment
  • NMOSD: AQP4-IgG antibody, MRI findings

Timeline to Re-apply:

  1. Weeks 1-2: Complete diagnostic testing
  2. Week 3: Receive meningococcal vaccinations
  3. Week 5+: Submit prior authorization (≥2 weeks post-vaccination)

What to Track

  • Keep detailed symptom diary
  • Document any hospitalizations or emergency visits
  • Track current medication effectiveness
  • Monitor lab values (disease-specific markers)

If "Not Yet Eligible" - Alternative Paths

Alternatives to Discuss with Your Specialist

PNH alternatives:

  • Ultomiris (ravulizumab) - longer-acting C5 inhibitor
  • Empaveli (pegcetacoplan) - C3 inhibitor
  • Bkemv (eculizumab biosimilar) - may have different coverage

Myasthenia gravis alternatives:

  • Vyvgart (efgartigimod)
  • Zilbrysq (zilucoplan)
  • Traditional immunosuppressants (pyridostigmine, prednisone)

NMOSD alternatives:

  • Enspryng (satralizumab)
  • Uplizna (inebilizumab)

Prepare for Exception Requests

Formulary Exception Process:

  • Physician certifies preferred alternatives are contraindicated, ineffective, or detrimental
  • Submit clinical rationale for why Soliris is medically necessary
  • Include documentation of alternative therapy failures or contraindications

Exception Timeline: 72 hours standard, 24 hours expedited

If Denied - Appeal Path Chooser

Internal Appeals (Required First Step)

Appeal Level Filing Deadline Cigna Response Time Submission Method
Level 1 180 days from denial 30 days (72 hours expedited) Member portal or certified mail
Level 2 60 days from Level 1 denial 30 days Same as Level 1

Success tip: Request peer-to-peer review between your specialist and Cigna medical director. Studies show 80-85% success rates for specialty drugs with proper clinical discussion.

Florida External Review

When to use: After exhausting both internal appeal levels

Timeline:

  • File within: 4 months of final internal denial
  • Review time: 45 days standard, 72 hours expedited
  • Cost: Free to patients
  • Success rate: ~55-60% overturn rate for specialty drug denials

How to file: Contact Florida Department of Financial Services at 877-693-5236 or submit online complaint

Required documents:

  • All denial letters
  • Medical records supporting necessity
  • Specialist letters
  • Treatment history documentation

When to Request Expedited Review

Request expedited appeals if delaying Soliris would:

  • Seriously jeopardize your life or health
  • Jeopardize your ability to regain maximum function
  • Cause severe pain that cannot be managed without treatment

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all patients Submit via CoverMyMeds or provider portal Cigna PA Policy
REMS Enrollment Prescriber must enroll UltSolREMS.com FDA Requirement
Meningococcal Vaccination MenACWY + MenB ≥2 weeks prior Vaccination records to submit FDA Label
Diagnosis Confirmation FDA-approved indication only Specialist evaluation and testing Cigna PA Policy
Formulary Status Specialty tier, PA required Check via Cigna formulary Member portal
Step Therapy Removed July 2024 No longer required Cigna Policy Updates

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documents
Incomplete vaccination records Submit complete vaccination documentation MenACWY and MenB dates ≥2 weeks before treatment
Missing REMS enrollment Confirm prescriber enrollment REMS enrollment confirmation from UltSolREMS.com
Insufficient diagnosis documentation Provide comprehensive diagnostic workup Flow cytometry (PNH), antibody testing (gMG/NMOSD), complement studies (aHUS)
"Not medically necessary" Submit detailed clinical rationale Specialist letter explaining disease severity, prior failures, treatment goals
Coding errors Verify correct HCPCS codes Use current codes (not J1299); verify via provider portal

FAQ: Soliris Coverage in Florida

Q: How long does Cigna prior authorization take in Florida? A: Standard reviews take 72 hours; expedited reviews take 24 hours. Florida law requires Cigna to respond to standard requests within 7 calendar days.

Q: What if Soliris is non-formulary on my plan? A: You can request a formulary exception. Your physician must certify that formulary alternatives are contraindicated, ineffective, or detrimental to your health.

Q: Can I start Soliris while waiting for approval? A: No. Due to mandatory vaccination and REMS requirements, treatment cannot begin until approval and safety requirements are met.

Q: Does step therapy apply if I failed treatments in another state? A: Cigna accepts prior therapy documentation from any provider. Document specific drug names, doses, duration, and failure reasons.

Q: What's the cost with insurance? A: Costs vary by plan. The Alexion OneSource CoPay Program can reduce copays to $0 for eligible commercially insured patients.

Q: How do I request expedited appeal? A: Document that delaying treatment would seriously jeopardize your life, health, or ability to regain function. Submit via member portal or call member services.

From our advocates: We've seen Soliris appeals succeed when families work closely with their specialist to document disease progression and treatment failures comprehensively. One key factor is ensuring the medical necessity letter specifically addresses Cigna's coverage criteria rather than using generic language. Taking time to gather complete vaccination records and REMS documentation upfront prevents common delays.

Clinician Corner: Medical Necessity Letter Checklist

Essential Elements for Soliris Medical Necessity:

  1. Problem Statement: Clear diagnosis with specific test results (flow cytometry values for PNH, antibody titers for gMG/NMOSD)
  2. Disease Severity: Quantify symptoms using validated scales (MG-ADL for myasthenia gravis, transfusion requirements for PNH)
  3. Prior Treatments: List specific medications, doses, duration, and documented outcomes
    • Include reasons for discontinuation
    • Note contraindications to alternatives
  4. Clinical Rationale: Explain why Soliris is the appropriate choice
    • Reference FDA labeling for approved indications
    • Cite relevant treatment guidelines
  5. Treatment Goals: Define measurable outcomes (reduced transfusions, improved functional scores)
  6. Safety Considerations: Confirm vaccination status and REMS compliance

Key Guidelines to Reference:

  • FDA prescribing information for approved indications
  • International Myasthenia Gravis/Myasthenia Gravis Foundation of America guidelines for gMG
  • International PNH Registry data for treatment outcomes

For complex cases, Counterforce Health provides specialized support in developing evidence-backed appeals that align with specific payer requirements and medical guidelines.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual circumstances and plan details. Always consult with your healthcare provider and insurance company for specific guidance. For additional support with insurance appeals and coverage issues, contact the Florida Department of Financial Services Consumer Helpline at 877-693-5236.

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