By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (Eculizumab) Covered by Cigna in Virginia: Complete Prior Authorization Guide

Answer Box: Getting Soliris (Eculizumab) Covered by Cigna in Virginia

Cigna requires prior authorization for Soliris (eculizumab) with specific diagnostic tests and vaccination requirements. The fastest path: (1) Confirm your diagnosis meets FDA criteria with required lab tests, (2) Complete meningococcal vaccinations ≥2 weeks before treatment, (3) Submit PA through Cigna's provider portal with complete documentation. If denied, Virginia's external review process through the State Corporation Commission provides independent oversight with 72-hour expedited reviews available for urgent cases.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If "Likely Eligible": Document Checklist
  4. If "Possibly Eligible": Tests to Request
  5. If "Not Yet": Alternative Pathways
  6. If Denied: Virginia Appeals Process
  7. Clinician Corner: Medical Necessity Letters
  8. Common Denial Reasons & Solutions
  9. Costs & Patient Support
  10. FAQ

How to Use This Guide

This guide helps Virginia residents navigate Cigna's prior authorization process for Soliris (eculizumab), a high-cost complement inhibitor used for rare conditions like PNH, atypical HUS, myasthenia gravis, and NMOSD.

Before you start: Gather your insurance card, recent lab results, vaccination records, and a list of previous treatments. Contact your specialist to ensure they're enrolled in the Soliris REMS program—this is mandatory for prescribing.

Eligibility Triage: Do You Qualify?

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all indications Cigna provider portal Cigna Policy IP_0549
Specialty Pharmacy Must use Accredo/Express Scripts Member services Cigna Specialty Coverage
Meningococcal Vaccines MenACWY + MenB ≥2 weeks prior CDC vaccination card FDA REMS Requirements
REMS Enrollment Prescriber must be certified UltSolREMS.com Soliris USPI

Diagnosis-Specific Requirements

Paroxysmal Nocturnal Hemoglobinuria (PNH):

  • ✅ Flow cytometry confirming GPI-anchored protein deficiency
  • ✅ Age ≥18 years
  • ✅ Prescribed by/consultation with hematologist

Atypical Hemolytic Uremic Syndrome (aHUS):

  • ✅ Progressive thrombotic microangiopathy
  • ✅ Not Shiga toxin E. coli-related
  • ✅ Elevated creatinine, low platelets

Generalized Myasthenia Gravis (gMG):

  • ✅ Positive anti-acetylcholine receptor (AChR) antibodies
  • ✅ Age ≥18 years (continuation approval)
  • ✅ Inadequate response to pyridostigmine
  • ✅ Prescribed by/consultation with neurologist

Neuromyelitis Optica Spectrum Disorder (NMOSD):

  • ✅ Positive anti-aquaporin-4 (AQP4) antibody
  • ✅ Age ≥18 years
  • ✅ Prescribed by/consultation with neurologist

If "Likely Eligible": Document Checklist

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic Staff)
    • Call Cigna member services to confirm specialty pharmacy benefits
    • Document: Member ID, group number, effective dates
  2. Complete Vaccinations (Patient)
    • Get MenACWY (Menactra/Menveo) and MenB (Bexsero/Trumenba)
    • Wait ≥2 weeks before first Soliris dose
    • Document: CDC vaccination card or provider attestation
  3. Gather Diagnostic Tests (Prescriber)
    • PNH: Flow cytometry results, LDH, hemoglobin
    • gMG: AChR antibody test, MG-ADL score
    • NMOSD: AQP4 antibody test
    • aHUS: Creatinine, platelets, exclude Shiga toxin
  4. REMS Enrollment (Prescriber)
  5. Submit PA Request (Prescriber)
    • Use Cigna provider portal or CoverMyMeds
    • Include all documentation from steps 1-4
    • Timeline: 72 hours standard, 24 hours expedited
  6. Track Status (Clinic Staff)
    • Follow up within 48 hours if no response
    • Request expedited review if urgent
  7. Coordinate Specialty Pharmacy (Patient/Clinic)
    • Contact Accredo once approved
    • Schedule infusion at certified site

If "Possibly Eligible": Tests to Request

If you don't meet all criteria yet, work with your specialist to obtain:

For PNH:

  • Flow cytometry analysis (if not done recently)
  • Complete blood count with reticulocyte count
  • LDH level (must be ≥1.5x upper limit of normal)
  • Transfusion history documentation

For gMG:

  • Anti-AChR antibody test (binding assay)
  • MG-ADL (Activities of Daily Living) score
  • Documentation of pyridostigmine trial/failure
  • Neurologist evaluation within 30 days

For NMOSD:

  • Anti-AQP4 antibody (cell-based assay preferred)
  • MRI brain/spine if recent relapse
  • Relapse history documentation
  • Neurologist evaluation

Timeline to re-apply: Most tests take 1-2 weeks. Plan for 3-4 weeks total before PA submission.

If "Not Yet": Alternative Pathways

Formulary Exception Process

If Soliris isn't covered or requires step therapy you can't complete:

  1. Document Medical Necessity
    • Why preferred alternatives failed or are contraindicated
    • Clinical evidence supporting Soliris specifically
    • Peer-reviewed literature citations
  2. Submit Exception Request
    • Use Cigna's formulary exception form
    • Include prescriber letter of medical necessity
    • Attach diagnostic test results
  3. Consider Alternatives
    • Ultomiris (ravulizumab) - same mechanism, different dosing
    • Vyvgart (efgartigimod) for gMG - different mechanism
    • Clinical trials if available

If Denied: Virginia Appeals Process

Virginia residents have strong appeal rights through the State Corporation Commission (SCC) Bureau of Insurance.

Internal Appeals (Required First)

Level 1 Appeal:

  • Timeline: 180 days from denial date
  • Response: 30 days standard, 72 hours expedited
  • Submit to: Cigna Appeals Department (address on denial letter)

Level 2 Appeal:

  • Timeline: 60 days from Level 1 denial
  • Consider peer-to-peer review (80-85% success rate for specialty drugs)

Virginia External Review Process

After exhausting internal appeals, Virginia law provides independent review:

Standard External Review:

  • Form: Form 216-A
  • Deadline: 120 days from final Cigna denial
  • Submit to: Virginia Bureau of Insurance, SCC, P.O. Box 1157, Richmond, VA 23218
  • Timeline: 45 days for decision
  • Cost: Free to consumers

Expedited External Review:

  • When: Doctor certifies delay could jeopardize health
  • Timeline: 72 hours for decision
  • Same form: Form 216-A, mark "expedited"
Note: Virginia's external review has helped many patients obtain coverage for specialty drugs. The independent review organization includes board-certified physicians who specialize in your condition.

Contact Virginia Bureau of Insurance:

Clinician Corner: Medical Necessity Letters

Essential Elements for Soliris PA

Your medical necessity letter should include:

  1. Patient Demographics & Diagnosis
    • Full name, DOB, member ID
    • Primary diagnosis with ICD-10 code
    • Date of diagnosis confirmation
  2. Diagnostic Confirmation
    • Specific test results (flow cytometry, antibodies)
    • Laboratory values with reference ranges
    • Imaging results if applicable
  3. Treatment History
    • Previous therapies tried (drug names, doses, duration)
    • Reasons for discontinuation (inefficacy, intolerance)
    • Current symptom severity
  4. Clinical Rationale
    • Why Soliris is medically necessary
    • Expected outcomes and monitoring plan
    • Contraindications to alternatives
  5. Safety Considerations
    • Vaccination status documentation
    • Monitoring plan for meningococcal risk
    • REMS compliance confirmation

Supporting Guidelines

Reference these authoritative sources in your letters:

  • FDA-approved labeling
  • International consensus guidelines for your specific indication
  • Peer-reviewed studies demonstrating efficacy

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Missing vaccination proof Submit CDC card or provider attestation Vaccination dates ≥2 weeks before treatment
Incomplete diagnostic workup Provide specific test results Flow cytometry for PNH, antibodies for gMG/NMOSD
Site of care restrictions Verify approved infusion centers List from Accredo or Cigna
Quantity limits exceeded Justify dosing with clinical evidence Weight-based calculations, monitoring labs
Not medically necessary Enhanced clinical documentation Treatment failures, symptom severity, guidelines

Costs & Patient Support

Manufacturer Support Programs

Alexion Access Navigator:

  • Website: alexionaccessnavigator.com
  • Services: PA support, copay assistance, patient education
  • Eligibility: Commercial insurance patients (income limits apply)

Potential Savings:

  • Copay cards may reduce out-of-pocket costs significantly
  • Foundation grants available for qualified patients
  • Clinical trials may provide free medication

Virginia-Specific Resources

  • Virginia Poverty Law Center: Healthcare assistance for low-income residents
  • Patient Advocate Foundation: Insurance appeals support
  • Virginia Department of Health: Vaccine assistance programs

FAQ

Q: How long does Cigna PA take in Virginia? A: Standard review is 72 hours, expedited is 24 hours. Submit complete documentation to avoid delays.

Q: What if Soliris is non-formulary on my plan? A: Request a formulary exception with medical necessity documentation. Virginia external review is available if denied.

Q: Can I start treatment while waiting for PA approval? A: No, Soliris requires REMS enrollment and vaccination completion before any doses can be given.

Q: Does step therapy apply if I've tried treatments outside Virginia? A: Yes, document all prior therapies regardless of where they were tried. As of 2024, Cigna removed systematic step therapy for most Soliris indications.

Q: What if I need urgent treatment? A: Request expedited PA review and, if denied, expedited external review in Virginia (72-hour decision).

Q: How much does Soliris cost without insurance? A: Over $500,000 annually. Manufacturer programs and state assistance may help with costs.

Q: Can my family doctor prescribe Soliris? A: No, Cigna requires specialist prescribers (hematologist for PNH/aHUS, neurologist for gMG/NMOSD) and REMS enrollment.

When You Need Extra Help

Getting coverage for Soliris can be complex, especially when dealing with denials or appeals. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned to the plan's own rules, pulling the right citations and clinical evidence to strengthen your case.

If you're facing a Cigna denial in Virginia, don't navigate the appeals process alone. Professional advocacy can significantly improve your chances of approval, especially for complex specialty drugs like Soliris where clinical documentation and regulatory compliance are critical.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult your healthcare provider for medical decisions. Insurance coverage varies by plan and individual circumstances. Verify current requirements with your specific Cigna plan and Virginia regulatory authorities.

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