By Counterforce Health Team in Soliris (eculizumab) —

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

Answer Box: Getting Soliris Covered by Cigna in California

Cigna requires prior authorization for Soliris (eculizumab) across all FDA-approved indications in California. The fastest path to approval: (1) Ensure meningococcal vaccinations are completed ≥2 weeks before treatment, (2) Have your specialist submit the PA through Cigna's provider portal with complete diagnostic documentation and REMS enrollment proof, and (3) If denied, file an internal appeal within 180 days, then escalate to California's Independent Medical Review (IMR) through the DMHC, which overturns 60-80% of denials. Start today by calling Cigna member services at 1-800-244-6224 to verify your specific plan's formulary status.

Table of Contents

  1. Coverage Basics: Is Soliris Covered?
  2. Prior Authorization Process
  3. Timeline: How Long Does Approval Take?
  4. Coverage Criteria and Requirements
  5. Costs and Financial Assistance
  6. Denials and Appeals in California
  7. Specialty Pharmacy Coordination
  8. Common Issues and Troubleshooting
  9. Frequently Asked Questions

Coverage Basics: Is Soliris Covered?

Soliris (eculizumab) is covered by Cigna for FDA-approved indications, but prior authorization is mandatory for all uses. The drug is not explicitly listed in most Cigna formularies, placing it in a high specialty tier with significant cost-sharing requirements.

Covered Indications

  • Paroxysmal Nocturnal Hemoglobinuria (PNH) in adults
  • Atypical Hemolytic Uremic Syndrome (aHUS)
  • Generalized Myasthenia Gravis (gMG) in adults with anti-AChR antibodies
  • Neuromyelitis Optica Spectrum Disorder (NMOSD) in adults with anti-AQP4 antibodies
Note: Soliris is not covered for STEC-HUS or off-label uses under Cigna's current policy.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all indications Cigna Policy IP0549
REMS Enrollment Prescriber must enroll at ultsolrems.com FDA REMS
Vaccinations MenACWY + MenB ≥2 weeks pre-dose Cigna Policy IP0549
Specialist Required Hematologist, neurologist, or nephrologist Cigna Policy IP0549
Step Therapy Removed for most indications as of 2024 Counterforce Health Research

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient/Clinic)
    • Call Cigna member services: 1-800-244-6224
    • Confirm plan type and specialty pharmacy requirements
    • Timeline: 5-10 minutes
  2. Complete Vaccinations (Patient)
    • Get MenACWY (Menactra/Menveo) and MenB (Bexsero/Trumenba) vaccines
    • Wait ≥2 weeks before first Soliris dose
    • Timeline: 2-4 weeks
  3. REMS Enrollment (Prescriber)
    • Register at ultsolrems.com
    • Complete required training modules
    • Timeline: 1-2 hours
  4. Gather Documentation (Clinic)
    • Diagnostic labs (≤3 months old)
    • Vaccination records with dates
    • Prior therapy documentation if applicable
    • Timeline: 1-3 days
  5. Submit PA Request (Prescriber)
    • Use Cigna provider portal or CoverMyMeds
    • Fax option: 855-840-1678
    • Include medical necessity letter
    • Timeline: 30 minutes to submit
  6. Track Status (Clinic/Patient)
    • Standard review: 72 hours
    • Expedited (urgent): 24-72 hours
    • Follow up if no response in 48 hours
  7. Coordinate Specialty Pharmacy (Post-approval)
    • Contact assigned specialty pharmacy
    • Schedule delivery/infusion
    • Timeline: 2-7 business days

Timeline: How Long Does Approval Take?

Standard Process

  • PA Review: 72 hours (3 business days)
  • Additional Information Requests: 3-5 business days
  • Approval to Delivery: 2-7 business days
  • Total Timeline: 7-15 business days from complete submission

Expedited Process (Urgent Cases)

  • PA Review: 24-72 hours
  • Criteria: Life or health jeopardy
  • Request Method: Call 800-882-4462 for urgent verbal authorization
California-Specific: Under SB 170, Cigna must respond to prior authorizations within 5 business days for standard requests and 72 hours for urgent requests.

Coverage Criteria and Requirements

Diagnostic Requirements by Indication

PNH (≥18 years):

  • Flow cytometry showing GPI-anchored protein deficiency on ≥2 cell lineages
  • High LDH levels or transfusion history
  • ICD-10: D59.5

aHUS:

  • Confirmed diagnosis excluding STEC-HUS
  • Specialist evaluation by nephrologist
  • Initial approval: 1 year

gMG (≥6 years):

  • Anti-AChR antibody positive
  • MG-ADL score ≥6
  • Myasthenia Gravis Foundation Class II-V severity

NMOSD (≥18 years):

  • Anti-aquaporin-4 (AQP4) antibody positive
  • Neurologist evaluation required

Universal Requirements

  • Meningococcal vaccinations completed ≥2 weeks before first dose
  • REMS enrollment by prescriber with training completion
  • Specialist consultation within 30 days of request
  • Medical necessity letter with clinical rationale

Costs and Financial Assistance

Typical Cost Structure

Soliris costs approximately $500,000 annually at list price. Under Cigna specialty tiers, patients typically face:

  • Specialty copay: $100-500 per month
  • Coinsurance: 20-50% after deductible
  • Annual out-of-pocket maximum: Varies by plan

Financial Assistance Options

  • Alexion ONE Patient Assistance: Income-based free drug program
  • Copay assistance cards: For eligible commercial insurance patients
  • State programs: California's prescription assistance programs
  • Nonprofit foundations: Patient advocate organizations
Tip: Apply for patient assistance programs before starting treatment, as enrollment can take 2-4 weeks.

Denials and Appeals in California

Common Denial Reasons & Solutions

Denial Reason Solution Required Documentation
Incomplete diagnosis Submit flow cytometry/antibody results Labs ≤3 months old with reference ranges
Missing vaccinations Provide CDC vaccination cards Dates showing ≥2 weeks pre-dose
REMS not enrolled Complete prescriber enrollment Confirmation from ultsolrems.com
Not medically necessary Submit specialist letter with guidelines FDA labeling, peer-reviewed studies

California Appeals Process

Level 1: Internal Appeal (Cigna)

  • Deadline: 180 days from denial notice
  • Timeline: 15 days standard, 72 hours expedited
  • How to file: Cigna member portal or written request
  • Success rate: Approximately 80% for rare disease appeals

Level 2: Independent Medical Review (IMR)

  • Regulator: California DMHC (for HMO/managed care plans)
  • Deadline: 6 months from denial
  • Timeline: 45 days standard, 7 days expedited
  • Cost: Free to patients
  • Success rate: 60-80% of denials overturned
  • Contact: DMHC Help Center at 888-466-2219

Appeals Playbook

  1. File Internal Appeal Immediately
    • Use denial letter reference number
    • Include new clinical evidence if available
    • Request peer-to-peer review
  2. Prepare for IMR
    • Gather all medical records
    • Obtain specialist support letter
    • Include published clinical guidelines
  3. Track Deadlines
    • Internal appeal: 180 days from denial
    • IMR application: 6 months from denial
    • Mark calendar for follow-up dates
From Our Advocates: In our experience with California IMRs for rare disease treatments, cases with complete diagnostic documentation and specialist letters citing FDA labeling have the highest success rates. The key is demonstrating that the treatment meets established medical standards, not experimental criteria.

Specialty Pharmacy Coordination

Cigna typically coordinates Soliris through specialty pharmacies like Accredo or Express Scripts specialty services. The medication requires:

Pharmacy Requirements

  • REMS certification for dispensing
  • Cold chain management for shipping
  • Patient enrollment and benefits verification
  • Coordination with infusion sites

Delivery Process

  • Standard shipping: 2-7 business days
  • Refrigerated transport to home or clinic
  • Signature required for delivery
  • Backup coordination for missed deliveries

Troubleshooting Common Issues

PA Portal Problems

  • Portal down: Call Cigna provider line at 800-882-4462
  • Missing forms: Download from Cigna provider resources
  • Upload failures: Try smaller file sizes or different formats

Documentation Issues

  • Lab results unclear: Include reference ranges and normal values
  • Vaccination records missing: Contact previous healthcare providers
  • Prior therapy documentation: Gather pharmacy records and clinic notes

Communication Breakdowns

  • No response to PA: Follow up every 48 hours
  • Conflicting information: Request supervisor or case manager
  • Specialty pharmacy delays: Contact Cigna care coordination

Frequently Asked Questions

How long does Cigna PA take for Soliris in California? Standard review is 72 hours, with total time from submission to delivery typically 7-15 business days. Expedited reviews for urgent cases can be completed in 24-72 hours.

What if Soliris is non-formulary on my Cigna plan? You can request a formulary exception through the same PA process. Include documentation showing why formulary alternatives are inappropriate or have failed.

Can I request an expedited appeal in California? Yes, both Cigna internal appeals and California IMRs offer expedited pathways when treatment delays could jeopardize your health.

Does step therapy apply if I've tried treatments outside California? Cigna removed systematic step therapy requirements for most Soliris indications in 2024. Previous treatment failures from any location should be documented and count toward medical necessity.

What happens if my appeal is denied? After exhausting Cigna's internal appeals, you can file for California's Independent Medical Review (IMR), which has a 60-80% success rate for overturning denials.

Who can prescribe Soliris under Cigna coverage? Specialists including hematologists (for PNH/aHUS), neurologists (for gMG/NMOSD), and nephrologists (for aHUS) can prescribe after completing REMS enrollment.

How much will I pay out-of-pocket? Costs vary by plan but typically include specialty tier copays ($100-500/month) or coinsurance (20-50%). Patient assistance programs can significantly reduce these costs.

What if I need to start Soliris before vaccinations are complete? For urgent cases, treatment can begin with antibiotic prophylaxis while completing vaccinations, but this requires specific documentation of medical urgency.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed rebuttals. Our platform identifies denial reasons and drafts point-by-point responses aligned with each payer's specific requirements, significantly improving approval rates for complex medications like Soliris. Learn more about our services.

Sources & Further Reading

This guide provides educational information about insurance coverage and should not replace professional medical advice. Coverage policies and requirements may change. Always verify current requirements with Cigna and consult your healthcare provider for medical decisions. For assistance with California insurance issues, contact the DMHC Help Center at 888-466-2219.

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