By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (eculizumab) Covered by Cigna in New Jersey: Complete Prior Authorization and Appeals Guide

Answer Box: Your Fastest Path to Soliris Coverage

Cigna requires prior authorization for Soliris (eculizumab) with a 72-hour standard review (24 hours if expedited). Key requirements: confirmed diagnosis via flow cytometry (PNH) or antibody testing (gMG/NMOSD), meningococcal vaccinations ≥2 weeks before treatment, REMS enrollment, and documented prior therapy failures. If denied, New Jersey's IHCAP external review program (administered by Maximus) offers binding decisions within 45 days—and it's free to patients.

First step today: Have your specialist gather diagnostic labs, vaccination records, and prior treatment documentation, then submit via CoverMyMeds or Cigna's provider portal.

Table of Contents

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Timeline
Prior Authorization Required for all FDA-approved uses Cigna provider portal 72 hours standard, 24 hours expedited
Diagnosis Confirmation Flow cytometry (PNH), antibody testing (gMG/NMOSD) Specialist lab reports ≤3 months old Before PA submission
Vaccination Requirement MenACWY + MenB ≥2 weeks pre-dose CDC vaccination cards or pharmacy records 2+ weeks before treatment
REMS Enrollment FDA-mandated safety program Prescriber must enroll via FDA portal Before first dose
Prior Therapy Documentation Failed alternatives with specific details Medical records showing drug/dose/duration/failure For PA submission
Internal Appeals If initially denied Cigna member services 180 days from denial
External Review (IHCAP) Binding state review NJ IHCAP via Maximus 4 months from final denial

Step-by-Step: Fastest Path to Approval

1. Confirm Your Diagnosis and Gather Documentation

Who does it: Your specialist (hematologist for PNH/aHUS, neurologist for gMG) Documents needed:

  • Flow cytometry showing GPI-anchored protein deficiency (PNH)
  • Anti-AChR antibody results and MG-ADL score ≥6 (gMG)
  • Complement studies ruling out STEC-HUS (aHUS) Timeline: Schedule within 1-2 weeks

2. Complete Vaccination Requirements

Who does it: You or your primary care provider Documents needed: MenACWY and MenB vaccines, administered ≥2 weeks before planned treatment Where to submit: Keep CDC vaccination cards and pharmacy records Timeline: 2+ weeks before step 4

3. Document Prior Treatment Failures

Who does it: Your specialist Documents needed: Specific medications tried, doses, duration, and documented reasons for failure or intolerance Key point: As of July 2024, Cigna removed systematic rituximab requirements, but comprehensive prior therapy documentation strengthens your case

4. Submit Prior Authorization

Who does it: Your prescriber or their staff How to submit: CoverMyMeds portal or Cigna provider portal Documents to attach: All diagnostic tests, vaccination records, prior therapy notes, specialist consultation Timeline: 72 hours for standard review, 24 hours if marked urgent

5. Enroll in REMS Program

Who does it: Your prescriber What it is: FDA-mandated safety monitoring for meningococcal infection risk Timeline: Must be completed before first dose can be administered

6. Track Your Request

How: Provider portal or call Cigna customer service (number on your insurance card) What to watch for: Requests for additional information, approval notifications, or denial letters

7. If Denied: File Internal Appeal Immediately

Timeline: You have 180 days from denial date Documents: Include all medical records and a detailed medical necessity letter from your specialist Expedited option: Available if delay would jeopardize your health

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient diagnosis confirmation Submit recent specialist consultation with lab results Flow cytometry report (PNH), antibody testing (gMG), complement studies (aHUS)
Missing vaccination documentation Provide proof of MenACWY + MenB vaccines ≥2 weeks old CDC vaccination cards, pharmacy immunization records
Lack of prior therapy history Document specific failed treatments with clinical rationale Medical records showing drug names, doses, duration, and failure reasons
REMS enrollment not verified Confirm prescriber enrollment in safety program REMS enrollment confirmation from prescriber
"Not medically necessary" Submit comprehensive medical necessity letter Specialist letter addressing diagnosis severity, treatment goals, and clinical guidelines
From our advocates: We've seen cases where initial denials were overturned simply by resubmitting with complete vaccination documentation and a detailed timeline of prior therapy failures. The key is thoroughness upfront—Cigna's reviewers need to see that all safety requirements are met and that alternative treatments have been appropriately tried.

Medical Necessity Documentation

Essential Elements for Your Specialist's Letter

Your prescriber's medical necessity letter should address these key points based on Cigna's coverage policy:

1. Confirmed Diagnosis

  • For PNH: Flow cytometry results showing GPI-anchored protein deficiency on ≥2 cell lineages
  • For gMG: Anti-AChR antibody positivity and MG-ADL score ≥6 with Class II-V severity
  • For aHUS: Thrombocytopenia with hemolytic anemia, excluding STEC-HUS

2. Clinical Severity

  • Current symptom burden and functional impact
  • Recent hospitalizations, transfusion requirements, or crisis episodes
  • Objective measures (lab values, standardized scales)

3. Prior Treatment History

  • Specific immunosuppressive agents tried (names, doses, duration)
  • Clinical response or reasons for discontinuation
  • Contraindications to standard therapies

4. Treatment Goals

  • Expected clinical outcomes (reduced transfusions, improved function)
  • Monitoring plan and success metrics
  • Long-term management strategy

Clinician Corner: Key Documentation Tips

When preparing your prior authorization, ensure your medical necessity letter includes:

  • Problem statement: Clear diagnosis with ICD-10 codes (D59.5 for PNH, G70.01 for gMG with exacerbation)
  • Severity indicators: Quantifiable measures like LDH levels, transfusion frequency, or MG-ADL scores
  • Treatment rationale: Reference to FDA labeling and relevant clinical guidelines
  • Safety compliance: Documentation of completed vaccinations and REMS enrollment

Appeals Process in New Jersey

Internal Appeals with Cigna

If your initial prior authorization is denied, you have 180 days to file an internal appeal. Cigna must respond within 30-60 days for standard appeals, or 72 hours for expedited appeals when delay could jeopardize your health.

How to submit:

  • Online via Cigna member portal
  • Phone: Customer service number on your insurance card
  • Mail: Address provided in your denial letter

Required documents:

  • Copy of denial letter
  • Medical necessity letter from your specialist
  • All supporting medical records
  • Any additional clinical evidence

External Review Through IHCAP

New Jersey offers one of the strongest consumer protection programs in the country through the Independent Health Care Appeals Program (IHCAP). After completing Cigna's internal appeals, you can request an external review administered by Maximus Federal Services.

Key advantages:

  • Free to patients - insurers pay all costs
  • Binding decisions - if overturned, Cigna must provide coverage
  • Expert review - physician panels with appropriate specialty expertise
  • Strong track record - approximately 50% of external appeals favor consumers nationwide

Timeline:

  • File within: 4 months (180 days) of final internal denial
  • Preliminary review: 5 business days to confirm eligibility
  • Final decision: 45 days for standard appeals, expedited for urgent cases

How to submit: Contact IHCAP directly at 1-888-393-1062 or submit through the online portal referenced on the NJ Department of Banking and Insurance website.

Costs and Financial Assistance

Soliris carries a list price that can exceed $500,000 annually, making financial assistance crucial for most patients. Here are your options:

Manufacturer Support

  • Alexion Access Navigator: Comprehensive support program including insurance navigation and financial assistance
  • Patient Assistance Program: For uninsured or underinsured patients meeting income criteria
  • Co-pay assistance: May reduce out-of-pocket costs for commercially insured patients

Foundation Grants

  • National Organization for Rare Disorders (NORD): Financial assistance for rare disease treatments
  • HealthWell Foundation: Co-payment assistance for eligible patients
  • Patient Advocate Foundation: Co-pay relief and case management services

State Resources

New Jersey residents may also qualify for:

  • NJ FamilyCare: Medicaid expansion program with specialty drug coverage
  • Pharmaceutical Assistance to the Aged and Disabled (PAAD): Prescription assistance for seniors and disabled residents

Counterforce Health specializes in helping patients navigate insurance denials for specialty medications like Soliris. Their platform analyzes denial letters and plan policies to create targeted, evidence-backed appeals that align with each payer's specific requirements—significantly improving approval rates for complex cases like complement inhibitor therapies.

Frequently Asked Questions

Q: How long does Cigna's prior authorization process take for Soliris? A: Standard review takes 72 hours, with expedited review available in 24 hours if you can demonstrate that delay would jeopardize your health.

Q: What if Soliris is not on Cigna's formulary? A: You can request a formulary exception through the same prior authorization process. Your doctor will need to demonstrate medical necessity and explain why formulary alternatives are inappropriate.

Q: Can I start treatment while my appeal is pending? A: No. Treatment cannot begin until prior authorization is approved AND all safety requirements (vaccination, REMS enrollment) are completed.

Q: What happens if I move to New Jersey from another state while on Soliris? A: Contact Cigna immediately to ensure continuity of coverage. You may need to resubmit documentation, but established medical necessity often expedites the process.

Q: Does step therapy apply if I've already failed other treatments? A: Cigna may still require documentation of prior therapy failures, but comprehensive records of previous treatment attempts can support step therapy overrides.

Q: How much will Soliris cost me out-of-pocket? A: This depends on your specific plan's specialty drug tier and annual out-of-pocket maximum. Contact Cigna customer service for your exact cost-sharing details.

Q: What if my appeal is denied at every level? A: After exhausting internal appeals and IHCAP external review, you may have additional options through state insurance regulators or legal advocacy organizations specializing in rare disease access.

Q: Can my doctor request a peer-to-peer review? A: Yes. If your initial PA is denied, your prescriber can request to speak directly with a Cigna medical director to discuss the clinical rationale for Soliris.

When preparing your case, remember that Counterforce Health can help streamline this complex process by automatically generating appeals that address your specific denial reasons with evidence-backed arguments tailored to Cigna's policies.

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 directly for guidance specific to your situation. For additional consumer assistance in New Jersey, contact the Department of Banking and Insurance at 1-800-446-7467.

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