By Counterforce Health Team in Soliris (eculizumab) —

Myths vs. Facts: Getting Soliris (eculizumab) Covered by Cigna in North Carolina - Appeals Process and Requirements

Answer Box: Getting Soliris (eculizumab) Covered by Cigna in North Carolina

Quick Facts: Cigna requires prior authorization for Soliris across all FDA-approved indications (PNH, aHUS, gMG, NMOSD). Coverage depends on meeting specific diagnostic criteria, meningococcal vaccination, and REMS enrollment. If denied, you have 180 days for internal appeals, followed by external review through North Carolina's Smart NC program.

Fastest Path: Submit PA request with complete diagnostic documentation → If denied, file internal appeal within 180 days → Escalate to Smart NC external review if needed.

First Step Today: Contact Alexion OneSource at 1-888-765-4747 for prior authorization support and financial assistance enrollment.

Table of Contents

  1. Why Myths About Soliris Coverage Persist
  2. Myth vs. Fact: Common Misconceptions
  3. What Actually Influences Cigna's Approval Decision
  4. Avoid These Critical Mistakes
  5. Your 3-Step Action Plan
  6. Appeals Process for North Carolina
  7. Financial Support Resources
  8. FAQ
  9. Sources & Further Reading

Why Myths About Soliris Coverage Persist

Soliris (eculizumab) is one of the most expensive medications in the world, with annual costs reaching $500,000+. This price tag, combined with its use for rare diseases, creates a perfect storm for misinformation about insurance coverage.

Patients and families facing conditions like paroxysmal nocturnal hemoglobinuria (PNH) or myasthenia gravis often receive conflicting advice from well-meaning sources. Online forums, social media groups, and even some healthcare staff may share outdated information or experiences that don't apply to current Cigna policies in North Carolina.

The reality is that Cigna does cover Soliris when specific criteria are met—but the approval process requires precise documentation and understanding of their requirements. Let's separate myth from fact.

Myth vs. Fact: Common Misconceptions

Myth 1: "If my doctor prescribes Soliris, Cigna has to cover it"

Fact: All specialty drugs require prior authorization. Cigna follows specific coverage criteria that must be met regardless of the prescription.

Myth 2: "Cigna automatically denies expensive drugs like Soliris"

Fact: Cigna covers Soliris for FDA-approved indications when clinical criteria are satisfied. The key is submitting complete documentation upfront, including diagnostic confirmation and vaccination records.

Myth 3: "I can't afford Soliris even with insurance"

Fact: Multiple financial assistance programs exist. The Alexion OneSource CoPay Program can reduce out-of-pocket costs to $0 for eligible commercially insured patients.

Myth 4: "Appeals never work for high-cost drugs"

Fact: External reviews in North Carolina have significant overturn rates. Smart NC's independent review process has helped patients access expensive specialty medications when proper evidence is presented.

Myth 5: "I need to try cheaper drugs first (step therapy)"

Fact: While some plans require step therapy, Cigna's current policy doesn't mandate trying other complement inhibitors before Soliris for most indications—though this may change as biosimilars become available.

Myth 6: "Medicare patients can't get financial help"

Fact: The PAN Foundation offers up to $10,100/year for Medicare patients with myasthenia gravis, and other disease-specific foundations provide assistance.

Myth 7: "The appeals process takes forever"

Fact: Cigna has specific timelines: 72 hours for expedited internal appeals, 15 days for standard internal appeals, and North Carolina's external review process typically concludes within 45 days.

What Actually Influences Cigna's Approval Decision

Understanding Cigna's actual decision-making process helps you prepare a stronger case:

Clinical Documentation Requirements

  • Confirmed diagnosis with specific lab results (flow cytometry for PNH, antibody tests for gMG/NMOSD)
  • Medical necessity demonstrating why Soliris is appropriate for your specific case
  • Specialist involvement from relevant specialists (hematologist, neurologist, etc.)

Safety Requirements

  • Meningococcal vaccination completed at least 2 weeks before treatment (or documented medical contraindication)
  • REMS enrollment by the prescribing physician
  • Monitoring plan for ongoing safety assessments

Administrative Factors

  • Complete prior authorization submission with all required forms
  • Correct coding (NDC, HCPCS, diagnosis codes)
  • Site of care approval (infusion center, hospital outpatient, etc.)
From our advocates: We've seen cases where patients were initially denied because vaccination records weren't included in the PA request. Once the complete documentation was resubmitted showing proper vaccination timing, approval came within days. The lesson: completeness matters more than speed in the initial submission.

Avoid These Critical Mistakes

1. Incomplete Initial Submission

Don't rush the prior authorization. Missing vaccination records, incomplete diagnostic workup, or generic medical necessity letters lead to predictable denials.

2. Ignoring REMS Requirements

The prescriber must be enrolled in the Soliris REMS program. This isn't optional—it's an FDA requirement that Cigna will verify.

3. Missing Appeal Deadlines

You have 180 days from the denial notice to file an internal appeal with Cigna. Missing this deadline eliminates your appeal rights.

4. Not Using Available Resources

Alexion OneSource provides free prior authorization support. Many denials could be prevented by using their expertise upfront.

5. Giving Up After One Denial

Initial denials are common for high-cost drugs. The appeals process exists specifically to review these decisions with additional evidence and clinical context.

Your 3-Step Action Plan

Step 1: Contact Alexion OneSource Today

Call 1-888-765-4747 or visit AlexionOneSource.com to:

  • Enroll in the CoPay Program
  • Get prior authorization assistance
  • Access reimbursement navigation support

Step 2: Gather Complete Documentation

Work with your healthcare team to compile:

  • Diagnostic test results confirming your condition
  • Vaccination records (meningococcal)
  • Prior treatment history and outcomes
  • Specialist consultation notes

Step 3: Submit Through Proper Channels

Your healthcare provider should submit the prior authorization through Cigna's provider portal with all required documentation. Don't attempt to handle this yourself—let the clinical team manage the submission.

Appeals Process for North Carolina

If Cigna denies your Soliris request, North Carolina provides robust appeal rights:

Internal Appeals (First Step)

  • Timeline: 180 days from denial notice
  • Process: Submit through Cigna's member portal or by mail
  • Expedited option: Available for urgent medical situations (72-hour response)

External Review (Final Step)

If internal appeals fail, contact Smart NC:

  • Phone: 855-408-1212
  • Timeline: 120 days to request after final internal denial
  • Cost: Free to consumers
  • Decision: Binding on Cigna if approved

Smart NC staff can help you complete the external review application and gather supporting documentation. Their assistance is particularly valuable for complex rare disease cases.

Financial Support Resources

Manufacturer Programs

Foundation Grants

  • PAN Foundation: Up to $10,100/year for Medicare patients with myasthenia gravis
  • NORD: Assistance for PNH patients through disease-specific programs

Government Programs

  • Medicare Extra Help: Low-income subsidy program for Medicare beneficiaries
  • Medicaid: North Carolina's expanded Medicaid may cover Soliris for eligible patients

FAQ

Q: How long does Cigna's prior authorization process take in North Carolina? A: Standard PA decisions are typically made within 15 days. Expedited requests for urgent medical situations receive responses within 72 hours.

Q: What if Soliris isn't on Cigna's formulary? A: You can request a formulary exception through the appeals process. Provide clinical evidence showing medical necessity and lack of suitable alternatives.

Q: Can I request an expedited appeal if I'm already hospitalized? A: Yes. Expedited appeals are available when delays could seriously jeopardize your health or ability to regain function. Contact Cigna immediately.

Q: Does step therapy apply if I've tried other treatments outside North Carolina? A: Prior treatment history from other states should count toward step therapy requirements. Ensure your provider includes complete documentation of previous therapies.

Q: What happens if my employer's plan is self-funded? A: Self-funded plans may not be subject to North Carolina's external review process. However, federal ERISA rights still apply, and you should contact your plan administrator for appeal procedures.

Q: Can biosimilar requirements affect my Soliris coverage? A: As biosimilars like Bkemv become available, some plans may implement step therapy requiring biosimilar trials first. Clinical contraindications or previous biosimilar failures can support exceptions.

Sources & Further Reading

Counterforce Health helps patients navigate complex prior authorization and appeals processes for specialty medications like Soliris. Our platform analyzes denial letters and insurance policies to create targeted, evidence-backed appeals that address each payer's specific requirements. Learn more at www.counterforcehealth.org.

This article provides educational information and should not be considered medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional help with insurance appeals in North Carolina, contact Smart NC at 855-408-1212.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.