By Counterforce Health Team in Soliris (eculizumab) —

Get Soliris (Eculizumab) Covered by Aetna CVS Health in North Carolina: Complete Prior Authorization Guide

Answer Box: Fastest Path to Soliris Coverage

Getting Soliris (eculizumab) covered by Aetna CVS Health in North Carolina requires meeting strict diagnostic criteria and completing mandatory vaccinations. Step 1: Confirm your diagnosis with required lab tests (flow cytometry for PNH, anti-AChR antibodies for myasthenia gravis). Step 2: Complete meningococcal vaccination at least 2 weeks before treatment. Step 3: Submit prior authorization through CVS Specialty Pharmacy with all documentation. If denied, you have 180 days to appeal internally, then 120 days for North Carolina's Smart NC external review program.

Table of Contents

  1. Aetna CVS Health Policy Overview
  2. Diagnostic Requirements by Condition
  3. Prior Authorization Process
  4. Site of Care and Specialty Pharmacy Rules
  5. Common Denial Reasons & Solutions
  6. Appeals Process in North Carolina
  7. Smart NC External Review
  8. Step-by-Step: Your Action Plan
  9. Costs and Patient Support
  10. FAQ

Policy Overview

Aetna CVS Health requires prior authorization for Soliris (eculizumab) across all commercial and Medicare plans. The drug must be obtained through CVS Specialty Pharmacy and administered at approved sites of care.

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all indications Aetna Precertification List
Formulary Status Specialty tier (non-formulary exceptions available) Verify with plan
Step Therapy None required for FDA-approved indications Aetna Policy 0807
Specialty Pharmacy CVS Specialty Pharmacy required Plan documents
Site of Care Home/office/infusion center preferred; hospital outpatient requires justification Site of Care Policy
Vaccination Meningococcal vaccination mandatory FDA REMS requirement

Diagnostic Requirements by Condition

Aetna requires specific diagnostic confirmation for each of Soliris's four FDA-approved indications:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Flow cytometry showing ≥5% PNH cells or ≥51% GPI-deficient neutrophils
  • Clinical evidence of hemolysis (LDH >1.5x upper normal limit)
  • Prescription by or consultation with hematologist

Atypical Hemolytic Uremic Syndrome (aHUS)

  • Laboratory evidence of thrombotic microangiopathy
  • ADAMTS13 activity >5% (to exclude TTP)
  • Exclusion of Shiga toxin-producing E. coli
  • Nephrology or hematology consultation required

Generalized Myasthenia Gravis (gMG)

  • Anti-acetylcholine receptor (AChR) antibody positive
  • Abnormal neuromuscular transmission testing
  • Neurology specialist prescription required
  • Note: Soliris is not approved for antibody-negative MG

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Anti-aquaporin-4 (AQP4) IgG antibody positive
  • Neurology or neuroimmunology specialist required
  • Note: Not approved for AQP4-negative NMOSD
Clinician Corner: All diagnostic tests must be documented with specific values and dates. Generic statements like "positive antibodies" won't meet Aetna's criteria. Include the actual lab values and reference ranges in your prior authorization submission.

Prior Authorization Process

Required Documentation

Submit through CVS Specialty Pharmacy with:

  • Soliris prior authorization form
  • Laboratory confirmation of diagnosis
  • Clinical notes supporting medical necessity
  • Vaccination records (meningococcal required)
  • Prescription from qualified specialist

Vaccination Requirements

Mandatory before treatment:

  • MenACWY vaccine (2 doses, 8 weeks apart)
  • MenB vaccine (2-3 doses depending on brand)
  • Must be completed ≥2 weeks before first infusion

If urgent treatment needed, provide antibiotic prophylaxis for 2 weeks minimum while completing vaccination.

Timeline

  • Standard determination: 30-45 days
  • Expedited review: ≤72 hours (if urgent medical need)
  • Medicare Part D: ≤72 hours standard

Site of Care and Specialty Pharmacy Rules

Aetna requires Soliris infusions at the most cost-effective appropriate setting:

Preferred Sites:

  • Home infusion
  • Physician's office
  • Independent infusion center

Hospital Outpatient (requires prior authorization):

  • First 4 infusions only
  • History of severe infusion reactions
  • Medical instability requiring hospital resources

All Soliris must be sourced through CVS Specialty Pharmacy, which coordinates delivery and site scheduling.

Common Denial Reasons & Solutions

Denial Reason Solution Documentation Needed
Missing vaccination Complete meningococcal vaccines Vaccination records
Insufficient diagnostic proof Provide specific lab values Flow cytometry report, antibody titers
Non-qualified prescriber Obtain specialist consultation Referral or co-signature
Site of care denial Justify hospital need or switch sites Clinical rationale for hospital setting
"Experimental" determination Cite FDA approval and guidelines FDA label, clinical guidelines

Appeals Process in North Carolina

If Aetna denies your Soliris prior authorization, North Carolina provides robust appeal rights:

Internal Appeals (Aetna)

  1. First Level: Submit within 180 days of denial
  2. Second Level: If first appeal denied
  3. Expedited: Available for urgent situations (≤72 hours)

Required for Appeals:

  • Copy of denial letter
  • Medical records supporting necessity
  • Prescriber letter addressing denial reasons
  • Any new clinical information

Submit appeals through Aetna member portal or by mail to address on denial letter.

When dealing with insurance denials for complex medications like Soliris, having expert support can make the difference between approval and continued delays. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals that align with each payer's specific requirements.

Smart NC External Review

If Aetna's internal appeals fail, North Carolina's Smart NC program offers independent external review:

Eligibility

  • Exhausted Aetna's internal appeals
  • State-regulated plan (not self-funded employer plans)
  • Denial based on medical necessity or experimental determination

Process

  1. Request deadline: 120 days from final internal denial
  2. Preliminary review: NCDOI determines eligibility (10 business days)
  3. IRO assignment: Independent Review Organization conducts clinical review
  4. Decision timeline: 45 days standard, 3-4 days expedited

Success Rates

Approximately 61% of external review requests are accepted for processing, with IROs overturning roughly 40-60% of specialty drug denials nationally.

Contact Smart NC:

From Our Advocates: "We've seen Soliris denials overturned most often when the appeal directly addresses the specific denial reason with targeted clinical evidence. For example, if denied for 'insufficient diagnostic proof,' include the exact flow cytometry percentages and reference the plan's own policy criteria. Generic medical necessity letters rarely succeed with high-cost biologics."

Step-by-Step: Your Action Plan

Before You Start

Gather these documents:

  • Insurance card and policy information
  • Complete medical records for your condition
  • Laboratory results confirming diagnosis
  • List of prior treatments and outcomes
  • Vaccination records

7-Step Process

  1. Confirm Diagnosis (Patient + Doctor)
    • Obtain required lab tests specific to your condition
    • Ensure specialist consultation/prescription
    • Timeline: 1-2 weeks
  2. Complete Vaccinations (Patient)
    • Schedule MenACWY and MenB vaccines
    • Wait minimum 2 weeks before treatment
    • Timeline: 2-6 weeks depending on vaccine schedule
  3. Submit Prior Authorization (Doctor's Office)
    • Complete Aetna forms with CVS Specialty Pharmacy
    • Include all required documentation
    • Timeline: 1-2 days to submit
  4. Await Decision (30-45 days standard)
    • Track status through provider portal
    • Prepare appeal materials if needed
  5. Appeal if Denied (Patient + Doctor)
    • Submit within 180 days
    • Address specific denial reasons
    • Timeline: 30-45 days for decision
  6. Request External Review (Patient)
    • File with Smart NC within 120 days
    • Include all prior appeal documentation
    • Timeline: 45 days standard, 3-4 days expedited
  7. Begin Treatment (Patient)
    • Coordinate with CVS Specialty Pharmacy
    • Schedule at approved infusion site

Costs and Patient Support

Manufacturer Support

  • Alexion OneSource: Patient access program with financial assistance
  • Copay assistance: May reduce out-of-pocket costs for eligible patients
  • Free drug program: For uninsured patients meeting income criteria

North Carolina Resources

  • Smart NC: Free advocacy and appeals assistance (855-408-1212)
  • North Carolina Consumer Assistance Program: Insurance navigation support

Counterforce Health helps patients and providers navigate these complex approval processes by creating targeted appeals that directly address payer-specific requirements, potentially reducing delays and improving approval rates.

FAQ

How long does Aetna CVS Health prior authorization take for Soliris in North Carolina? Standard decisions take 30-45 days. Expedited reviews for urgent medical situations are completed within 72 hours.

What if Soliris is not on my formulary? Aetna offers formulary exception processes. Submit medical necessity documentation showing why formulary alternatives are inappropriate.

Can I request an expedited appeal? Yes, if waiting for standard processing would seriously jeopardize your health. Both Aetna and Smart NC offer expedited reviews.

Does step therapy apply to Soliris? No step therapy requirements exist for Soliris's FDA-approved indications under current Aetna policies.

What happens if I move from another state where I was already on Soliris? You'll need new prior authorization under North Carolina regulations, but existing clinical documentation should support approval.

Can I appeal to Smart NC if I have a self-funded employer plan? Most self-funded plans aren't eligible for state external review, but some opt into North Carolina's system. Check with your HR department.

How much does Soliris cost without insurance? Soliris costs over $500,000 annually. Patient assistance programs and appeals are essential for access.

What if my doctor isn't the right specialist for prescribing? Obtain consultation or referral to appropriate specialist (hematology for PNH/aHUS, neurology for gMG/NMOSD) before submitting prior authorization.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance policies and state regulations may change. Always verify current requirements with your insurer and consult healthcare providers for medical decisions. For personalized assistance with North Carolina insurance appeals, contact Smart NC at 855-408-1212.

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