By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (Eculizumab) Covered by Aetna CVS Health in Georgia: Complete Prior Authorization Guide

Quick Answer: Getting Soliris Covered by Aetna CVS Health in Georgia

Aetna CVS Health requires prior authorization for Soliris (eculizumab) with diagnosis-specific criteria, mandatory meningococcal vaccination ≥2 weeks before treatment, and CVS Specialty Pharmacy dispensing. Submit the Soliris Precertification Form (GR-68742) via Availity portal or fax 1-844-268-7263. If denied, Georgia residents have 180 days for internal appeals and 4 months for external review through Georgia DOI. First step today: Confirm vaccination status and gather flow cytometry results (PNH) or antibody testing (gMG/NMOSD).

Table of Contents

Coverage Requirements Overview

Soliris (eculizumab) is among the highest-cost biologics, often exceeding $500,000 annually before rebates. Aetna CVS Health covers it for FDA-approved indications but requires strict documentation and safety protocols.

Requirement Details Source
Prior Authorization Required for all indications Aetna 2025 Precert List
Formulary Status Specialty tier, CVS Specialty only CVS Specialty Drug List
Meningococcal Vaccination MenACWY + MenB ≥2 weeks pre-treatment FDA Soliris Label
REMS Enrollment Prescriber and patient required Alexion OneSource
Site of Care Restrictions Home/office preferred; hospital requires justification Aetna Site of Care Policy

Diagnostic Testing and Eligibility

Indication-Specific Requirements

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Flow cytometry showing ≥10% CD55/CD59-deficient red blood cell clone
  • Elevated LDH indicating hemolysis
  • Clinical symptoms of intravascular hemolysis

Atypical Hemolytic Uremic Syndrome (aHUS)

  • Thrombotic microangiopathy with ADAMTS13 >10% (rules out TTP)
  • No evidence of Shiga toxin-producing E. coli
  • Genetic testing recommended but not required for coverage

Generalized Myasthenia Gravis (gMG)

  • Anti-acetylcholine receptor (AChR) antibody positive
  • Inadequate response to ≥2 immunosuppressants (azathioprine, mycophenolate, rituximab)
  • Failed chronic IVIG therapy

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Anti-aquaporin-4 (AQP4) antibody positive
  • ≥1 core clinical characteristic (optic neuritis, transverse myelitis)
  • Relapsing disease pattern
Clinician Corner: Include complete diagnostic workup in your PA submission. For aHUS, genetic testing results (even if negative) strengthen the case by demonstrating thorough evaluation. The Mayo aHUS genetic panel tests 12-15 complement genes and aids in prognosis.

Vaccination Requirements (Mandatory)

All patients must receive meningococcal vaccines ≥2 weeks before starting Soliris. This is non-negotiable due to increased meningococcal infection risk from complement inhibition.

Required Vaccines

  • MenACWY (Menactra, Menveo): Covers serogroups A, C, W, Y
  • MenB (Bexsero, Trumenba): Covers serogroup B
  • Both can be given same day at different sites

Urgent Treatment Protocol

If treatment cannot be delayed 2 weeks:

  1. Start antibacterial prophylaxis (penicillin VK 250mg twice daily for adults)
  2. Administer vaccines immediately
  3. Continue prophylaxis until 2 weeks post-vaccination
  4. Document rationale for urgent initiation

Additional Recommendations

  • Pneumococcal vaccines (PCV13 + PPSV23): Recommended for all ages, mandatory for patients <18
  • Haemophilus influenzae type b (Hib): Recommended for all, mandatory for patients <18

Documentation Required: Submit vaccination cards or provider documentation with dates. Aetna will deny without proof of appropriate vaccination timing.

Step-by-Step Prior Authorization Process

Step 1: Gather Required Documentation

  • Complete diagnostic testing results
  • Vaccination records with dates
  • Clinical notes documenting indication and severity
  • Prior therapy trials and outcomes
  • Current medication list and dosing

Step 2: Complete Aetna Soliris PA Form

Download the Soliris Precertification Request Form (GR-68742) and complete all sections:

  • Patient demographics and insurance information
  • ICD-10 diagnosis codes
  • HCPCS codes (J1290/J1300)
  • NDC number (25682-0001-01)
  • Clinical justification

Step 3: Submit via Preferred Method

Primary: Availity provider portal (includes Novologix for specialty drugs) Alternative: Fax to 1-844-268-7263 Phone: 866-752-7021 to initiate request

Step 4: Track Your Request

  • Standard PA decisions: 30-45 days
  • Expedited (urgent): ≤72 hours
  • Use Aetna provider portal to check status
  • Follow up if no response within expected timeframe
From Our Advocates: We've seen the fastest approvals when clinicians submit comprehensive packets upfront rather than responding to information requests. Include everything—labs, prior therapy documentation, vaccination records, and a detailed clinical narrative—in your initial submission.

Site of Care and Pharmacy Requirements

CVS Specialty Pharmacy Requirement

Soliris must be dispensed exclusively through CVS Specialty Pharmacy. Your prescriber will need to:

  1. Send prescription to CVS Specialty
  2. Coordinate delivery to infusion site
  3. Ensure proper storage and handling

Preferred Infusion Sites

Covered without additional authorization:

  • Home infusion services
  • Physician office
  • Independent infusion center

Requires separate authorization:

  • Hospital outpatient (only for first 4 doses or with medical justification)

Infusion Administration

  • IV infusion only (subcutaneous not approved)
  • Typical dosing: 600mg weekly x4 weeks, then 900mg every 2 weeks
  • Monitor for infusion reactions
  • Emergency protocols required due to infection risk

Appeals Process in Georgia

Internal Appeals (First Step)

Timeline: File within 180 days of denial notice Decision: Aetna must respond within 30 days (pre-service) or 60 days (post-service) How to file:

  • Online through member portal
  • Written request to address on denial letter
  • Include all supporting documentation

External Review (Georgia Department of Insurance)

If internal appeal is denied, Georgia residents can request external review:

Timeline: File within 4 months of final internal denial Decision: ≤30 days for standard review, ≤72 hours for expedited Cost: Free to consumer How to file: Georgia DOI complaint form

Expedited External Review: Available if waiting would jeopardize life or function. Can be filed concurrently with expedited internal appeal for urgent situations.

Note: External review decisions are binding on Aetna. Independent physicians in the same specialty will review your case using current medical literature and guidelines.

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing vaccination proof Submit vaccination records CDC cards or provider documentation with dates
Insufficient diagnostic evidence Provide complete testing Flow cytometry (PNH), antibody results (gMG/NMOSD)
Site of care not authorized Justify hospital setting or switch sites Medical necessity letter for hospital infusion
"Experimental/investigational" Cite FDA approval and guidelines FDA label, specialty society recommendations
Step therapy not completed Document prior failures Medication trial records, intolerance documentation

Peer-to-Peer Review Strategy

If initial denial occurs, request peer-to-peer review with Aetna medical director:

  • Prepare clinical summary focusing on medical necessity
  • Emphasize disease severity and treatment urgency
  • Reference published guidelines and FDA labeling
  • Document failed alternative therapies

Cost Assistance and Support Programs

Manufacturer Support

Alexion OneSource: Provides comprehensive support including:

  • Prior authorization assistance
  • Insurance verification
  • Copay assistance programs
  • Patient education materials

Contact: Visit Alexion OneSource or call patient services

Foundation Assistance

Several foundations provide grants for specialty medications:

  • Patient Access Network Foundation
  • Good Days Foundation
  • HealthWell Foundation

Eligibility: Typically based on income and insurance status

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for specialty medications like Soliris. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer-specific requirements, potentially saving weeks in the approval process.

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take for Soliris in Georgia? Standard PA decisions take 30-45 days. Expedited requests for urgent cases are decided within 72 hours.

What if Soliris is non-formulary on my plan? Request a formulary exception through the standard PA process. Include documentation of medical necessity and failed alternatives.

Can I get expedited approval if my condition is worsening? Yes. Submit an expedited PA request with documentation that waiting would jeopardize your health or function.

Does step therapy apply to Soliris? For gMG, yes—you must have failed ≥2 immunosuppressants and chronic IVIG. Other indications don't have explicit step therapy requirements.

What happens if my appeal is denied? In Georgia, you can request external review through the Department of Insurance within 4 months. This review is conducted by independent physicians and is binding on Aetna.

Do I need genetic testing for aHUS coverage? Genetic testing is recommended but not required for coverage. However, results can strengthen your case and inform treatment duration decisions.

Can I receive Soliris at any infusion center? Home, office, and independent centers are preferred. Hospital outpatient requires additional authorization unless medically justified.

How do I track my PA status? Use the Aetna provider portal or call the number on your denial letter for status updates.

Sources and Further Reading

For additional support navigating complex prior authorizations and appeals, Counterforce Health offers specialized assistance in converting insurance denials into successful approvals through evidence-based appeals tailored to specific payer requirements.

This guide is for informational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance company for the most current requirements and procedures. Coverage policies may vary by plan type and can change without notice.

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