By Counterforce Health Team in Soliris (eculizumab) —

How to Get Soliris (eculizumab) Covered by Aetna (CVS Health) in New York: Complete Prior Authorization Guide

Answer Box: Get Soliris Covered by Aetna (CVS Health) in New York

Aetna (CVS Health) requires prior authorization for Soliris (eculizumab) with strict diagnostic and documentation criteria. Success requires: (1) Complete the Aetna Soliris prior authorization form with disease-specific lab results (flow cytometry for PNH, AChR antibodies for myasthenia gravis, AQP4 antibodies for NMOSD); (2) Document meningococcal vaccination ≥2 weeks before treatment; (3) Submit through CVS Specialty Pharmacy. If denied, New York residents can file an external appeal with the Department of Financial Services within 4 months, with 38-55% overturn rates for specialty drug denials.

Table of Contents

  1. Policy Overview: How Aetna (CVS Health) Covers Soliris
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Quantity Limits & Renewal Thresholds
  5. Required Diagnostic Documentation
  6. Site of Care & CVS Specialty Pharmacy Rules
  7. Evidence for Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process in New York
  10. Common Denial Reasons & Solutions
  11. Cost Support Programs
  12. FAQ

Policy Overview: How Aetna (CVS Health) Covers Soliris

Aetna (CVS Health) requires prior authorization for Soliris (eculizumab) across all plan types—commercial PPO/HMO, Medicare Advantage, and Medicaid managed care. The drug typically sits in a specialty tier with high cost-sharing, but coverage is available when medical necessity criteria are met.

Coverage at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all indications Complete Aetna PA form
Formulary Status Specialty tier (non-formulary exceptions available) Medical exception request
Step Therapy May apply (varies by indication) Prior failure documentation
Quantity Limits 20 vials initial, 8 vials/month maintenance Clinical justification for higher doses
Site of Care CVS Specialty Pharmacy required Network provider verification
Vaccination Meningococcal vaccine ≥2 weeks prior Vaccination record

FDA Indication Requirements

Aetna (CVS Health) covers Soliris only for FDA-approved indications with specific diagnostic criteria:

Covered Indications

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Flow cytometry confirming PNH clones
  • Baseline LDH elevation
  • Clinical symptoms consistent with PNH

Atypical Hemolytic Uremic Syndrome (aHUS)

  • Exclusion of Shiga toxin E. coli-related HUS
  • Evidence of complement-mediated hemolysis
  • Not applicable for typical (STEC-HUS) cases

Generalized Myasthenia Gravis (gMG)

  • Age ≥6 years
  • Positive anti-AChR antibody test
  • MGFA Classification II-IV
  • MG-ADL score ≥6
  • Inadequate response to standard therapies

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Age ≥18 years
  • Positive anti-AQP4 antibody (AQP4-IgG)
  • History of relapses requiring rescue therapy
  • Exclusion of multiple sclerosis
Note: Off-label use is considered investigational and typically not covered.

Step Therapy & Medical Exceptions

While Aetna's current policy doesn't require step therapy for Soliris, some newer complement inhibitors may need to be tried first depending on your specific plan and indication.

Potential Step Therapy Requirements

For PNH/aHUS:

  • May require trial of Empaveli (pegcetacoplan) first
  • Document inadequate response or intolerance

For Generalized Myasthenia Gravis:

  • Prior trials of Vyvgart (efgartigimod) or Rystiggo (rozanolixizumab) may be required
  • Standard immunosuppressive therapy failure must be documented

Medical Exception Pathway

If step therapy applies, you can request a medical exception by documenting:

  • Contraindications to required first-line therapies
  • Previous trial and failure outside the current plan
  • Clinical urgency requiring immediate Soliris treatment

Quantity Limits & Renewal Thresholds

Aetna (CVS Health) typically authorizes:

  • Initial approval: 20 vials (covers loading doses)
  • Maintenance: 8 vials per month
  • Authorization period: 6-12 months with renewal required

Renewal Requirements

For continued coverage, document:

  • Clinical response to treatment (improved LDH, MG-ADL scores, reduced relapses)
  • Ongoing medical necessity
  • Compliance with monitoring requirements
  • Updated vaccination status

Required Diagnostic Documentation

Precise diagnostic documentation is critical for Soliris approval. Here's what Aetna (CVS Health) requires for each indication:

PNH Documentation

  • Flow cytometry report showing PNH clone percentage
  • Baseline and follow-up LDH levels
  • Complete blood count with evidence of hemolysis
  • Clinical notes documenting PNH symptoms

Myasthenia Gravis Documentation

  • Positive anti-AChR antibody test (required)
  • MGFA clinical classification assessment
  • MG-ADL score ≥6
  • Documentation of prior therapy failures
  • Pulmonary function tests if applicable

NMOSD Documentation

  • Positive anti-AQP4 antibody test (required)
  • MRI findings consistent with NMOSD
  • Relapse history and rescue therapy records
  • Exclusion of MS diagnosis

aHUS Documentation

  • Laboratory evidence of hemolytic anemia
  • Thrombocytopenia and acute kidney injury
  • Exclusion of STEC-HUS (negative Shiga toxin)
  • Complement studies if available
Tip: Ensure all lab results are recent (within 30-90 days) and include reference ranges.

Site of Care & CVS Specialty Pharmacy Rules

Aetna (CVS Health) has specific site-of-care requirements for Soliris administration:

Approved Administration Sites

  • Physician office (preferred for stable patients)
  • Ambulatory infusion center (in-network)
  • Hospital outpatient (requires medical justification)
  • Home infusion (limited availability, requires approval)

CVS Specialty Pharmacy Requirements

  • Soliris must be obtained through CVS Specialty
  • Prior authorization must be approved before dispensing
  • Coordination with approved infusion sites required
  • Patient enrollment in CVS specialty programs

Infusion Monitoring

  • 35-minute minimum infusion time
  • 1-hour post-infusion observation required
  • Documentation of vital signs and adverse reactions
  • Emergency protocols must be in place

Evidence for Medical Necessity

Strong medical necessity documentation should reference:

Clinical Guidelines

  • FDA prescribing information
  • Specialty society treatment guidelines (e.g., International PNH Interest Group)
  • Peer-reviewed literature supporting efficacy
  • Drug compendia listings (if applicable)

Patient-Specific Factors

  • Severity of condition and functional impact
  • Prior treatment history and outcomes
  • Contraindications to alternative therapies
  • Risk-benefit analysis for the individual patient

Sample Medical Necessity Letter

Template for Clinicians:

"This 45-year-old patient has laboratory-confirmed PNH with flow cytometry showing 85% PNH clones (normal <1%) and persistently elevated LDH at 2,400 U/L (normal 140-280). Despite supportive care including folic acid and iron supplementation, the patient continues to experience debilitating fatigue, dyspnea, and hemoglobinuria significantly impacting quality of life.

Soliris (eculizumab) is FDA-approved for PNH and represents the standard of care per International PNH Interest Group recommendations. The patient has received meningococcal vaccination on [date], meeting safety requirements. Alternative treatments are not available for this rare complement-mediated disorder.

Request approval for Soliris 600mg IV every 7 days x 4 doses, then 900mg every 14 days thereafter, to be administered at [facility name] with appropriate monitoring."

Appeals Process in New York

If Aetna (CVS Health) denies your Soliris request, New York residents have strong appeal rights through the Department of Financial Services (DFS).

Internal Appeal (First Step)

  • Timeline: File within 180 days of denial
  • Process: Submit through Aetna member portal or mail
  • Decision timeframe: 30-45 days (72 hours for urgent)
  • Required: Original denial letter, additional clinical documentation

External Appeal (New York DFS)

  • Timeline: File within 4 months of final internal denial
  • Cost: $25 fee (refunded if successful, waived for Medicaid/hardship)
  • Success rate: 38-55% for specialty drug appeals
  • Decision: Binding on Aetna (CVS Health)
From our advocates: "We've seen many Soliris denials overturned on external appeal when patients submitted comprehensive diagnostic documentation and peer-reviewed literature supporting medical necessity. The key is addressing the specific denial reason with targeted evidence."

Expedited Appeals

For urgent medical needs, both internal and external appeals can be expedited:

  • Internal expedited: 72-hour decision
  • External expedited: 72-hour decision (24 hours for urgent drug denials)

Getting Help

  • Community Health Advocates: 888-614-5400 (free counseling)
  • DFS Consumer Hotline: 800-342-3736
  • Counterforce Health helps patients and clinicians turn insurance denials into evidence-backed appeals, identifying denial reasons and drafting targeted rebuttals aligned with payer policies.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
Missing diagnostic confirmation Submit flow cytometry (PNH), antibody tests (gMG/NMOSD), or genetic testing (aHUS)
No vaccination proof Provide meningococcal vaccination record ≥2 weeks before start date
Investigational/experimental Cite FDA approval, prescribing information, and clinical guidelines
Non-formulary Request formulary exception with medical necessity documentation
Site of care restriction Justify medical need for specific administration setting
Quantity limit exceeded Document clinical rationale for higher dosing

Cost Support Programs

Manufacturer Support

  • Alexion Access Navigator: Patient assistance programs
  • Co-pay assistance: Up to $10,000/year for eligible commercial patients
  • Free drug program: For uninsured/underinsured patients

Foundation Grants

  • Patient Advocate Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs

  • New York State of Health premium assistance
  • Medicaid expansion coverage
  • Essential Plan for moderate-income residents

FAQ

How long does Aetna (CVS Health) prior authorization take in New York? Standard decisions take 30-45 days. Expedited reviews for urgent cases are completed within 72 hours.

What if Soliris is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and lack of appropriate alternatives.

Can I appeal if I've been stable on Soliris but get denied for renewal? Yes. Document ongoing clinical benefit and medical necessity. Discontinuation could cause disease relapse.

Does step therapy apply if I failed other treatments outside of New York? Prior treatment history from other states should count. Provide documentation of previous trials and outcomes.

What's the difference between internal and external appeals? Internal appeals are reviewed by Aetna (CVS Health). External appeals are reviewed by independent medical experts through New York DFS and are binding.

How much does Soliris cost without insurance? Soliris costs over $500,000 annually. Patient assistance programs and foundation grants may help cover costs.

This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider about treatment decisions. For official information about insurance appeals in New York, visit the Department of Financial Services website.

About Counterforce Health: Counterforce Health specializes in helping patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements and turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies specific coverage criteria, and generates evidence-backed appeals tailored to each payer's policies and procedures.

Sources & Further Reading

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