By Counterforce Health Team in Soliris (eculizumab) —

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

Quick Answer: Getting Soliris (Eculizumab) Covered by Aetna CVS Health in California

Soliris requires prior authorization from Aetna CVS Health before dispensing, with meningococcal vaccination required at least 2 weeks prior to first dose. Submit the Soliris Precertification Request Form (GR-68742) via fax (888) 267-3277 or Availity portal. California residents have strong appeal rights through Independent Medical Review (IMR) with 55-73% overturn rates for specialty drug denials.

First step today: Download the precertification form and gather vaccination records, labs within 30 days, and diagnosis-specific evidence (flow cytometry for PNH, antibody tests for myasthenia gravis/NMOSD).

Table of Contents

  1. Plan Types & Coverage Implications
  2. Formulary Status & Tier Placement
  3. Prior Authorization Requirements
  4. Step Therapy & Utilization Controls
  5. CVS Specialty Pharmacy Process
  6. Cost-Share Basics
  7. Submission Process & Forms
  8. Common Approval Patterns
  9. Appeals Process in California
  10. FAQ

Plan Types & Coverage Implications

Aetna CVS Health offers multiple plan types in California, each with different referral and network requirements:

  • HMO plans: Require primary care physician referrals for specialty medications
  • PPO plans: Allow direct access to specialists but may have higher out-of-network costs
  • EPO plans: In-network only coverage with no referrals required
  • Medicare Advantage: Uses different prior authorization forms and timelines
Note: Soliris requires prior authorization across all Aetna plan types. The specific precertification requirements remain consistent regardless of your plan structure.

Formulary Status & Tier Placement

Soliris appears on Aetna's 2025 precertification list requiring prior authorization for all FDA-approved indications. The medication must be dispensed through CVS Specialty Pharmacy exclusively.

Biosimilar alternatives now available include:

  • Eculizumab-aagh (Epysqli) - approved July 2024
  • Eculizumab-aeeb (Bkemv) - interchangeable with Soliris

These biosimilars follow the same prior authorization requirements as brand-name Soliris.

Prior Authorization Requirements

Coverage at a Glance

Requirement Details Source
Prior Auth Needed Yes, all indications Aetna Precert List
Vaccination Required Meningococcal (MenACWY + MenB) ≥2 weeks before FDA Label
Specialty Pharmacy CVS Specialty only Aetna Policy
Timeline 5-15 business days standard Aetna Forms

Essential Documentation

All indications require:

  • ICD-10 diagnosis codes
  • Current labs within 30 days of submission
  • Meningococcal vaccination records (MenACWY and MenB series)
  • Weight-based dosing calculations
  • Treatment goals and expected duration

Diagnosis-specific requirements:

Paroxysmal Nocturnal Hemoglobinuria (PNH):

  • Flow cytometry showing PNH clone percentage
  • LDH levels demonstrating hemolysis
  • Complete blood count with evidence of anemia

Myasthenia Gravis:

  • AChR antibody test results
  • MG-ADL score ≥5
  • Documentation of inadequate response to ≥2 immunosuppressive therapies over 12 months

NMOSD:

  • AQP4-IgG antibody results
  • MRI evidence of lesions
  • Clinical relapse history

Step Therapy & Utilization Controls

Step therapy requirements vary by indication:

Condition Step Therapy Required Acceptable Prior Therapies
PNH No N/A
aHUS No N/A
Myasthenia Gravis Yes Azathioprine, corticosteroids, cyclosporine, methotrexate, mycophenolate, tacrolimus
NMOSD Not specified Verify with Aetna

For myasthenia gravis, you must document at least 12 months of inadequate response or intolerable side effects from two different immunosuppressive agents before Soliris approval.

CVS Specialty Pharmacy Process

Soliris must be dispensed exclusively through CVS Specialty Pharmacy. The process involves:

  1. Prescription routing: Your doctor sends the prescription directly to CVS Specialty
  2. Patient enrollment: CVS Specialty contacts you to complete enrollment forms
  3. Delivery coordination: Medication ships to your approved infusion site
  4. Quantity limits: 20 vials initial treatment, 8 vials monthly maintenance

Preferred infusion sites (no additional authorization needed):

  • Home infusion services
  • Physician offices
  • Independent infusion centers

Hospital outpatient infusion requires separate authorization except for the first 4 doses.

Submission Process & Forms

Step-by-Step: Fastest Path to Approval

  1. Download forms (Clinic): Get Soliris Precertification Form GR-68742
  2. Gather vaccination records (Patient/Clinic): Ensure meningococcal vaccines completed ≥2 weeks ago
  3. Collect recent labs (Clinic): Obtain all labs within 30 days of submission date
  4. Complete diagnosis-specific testing (Clinic): Flow cytometry for PNH, antibody tests for MG/NMOSD
  5. Submit electronically (Clinic): Use Availity portal or fax (888) 267-3277
  6. Track status (Patient/Clinic): Monitor through CVS Specialty for updates
  7. Coordinate infusion (Patient): Work with CVS Specialty on delivery to infusion site

Contact Information

  • Standard Prior Auth: (866) 752-7021 / Fax (888) 267-3277
  • Medicare Part B: (866) 503-0857 / Fax (1-844-268-7263)
  • CVS Specialty: Coordinates after approval

Common Approval Patterns

Strong submissions typically include:

Clinical documentation:

  • Comprehensive medical history with prior treatment failures documented
  • Specialist letter explaining medical necessity and treatment goals
  • Recent lab values showing disease activity or progression
  • Vaccination compliance with exact dates

Administrative completeness:

  • All form fields completed accurately
  • Correct ICD-10 codes for primary and secondary diagnoses
  • Proper dosing calculations based on patient weight
  • Clear start date and anticipated treatment duration
From our advocates: We've seen the fastest approvals when clinics submit a complete packet upfront rather than responding to requests for additional information. One effective approach is creating a checklist for each indication to ensure nothing is missed—this can reduce approval time from 15 days to 5-7 days.

Appeals Process in California

California offers robust appeal rights for denied specialty medications through a two-tier system.

Internal Appeals with Aetna

Timeline: You have 180 days from denial to file internal appeal Response time: 30 days standard, 72 hours for expedited appeals Filing: Submit through Aetna provider portal or by mail/fax

Required documentation for internal appeal:

  • Original denial letter
  • Additional clinical evidence addressing denial reasons
  • Updated specialist letter
  • Peer-reviewed guidelines supporting treatment
  • Documentation of prior treatment failures

California Independent Medical Review (IMR)

If Aetna upholds the denial, California residents can request Independent Medical Review through the Department of Managed Health Care.

Success rates for specialty drugs:

  • Overall denial overturn rate: 55-73%
  • Rare disease treatments: ~68%
  • Medical necessity disputes: 55.3%

How to file IMR:

  • Apply online at healthhelp.ca.gov
  • Call DMHC Help Center: (888) 466-2219
  • No cost to patients

Timeline: 45 days standard, 72 hours for urgent cases Decision: Binding on Aetna

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, pulling the right clinical evidence and FDA citations to strengthen your case.

When to Request Expedited Review

Request expedited processing if:

  • Standard timeline could seriously jeopardize your health
  • You're experiencing severe symptoms requiring immediate treatment
  • Ongoing treatment requires immediate continuation decision

Both Aetna internal appeals and California IMR offer expedited timelines for urgent medical situations.

Cost-Share Basics

Soliris is among the highest-cost biologics, often exceeding $500,000 annually before rebates. Your out-of-pocket costs depend on your specific Aetna plan's:

  • Annual deductible amount
  • Specialty tier copay or coinsurance percentage
  • Annual out-of-pocket maximum

Cost assistance options:

  • Alexion OneSource patient support program
  • Manufacturer copay assistance (verify eligibility)
  • State pharmaceutical assistance programs
  • Independent charitable foundations
Note: This information is educational only. Consult your plan documents or Aetna member services for specific cost-sharing details.

FAQ

How long does Aetna prior authorization take for Soliris in California? Standard timeline is 5-15 business days. Expedited reviews process within 72 hours for urgent medical need. Incomplete submissions add 5-10 days.

What if Soliris is denied as "not medically necessary"? File an internal appeal with additional clinical evidence, then request California IMR if upheld. IMR has 55-73% overturn rates for specialty drug denials.

Does step therapy apply if I failed treatments outside California? Yes, Aetna accepts documentation of prior therapy failures from any location, as long as you provide dates, dosages, and specific reasons for discontinuation.

Can I get emergency supply while waiting for approval? California doesn't mandate emergency supplies, but you can request expedited review (72 hours) if delay could seriously jeopardize your health.

What vaccination is required before starting Soliris? Meningococcal vaccines (both MenACWY and MenB series) must be completed at least 2 weeks before first dose per FDA requirements and REMS program.

How do I verify my specific Aetna plan requirements? Call Aetna member services at the number on your insurance card, or have your doctor contact the prior authorization unit at (866) 752-7021.

For complex cases involving multiple denials or urgent medical situations, Counterforce Health offers specialized support in preparing evidence-backed appeals that align with Aetna's specific policy requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on your specific insurance plan and medical circumstances. Always consult your healthcare provider and insurance company for guidance on your individual situation. For assistance with California insurance issues, contact the DMHC Help Center at (888) 466-2219.

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