By Counterforce Health Team in Soliris (eculizumab) —

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

Answer Box: Getting Soliris Covered by Humana in California

Humana requires prior authorization for Soliris (eculizumab) in California, with strict clinical criteria based on FDA-approved indications. Your fastest path to approval: 1) Confirm your diagnosis meets FDA criteria (PNH, aHUS, gMG, or NMOSD) with supporting lab work, 2) Submit a complete prior authorization request through CenterWell Specialty Pharmacy with medical necessity documentation, and 3) If denied, file an internal appeal within 65 days, then request an Independent Medical Review through California's DMHC if needed. Start today by gathering your diagnostic labs and vaccination records.

Table of Contents

Who Should Use This Guide

This guide is for Humana Medicare Advantage or Medicare Part D members in California who need Soliris (eculizumab) coverage, along with their healthcare providers. You'll find this most helpful if you're dealing with:

  • A new Soliris prescription requiring prior authorization
  • A denied prior authorization that needs appeal
  • Questions about Humana's specific coverage criteria
  • Preparing documentation for medical necessity

Expected outcome: With complete documentation meeting Humana's criteria, most medically appropriate requests get approved. If initially denied, California's Independent Medical Review process has a 53% overturn rate for prescription drug appeals.

Member & Plan Basics

Coverage Requirements

  • Active Humana coverage: Verify your plan includes specialty pharmacy benefits
  • Plan types: Medicare Advantage (Part C) and Medicare Part D both cover Soliris under medical benefits
  • Deductible status: Check if you've met your annual deductible, as this affects out-of-pocket costs
  • Prior authorization: Required for all Soliris uses—no exceptions
Tip: Call Humana member services at the number on your insurance card to confirm your specialty drug benefits before starting the authorization process.

Clinical Criteria Requirements

Humana covers Soliris for these FDA-approved indications with specific requirements:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Diagnosis: Flow cytometry confirming PNH clone in blood cells
  • Lab evidence: Elevated LDH, low haptoglobin, elevated indirect bilirubin
  • ICD-10 code: D59.5

Atypical Hemolytic Uremic Syndrome (aHUS)

  • Diagnosis: Microangiopathic hemolytic anemia, thrombocytopenia, acute kidney injury
  • Exclusions: Must rule out STEC-HUS (Shiga toxin negative) and TTP (ADAMTS13 >10%)
  • ICD-10 code: D59.39

Generalized Myasthenia Gravis (gMG)

  • Antibody requirement: Positive anti-acetylcholine receptor (AChR) antibodies
  • Clinical evidence: Generalized muscle weakness symptoms
  • ICD-10 codes: G70.00 or G70.01

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Antibody requirement: Positive anti-aquaporin-4 (AQP4) antibodies
  • Clinical history: Relapsing neurological symptoms
  • ICD-10 code: G36.0

Universal Requirements

  • Vaccination: Meningococcal vaccines (MenACWY and MenB) at least 2 weeks before treatment
  • REMS compliance: Enrollment in the shared Soliris/Ultomiris Risk Evaluation and Mitigation Strategy program

Coding and Billing Requirements

Component 2025 Requirements Notes
HCPCS J-Code J1299 (effective April 1, 2025) 1 unit = 2 mg
Legacy J-Code J1300 (through March 31, 2025) 1 unit = 10 mg
NDC 25682000101 (11-digit format) 300 mg/30 mL vial
Unit of Measure mL Required by most payers
Modifiers RE (REMS compliance), JZ (zero waste) Check payer requirements

Source: Alexion Access Navigator Coding Guide

Documentation Packet Essentials

Provider Note Requirements

Your prescriber's documentation must include:

  • Complete diagnostic workup with specific lab values
  • Treatment history and response to prior therapies
  • Clinical rationale for Soliris specifically
  • Dosing plan and monitoring schedule
  • Vaccination status and REMS enrollment

Medical Necessity Letter Components

A strong letter should address:

  1. Patient identification and insurance details
  2. Diagnosis confirmation with supporting test results
  3. Clinical course including hospitalizations and complications
  4. Treatment rationale explaining why Soliris is necessary
  5. Safety compliance documenting vaccination and REMS participation
Clinician Corner: Use Alexion's medical necessity letter templates as starting points, but customize each letter with your patient's specific clinical details and lab values.

Required Attachments

  • Recent lab results supporting the diagnosis
  • Flow cytometry reports (for PNH)
  • Antibody test results (for gMG and NMOSD)
  • Vaccination records
  • Prior treatment documentation
  • Hospital discharge summaries (if applicable)

Submission Process

Step-by-Step Submission

  1. Complete the PA request: Use Humana's Soliris-specific form
  2. Gather documentation: Assemble all required clinical records
  3. Submit via CenterWell: Fax to 1-877-405-7940 or use the provider portal
  4. Confirm receipt: Get a confirmation number for tracking
  5. Monitor status: Check for additional information requests

Common Submission Errors

  • Incomplete vaccination documentation
  • Missing specific lab values
  • Wrong ICD-10 codes for the indication
  • Outdated clinical information
  • Unsigned medical necessity letters

Specialty Pharmacy Requirements

Humana requires Soliris to be dispensed through CenterWell Specialty Pharmacy, their preferred specialty pharmacy network. This ensures proper handling of the temperature-sensitive medication and coordination of infusion services.

CenterWell Process

  • Patient enrollment: Call 1-800-486-2668 to initiate
  • Prescription routing: Providers fax prescriptions to 1-877-405-7940
  • Home delivery: Direct shipment to patients in California
  • Infusion coordination: Arranges home health services if needed
  • Financial assistance: Helps patients access copay support programs

After Submission: What to Expect

Timeline Expectations

  • Initial review: 7-30 days depending on plan type
  • Additional information requests: 3-5 business days to respond
  • Final determination: Communicated via phone and mail
  • Appeal deadline: 65 days from denial notice

Status Tracking

Keep detailed records of:

  • Confirmation numbers for all submissions
  • Names and dates of phone conversations
  • Additional documentation requests
  • Response deadlines

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Diagnosis not confirmed Submit complete lab workup Flow cytometry, antibody tests, comprehensive metabolic panel
Missing vaccination Provide vaccination records or contraindication documentation CDC vaccination card, medical exemption letter
Insufficient prior treatment Document conventional therapy trials Treatment logs, response assessments, intolerance documentation
Not medically necessary Strengthen clinical rationale Updated medical necessity letter, peer-reviewed literature
Non-formulary status Request formulary exception Comparative effectiveness data, alternative failure documentation

Sources: Humana Provider Appeals Process

Appeals Process for California

Internal Humana Appeals

  • Deadline: 65 days from denial notice
  • Timeline: 30 days for Part C, 7 days for Part D decisions
  • Submission: Online portal, phone, or mail
  • Documentation: Include all supporting clinical evidence

California Independent Medical Review (IMR)

If Humana upholds the denial, California residents can request an IMR through the Department of Managed Health Care:

  • Eligibility: Available after exhausting internal appeals
  • Timeline: 180 days to file, 30-day decision (7 days if expedited)
  • Success rate: 53% of prescription drug IMRs favor patients
  • Cost: No fee to patients
  • Contact: DMHC Help Center at 888-466-2219
From our advocates: We've seen patients succeed with IMR appeals by including detailed clinical timelines showing disease progression and comprehensive documentation of why alternative treatments aren't suitable. The key is demonstrating that Soliris meets established medical necessity criteria for the specific indication.

Frequently Asked Questions

How long does Humana prior authorization take for Soliris in California? Standard reviews take 7-30 days depending on your plan type. Expedited reviews for urgent situations can be processed within 72 hours.

What if Soliris is non-formulary on my plan? You can request a formulary exception by demonstrating medical necessity and showing that preferred alternatives aren't appropriate for your condition.

Can I get an expedited appeal if my condition is worsening? Yes, both Humana and California's IMR process offer expedited reviews for urgent medical situations that could jeopardize your health.

Does California's step therapy law affect Soliris coverage? California has step therapy override protections. If your doctor determines that preferred alternatives would be ineffective or harmful, you can request an override.

What happens if I move to California from another state while on Soliris? Contact Humana to ensure continuity of coverage and confirm that your California providers are in-network for specialty care.

How much will Soliris cost with Humana coverage? Costs depend on your specific plan, deductible status, and copay structure. CenterWell Specialty Pharmacy can provide cost estimates and help identify financial assistance programs.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating evidence-backed, payer-specific documentation. Our platform identifies denial reasons and drafts targeted rebuttals aligned with each plan's requirements, incorporating the right clinical evidence and regulatory citations to maximize approval rates.

For complex cases requiring additional support, consider working with coverage advocates who understand Humana's specific requirements and California's regulatory landscape. Counterforce Health's platform can help generate comprehensive appeals documentation tailored to your specific situation.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and is not medical advice. Coverage decisions depend on individual medical circumstances and specific plan benefits. Always consult with your healthcare provider about treatment options and work directly with your insurance plan for coverage determinations. For assistance with appeals in California, contact the DMHC Help Center at 888-466-2219.

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