By Counterforce Health Team in Soliris (eculizumab) —

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

Quick Answer: Soliris (eculizumab) requires prior authorization from Humana for all FDA-approved conditions (PNH, aHUS, myasthenia gravis, NMOSD). Key requirements: meningococcal vaccination ≥2 weeks before treatment, diagnostic confirmation, and step therapy documentation. Submit through CenterWell Specialty Pharmacy or fax to 877-486-2621. If denied, Texas residents have 65 days to appeal internally, then can request external review through an Independent Review Organization. First step today: Contact your prescriber to begin vaccination and gather diagnostic labs while they prepare your prior authorization request.

Table of Contents

Humana's Coverage Policy Overview

Humana Medicare Advantage and Part D plans require prior authorization for Soliris (eculizumab) across all covered indications. The medication falls under Medicare Part B when administered by healthcare providers and is included on Humana's 2025 Medicare Prior Authorization List.

Coverage at a Glance

Requirement Details Documentation Needed
Prior Authorization Required for all indications Complete PA form with supporting docs
Formulary Status Covered under Part B medical benefit N/A
Meningococcal Vaccination MenACWY and MenB ≥2 weeks before first dose Vaccination records with dates
REMS Enrollment Both prescriber and patient must enroll Confirmation of enrollment
Diagnostic Testing Condition-specific labs required Flow cytometry (PNH), AQP4-IgG (NMOSD), etc.
Site of Care Typically infusion center or office Administration plan

Plan Types Covered

Humana's prior authorization requirements apply to:

  • Medicare Advantage (Part C) plans
  • Medicare Part D prescription drug plans
  • Some commercial plans (verify with your specific policy)

FDA-Approved Indications and Requirements

Soliris is FDA-approved for four rare conditions, each with specific diagnostic and documentation requirements:

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Required testing: Flow cytometry showing CD55/CD59-deficient red blood cells
  • ICD-10 code: D59.5
  • Step therapy: Document transfusion dependence or hemolytic episodes

Atypical Hemolytic Uremic Syndrome (aHUS)

  • Required testing: Complement genetic testing, ADAMTS13 activity >10%
  • Documentation: Evidence of thrombotic microangiopathy
  • Exclusions: Rule out typical HUS, TTP

Generalized Myasthenia Gravis (gMG)

  • Required testing: Positive acetylcholine receptor (AChR) antibodies
  • ICD-10 codes: G70.00 or G70.01
  • Step therapy: Failed conventional immunosuppressive therapy

Neuromyelitis Optica Spectrum Disorder (NMOSD)

  • Required testing: Positive aquaporin-4 (AQP4) antibodies
  • ICD-10 code: G36.0
  • Documentation: History of optic neuritis or transverse myelitis

Step-by-Step: Fastest Path to Approval

1. Vaccination Requirements (Start Immediately)

Who: Patient with prescriber coordination
What: Get MenACWY and MenB vaccines at least 2 weeks before first Soliris dose
Timeline: 2-3 weeks before PA submission
Source: CDC meningococcal vaccination guidelines

Critical: This is non-negotiable. Humana will deny any request without proof of proper vaccination timing.

2. Diagnostic Confirmation

Who: Prescriber orders tests
What: Condition-specific laboratory confirmation
Timeline: Results needed before PA submission
Documentation: Include lab reports with reference ranges

3. REMS Program Enrollment

Who: Both prescriber and patient
What: Enroll in Soliris REMS program
Where: Alexion OneSource
Timeline: Complete before first infusion

4. Prior Authorization Submission

Who: Prescriber or authorized representative
What: Complete PA form with all supporting documentation
Where: CenterWell Specialty Pharmacy (preferred) or fax 877-486-2621
Timeline: 15-30 days for standard review, 72 hours for expedited

5. Appeals Preparation (If Needed)

Who: Patient or representative
What: Gather additional evidence, prepare appeal letter
Timeline: Must file within 65 days of denial notice

Medical Necessity Documentation

Clinician Corner: Essential Elements

Your prescriber's medical necessity letter should include:

Clinical History:

  • Confirmed diagnosis with supporting lab values
  • Symptom severity and functional impact
  • Previous hospitalizations or complications

Prior Treatments:

  • Detailed list of medications tried
  • Specific reasons for discontinuation (ineffectiveness, intolerance, contraindications)
  • Duration of each trial with outcomes

Evidence-Based Rationale:

  • Reference to FDA labeling for approved indication
  • Cite relevant clinical guidelines (e.g., International PNH Interest Group recommendations)
  • Include peer-reviewed studies supporting efficacy

Treatment Plan:

  • Proposed dosing schedule
  • Monitoring parameters
  • Expected outcomes and timeline

Required Coding Information

HCPCS J-code: J1300 for eculizumab
NDC format: 11-digit HIPAA format (N42568200010 for 300 mg/30 mL vial)
Required modifiers:

  • RE (FDA REMS compliance)
  • JZ (zero drug discarded when applicable)
  • TB (340B drug pricing program—informational)

Common Denial Reasons and Solutions

Denial Reason Solution Required Documentation
Missing vaccination records Submit proof of MenACWY and MenB ≥2 weeks before treatment Vaccination cards or provider records
Insufficient diagnostic testing Provide condition-specific confirmatory labs Flow cytometry, genetic testing, antibody results
Step therapy not met Document failed prior therapies with specific reasons Treatment history, adverse event reports
Site of care restrictions Request exception with medical justification Letter explaining why specific site is medically necessary
Quantity limits exceeded Provide dosing rationale based on patient factors Weight-based calculations, clinical guidelines

Appeals Process in Texas

Level 1: Internal Appeal (Redetermination)

  • Deadline: 65 days from denial notice date
  • Timeline: Standard 7 days, expedited 72 hours
  • How to file: Call 1-800-451-4651 or fax 1-877-556-7005
  • Required: Written request with supporting documentation

Level 2: Independent Review Entity (IRE)

  • Auto-escalation: If Level 1 denial or untimely response
  • Timeline: 72 hours for expedited cases
  • Cost: No charge to patient

Level 3: Administrative Law Judge (ALJ)

  • Threshold: $180 minimum for 2024
  • Timeline: 60 days to file after Level 2
  • Process: Formal hearing available

Texas-Specific Rights

Under Texas law, state-regulated plans must offer external review through an Independent Review Organization (IRO) when denials are based on medical necessity. Key details:

  • Filing deadline: 4 months from final internal denial
  • Timeline: 20 days for standard review, 5 days for urgent cases
  • Binding decision: IRO ruling is final and enforceable
  • Cost: Paid by insurer
Note: Medicare plans follow federal appeals process, not Texas IRO system.

Getting Help in Texas

Texas Department of Insurance (TDI):

Office of Public Insurance Counsel (OPIC):

  • Help line: 1-877-611-6742
  • Free assistance with appeals process

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create point-by-point rebuttals that align with payer-specific requirements, helping patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

Cost Considerations and Financial Assistance

Soliris is among the highest-cost biologics, often exceeding $500,000 annually before rebates. Financial assistance options include:

Manufacturer Programs

  • Alexion OneSource: Patient support services
  • Copay assistance: Available for eligible commercially insured patients
  • Free drug programs: For uninsured patients meeting criteria

Foundation Support

  • National Organization for Rare Disorders (NORD): Patient assistance programs
  • HealthWell Foundation: Copay assistance for rare diseases
  • Patient Advocate Foundation: Insurance appeals support

Medicare Coverage

  • Part B coverage: For physician-administered infusions
  • Supplemental insurance: May cover remaining costs after Medicare

FAQ: Soliris Coverage Questions

Q: How long does Humana prior authorization take in Texas? A: Standard review takes 15-30 days from complete submission. Expedited review for urgent medical situations takes 72 hours.

Q: What if Soliris is denied as "not medically necessary"? A: File an internal appeal within 65 days with additional clinical evidence. In Texas, you can also request external review through an IRO if the internal appeal fails.

Q: Can I get Soliris covered for off-label use? A: Humana typically covers only FDA-approved indications. Off-label use requires exceptional medical justification and supporting literature.

Q: Does step therapy apply if I failed treatments in another state? A: Yes, treatment history from other states counts toward step therapy requirements. Provide complete documentation of prior trials.

Q: What happens if I need Soliris urgently but haven't been vaccinated? A: Prescribers can request expedited approval with a plan for immediate vaccination and antibiotic prophylaxis for 2 weeks post-vaccination.

Q: Can I appeal if Humana requires a specific infusion site? A: Yes, you can request a site-of-care exception with medical justification for why an alternative location is necessary.

When to Contact Texas Regulators

Contact the Texas Department of Insurance if:

  • Humana violates appeal timelines
  • You're denied external review rights
  • The plan fails to follow its own policies
  • You experience discrimination or unfair treatment

File a complaint:

  • Online: TDI complaint portal
  • Phone: 1-800-252-3439
  • Mail: Texas Department of Insurance, Consumer Protection Division

For Medicare plan issues, also contact:

  • Medicare: 1-800-MEDICARE (1-800-633-4227)
  • State Health Insurance Assistance Program (SHIP): Local counseling

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and appeal procedures may change. Always verify current requirements with Humana and consult with your healthcare provider about treatment decisions. For personalized assistance with insurance appeals and prior authorization, Counterforce Health provides specialized support for complex medication approvals.

Sources & Further Reading

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