By Counterforce Health Team in Ultomiris (ravulizumab) —

The Requirements Checklist to Get Ultomiris (ravulizumab) Covered by UnitedHealthcare in Illinois: Complete PA Guide

Answer Box: Getting Ultomiris Covered by UnitedHealthcare in Illinois

Fastest path to approval: Submit prior authorization through UnitedHealthcare Provider Portal with complete clinical documentation showing FDA-approved indication (PNH, aHUS, gMG, or NMOSD), meningococcal vaccination records, and step therapy exception if bypassing eculizumab. In Illinois, you have strong appeal rights including external review within 30 days if denied. First step today: Gather your diagnosis labs, treatment history, and vaccination records, then call OptumRx at 1-800-711-4555 to confirm current PA requirements for your specific plan.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Billing Hygiene
  5. Documentation Packet
  6. Submission Mechanics
  7. Specialty Pharmacy Routing
  8. After Submission
  9. Denial Prevention Tips
  10. Illinois Appeal Rights
  11. Printable One-Pager Checklist

Who Should Use This Checklist

This guide is for Illinois patients, caregivers, and clinicians seeking UnitedHealthcare coverage for Ultomiris (ravulizumab), a high-cost complement inhibitor treating rare diseases. You'll need this if:

  • Your doctor prescribed Ultomiris for PNH, aHUS, generalized myasthenia gravis, or NMOSD
  • UnitedHealthcare is your primary insurer (commercial, exchange, or Medicare Advantage)
  • You received a prior authorization denial or want to prevent one
  • You're switching from another complement inhibitor like Soliris

Expected outcome: Following this checklist increases your approval odds significantly by addressing UnitedHealthcare's specific requirements and Illinois appeal rights upfront.

Member & Plan Basics

✓ Active Coverage Verification

  • Confirm UnitedHealthcare coverage is active through member portal or 1-800 number on your card
  • Verify Ultomiris requires medical benefit prior authorization (not pharmacy benefit)
  • Check if your plan uses OptumRx for specialty drug management

✓ Plan Type Identification

  • Commercial/Exchange: Standard PA through UHC Provider Portal
  • Medicare Advantage: May have additional Part B step therapy requirements starting 2026
  • Medicaid managed care: Follow state Medicaid PA process plus UHC requirements

✓ Financial Responsibility

  • Understand your medical deductible and coinsurance for infused biologics
  • Research manufacturer copay assistance at alexionaccessnavigator.com
  • Consider foundation grants for rare disease medications

Clinical Criteria Requirements

✓ FDA-Approved Indication Status

Paroxysmal Nocturnal Hemoglobinuria (PNH)

  • Flow cytometry confirming PIG-A mutant clone with GPI-anchored protein deficiency
  • LDH ≥1.5x upper limit of normal showing active hemolysis
  • Clinical symptoms: thrombosis history, transfusion dependence (≥4 units/year), or severe fatigue/pain

Atypical Hemolytic Uremic Syndrome (aHUS)

  • TMA triad: thrombocytopenia, microangiopathic hemolytic anemia, acute kidney injury
  • Negative Shiga toxin test (excludes STEC-HUS)
  • ADAMTS13 activity >5% (excludes TTP)

Generalized Myasthenia Gravis (gMG)

  • Age ≥18 years with MGFA class II-IV disease
  • AChR antibody positive (required for Ultomiris coverage)
  • Failed ≥2 standard therapies: pyridostigmine, corticosteroids, immunosuppressants

NMOSD (if covered by your plan)

  • AQP4-IgG positive by cell-based assay
  • Relapsing disease course with core clinical characteristics
  • Prior immunosuppressive therapy failure or intolerance

✓ Step Therapy Documentation

UnitedHealthcare typically requires eculizumab (Soliris) or biosimilar trial first. Document:

  • Prior eculizumab failure: Breakthrough hemolysis, continued transfusions, inadequate response
  • Intolerance: Severe infusion reactions, allergic responses
  • Access barriers: Transportation issues, work conflicts with q2-week infusions
  • Clinical stability: Already stable on Ultomiris from previous insurer

✓ REMS and Safety Requirements

  • Meningococcal vaccination (MenACWY and MenB) ≥2 weeks before first dose
  • Vaccination records with dates and lot numbers
  • REMS counseling documentation about infection risks
  • No active meningococcal infection

Coding and Billing Hygiene

✓ ICD-10 Diagnosis Codes

  • PNH: D59.5 (Paroxysmal nocturnal hemoglobinuria)
  • aHUS: D59.3 (Hemolytic-uremic syndrome)
  • gMG: G70.00 (without exacerbation) or G70.01 (with exacerbation)
  • NMOSD: G36.0 (Neuromyelitis optica [Devic])

✓ HCPCS/J-Code Information

  • Primary code: J1303 (injection, ravulizumab-cwvz, 10 mg)
  • Unit calculation: Total mg dose ÷ 10 = billing units
  • Administration: CPT 96365 for initial IV infusion
  • NDC codes: 25682-0025-01 (300mg) or 25682-0028-01 (1,100mg)

✓ Required Modifiers

  • JZ: No drug discarded (when applicable)
  • RE: REMS compliance (some plans require)
  • UD: 340B purchased drug (if applicable)

Documentation Packet

✓ Provider Note Elements

  • Complete medical history with disease onset and progression
  • All prior treatments with specific doses, duration, and outcomes
  • Current disease severity with objective measures (LDH, transfusions, MGFA class)
  • Rationale for Ultomiris vs. alternatives
  • Weight-based dosing calculation per FDA label

✓ Letter of Medical Necessity Components

Use the Alexion sample template as your foundation:

  • Patient demographics and UnitedHealthcare member ID
  • Prescriber credentials, NPI, and specialty
  • Precise diagnosis with ICD-10 code
  • FDA-approved indication statement
  • Clinical rationale with guideline references
  • Step therapy exception justification (if applicable)
  • Expected clinical outcomes and monitoring plan

✓ Required Attachments

  • Recent lab results supporting diagnosis
  • Flow cytometry report (PNH)
  • Complement testing (aHUS)
  • Antibody test results (AChR for gMG, AQP4 for NMOSD)
  • Vaccination records with dates
  • Prior therapy documentation (medication lists, hospital records)
  • Treatment failure/intolerance notes

Submission Mechanics

✓ Correct Form and Portal Access

  • Use UnitedHealthcare Provider Portal for fastest processing
  • Alternative: OptumRx PA phone line at 1-800-711-4555
  • Ensure you have current PA form version (verify with UHC)
  • Double-check required fields that commonly cause auto-rejections

✓ Critical Submission Details

  • Submit as medical benefit claim, not pharmacy benefit
  • Include exact dosing schedule (loading dose + maintenance every 8 weeks)
  • Specify site of care (outpatient infusion center, hospital, office)
  • Attach all supporting documents in accepted formats (PDF preferred)
Tip: UnitedHealthcare's PreCheck Prior Authorization system can approve qualifying requests in under 30 seconds when all criteria are clearly met in the electronic submission.

Specialty Pharmacy Routing

✓ Network Verification

  • Confirm which specialty pharmacies are in-network for Ultomiris under your plan
  • Common options: Optum Specialty Pharmacy, contracted partners
  • Verify if "white bagging" (pharmacy ships to infusion center) is required

✓ Transfer Process

  • Coordinate prescription transfer from retail pharmacy if needed
  • Provide specialty pharmacy with PA approval number once obtained
  • Confirm shipping address and infusion center coordination
  • Verify insurance billing setup before first shipment

After Submission

✓ Tracking and Follow-up

  • Record PA confirmation number and submission date
  • Set calendar reminder to check status in 72 hours for standard requests
  • Monitor UHC provider portal for status updates
  • Document all communications with reference numbers

✓ Decision Timeline Expectations

  • Standard PA: Up to 72 hours after complete submission
  • Urgent/expedited: 24-72 hours if delay risks health
  • Incomplete submissions: May take longer; respond to requests quickly

At Counterforce Health, we help patients and clinicians navigate complex prior authorization challenges by turning insurance denials into targeted, evidence-backed appeals. Our platform analyzes denial letters and plan policies to create compelling medical necessity arguments that align with each payer's specific requirements.

Denial Prevention Tips

Top 5 Common Pitfalls and Solutions

Pitfall How to Avoid Documentation Fix
Missing step therapy documentation Document eculizumab trial or valid exception reason Include detailed treatment history with outcomes
Incomplete REMS compliance Provide vaccination dates and counseling records Attach immunization records with lot numbers
Wrong diagnosis code Use specific ICD-10 for FDA indication Verify D59.5 for PNH, appropriate codes for others
Insufficient disease severity Include objective measures and clinical impact Provide LDH levels, transfusion records, functional scores
Generic medical necessity letter Use disease-specific rationale with guidelines Reference FDA label and specialty society recommendations

Illinois Appeal Rights

If your initial PA is denied, Illinois provides robust appeal options:

✓ Internal Appeals

  • Timeline: Must request within 180 days of denial
  • Decision: Within 15 business days (standard) or 24 hours (expedited)
  • Process: Submit through UHC member portal or written request
  • Include: Additional clinical evidence, peer-reviewed studies, specialist letters

✓ External Review (Illinois-Specific)

  • When to use: After internal appeal denial or concurrent with first internal appeal
  • Timeline: Must request within 30 days of final internal denial (shorter than many states)
  • Authority: Illinois Department of Insurance oversees process
  • Reviewer: Independent board-certified physician with relevant expertise
  • Decision time: Within 5 business days after IRO receives all materials
  • Cost: Free to consumers; insurers pay review costs

✓ Illinois Resources for Help

  • Illinois Department of Insurance: (877) 527-9431
  • Illinois Attorney General Health Care Helpline: (877) 305-5145
  • Online external review request: Through Illinois DOI website
Note: Illinois' 30-day external review deadline is stricter than the 4-month window in many other states, so act promptly after an appeal denial.

Printable One-Pager Checklist

Before Starting: □ Active UnitedHealthcare coverage confirmed
□ Diagnosis labs and treatment history gathered
□ Vaccination records located
□ Provider willing to submit PA

Clinical Requirements Met: □ FDA-approved indication documented
□ Disease severity demonstrated with labs
□ Step therapy addressed (trial or exception)
□ REMS compliance ready

Documentation Complete: □ Medical necessity letter drafted
□ All lab results attached
□ Prior treatment records included
□ Vaccination proof provided

Submission Ready: □ Correct ICD-10 and J-code identified
□ UHC Provider Portal access confirmed
□ Specialty pharmacy coordination planned
□ Follow-up schedule set

If Denied: □ Internal appeal filed within 180 days
□ External review requested within 30 days (Illinois)
□ Additional clinical evidence gathered
□ State resources contacted if needed

FAQ

How long does UnitedHealthcare PA take for Ultomiris in Illinois? Standard requests typically receive decisions within 72 hours of complete submission. Expedited requests for urgent medical situations are decided within 24-72 hours.

What if Ultomiris is non-formulary on my plan? Ultomiris is typically covered under the medical benefit rather than pharmacy formulary. Your doctor can request a formulary exception with medical necessity documentation if pharmacy coverage is denied.

Does step therapy apply if I've failed eculizumab outside Illinois? Yes, prior treatment history from other states counts toward step therapy requirements. Provide complete documentation of the eculizumab trial and failure/intolerance reasons.

Can I request an expedited appeal in Illinois? Yes, if denial of Ultomiris would seriously jeopardize your health or cause severe pain. Both internal appeals and external reviews can be expedited, with decisions in 24-72 hours.

What happens if I'm already stable on Ultomiris and switch to UnitedHealthcare? Document your clinical stability and response to support continuity of care. Include treatment duration, current labs showing disease control, and risks of switching to alternative therapy.

For complex cases or repeated denials, Counterforce Health specializes in transforming insurance obstacles into successful approvals through targeted, evidence-based appeal strategies.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual circumstances and plan terms. Always consult your healthcare provider and insurance plan documents for personalized guidance. For additional help with Illinois insurance appeals, contact the Illinois Department of Insurance at (877) 527-9431.

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