By Counterforce Health Team in Ultomiris (ravulizumab) —

Do You Qualify for Ultomiris Coverage by Blue Cross Blue Shield in North Carolina? Complete Decision Tree & Appeals Guide

Quick Answer: To get Ultomiris (ravulizumab) covered by Blue Cross Blue Shield in North Carolina, you need: (1) confirmed diagnosis with required lab tests (flow cytometry for PNH, antibody testing for myasthenia gravis/NMOSD), (2) meningococcal vaccination completed 2+ weeks before treatment, and (3) prior authorization through your provider's portal. If denied, North Carolina's Smart NC external review provides fast appeals—within 24-72 hours for urgent cases. Start with the eligibility checker below.

Table of Contents

  1. How to Use This Guide
  2. Eligibility Triage: Do You Qualify?
  3. If You're Likely Eligible
  4. If You're Possibly Eligible
  5. If You're Not Yet Eligible
  6. If Your Request Gets Denied
  7. Coverage Requirements at a Glance
  8. Appeals Playbook for North Carolina
  9. Common Denial Reasons & How to Fix Them
  10. FAQ

How to Use This Guide

This decision tree helps you determine whether you qualify for Ultomiris (ravulizumab) coverage through Blue Cross Blue Shield in North Carolina, and what to do next based on your situation.

Start here: Answer the questions in the eligibility triage section below. Based on your answers, you'll be directed to the most relevant action steps—whether that's gathering documentation, requesting additional tests, or preparing an appeal.

For clinicians: Look for the "Clinician Corner" callouts throughout this guide for medical necessity documentation requirements and peer-to-peer review tips.

Eligibility Triage: Do You Qualify?

Work through these questions to determine your coverage pathway:

Step 1: Diagnosis Confirmation

Do you have a confirmed diagnosis for one of Ultomiris's FDA-approved conditions?

  • Paroxysmal Nocturnal Hemoglobinuria (PNH): Requires flow cytometry showing ≥5% PNH cells
  • Atypical Hemolytic Uremic Syndrome (aHUS): Clinical diagnosis, but NOT Shiga toxin E. coli-related HUS
  • Generalized Myasthenia Gravis (gMG): Must be anti-AChR antibody positive, adults only, MGFA class II-IV
  • Neuromyelitis Optica Spectrum Disorder (NMOSD): Must be anti-AQP4 antibody positive

Step 2: Required Lab Tests

Do you have the necessary lab confirmation?

  • PNH: High-sensitivity flow cytometry results
  • gMG: Positive anti-AChR antibody serology
  • NMOSD: Positive anti-AQP4 antibody serology
  • aHUS: Clinical exclusion of STEC-HUS

Step 3: Vaccination Status

Are you up to date on meningococcal vaccination?

Ultomiris requires current meningococcal vaccination completed at least 2 weeks before starting treatment, per the FDA REMS program requirements.

Step 4: Prior Therapy Requirements

Have you tried and failed other treatments (if required by your plan)?

Some Blue Cross Blue Shield plans may require step therapy—trying other medications first before approving Ultomiris. As of December 2024, some plans require a trial and failure of eculizumab (Soliris) for certain indications.

If You're Likely Eligible

✅ You answered "yes" to all the questions above

Document Checklist

Gather these items before your provider submits the prior authorization:

  • Lab results confirming diagnosis (flow cytometry or antibody tests)
  • Meningococcal vaccination records (completed ≥2 weeks ago)
  • Documentation of disease severity (LDH levels for PNH, MG-ADL scores for myasthenia gravis)
  • Records of prior treatment failures or contraindications (if step therapy required)
  • Current weight and dosing calculations
  • REMS program enrollment confirmation
Clinician Corner: Your medical necessity letter should include: (1) specific diagnosis with ICD-10 code, (2) lab values confirming diagnosis, (3) disease severity markers, (4) vaccination status, (5) prior treatments tried and outcomes, and (6) expected treatment goals. Reference the FDA prescribing information for dosing and safety requirements.

Submission Path

  1. Provider Portal: Your doctor submits the prior authorization through Blue Cross Blue Shield's provider portal
  2. Timeline: Standard review typically takes 48-72 hours for non-urgent requests
  3. Expedited Review: Available for urgent medical situations with 24-hour turnaround

If You're Possibly Eligible

⚠️ You're missing 1-2 key requirements

Tests to Request

  • Missing lab confirmation: Ask your doctor to order flow cytometry (PNH) or antibody testing (gMG/NMOSD)
  • Vaccination needed: Schedule meningococcal vaccination at least 2 weeks before planned treatment start
  • Severity documentation: Request MG-ADL scoring (myasthenia gravis) or recent LDH levels (PNH)

What to Track

  • Lab result timelines
  • Vaccination completion dates
  • Any worsening symptoms that might qualify you for expedited review

Timeline to Re-apply

Plan to resubmit your prior authorization request 2-4 weeks after completing missing requirements.

If You're Not Yet Eligible

❌ You're missing multiple key requirements or don't meet diagnostic criteria

Alternatives to Discuss

  • For PNH: Soliris (eculizumab), Empaveli (pegcetacoplan), or supportive care
  • For myasthenia gravis: Conventional immunosuppressants, IVIG, plasmapheresis
  • For NMOSD: Other immunosuppressive therapies per neurologist guidance

Prepare for Exception Requests

Even if you don't meet standard criteria, you may qualify for a formulary exception if:

  • Standard treatments are contraindicated
  • You've experienced severe adverse effects with alternatives
  • Your condition is rapidly worsening

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing your specific plan's policies and crafting point-by-point rebuttals. Their platform helps identify the exact denial basis and pulls the right clinical evidence to support your case.

If Your Request Gets Denied

First Steps

  1. Review the denial letter carefully—it will specify the exact reason for denial
  2. Contact your provider to discuss appeal options
  3. Gather additional documentation based on the denial reason

Appeal Path Chooser

Internal Appeal (First Level)

  • Timeline: Must be filed within 180 days of denial
  • Process: Submit through Blue Cross Blue Shield's member portal or by mail
  • Documentation: Include any missing clinical information

Peer-to-Peer Review

  • When: If denial is based on medical necessity
  • Process: Your doctor requests a call with Blue Cross Blue Shield's medical director
  • Timeline: Usually scheduled within 24-48 hours

External Review (North Carolina Smart NC)

  • When: After exhausting internal appeals or for urgent situations
  • Timeline: 120 days to request after final internal denial
  • Expedited: 24-72 hours for urgent medical situations
  • Cost: Free
  • Contact: North Carolina Department of Insurance Smart NC at 1-855-408-1212

Coverage Requirements at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before treatment Provider portal submission Blue Cross Blue Shield NC
Lab Confirmation Flow cytometry (PNH) or antibody tests (gMG/NMOSD) Hospital/specialty lab FDA Prescribing Information
Vaccination Meningococcal vaccine ≥2 weeks before treatment Primary care or specialty clinic REMS Program Requirements
Step Therapy May require eculizumab trial first Plan-specific policy Verify with your specific Blue plan
Age Limits Adult-only for gMG and NMOSD FDA labeling FDA Access Data

Appeals Playbook for North Carolina

Internal Appeals with Blue Cross Blue Shield

  • Level 1: Submit appeal within 180 days via member portal
  • Level 2: If Level 1 denied, automatic second review
  • Timeline: 30 days for standard, 72 hours for urgent

External Review through Smart NC

North Carolina offers one of the most patient-friendly external review processes in the country:

Standard External Review

  • File within 120 days of final internal denial
  • Decision within 45 days
  • Binding on the insurance company

Expedited External Review

  • For urgent medical situations
  • Decision within 24-72 hours
  • Can bypass internal appeals if medically urgent

How to Apply

  1. Download the External Review Request Form from the NC Department of Insurance website
  2. Include medical records supporting medical necessity
  3. Submit by mail, fax, or online portal
  4. Smart NC staff provide free assistance at 1-855-408-1212
From Our Advocates: We've seen several North Carolina patients successfully overturn Ultomiris denials through Smart NC's external review process. The key was providing comprehensive lab documentation and clear evidence that standard treatments had failed or were contraindicated. While outcomes vary by individual case, thorough preparation significantly improves success rates.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Documents Needed
"Not medically necessary" Provide disease severity markers, treatment goals Recent lab values, MG-ADL scores, LDH trends
"Try eculizumab first" Request step therapy exception Document contraindications or prior failures
"Missing vaccination" Complete meningococcal vaccination Vaccination records dated ≥2 weeks before
"Insufficient diagnosis documentation" Submit complete lab workup Flow cytometry or antibody test results
"Experimental/investigational" Reference FDA approval FDA prescribing information

When facing denials, Counterforce Health can help by analyzing your specific Blue Cross Blue Shield policy and crafting targeted appeals that address each denial reason with evidence-backed rebuttals aligned to your plan's own rules.

FAQ

How long does Blue Cross Blue Shield prior authorization take in North Carolina? Standard requests typically take 48-72 hours. Urgent requests are reviewed within 24 hours.

What if Ultomiris is non-formulary on my plan? You can request a formulary exception with your provider's support. Include clinical justification for why formulary alternatives aren't appropriate.

Can I request an expedited appeal? Yes, if delays would seriously jeopardize your health. North Carolina offers 24-72 hour expedited external reviews through Smart NC.

Does step therapy apply if I failed treatments in another state? Yes, prior treatment failures from other states count toward step therapy requirements. Include complete medical records.

What's the annual cost of Ultomiris? Industry estimates place annual costs in the $470,000-$570,000 range, varying by weight and dosing requirements.

How do I know if my Blue Cross plan covers Ultomiris? Check your plan's formulary or use the prior authorization lookup tool on the Blue Cross NC provider website.

What happens if my external review is denied? The external review decision is binding on the insurance company. If approved, coverage must be provided within 3 business days.

Do I need to be enrolled in the REMS program? Yes, both providers and patients must be enrolled in the Ultomiris REMS program before treatment can begin.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies vary by specific Blue Cross Blue Shield plan and individual circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For free assistance with North Carolina insurance appeals, contact Smart NC at 1-855-408-1212.

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