By Counterforce Health Team in Ultomiris (ravulizumab) —

How to Get Ultomiris (ravulizumab) Approved by UnitedHealthcare in North Carolina: Complete Prior Authorization Guide

Answer Box: Getting Ultomiris Approved by UnitedHealthcare in North Carolina

To get Ultomiris (ravulizumab) covered by UnitedHealthcare in North Carolina, you'll need prior authorization with documented medical necessity. Most plans require step therapy (trying eculizumab/Soliris first) unless you qualify for an exception. The fastest path: 1) Verify your plan's formulary status via the UHC provider portal, 2) Submit complete PA documentation including meningococcal vaccination records and clinical failure of standard treatments, 3) If denied, file internal appeal within 180 days, then request external review through North Carolina's Smart NC program within 120 days.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Plan Verification
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Tracking
  6. Typical Timeline Expectations
  7. If You Need to Provide More Information
  8. If Your Request is Denied
  9. Renewal and Re-authorization
  10. Quick Reference Checklist

What This Guide Covers

This comprehensive guide helps patients, caregivers, and clinicians navigate UnitedHealthcare's prior authorization process for Ultomiris (ravulizumab) in North Carolina. Ultomiris is a long-acting complement inhibitor FDA-approved for paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), generalized myasthenia gravis (gMG), and neuromyelitis optica spectrum disorder (NMOSD).

With annual costs often exceeding $450,000, UnitedHealthcare requires robust documentation of medical necessity and safety compliance. This guide provides the specific forms, timelines, and appeal strategies you need to secure coverage in North Carolina.

Note: This guide applies to UnitedHealthcare commercial and Medicare Advantage plans. Medicaid coverage follows different rules not covered here.

Before You Start: Plan Verification

Step 1: Confirm Your Coverage Type

Contact UnitedHealthcare member services using the number on your insurance card to verify:

  • Plan type: Commercial, Medicare Advantage, or other
  • Benefit structure: Medical benefit (J-code J2356) vs. pharmacy benefit
  • Network status: Ensure your prescribing physician and infusion center are in-network

Step 2: Check Formulary Status

Access your plan's 2024 formulary through the UnitedHealthcare member portal to confirm:

  • Coverage status: Whether Ultomiris is covered
  • Tier placement: Specialty preferred vs. non-preferred
  • Utilization management: Prior authorization and step therapy requirements

Step 3: Understand Step Therapy Requirements

Most UnitedHealthcare plans require step therapy with eculizumab (Soliris) or an approved biosimilar before covering Ultomiris. You may qualify for an exception if you have:

  • Clinical contraindications to eculizumab
  • Previous intolerance or serious adverse reactions
  • Access barriers that make every-2-week Soliris infusions impractical
  • Prior treatment failure with documented inadequate response

Counterforce Health specializes in helping patients navigate these complex prior authorization requirements, turning insurance denials into targeted, evidence-backed appeals that align with each payer's specific policies.

Gather Required Documentation

Medical Documentation Checklist

For All Indications:

  • Complete medical records and progress notes
  • Confirmed FDA-approved diagnosis with appropriate ICD-10 codes:
    • PNH: D59.5
    • aHUS: D59.3
    • gMG: G70.00 or G70.01
    • NMOSD: G36.0
  • Laboratory results supporting diagnosis
  • Meningococcal vaccination records (MenACWY and MenB) with dates
  • Documentation of REMS program enrollment and patient counseling

Indication-Specific Requirements:

PNH:

  • Flow cytometry showing GPI-anchored protein deficiency
  • LDH ≥1.5 times upper limit of normal
  • Evidence of symptomatic disease (anemia, thrombosis, organ damage)

aHUS:

  • Thrombotic microangiopathy evidence (schistocytes, low platelets, elevated LDH)
  • Acute kidney injury or renal impairment
  • Exclusion of STEC-HUS, TTP, and secondary causes

gMG:

  • Positive AChR antibody test
  • MGFA Class II-IV generalized disease
  • MG-ADL score ≥6
  • Failed standard immunosuppressive therapy

NMOSD:

  • Positive AQP4-IgG antibody
  • Core clinical characteristics (optic neuritis, myelitis, etc.)
  • Relapsing disease history
  • EDSS ≤7.0

Prior Treatment Documentation

Document all previous therapies with:

  • Medication names and doses
  • Treatment duration
  • Clinical response or lack thereof
  • Reasons for discontinuation (failure, intolerance, contraindications)
  • Specific adverse events if applicable

Submit Your Prior Authorization Request

Preferred Submission Method

Use the UnitedHealthcare Provider Portal at UHCprovider.com for fastest processing. The portal provides:

  • Real-time status tracking
  • Confirmation numbers
  • Automated routing to appropriate reviewers

Alternative Submission Options

If portal access isn't available:

  • Phone: Call OptumRx Prior Authorization at 1-800-711-4555 for the correct fax form
  • Fax: Use plan-specific fax numbers provided in denial letters or formulary documents

Complete Request Packet

Your submission should include:

  1. Completed PA form (plan-specific)
  2. Medical necessity letter from prescribing physician
  3. Supporting clinical documentation
  4. Vaccination records
  5. Prior therapy documentation
  6. Relevant laboratory results
  7. REMS compliance documentation
Tip: Incomplete submissions are the most common cause of delays. Double-check that all required fields are filled and all supporting documents are attached.

Follow-Up and Tracking

When to Call

Contact UnitedHealthcare if you haven't received a determination within:

  • 24 hours for urgent requests
  • 72 hours for standard requests

Sample Call Script

"Hello, I'm calling to check on the status of a prior authorization request for Ultomiris (ravulizumab) for patient [name], member ID [number]. The request was submitted on [date]. Can you provide the current status and expected timeline for a decision? If additional information is needed, what specifically is required?"

Document Everything

Keep detailed records of:

  • Confirmation numbers from all submissions
  • Representative names and call dates
  • Reference numbers for follow-up calls
  • Any additional information requests

Typical Timeline Expectations

Standard Processing Times

  • Urgent requests: 24 hours
  • Standard requests: 72 hours (3 business days)
  • Complex cases requiring medical review: Up to 15 calendar days

North Carolina-Specific Timelines

North Carolina insurance law requires insurers to:

  • Acknowledge receipt within 5 business days
  • Issue determination within 30 days for standard requests
  • Process urgent requests within 72 hours

If You Need to Provide More Information

Common Information Requests

UnitedHealthcare may request additional documentation for:

  • Clinical guidelines supporting off-label use
  • Peer-reviewed literature for rare indications
  • Updated laboratory values or imaging
  • Specialist consultation notes
  • Quality of life assessments (MG-ADL, EDSS scores)

How to Respond

Submit additional information promptly through the same channel as your original request. Include:

  • Original confirmation number
  • Clear cover letter explaining what's being provided
  • Organized documentation with clear labels

If Your Request is Denied

Understanding Denial Reasons

Common denial codes include:

  • Medical necessity not established
  • Step therapy requirements not met
  • Incomplete documentation
  • Non-formulary medication
  • Quantity limits exceeded

Internal Appeal Process

UnitedHealthcare allows up to 180 days from denial to file an internal appeal. Submit:

  1. Completed appeal form
  2. Updated medical necessity letter addressing specific denial reasons
  3. Additional clinical evidence
  4. Peer-reviewed literature supporting treatment
  5. Patient impact statement if applicable

Peer-to-Peer Review

Request a peer-to-peer consultation within:

  • 3 business days for inpatient cases
  • 21 calendar days for outpatient cases

Your physician can discuss the case directly with a UnitedHealthcare medical director.

North Carolina External Review

If internal appeals are unsuccessful, North Carolina residents can request external review through Smart NC:

Eligibility Requirements:

  • Completed all internal appeal levels
  • State-regulated plan (not self-funded ERISA plans)
  • Denial based on medical necessity or experimental treatment determination

How to Request:

  • Contact Smart NC at 1-855-408-1212
  • Submit external review request form within 120 days of final internal denial
  • Provide all relevant medical documentation

Timeline:

  • Standard review: Decision within 45 days
  • Expedited review: Decision within 72 hours for urgent cases

The external review decision is binding on UnitedHealthcare.

From our advocates: We've seen patients successfully overturn Ultomiris denials by working closely with their neurologists to document specific functional improvements that only occurred with complement inhibition, particularly when other immunosuppressants had failed. The key was showing measurable outcomes like reduced relapse rates in NMOSD or transfusion independence in PNH, not just clinical stability.

Renewal and Re-authorization

When to Reapply

Most Ultomiris authorizations are approved for 6-12 months. Begin the renewal process 30-45 days before expiration.

Renewal Documentation

Include evidence of:

  • Clinical response to treatment
  • Objective improvement measures:
    • PNH: LDH normalization, reduced transfusions
    • aHUS: Improved renal function, platelet recovery
    • gMG: Improved MG-ADL scores, reduced exacerbations
    • NMOSD: Reduced relapse rate, EDSS stability
  • Continued medical necessity
  • No unacceptable adverse events
  • Updated vaccination status

Quick Reference Checklist

Before Submitting:

  • Verify plan formulary status
  • Confirm step therapy requirements
  • Gather all medical records
  • Document vaccination compliance
  • Complete REMS enrollment

Submission Package:

  • PA form completed in full
  • Medical necessity letter
  • Diagnostic laboratory results
  • Prior treatment failure documentation
  • Vaccination records with dates
  • REMS compliance documentation

After Submission:

  • Record confirmation number
  • Set calendar reminder for follow-up
  • Prepare for potential information requests
  • Know your appeal rights and deadlines

If Denied:

  • Review denial reason carefully
  • File internal appeal within 180 days
  • Consider peer-to-peer review
  • Contact Smart NC if needed (1-855-408-1212)

Counterforce Health transforms the complex prior authorization process into a streamlined pathway to approval. Our platform ingests denial letters, plan policies, and clinical notes to create targeted appeals that align with each payer's specific requirements, significantly improving approval rates for specialty medications like Ultomiris.

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in North Carolina? A: Standard requests typically receive decisions within 72 hours, while urgent requests are processed within 24 hours. Complex cases may take up to 15 days.

Q: What if Ultomiris is non-formulary on my plan? A: You can request a formulary exception with strong medical necessity documentation. Focus on why covered alternatives are inappropriate for your specific condition.

Q: Can I request an expedited appeal? A: Yes, if delays could seriously jeopardize your health. Your physician must document the urgency and submit appropriate clinical justification.

Q: Does step therapy apply if I've failed eculizumab outside North Carolina? A: Prior treatment history from other states is typically accepted. Provide complete documentation of the trial, duration, and reasons for failure.

Q: What's the difference between internal appeals and external review? A: Internal appeals are processed by UnitedHealthcare. External review through Smart NC uses independent medical experts and produces binding decisions.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual plan terms and medical circumstances. Always consult with your healthcare provider and insurance plan for specific guidance. For assistance with insurance appeals and coverage issues in North Carolina, contact Smart NC at 1-855-408-1212.

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