By Counterforce Health Team in Ultomiris (ravulizumab) —

Ultomiris (Ravulizumab) Approval with UnitedHealthcare in Virginia: Answers to the Most Common Questions

Answer Box: Getting Ultomiris Covered by UnitedHealthcare in Virginia

UnitedHealthcare requires prior authorization for Ultomiris (ravulizumab) with step therapy typically mandating prior eculizumab trial first. Submit PA via UnitedHealthcare provider portal with diagnosis confirmation, REMS vaccination records, and clinical rationale. Standard decisions take up to 72 hours; expedited reviews (when medically urgent) within 24-72 hours. If denied, file internal appeal within 180 days, then Virginia external review within 120 days through the State Corporation Commission Bureau of Insurance.

First step today: Have your prescriber check your UnitedHealthcare formulary status and submit prior authorization with complete clinical documentation including meningococcal vaccination records.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria and Requirements
  5. Costs and Financial Assistance
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Virginia-Specific Appeals Rights

Coverage Basics

Is Ultomiris Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Ultomiris (ravulizumab) under the medical benefit (not pharmacy benefit) as a provider-administered infusion for FDA-approved indications including:

  • Paroxysmal nocturnal hemoglobinuria (PNH)
  • Atypical hemolytic uremic syndrome (aHUS) - excluding STEC-HUS
  • Adult acetylcholine receptor antibody-positive generalized myasthenia gravis (gMG)
  • Adult aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD)

Which UnitedHealthcare Plans Cover Ultomiris?

Coverage applies to UnitedHealthcare commercial plans, Medicare Advantage, and Individual & Family Exchange plans in Virginia, all managed through OptumRx prior authorization requirements.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician (typically a hematologist, nephrologist, or neurologist) must submit the PA request through:

  • UnitedHealthcare provider portal (fastest option)
  • Phone: 1-800-711-4555 (OptumRx)
  • Fax: Number provided on denial notices

Required Documentation Checklist

Document Type Specific Requirements Why It's Needed
Diagnosis Confirmation ICD-10 codes, lab results (e.g., flow cytometry for PNH, LDH >1.5x ULN) Proves FDA-labeled indication
REMS Compliance Meningococcal vaccination records (MenACWY, MenB) ≥2 weeks before treatment FDA safety requirement
Clinical Notes Treatment history, symptom severity, functional impact Medical necessity justification
Step Therapy Documentation Eculizumab trial/failure or contraindication rationale UnitedHealthcare policy requirement

Timing and Urgency

Standard Processing Times

  • Initial PA Review: Up to 72 hours for complete submissions
  • Expedited Review: 24-72 hours when medically urgent
  • Appeal Decisions: 30 days standard, 72 hours expedited

When to Request Expedited Review

Request urgent processing if delay could:

  • Seriously jeopardize life or health
  • Cause severe pain that cannot be adequately managed
  • Risk permanent functional impairment

Your prescriber must certify the urgent medical need in writing.

Clinical Criteria and Requirements

Step Therapy Requirements

UnitedHealthcare typically requires prior eculizumab (Soliris) trial unless you can document:

  • Treatment failure: Breakthrough hemolysis, continued transfusion needs
  • Intolerance: Severe infusion reactions, allergic responses
  • Contraindication: Medical reasons preventing eculizumab use
  • Access barriers: Geographic limitations, travel constraints for bi-weekly infusions

REMS (Risk Evaluation and Mitigation Strategy) Compliance

Due to meningococcal infection risk, both prescriber and patient must:

  • Complete REMS certification training
  • Ensure meningococcal vaccination ≥2 weeks before first dose
  • Monitor for signs of serious bacterial infections
  • Maintain vaccination records in medical file
Tip: Download vaccination records from your primary care provider early in the process to avoid delays.

Costs and Financial Assistance

Understanding Your Out-of-Pocket Costs

Since Ultomiris is billed under the medical benefit, you'll typically pay:

  • Medical deductible (if not met)
  • Coinsurance (commonly 10-40% depending on your plan)
  • Costs vary significantly by site of care (hospital outpatient vs. infusion center)

Financial Assistance Options

Commercial Insurance Patients:

Medicare/Medicaid Patients:

  • Manufacturer copay assistance not available
  • Contact Virginia Medicaid or Medicare for coverage details

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn
Missing step therapy Document eculizumab failure/intolerance with clinical notes and lab results
Incomplete REMS Submit vaccination records and REMS certification
Insufficient medical necessity Provide detailed clinical rationale comparing Ultomiris 8-week dosing advantage
Site of care restriction Request medical exception if required site is inappropriate

UnitedHealthcare Internal Appeals Process

Filing Requirements:

  • Deadline: 180 days from denial notice
  • Method: Provider portal, fax, or mail (address on denial letter)
  • Documentation: Original denial, medical records, prescriber letter

Decision Timeframes:

  • Standard appeals: 30 days
  • Expedited appeals: 72 hours (when health at risk)
From our advocates: We've seen strong appeals succeed when prescribers clearly document why the 8-week Ultomiris dosing schedule specifically benefits the patient compared to bi-weekly eculizumab - whether due to travel limitations, work schedules, or improved quality of life that supports better adherence.

Renewal Requirements

When to Reauthorize

Most UnitedHealthcare PAs require renewal every:

  • 6-12 months for initial approvals
  • Annual renewals for stable patients

What Documentation to Update

  • Current clinical status and stability markers
  • Continued medical necessity
  • Any changes in condition or response
  • Updated lab values (LDH, hemoglobin, etc.)

Specialty Pharmacy Requirements

Why Was My Prescription Transferred?

UnitedHealthcare requires Ultomiris dispensing through designated specialty pharmacies (such as Accredo or CenterWell) that:

  • Drop-ship directly to your infusion site
  • Handle prior authorization coordination
  • Manage REMS compliance
  • Provide patient support services

The specialty pharmacy files the drug claim while your provider bills separately for administration.

Troubleshooting Common Issues

Provider Portal Problems

If the UnitedHealthcare portal is down:

  • Call OptumRx directly: 1-800-711-4555
  • Fax submissions to number on denial notice
  • Request confirmation of receipt

Missing Forms or Documentation

Common missing items:

  • Vaccination records (contact primary care provider)
  • Prior therapy documentation (request from previous specialists)
  • Current lab results (coordinate with prescriber)

Virginia-Specific Appeals Rights

Virginia External Review Process

If UnitedHealthcare denies your internal appeal, Virginia law provides independent external review through the State Corporation Commission Bureau of Insurance.

Key Details:

  • Filing deadline: 120 days from final internal denial
  • Form required: Form 216-A (External Review Request)
  • Decision timeframe: 45 days standard, 72 hours expedited
  • Cost: Free to patients
  • Binding: Decision is final and binding on UnitedHealthcare

How to File External Review

  1. Download Form 216-A from the SCC website
  2. Submit to: Virginia SCC Bureau of Insurance, P.O. Box 1157, Richmond, VA 23218
  3. Include: Denial notices, medical records, provider recommendations
  4. Contact: (804) 371-9631 or [email protected] for guidance

Virginia Consumer Protection Resources

  • SCC Bureau of Insurance: Primary regulator for insurance complaints
  • Managed Care Ombudsman: Specialized help with HMO/managed care issues
  • Virginia Poverty Law Center: Legal assistance for coverage appeals

Getting Expert Help

When navigating complex prior authorizations and appeals, many patients and providers turn to specialized services for assistance. Counterforce Health helps patients, clinicians, and specialty pharmacies convert insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

The platform identifies specific denial reasons—whether PA criteria, step therapy, or "not medically necessary" determinations—and incorporates the right evidence including FDA labeling, peer-reviewed studies, and clinical facts like diagnosis codes, prior treatment failures, and dosing rationale. For complex cases like Ultomiris approvals, having professional appeal assistance can significantly improve success rates while saving valuable time for both patients and healthcare providers.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult your healthcare provider for medical decisions and contact UnitedHealthcare directly for plan-specific coverage details.

Sources & Further Reading

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