By Counterforce Health Team in Orladeyo (berotralstat) —

Get Orladeyo (berotralstat) Approved by UnitedHealthcare in Virginia: Complete Guide to Prior Authorization, Appeals, and Coverage

Answer Box: Getting Orladeyo (berotralstat) Covered by UnitedHealthcare in Virginia

Orladeyo requires prior authorization from UnitedHealthcare and is subject to step therapy requirements. Most patients must try and fail other HAE prophylaxis drugs first. The fastest path to approval: (1) Have your HAE specialist complete UnitedHealthcare's prior authorization form with documented step therapy failures, (2) Submit comprehensive lab results confirming HAE diagnosis (C4, C1-INH levels), and (3) If denied, file an internal appeal within 180 days, then external review through Virginia's Bureau of Insurance within 120 days. Start today by calling UnitedHealthcare at 1-800-711-4555 to request the current PA form.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Medical Necessity Criteria
  5. Cost and Financial Support
  6. Denials and Appeals
  7. Renewal Requirements
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Frequently Asked Questions

Coverage Basics

Is Orladeyo Covered by UnitedHealthcare?

Orladeyo (berotralstat) is typically excluded from standard UnitedHealthcare formularies but can be covered through exceptions and prior authorization. Coverage varies by specific plan type and may be subject to state mandates in Virginia.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all UHC plans UHC Provider Portal UHC Policy
Step Therapy Must try 2+ alternative HAE drugs first PA form requirements UHC PA Guidelines
Specialty Pharmacy Required dispensing restriction Plan documents UHC Formulary
Age Restriction 12 years or older FDA labeling FDA Package Insert
Quantity Limits Typically 30-day supply Plan formulary UHC Policy

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

  1. Confirm HAE Diagnosis (Patient/Clinician)
    • Required labs: C4, C1-INH antigen and function levels
    • Submit within last 12 months
    • Timeline: 1-2 business days for results
  2. Document Step Therapy Failures (Clinician)
    • Must show trials of 2+ HAE prophylaxis drugs (Takhzyro, Haegarda, Cinryze)
    • Include dates, doses, outcomes, and reasons for discontinuation
    • Timeline: Ongoing documentation needed
  3. Complete Prior Authorization Form (Clinician)
    • Download from UHC Provider Portal
    • Submit via portal or fax (verify current number)
    • Timeline: 15 business days for standard review
  4. Request Peer-to-Peer if Needed (Clinician)
    • Available within 24 hours of initial denial
    • Direct discussion with UHC medical director
    • Timeline: Same-day scheduling possible
  5. File Internal Appeal if Denied (Patient/Clinician)
    • Submit within 180 days of denial (Virginia law)
    • Include additional clinical documentation
    • Timeline: 30 days for standard, 72 hours for urgent
  6. External Review Through Virginia (Patient)
    • File within 120 days after final internal denial
    • Contact Virginia Bureau of Insurance
    • Timeline: 45 days for standard, 72 hours for urgent
  7. Access Patient Support Programs (Patient)
    • Contact Empower Patient Services: 866-536-7693
    • Copay assistance for commercial insurance
    • Timeline: Immediate enrollment possible

Timeline and Urgency

Standard Processing Times

  • Prior Authorization: Up to 15 business days
  • Internal Appeal: 30 calendar days (72 hours if urgent)
  • External Review: 45 days (72 hours if urgent)
  • Peer-to-Peer Review: Within 24-48 hours of request

When to Request Expedited Review

Request urgent processing if delay could:

  • Seriously jeopardize your life or health
  • Significantly impair your ability to regain maximum function
  • Subject you to severe pain that cannot adequately be managed without the treatment
Tip: Your HAE specialist must provide written certification that delay would be detrimental to your health for expedited review approval.

Medical Necessity Criteria

Clinician Corner: Medical Necessity Letter Checklist

For UnitedHealthcare Orladeyo approval, your medical necessity letter should include:

Required Clinical Documentation:

  • ✅ Confirmed HAE diagnosis with lab results (C4, C1-INH levels)
  • ✅ Frequency and severity of HAE attacks (baseline attack rate)
  • ✅ Complete history of prior HAE therapies with specific outcomes
  • ✅ Contraindications or intolerances to injectable therapies
  • ✅ Patient preference rationale for oral vs. injectable therapy
  • ✅ Treatment goals and expected outcomes

Laboratory Requirements:

  • C4 Level: Must be low (typically <10 mg/dL)
  • C1-INH Antigen: Low in Type I HAE, normal/high in Type II
  • C1-INH Function: Low in both Type I and Type II HAE
  • C1q Antigen: Normal (to rule out acquired angioedema)

Step Therapy Requirements

UnitedHealthcare typically requires documented trials and failures of:

  1. Takhzyro (lanadelumab) - subcutaneous injection
  2. Haegarda (C1-INH concentrate) - subcutaneous injection
  3. Cinryze (C1-INH concentrate) - intravenous infusion

Documentation must include:

  • Specific dates of therapy
  • Dosing and duration
  • Clinical outcomes
  • Reasons for discontinuation (efficacy, tolerability, adherence)

Cost and Financial Support

Commercial Insurance Support

Empower Patient Services offers comprehensive support for UnitedHealthcare patients:

  • $0 copay program for eligible commercial patients
  • Benefits investigation and prior authorization assistance
  • Quick Start program for urgent access
  • Contact: 866-536-7693
Note: Copay assistance is not available for Medicare, Medicaid, or other government insurance programs due to federal regulations.

Medicare and Government Insurance

For patients with Medicare or other government coverage:

  • BioCryst Patient Assistance Program provides needs-based support
  • Nonprofit foundations like NORD and HealthWell Foundation may offer grants
  • Contact BioCryst directly for assistance program details

Cost Considerations

  • Wholesale Acquisition Cost: Approximately $44,484 per 28-day supply (2025)
  • Specialty tier placement: Typically 20-50% coinsurance for commercial plans
  • Out-of-pocket maximums apply to specialty medications

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Insufficient step therapy Document specific failures of 2+ alternatives Detailed therapy history with outcomes
Missing HAE diagnosis Submit complete lab workup C4, C1-INH levels, specialist confirmation
Age restriction Confirm patient is ≥12 years old Birth certificate or medical records
Concurrent prophylaxis Discontinue other HAE preventive therapies Provider attestation of medication changes
Inadequate specialist involvement HAE specialist consultation Referral to immunology/allergy specialist

Appeals Playbook for UnitedHealthcare in Virginia

Level 1: Internal Appeal

  • Deadline: 180 days from denial (Virginia law)
  • Decision Timeline: 30 days standard, 72 hours urgent
  • How to File: UHC member portal or written appeal
  • Required: Denial letter, additional medical records, provider letter

Level 2: External Review

  • Deadline: 120 days after final internal denial
  • Decision Timeline: 45 days standard, 72 hours urgent
  • How to File: Virginia Bureau of Insurance Form 216-A
  • Contact: 1-877-310-6560
  • Cost: Free to patient
Important: Virginia's external review decisions are binding on UnitedHealthcare and must be implemented within 24-72 hours of approval.

Renewal Requirements

When Reauthorization is Needed

UnitedHealthcare typically requires Orladeyo reauthorization:

  • Annually for most commercial plans
  • Every 6 months for some Medicaid plans
  • Upon plan changes or formulary updates

Renewal Documentation

  • Updated attack frequency data
  • Continued medical necessity
  • Any changes in health status
  • Confirmation of ongoing specialist care
Note: As of 2025, Orladeyo is not included in OptumRx's list of medications exempt from annual reauthorization requirements.

Specialty Pharmacy Requirements

Why Specialty Pharmacy is Required

Orladeyo is classified as a specialty medication requiring:

  • Temperature-controlled storage
  • Patient education and monitoring
  • Adherence support programs
  • Coordination with healthcare providers

UnitedHealthcare Preferred Specialty Pharmacies

Contact your plan to confirm current preferred specialty pharmacy network. Common options include:

  • OptumRx Specialty Pharmacy
  • Accredo Specialty Pharmacy
  • CVS Specialty
  • Express Scripts Specialty

Troubleshooting Common Issues

Portal and System Issues

UHC Provider Portal Down:

  • Call UnitedHealthcare directly: 1-800-711-4555
  • Submit PA via fax (verify current number with customer service)
  • Request expedited processing if time-sensitive

Missing Prior Authorization Forms:

  • Download latest versions from UHC Provider Portal
  • Contact provider services for form assistance
  • Verify you're using the most current version

Prescription Transfer Issues:

  • Confirm specialty pharmacy is in-network
  • Provide complete insurance information
  • Allow 3-5 business days for transfer processing

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Orladeyo in Virginia? A: Standard PA decisions are made within 15 business days. Urgent requests are processed within 72 hours if medical necessity for expedited review is demonstrated.

Q: What if Orladeyo is non-formulary on my UnitedHealthcare plan? A: Non-formulary drugs can still be covered through formulary exceptions. Submit a detailed medical necessity letter with step therapy documentation and specialist support.

Q: Can I request an expedited appeal if my Orladeyo is denied? A: Yes, if your HAE specialist certifies that delay would jeopardize your health. Expedited appeals are decided within 72 hours at both internal and external review levels.

Q: Does UnitedHealthcare step therapy apply if I failed therapies in another state? A: Yes, documented therapy failures from other states count toward step therapy requirements. Ensure you have complete medical records from previous providers.

Q: What happens if Virginia's external review overturns my denial? A: UnitedHealthcare must authorize coverage within 24 hours for expedited cases or 72 hours for standard cases. The decision is binding and cannot be appealed by the insurer.

Q: Can I use manufacturer copay cards with UnitedHealthcare? A: Yes, if you have commercial UnitedHealthcare coverage. Copay assistance is prohibited for Medicare, Medicaid, and other government insurance programs.

Q: How do I find an HAE specialist in Virginia for my Orladeyo prescription? A: Contact the Hereditary Angioedema Association for specialist referrals, or ask your primary care doctor for a referral to an immunologist or allergist experienced with HAE.

Q: What if my UnitedHealthcare plan changes during Orladeyo treatment? A: Contact your new plan immediately to initiate prior authorization. Provide documentation of current therapy and medical necessity. Consider requesting expedited review to prevent treatment interruption.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, plan policies, and clinical notes to create targeted, evidence-backed appeals that align with each payer's specific requirements. For complex cases like Orladeyo denials, we provide the clinical citations, procedural expertise, and payer-specific workflows needed to maximize approval chances.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeal processes. It is not medical advice and should not replace consultation with your healthcare provider or insurance plan. Coverage policies and procedures may change. Always verify current requirements with UnitedHealthcare and Virginia regulatory authorities. For personalized assistance with insurance appeals, consider consulting with Counterforce Health or other qualified advocacy services.

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