By Counterforce Health Team in Orladeyo (berotralstat) —

Work With Your Doctor to Get Orladeyo (Berotralstat) Approved by UnitedHealthcare in Georgia: Forms, Appeal Scripts, and Clinical Documentation Guide

Answer Box: Getting Orladeyo Covered by UnitedHealthcare in Georgia

Orladeyo (berotralstat) requires prior authorization from UnitedHealthcare with step therapy documentation showing failure or contraindication to first-line HAE prophylaxis treatments. Your allergist/immunologist must submit a medical necessity letter proving ≥1 moderate-to-severe HAE attack monthly and that alternatives like Cinryze or Haegarda haven't worked. If denied, Georgia residents have 60 days to request external review through the Georgia Department of Insurance. Start today: Schedule an appointment with an HAE specialist to document your attack history and begin the prior authorization process.

Table of Contents

  1. Set Your Goal: What Approval Requires
  2. Visit Preparation: Building Your Clinical Case
  3. Evidence Kit: Documentation That Gets Results
  4. Medical Necessity Letter Structure
  5. Peer-to-Peer Review Support
  6. After Your Visit: Following Through
  7. Respectful Persistence: When and How to Follow Up
  8. Appeals Playbook for Georgia Residents
  9. FAQ: Common Questions About Orladeyo Coverage

Set Your Goal: What Approval Requires

UnitedHealthcare requires prior authorization and step therapy documentation for Orladeyo (berotralstat) through their pharmacy benefit manager OptumRx. Your partnership with your doctor is crucial because approval hinges on proving medical necessity through clinical documentation.

Coverage Requirements at a Glance

Requirement What It Means Documentation Needed
HAE Diagnosis Confirmed hereditary angioedema Lab results showing low C4 and C1-INH levels/function
Age Eligibility Patient ≥12 years old Birth date verification
Attack Frequency ≥1 moderate-to-severe attack monthly Attack calendar with dates, severity, locations
Step Therapy Failed or contraindicated alternatives Prior therapy records showing inadequate response
Specialist Care Prescribed by allergy/immunology specialist Provider credentials and referral documentation
Note: UnitedHealthcare's prior authorization requirements are updated annually. Always verify current criteria with your provider portal.

How You'll Partner With Your Provider

Your doctor handles the clinical documentation and prior authorization submission, but your preparation makes their job easier and more likely to succeed. You'll provide the detailed symptom history, treatment timeline, and functional impact data that transforms a routine PA request into a compelling medical necessity case.

Visit Preparation: Building Your Clinical Case

Come to your appointment armed with specific data that proves Orladeyo's medical necessity. Generic descriptions won't cut it—you need concrete details that match UnitedHealthcare's approval criteria.

Symptom Timeline Documentation

Create a detailed attack calendar covering the past 6-12 months:

  • Date of each attack
  • Location (face, throat, abdomen, extremities)
  • Severity (mild, moderate, severe)
  • Duration (hours to resolution)
  • Triggers (stress, trauma, illness)
  • Treatment used (rescue medications, ER visits)
  • Functional impact (missed work/school, hospitalization)

Previous Treatments Tried

Document every HAE therapy you've attempted:

Prophylactic treatments:

  • C1-inhibitor products (Cinryze, Haegarda)
  • Other preventive therapies
  • Dates of use, dosing, duration
  • Specific reasons for discontinuation (inadequate response, side effects, access issues)

On-demand treatments:

  • Icatibant (Firazyr)
  • Ecallantide (Kalbitor)
  • C1-inhibitor concentrates
  • Frequency of use, effectiveness

Side Effects and Contraindications

Be specific about why alternatives didn't work:

  • Injection site reactions
  • Allergic responses
  • Inadequate attack prevention
  • Access or insurance coverage problems
  • Lifestyle incompatibility (frequent travel, needle phobia)

Evidence Kit: Documentation That Gets Results

Gather supporting documents before your visit to streamline the approval process.

Essential Lab Results

Your HAE specialist needs current diagnostic labs:

  • C4 complement levels (typically low in HAE)
  • C1-esterase inhibitor antigenic levels
  • C1-esterase inhibitor functional levels
  • Genetic testing results (if applicable for HAE with normal C1-INH)

Treatment History Summary

Create a one-page summary including:

  • Previous medications with dates, doses, and outcomes
  • Hospitalizations or ER visits for HAE attacks
  • Specialist consultations and recommendations
  • Current symptom severity and frequency

Published Guidelines Support

Your doctor will reference clinical guidelines, but you can help by noting:

  • Family history of HAE (50% inheritance pattern)
  • Pattern of attacks without urticaria (distinguishes from allergic angioedema)
  • Response to previous HAE-specific treatments

Medical Necessity Letter Structure

Your specialist will write the medical necessity letter, but understanding the required elements helps you provide relevant information during your visit.

Required Clinical Documentation Elements

Patient Information:

  • Age verification (≥12 years for Orladeyo)
  • HAE diagnosis with supporting labs
  • Prescriber credentials (board-certified allergist/immunologist)

Medical Necessity Justification:

  • Baseline attack frequency: "≥1 moderate to severe attack per month"
  • Attack characteristics: airway swelling, severe abdominal pain, facial swelling
  • Previous treatment failures or contraindications
  • Recommended dosing: 150 mg orally once daily

Clinical Outcomes for Reauthorization:

  • ≥50% reduction in attack frequency compared to baseline
  • Monthly attack calendar documentation
  • Chart notes showing clinical improvement
  • Continued monitoring for safety and efficacy
Clinician Corner: The UnitedHealthcare medical necessity template provides specific language requirements. Include FDA endpoints: attack number, location, duration, severity, rescue medication use, and healthcare utilization.

Peer-to-Peer Review Support

If UnitedHealthcare requests a peer-to-peer review, you can support your doctor's preparation.

Offering Availability Windows

Let your doctor know when you're available for additional questions or clarifications during the peer-to-peer call, typically scheduled within 7 business days of the request.

Concise Case Summary for Your Provider

Prepare a one-page summary highlighting:

  • Most compelling aspects of your case
  • Specific failures of alternative treatments
  • Functional impact of untreated HAE
  • Why delay in treatment poses health risks

Supporting Your Doctor's Arguments

Be ready to provide additional documentation if requested:

  • Detailed attack diaries
  • Work/school absence records
  • Emergency department visit summaries
  • Quality of life impact statements

After Your Visit: Following Through

Successful approval often requires active follow-up after your initial appointment.

What to Save

Keep copies of:

  • Prior authorization submission confirmation
  • Medical necessity letter
  • Supporting lab results and clinical notes
  • UnitedHealthcare correspondence
  • Attack calendar updates

Patient Portal Communication

Use your healthcare provider's patient portal to:

  • Check prior authorization status
  • Submit additional documentation requests
  • Schedule follow-up appointments
  • Report any urgent changes in symptoms

Tracking Your Request

UnitedHealthcare must respond to prior authorization requests within specific timelines:

  • Standard review: 15 calendar days
  • Expedited review: 72 hours for urgent medical situations

Respectful Persistence: When and How to Follow Up

Professional persistence increases approval chances without damaging relationships.

Follow-Up Cadence

Week 1: Confirm PA submission and completeness Week 2: Check status if no response received Week 3: Request expedited review if medically appropriate Beyond 15 days: Initiate internal appeal process

How to Escalate Politely

With your provider's office:

  • Ask for PA status updates
  • Request peer-to-peer review if initially denied
  • Discuss appeal strategy if needed

With UnitedHealthcare:

  • Use member services to check PA status
  • Request supervisor review for procedural issues
  • File formal complaints for unreasonable delays

Appeals Playbook for Georgia Residents

If UnitedHealthcare denies your Orladeyo request, Georgia residents have specific appeal rights and deadlines.

Internal Appeal Process

Timeline: File within 180 days of denial notice Process: Submit through UnitedHealthcare member portal or by mail Decision time:

  • Standard: 30 days
  • Expedited: 72 hours for urgent situations

Required documents:

  • Denial notice
  • Additional medical records
  • Updated medical necessity letter
  • Attack frequency documentation

External Review Through Georgia Department of Insurance

Deadline: 60 days after internal appeal denial How to file: Georgia DOI complaint process Cost: Free to consumers Timeline: 30 business days for standard review, 72 hours for urgent cases

Contact Information:

  • Website: oci.georgia.gov/file-consumer-insurance-complaint
  • Consumer Services: Available through DOI website for guidance

When External Review Applies

Georgia's external review covers denials based on:

  • Medical necessity determinations
  • Experimental/investigational treatment claims
  • Utilization management decisions
Important: External review decisions are binding on UnitedHealthcare. If the review supports your case, they must cover Orladeyo.

FAQ: Common Questions About Orladeyo Coverage

How long does UnitedHealthcare prior authorization take in Georgia? Standard PA requests: 15 calendar days. Expedited reviews for urgent medical situations: 72 hours. Incomplete submissions may extend timelines.

What if Orladeyo isn't on UnitedHealthcare's formulary? Non-formulary medications require additional documentation proving medical necessity and lack of suitable formulary alternatives. Your doctor may need to request a formulary exception.

Can I request expedited review for Orladeyo? Yes, if waiting for standard review would seriously jeopardize your health. Your doctor must document the urgent medical need in the request.

Does step therapy apply if I've tried treatments outside Georgia? Yes, prior treatment history from any location counts toward step therapy requirements. Provide complete documentation from all previous providers.

What happens if I'm hospitalized for HAE while awaiting approval? Emergency treatment is typically covered regardless of PA status. Use this documentation to support expedited review of your Orladeyo request.

How much does Orladeyo cost without insurance coverage? The wholesale acquisition cost is approximately $44,484 per 28-day supply as of 2025. Patient assistance programs from BioCryst Pharmaceuticals may significantly reduce out-of-pocket costs.

Can my pharmacist help with the prior authorization? Specialty pharmacies often provide PA support services and can coordinate with your doctor's office to ensure complete submissions and timely follow-up.

What if UnitedHealthcare requires quantity limits? Orladeyo's standard dosing is one 150mg capsule daily. If quantity limits are imposed, your doctor can request exceptions based on FDA-approved dosing guidelines.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals through evidence-based advocacy. Their platform streamlines the prior authorization process by identifying denial reasons and crafting targeted rebuttals aligned with each payer's specific requirements.

Getting Orladeyo approved requires thorough preparation, strong clinical documentation, and persistence through the approval process. By working closely with your HAE specialist and understanding UnitedHealthcare's requirements, you can build a compelling case for coverage. Remember that Georgia residents have strong appeal rights through the state Department of Insurance if initial requests are denied.

For additional support with complex prior authorizations and appeals, platforms like Counterforce Health specialize in transforming insurance denials into successful approvals through targeted, evidence-backed advocacy.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Always consult with your healthcare provider and insurance company for guidance specific to your situation. Coverage policies and appeal procedures may change; verify current requirements with official sources.

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