By Counterforce Health Team in Orladeyo (berotralstat) —

The Requirements Checklist to Get Orladeyo (berotralstat) Covered by UnitedHealthcare in Texas: Forms, Appeals, and Timeline

Answer Box: Getting Orladeyo Covered by UnitedHealthcare in Texas

UnitedHealthcare requires prior authorization for Orladeyo (berotralstat) in Texas. The fastest path: (1) Confirm HAE diagnosis with C1-INH lab results, (2) Submit OptumRx PA form with complete clinical documentation, (3) Use electronic submission for 24-72 hour decisions. New users may face step therapy requiring trial/failure of preferred HAE prophylaxis agents first. Start by downloading the UnitedHealthcare Orladeyo PA form.

Table of Contents

  1. Who Should Use This Checklist
  2. Member & Plan Basics
  3. Clinical Criteria Requirements
  4. Coding and Documentation
  5. Documentation Packet Essentials
  6. Submission Process
  7. Specialty Pharmacy Requirements
  8. After Submission: What to Expect
  9. Common Denial Prevention Tips
  10. Appeals Process in Texas
  11. Costs and Patient Support
  12. Quick Reference Checklist

Who Should Use This Checklist

This guide is designed for:

  • Patients with hereditary angioedema (HAE) needing Orladeyo prophylaxis
  • Clinicians submitting prior authorization requests to UnitedHealthcare
  • Specialty pharmacy staff coordinating HAE medication access
  • Patient advocates helping navigate coverage challenges

Expected outcome: With complete documentation following this checklist, most medically appropriate Orladeyo requests receive approval within 24-72 hours through UnitedHealthcare's electronic system.

Member & Plan Basics

Coverage Requirements

  • Active UnitedHealthcare coverage through commercial, Medicare Advantage, or Medicaid plans
  • Prior authorization mandatory for all Orladeyo prescriptions
  • Specialty pharmacy dispensing required for commercial plans
  • Age requirement: Patient must be 12 years or older

Plan-Specific Considerations

UnitedHealthcare implemented step therapy requirements for Medicare Advantage Part B starting January 1, 2025. Existing users with documented current use are exempt, but new users may need to try preferred HAE agents first.

Clinical Criteria Requirements

Primary Indication

Orladeyo must be prescribed for prophylaxis of hereditary angioedema attacks in patients 12 years and older. It cannot be used for:

  • Acute HAE attack treatment
  • Combination with other HAE prophylactic therapies (Takhzyro, Haegarda, Cinryze)

Diagnosis Confirmation Required

UnitedHealthcare requires objective laboratory evidence of HAE:

HAE Type C4 Level C1-INH Antigenic C1-INH Functional Required Documentation
Type I Low Low Low Lab results with reference ranges
Type II Low Normal/High Low Lab results with reference ranges
Normal C1-INH HAE Normal Normal Normal Genetic testing results

Essential tests: C4 complement, C1-INH quantitative and functional assays. For patients with normal C1-INH levels, genetic testing may be required to confirm HAE with normal C1-INH.

Step Therapy Considerations

New UnitedHealthcare members may need to demonstrate trial and failure of preferred HAE prophylaxis agents. Document any:

  • Previous HAE medications tried and reasons for discontinuation
  • Contraindications to preferred therapies
  • Clinical reasons why Orladeyo is most appropriate

Coding and Documentation

ICD-10 Code

  • D84.1 - Hereditary angioedema

NDC and Billing

  • NDC: Use the specific NDC from the dispensed Orladeyo package (commonly 75788-150-01 for 30 capsules)
  • No unique HCPCS J-code exists for Orladeyo as of 2025
  • Billing method: Through pharmacy benefit using NDC

Required Clinical Documentation

  • HAE attack frequency (typically ≥2 attacks per month)
  • Specialist involvement (allergist/immunologist consultation recommended)
  • Treatment goals and expected outcomes

Documentation Packet Essentials

Medical Necessity Letter Components

Your clinician's letter should include:

  1. Patient demographics and insurance information
  2. Confirmed HAE diagnosis with specific lab values and dates
  3. Attack frequency and severity with specific examples
  4. Prior therapy history including dates, doses, and outcomes
  5. Clinical rationale for Orladeyo specifically
  6. Contraindications to alternative therapies if applicable
  7. Prescriber credentials and specialty

Required Attachments

  • Laboratory results (C1-INH levels, C4, genetic testing if applicable)
  • Specialist consultation notes
  • Prior therapy documentation
  • Attack diary or clinical notes documenting frequency
Clinician Corner: Medical Necessity Essentials

Include specific attack details: "Patient experiences 3-4 HAE attacks monthly affecting face/throat requiring emergency care." Reference FDA labeling for Orladeyo prophylactic indication. Document any contraindications to preferred alternatives like Takhzyro or Haegarda.

Submission Process

  • Fastest processing: 24-72 hours for complete submissions
  • Portal access: UnitedHealthcare Provider Portal
  • Electronic PA system: PreCheck Prior Authorization available

Alternative Submission Methods

Common Submission Errors to Avoid

  • Incomplete diagnosis documentation
  • Missing specialist consultation
  • Incorrect age documentation
  • Failure to address step therapy requirements

Specialty Pharmacy Requirements

UnitedHealthcare requires Orladeyo to be dispensed through designated specialty pharmacy vendors for commercial plans.

Preferred Vendor Coordination

  • Contact UnitedHealthcare Provider Services using the number on the member ID card
  • Coordinate with Empower Patient Services for shipment and financial assistance
  • Verify specialty pharmacy can bill UnitedHealthcare directly

Texas-Specific Requirements

The specialty pharmacy protocol applies to most UnitedHealthcare commercial plans in Texas, with exceptions for UnitedHealthcare West, UMR, Student Resources, and UnitedHealthOne plans.

After Submission: What to Expect

Decision Timelines

  • Electronic submissions: 24-72 hours
  • Standard submissions: Up to 72 hours
  • Expedited requests: Within 24 hours with clinical urgency documentation

Status Tracking

  • Record confirmation numbers from all submissions
  • Check status through UnitedHealthcare Provider Portal
  • Document all communications with reference numbers

What to Record

  • Submission date and method
  • Confirmation or reference numbers
  • Follow-up call dates and representatives spoken with
  • Any additional information requested

Common Denial Prevention Tips

Common Denial Reason Prevention Strategy Required Documentation
Insufficient diagnosis proof Submit complete lab panel C1-INH levels, C4, genetic testing if needed
Missing specialist involvement Include consultation notes Allergist/immunologist evaluation
Step therapy not addressed Document prior failures Previous HAE medication trials and outcomes
Age requirement not met Verify patient age ≥12 years Birth date documentation
Combination therapy concern Confirm no concurrent prophylaxis Current medication list

Five Critical Pitfalls

  1. Incomplete lab documentation - Always include reference ranges and dates
  2. Missing step therapy justification - Address why preferred agents aren't suitable
  3. Vague attack documentation - Provide specific frequency and severity details
  4. Wrong submission method - Use electronic portal when possible for faster processing
  5. Outdated forms - Always download the most current PA form

Appeals Process in Texas

If your Orladeyo request is denied, Texas law provides strong appeal rights for state-regulated health plans.

Internal Appeals

  • Deadline: 180 days from denial date
  • Timeline: 30 days for pre-service requests
  • Submission: UnitedHealthcare appeals department via portal, fax, or mail

External Review (Texas)

After internal appeal denial, request Independent Review Organization (IRO) review:

  • Deadline: 4 months from final internal denial
  • Timeline: 20 days for standard review, 5 days for urgent cases
  • Cost: Paid by UnitedHealthcare
  • Binding decision: IRO ruling is final

Texas Resources for Help

  • Texas Department of Insurance: 1-800-252-3439
  • Office of Public Insurance Counsel: 1-877-611-6742
  • IRO Information Line: 1-866-554-4926
Note: ERISA self-funded employer plans, Medicare, and Medicaid follow federal appeal processes, not Texas state IRO procedures.

Costs and Patient Support

Manufacturer Support

Empower Patient Services provides:

  • Insurance navigation assistance
  • Copay support programs for eligible patients
  • Specialty pharmacy coordination
  • Prior authorization support

Financial Assistance Options

  • Patient assistance programs through BioCryst Pharmaceuticals
  • Foundation grants for HAE patients
  • State pharmaceutical assistance programs

WAC pricing: Approximately $44,484 per 28-day supply (2025), but patient assistance programs significantly reduce out-of-pocket costs for eligible individuals.

Quick Reference Checklist

Before Submission:

  • Confirmed HAE diagnosis with lab results
  • Patient age ≥12 years documented
  • Specialist consultation obtained
  • Attack frequency documented (≥2/month typically required)
  • Prior therapy history compiled
  • Step therapy requirements addressed
  • Current UnitedHealthcare PA form downloaded

Documentation Packet:

  • Completed PA form
  • Medical necessity letter
  • Lab results (C1-INH, C4, genetic testing if needed)
  • Specialist consultation notes
  • Prior medication trial documentation
  • Attack diary or frequency documentation

Submission:

  • Electronic portal used (preferred)
  • Confirmation number recorded
  • Follow-up scheduled for 72 hours
  • Specialty pharmacy contacted if approved

Getting insurance coverage for specialty medications like Orladeyo can feel overwhelming, but with the right documentation and persistence, most medically appropriate requests are ultimately approved. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and drafting point-by-point rebuttals aligned to each plan's specific requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance requirements change frequently. Always verify current policies with UnitedHealthcare and consult your healthcare provider for medical decisions. For personalized insurance appeal assistance, consider contacting Counterforce Health or other qualified patient advocacy services.

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