By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Covered by Blue Cross Blue Shield in New Jersey: Complete Prior Authorization & Appeals Guide

Answer Box: Getting Orladeyo Covered by Blue Cross Blue Shield in New Jersey

Horizon Blue Cross Blue Shield of New Jersey requires prior authorization for Orladeyo (berotralstat), a specialty-tier drug for HAE prophylaxis in patients ≥12 years old. The fastest path to approval: (1) Have your allergist/immunologist submit prior authorization via Horizon's provider portal with documented HAE diagnosis (low C1-INH/C4 levels), attack logs, and prior therapy failures; (2) Use an in-network specialty pharmacy like Accredo or CVS Caremark; (3) If denied, file internal appeals within 180 days, then external review through New Jersey's IHCAP program. Start today by calling your doctor to gather C1-INH lab results and attack frequency records.

Table of Contents

Plan Types & Network Implications

Horizon Blue Cross Blue Shield of New Jersey operates several plan types that affect how you access Orladeyo:

  • HMO plans: Require referrals to specialists; your primary care doctor must refer you to an allergist/immunologist for HAE management
  • PPO/EPO plans: Allow direct specialist access without referrals, streamlining the path to HAE care
  • Marketplace plans: Follow federal essential health benefits but may have different formulary tiers
  • Medicare Advantage: Subject to Medicare Part D rules with different appeal timelines

All plan types require you to use Horizon's contracted specialty pharmacy network for Orladeyo. Out-of-network fills aren't covered, even with prior authorization.

Formulary Status & Tier Placement

Orladeyo appears on Horizon BCBSNJ formularies as a specialty-tier, non-preferred drug requiring prior authorization. This means:

Coverage Aspect Details
Formulary Status Covered but non-preferred
Tier Specialty (highest cost-sharing)
Prior Authorization Required for all new starts
Quantity Limits 30 capsules per 30 days (150mg daily max)
Step Therapy May require trials of preferred alternatives first

Alternative HAE prophylaxis options on Horizon's formulary include Takhzyro (lanadelumab), Haegarda, and Cinryze, which may have different tier placements or requirements.

Prior Authorization Requirements

Horizon BCBSNJ requires comprehensive documentation for Orladeyo approval:

Core Documentation Requirements

Requirement Specific Details
HAE Diagnosis Low C1-INH levels (functional/antigenic), low C4, or genetic testing (SERPING1/F12 mutations)
Age Verification Patient ≥12 years old per FDA approval
Specialist Prescription Must be prescribed by allergist/immunologist with HAE expertise
Attack Documentation Frequency logs showing ≥1 attack every 4 weeks or severe episodes requiring medical intervention
Prior Therapy History Documentation of inadequate response, intolerance, or contraindications to preferred alternatives
Medical Necessity Letter Detailed clinical rationale from prescribing specialist

Medical Necessity Letter Checklist

Your allergist/immunologist should include:

  • HAE type (I, II, or normal C1-INH) with supporting lab values
  • Attack frequency, severity, and impact on daily activities
  • Prior prophylaxis trials with specific durations and failure reasons
  • Contraindications to injectable options (if applicable)
  • Treatment goals and monitoring plan
  • References to FDA labeling and HAE management guidelines

Specialty Pharmacy Requirements

Orladeyo must be dispensed through Horizon's contracted specialty pharmacy network. These pharmacies provide enhanced services including:

  • 24/7 pharmacist access for questions
  • Home delivery and physician office delivery
  • Refill reminders and adherence monitoring
  • Insurance coverage verification and prior authorization support

In-Network Specialty Pharmacies

Pharmacy Phone Number
Accredo Health Group 866-515-1437
CVS Caremark Specialty 800-237-2767
Walgreens Specialty 866-823-9575
Optum Pharmacy 855-427-4682
BioPlus Specialty 866-841-4714
Note: Some employer plans may restrict to specific pharmacies. Verify your plan's requirements by calling the pharmacy services number on your insurance card.

Step-by-Step: Fastest Path to Approval

1. Gather Required Documentation

Who: Patient and clinic staff
What: Insurance card, C1-INH/C4 lab results, attack diary, prior medication records
Timeline: 1-2 days

2. Schedule HAE Specialist Consultation

Who: Patient
What: Appointment with allergist/immunologist experienced in HAE
Timeline: 1-4 weeks (may vary by specialist availability)

3. Specialist Submits Prior Authorization

Who: Prescribing physician
What: Complete PA request via Horizon provider portal or MagellanRx (1-800-424-4508)
Timeline: Same day submission recommended

4. PA Review Process

Who: Horizon/MagellanRx utilization management
What: Clinical review of submitted documentation
Timeline: 72 hours standard, 24 hours expedited

5. If Approved: Specialty Pharmacy Setup

Who: Patient
What: Contact assigned specialty pharmacy for prescription fulfillment
Timeline: 1-3 business days for first fill

6. If Denied: Internal Appeal

Who: Patient or physician
What: Submit appeal with additional clinical evidence
Timeline: File within 180 days of denial

7. External Review (If Needed)

Who: Patient
What: File with New Jersey IHCAP through Maximus
Timeline: Within 180 days of final internal denial

Common Denial Reasons & Fixes

Denial Reason How to Overturn
Insufficient HAE documentation Submit complete C1-INH functional and antigenic levels, C4, and genetic testing results
Age <12 years Orladeyo is only FDA-approved for patients ≥12; consider alternative HAE prophylaxis
Step therapy not completed Document trials and failures of Takhzyro, Haegarda, or Cinryze with specific durations and reasons for discontinuation
Concurrent prophylaxis Discontinue other HAE prophylaxis medications; Orladeyo should be used as monotherapy
Inadequate specialist involvement Ensure prescription comes from allergist/immunologist with HAE expertise
Missing medical necessity Provide detailed letter addressing attack frequency, severity, and impact on quality of life

Appeals Process in New Jersey

New Jersey provides robust appeal rights for denied specialty medications through a two-tier internal process followed by external review.

Internal Appeals

Appeal Level Filing Deadline Decision Timeline Required Documents
First Level 180 days from denial 30 days (72 hours expedited) Appeal form, denial letter, medical records
Second Level After first denial 15 days (72 hours expedited) Additional clinical evidence, peer-reviewed studies

Submit internal appeals using Horizon's Appeal/Dispute Form with supporting documentation.

External Review (IHCAP)

If internal appeals are unsuccessful, New Jersey's Independent Health Care Appeals Program (IHCAP) provides free external review with approximately 50% success rates for patients.

Key Details:

  • Filing deadline: 180 days from final internal denial
  • Cost: Free to patients
  • Contact: Maximus Federal Services at 1-888-393-1062
  • Timeline: 45 days for standard review, expedited for urgent cases
  • Success rate: Approximately 50% of appeals favor patients

Required documents:

  • Completed IHCAP application
  • Final denial letter from Horizon
  • Complete medical records
  • Physician support letter
  • Relevant clinical studies or guidelines

Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes for specialty medications like Orladeyo. Their platform can help identify denial reasons and craft evidence-backed appeals that address payer-specific requirements.

Cost-Share Dynamics & Assistance

Orladeyo's wholesale acquisition cost is approximately $44,484 per 28-day supply as of 2025. Your out-of-pocket costs depend on your specific Horizon plan:

Typical Cost Structure

  • Specialty tier deductible: Applied first (varies by plan)
  • Coinsurance: Usually 25-40% for specialty drugs
  • Out-of-pocket maximum: Caps annual spending (ACA plans: ~$9,450 individual)

Cost Assistance Options

BioCryst Empower Patient Services (866-536-7693):

  • $0 copay card for commercially insured patients
  • Free drug program for uninsured/underinsured patients
  • Quick Start program for temporary supply during PA review

Additional Resources:

  • Patient Advocate Foundation: Financial assistance for qualifying patients
  • HealthWell Foundation: Grants for rare disease medications
  • New Jersey pharmaceutical assistance programs

When to Escalate

Contact these resources if you encounter persistent coverage issues:

  • New Jersey Department of Banking and Insurance: 1-800-446-7467 for consumer assistance
  • IHCAP Hotline: 1-888-393-1062 for external review questions
  • Horizon Member Services: Number on your insurance card for plan-specific issues

Consider escalation if:

  • PA decisions exceed required timeframes (72 hours standard, 24 hours expedited)
  • Appeals are processed improperly or miss deadlines
  • You're denied access to specialty pharmacy network

FAQ

How long does Horizon BCBSNJ prior authorization take for Orladeyo? Standard PA decisions are required within 72 hours. Expedited requests (when delay could harm your health) must be decided within 24 hours per New Jersey law.

What if Orladeyo isn't on my specific Horizon formulary? You can request a formulary exception by demonstrating medical necessity and that preferred alternatives are inappropriate. Include documentation of failed trials or contraindications.

Can I request expedited appeals in New Jersey? Yes, if delaying treatment could seriously harm your health. Both internal appeals and IHCAP external reviews offer expedited timelines for urgent cases.

Does step therapy apply if I've tried alternatives outside New Jersey? Yes, document all prior HAE prophylaxis trials regardless of where they occurred. Include medical records showing durations, dosages, and reasons for discontinuation.

What happens if IHCAP overturns Horizon's denial? Horizon must comply with IHCAP decisions and provide coverage. The external review decision is legally binding on the insurer.

Can my doctor help with the appeals process? Absolutely. Physicians can file appeals on your behalf and provide peer-to-peer consultations with Horizon's medical directors to discuss clinical rationale.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. Their platform ingests denial letters, plan policies, and clinical notes to identify denial reasons and draft point-by-point rebuttals aligned with each payer's specific requirements. By pulling the right clinical evidence and weaving it into appeals that meet procedural requirements, Counterforce Health helps reduce the back-and-forth that delays patient access to critical medications.

Sources & Further Reading

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

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