By Counterforce Health Team in Orladeyo (berotralstat) —

Get Orladeyo (Berotralstat) Covered by Blue Cross Blue Shield in Pennsylvania: Complete Prior Authorization Guide with Appeals Process

Answer Box: Getting Orladeyo Covered by Blue Cross Blue Shield in Pennsylvania

Fastest Path to Approval: Orladeyo requires prior authorization from all Pennsylvania Blue Cross Blue Shield plans. You'll need documented HAE diagnosis with C1-INH testing, evidence of failed injectable prophylaxis (Takhzyro, Haegarda, or Cinryze), and HAE specialist involvement. Start today: Contact your HAE specialist to request a medical necessity letter citing step therapy exceptions under Pennsylvania's 2024 utilization management reforms, then submit through your insurer's provider portal. If denied, Pennsylvania's new external review program overturns 50% of appeals.

Table of Contents

  1. Coverage at a Glance
  2. Policy Overview: Pennsylvania Blue Cross Blue Shield Plans
  3. Medical Necessity Requirements
  4. Step Therapy Requirements & Exceptions
  5. Required Diagnostics & Documentation
  6. Fastest Path to Approval: Step-by-Step
  7. Common Denial Reasons & How to Fix Them
  8. Appeals Playbook for Pennsylvania
  9. Costs & Patient Assistance
  10. FAQ

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all PA BCBS plans Provider portal or PA form BCBS PA Requirements
Formulary Status Non-formulary/Tier 4 Plan formulary document Plan-specific
Step Therapy Must try Takhzyro, Haegarda, or Cinryze first Medical policy FEP Blue Policy
Age Requirement 12 years or older FDA labeling FDA Package Insert
Quantity Limit 84 capsules per 84 days Pharmacy benefit Plan documents
HAE Specialist Required or strongly preferred Medical policy Plan-specific
Appeals Deadline 180 days internal, 4 months external PA Insurance Code PA.gov External Review

Policy Overview: Pennsylvania Blue Cross Blue Shield Plans

Pennsylvania has two major Blue Cross Blue Shield plans: Highmark Blue Shield (western PA, ~31% market share) and Independence Blue Cross (Philadelphia region). Both follow similar prior authorization frameworks but may have slight variations in coverage criteria.

Plan Types Covered:

  • Commercial HMO/PPO plans
  • Medicare Advantage (with Part D)
  • Medicaid managed care (through PA Department of Human Services)

All Pennsylvania Blues participate in the state's enhanced external review program launched in January 2024, giving you stronger appeal rights than most other states.

Note: Policy documents are typically updated quarterly. Always verify current requirements through your specific plan's provider portal or member services.

Medical Necessity Requirements

FDA-Approved Indication

Orladeyo is approved for routine prevention of hereditary angioedema (HAE) attacks in patients 12 years and older. It's not approved for acute treatment of attacks.

Core Coverage Criteria

Based on FEP Blue's policy and typical BCBS requirements, Orladeyo may be considered medically necessary when:

  1. Age: Patient is 12 years or older
  2. Diagnosis: Confirmed HAE with appropriate laboratory testing
  3. Prevention Use: For routine prophylaxis, not acute treatment
  4. Efficacy: Patient has experienced significant reduction in HAE attack frequency
  5. No Dual Therapy: Not used concurrently with other HAE prevention agents

HAE Specialist Requirement

Most Pennsylvania BCBS plans require or strongly prefer:

  • Initial diagnosis confirmation by HAE specialist or immunologist
  • Specialist prescription (not primary care)
  • Ongoing specialist monitoring as condition of continued coverage

Step Therapy Requirements & Exceptions

Required Failed Therapies

You must document inadequate response, intolerance, or contraindication to:

Injectable Prophylaxis Options:

  • Takhzyro (lanadelumab) - subcutaneous injection every 2-4 weeks
  • Haegarda (C1-INH concentrate) - subcutaneous injection twice weekly
  • Cinryze (C1-INH concentrate) - intravenous infusion every 3-4 days

Documentation Requirements

For each failed therapy, include:

  • Specific dates of treatment
  • Dosing and duration attempted
  • Clinical outcomes (attack frequency/severity)
  • Detailed reason for discontinuation
  • Supporting clinical notes

Pennsylvania Step Therapy Protections

Pennsylvania's 2024 utilization management reforms provide enhanced step therapy override protections. You can request exceptions for:

  • Medical contraindications
  • Drug interactions
  • Documented intolerance
  • Therapeutic failure of required medication

Required Diagnostics & Documentation

Laboratory Testing

C1-Inhibitor Testing (within 12 months):

  • C1-INH quantitative (antigenic) levels
  • C1-INH functional activity
  • C4 complement levels

Diagnostic Patterns:

  • Type I HAE: Low C1-INH quantity and function, low C4
  • Type II HAE: Normal/elevated C1-INH quantity, low function, low C4
  • HAE-nC1INH: Normal C1-INH levels/function; genetic testing required

Clinical Documentation

  • Baseline attack frequency and severity
  • Impact on quality of life
  • Emergency department visits or hospitalizations
  • Response to acute treatments (if any)

Fastest Path to Approval: Step-by-Step

  1. Gather Documentation (Patient + Clinic)
    • Insurance card and policy details
    • Complete HAE diagnostic testing results
    • Documentation of failed injectable therapies
    • Timeline: 1-2 weeks
  2. HAE Specialist Consultation (Clinic)
    • Schedule appointment if not already established
    • Request comprehensive medical necessity letter
    • Timeline: 2-4 weeks for new patients
  3. Submit Prior Authorization (Clinic)
    • Use BCBS provider portal or PA form
    • Include all required documentation
    • Timeline: Same day submission
  4. BCBS Review Process (Insurer)
    • Standard review: 15 business days maximum
    • Expedited review: 72 hours (if urgent)
    • Timeline: Per Pennsylvania law
  5. If Approved (Pharmacy)
    • Fill prescription at specialty pharmacy
    • Coordinate with BioCryst patient support
    • Timeline: 1-3 days
  6. If Denied (Patient + Clinic)
    • Request internal appeal within 180 days
    • Gather additional supporting evidence
    • Timeline: 30 days for decision
  7. External Review (Pennsylvania)
    • File with PA Insurance Department within 4 months
    • Independent medical review
    • Timeline: 45 days for standard review

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Insufficient step therapy Provide detailed failure documentation Clinical notes showing inadequate response or intolerance to Takhzyro, Haegarda, or Cinryze
Age under 12 Appeal if patient is 12+ Birth certificate or medical record confirming age
Lack of HAE specialist Obtain specialist consultation Referral to HAE center or immunologist
Incomplete diagnosis Submit full testing panel C1-INH levels, function, C4, and genetic testing if needed
Concurrent prophylaxis Discontinue other HAE preventive therapy Documentation of medication discontinuation
Requested for acute use Clarify prophylactic indication Specialist letter confirming long-term prevention use

Appeals Playbook for Pennsylvania

Internal Appeals Process

Level 1: Standard Internal Appeal

  • Deadline: 180 days from denial
  • Timeline: 30 days for decision (15 days for PA/referral denials)
  • How to File: BCBS member portal, phone, or written request
  • Required: Denial letter, supporting medical records, physician statement

Level 2: Independent Review (If Available)

  • Some BCBS plans offer second-level internal review
  • Timeline: Additional 30 days
  • Escalation: Automatic or upon request

Pennsylvania External Review Program

Eligibility: After receiving Final Adverse Benefit Determination from internal appeals

How to File:

  • Online: PA.gov External Review Portal
  • Mail: Pennsylvania Insurance Department, External Review Program
  • Deadline: 4 months from final internal denial

Process:

  • Day 1-5: PID determines eligibility
  • Day 6-20: Submit additional medical information (optional)
  • Day 21-45: Independent Review Organization (IRO) decision

Success Rate: Pennsylvania's program overturned 50% of appealed denials in 2024 (259 out of 517 appeals).

From Our Advocates: We've seen Pennsylvania external reviews succeed when patients provide comprehensive documentation showing how Orladeyo specifically addresses their clinical needs that injectable therapies couldn't meet. The independent physicians reviewing these cases often understand the practical challenges of frequent injections for HAE patients.

Expedited Appeals

Available when delay would jeopardize health or ability to function:

  • Internal: 72 hours
  • External: 72 hours for IRO decision

Costs & Patient Assistance

Orladeyo Pricing

  • Wholesale Acquisition Cost: $44,484.33 per 28-day supply (2025)
  • Annual Cost: Approximately $580,000+ without insurance

Patient Support Programs

BioCryst Patient Assistance:

  • Phone: 1-866-536-7693
  • Copay assistance for commercially insured patients
  • Free drug program for uninsured/underinsured

Third-Party Foundations:

  • NORD Patient Assistance: Disease-specific grants
  • HealthWell Foundation: HAE-specific assistance program
  • Patient Access Network (PAN): Copay assistance

Pennsylvania-Specific Resources

  • PA Insurance Department Consumer Services: Help with appeals process
  • Pennsylvania Health Law Project: Free legal assistance for complex cases
  • Pennie Consumer Hotline: For marketplace plan issues

FAQ

How long does BCBS prior authorization take in Pennsylvania? Standard PA requests take up to 15 business days. Expedited requests (when delay would jeopardize health) must be decided within 72 hours per Pennsylvania law.

What if Orladeyo is non-formulary on my plan? Non-formulary medications can be covered through medical exception processes. You'll need to demonstrate medical necessity and typically complete step therapy requirements.

Can I request an expedited appeal if my HAE is severe? Yes. If your HAE specialist certifies that delay would jeopardize your health or ability to function, you can request expedited internal (72 hours) and external (72 hours) appeals.

Does step therapy apply if I failed injectable therapies in another state? Yes, properly documented therapy failures from other states should count toward Pennsylvania step therapy requirements. Ensure you have complete clinical records.

What happens if my appeal is successful? If your internal or external appeal is successful, BCBS must immediately provide coverage, including retroactive coverage for any out-of-pocket payments made during the appeal.

How do I find an HAE specialist in Pennsylvania? Contact the Hereditary Angioedema Association for a list of HAE treatment centers. Major centers include University of Pennsylvania and UPMC.

Can my primary care doctor prescribe Orladeyo? While technically possible, most BCBS plans require or strongly prefer HAE specialist involvement for prior authorization approval.

What if I'm on Medicare in Pennsylvania? Medicare Part D plans have different appeals processes. You'll go through the Medicare appeals system rather than Pennsylvania's external review program.

About Counterforce Health

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. The platform ingests denial letters, plan policies, and clinical notes, then identifies the denial basis and drafts point-by-point rebuttals aligned to the plan's own rules, pulling the right citations and weaving them into appeals with required clinical facts.

Sources & Further Reading

Disclaimer: This article provides general information about insurance coverage and appeals processes. It is not medical advice or a guarantee of coverage outcomes. Always consult with your healthcare provider about treatment decisions and contact your insurance plan directly for current policy information. For personalized help with appeals, consider contacting Counterforce Health or the Pennsylvania Health Law Project.

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