By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (berotralstat) Covered by Blue Cross Blue Shield in Washington: Prior Authorization, Appeals, and Cost Assistance Guide

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

Orladeyo (berotralstat) requires prior authorization from Blue Cross Blue Shield plans in Washington, with coverage typically requiring confirmed HAE diagnosis, age ≥12 years, and prophylaxis indication. Your fastest path to approval:

  1. Gather documentation: HAE diagnosis with C1-INH/C4 lab results, attack frequency records, and prior therapy history
  2. Submit PA through specialty pharmacy: Most BCBS plans require specialty pharmacy dispensing with comprehensive PA submission
  3. Appeal if denied: Washington law provides 180-day appeal window with external review through the Office of the Insurance Commissioner

Start today by calling the number on your BCBS ID card to confirm your specific plan's formulary status and PA requirements.

Table of Contents

Understanding Your BCBS Coverage for Orladeyo

Blue Cross Blue Shield plans in Washington—including Premera Blue Cross and Regence BlueShield—typically classify Orladeyo as a specialty drug requiring prior authorization. The medication appears on formularies as non-preferred with specific restrictions:

  • Prior Authorization (PA): Required for all new starts
  • Quantity Limits: Usually 30 capsules per 30 days
  • Specialty Pharmacy: Must be dispensed through designated specialty pharmacies
  • Tier Placement: High-tier specialty with significant cost-sharing

Coverage at a Glance

Requirement Details Where to Verify
PA Required Yes, for all new prescriptions BCBS formulary lookup
Age Restriction ≥12 years Plan medical policy
Indication HAE prophylaxis only (not acute treatment) FDA labeling requirements
Quantity Limit 30 capsules/30 days Member portal or pharmacy benefits
Specialty Pharmacy Required through network providers Call member services
Appeal Deadline 180 days from denial in Washington WA Insurance Commissioner

Prior Authorization Requirements

Clinical Documentation Needed

Your prescriber must submit comprehensive documentation including:

Diagnosis Requirements:

  • Confirmed hereditary angioedema (HAE) Type I or II
  • Laboratory evidence: Low C1-INH levels and/or C4 levels
  • Genetic testing results (if applicable for HAE with normal C1-INH)
  • Documentation of recurrent angioedema episodes

Treatment History:

  • Frequency and severity of HAE attacks (typically ≥1 attack per month)
  • Previous prophylactic treatments tried and outcomes
  • Contraindications or intolerances to alternative therapies
  • Emergency department visits or hospitalizations due to HAE

Clinical Rationale:

  • Why prophylaxis is medically necessary
  • Why Orladeyo is preferred over alternatives like Takhzyro or Haegarda
  • Dosing plan (110mg or 150mg daily)
  • Monitoring plan for effectiveness and safety
Clinician Corner: Include specific attack frequency data (e.g., "Patient experienced 4 HAE attacks in the past 3 months requiring emergency care") and reference the World Allergy Organization guidelines for HAE prophylaxis selection criteria.

Step-by-Step Approval Process

Step 1: Verify Coverage and Benefits

Who: Patient or caregiver
Timeline: Same day
Action: Call the member services number on your BCBS ID card and ask:

  • "Is Orladeyo on my plan's formulary?"
  • "What tier is it on and what's my cost-sharing?"
  • "Which specialty pharmacies are in-network for Orladeyo?"
  • "What PA criteria must be met?"

Step 2: Connect with Specialty Pharmacy

Who: Patient with prescriber's office
Timeline: 1-2 business days
Action: Contact your plan's preferred specialty pharmacy (often Accredo for BCBS plans). They will:

  • Run a comprehensive benefits investigation
  • Coordinate PA submission with your prescriber
  • Enroll you in manufacturer assistance programs
  • Handle prior authorization appeals if needed

Step 3: Clinical Documentation Submission

Who: Prescriber's office
Timeline: 3-5 business days
Action: Your healthcare provider submits PA request including all required clinical documentation. Ensure they include:

  • Complete HAE diagnosis workup
  • Attack frequency logs
  • Previous treatment history
  • Medical necessity justification

Step 4: PA Review and Decision

Who: BCBS medical review team
Timeline: 5-10 business days (72 hours if expedited)
Action: Plan reviews submission and issues approval or denial. If urgent, request expedited review due to potential for life-threatening laryngeal attacks.

Cost Reduction Strategies

Manufacturer Assistance Programs

BioCryst Empower Patient Services offers comprehensive support for Orladeyo patients:

  • Copay Card: Reduces copays to $0 for commercially insured patients (annual maximum applies)
  • Patient Assistance Program: Free medication for uninsured or underinsured patients meeting income criteria
  • Quick Start Program: Bridge supply while coverage is being arranged

Contact: Call 866-5-EMPOWER (866-536-7693) or visit orladeyo.com

Important: Copay cards cannot be used with Medicare, Medicaid, or other government insurance due to federal anti-kickback regulations.

Independent Foundation Assistance

The US Hereditary Angioedema Association (US HAEA) provides personalized reimbursement support:

  • Insurance navigation assistance
  • Appeal support and documentation help
  • Connection to independent copay foundations
  • Contact: (866) 798-5598

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to craft point-by-point rebuttals aligned with your specific BCBS plan's criteria, incorporating the right clinical evidence and procedural requirements for Washington appeals.

Formulary Exception Requests

If Orladeyo is non-formulary or on a high tier, request a formulary exception by demonstrating:

  • Medical necessity for Orladeyo specifically
  • Contraindications or failures with preferred alternatives
  • Clinical evidence supporting superior outcomes
  • Cost-effectiveness compared to emergency treatments

Appeals Process in Washington

Washington provides strong consumer protections for insurance denials, with multiple appeal levels and external review rights.

Internal Appeals (Level 1)

Timeline: Must file within 180 days of denial
Decision: 30 days (72 hours if expedited)
How to File:

  • Submit written appeal to address on denial letter
  • Include: denial notice copy, medical records, provider letter of medical necessity
  • For Premera: Mail to Member Appeals, PO Box 91102, Seattle, WA 98111-9202 or fax 425-918-5592

Internal Appeals (Level 2)

Timeline: 180 days from Level 1 denial
Decision: 30 days
Requirements: Must include new evidence not previously submitted

External Review (Independent Review Organization)

Timeline: 180 days from final internal denial
Decision: 20 days (72 hours if expedited)
Process: Contact Washington Office of the Insurance Commissioner at 800-562-6900

Key Advantage: External reviewers can override restrictive plan definitions of "medical necessity" and often overturn ~40% of denials nationally.

Common Denial Reasons & Solutions

Denial Reason How to Overturn
"Not medically necessary" Submit attack frequency data, ER visits, quality of life impact
"Experimental/investigational" Cite FDA approval and clinical guidelines
Age restriction Provide documentation of ≥12 years age
Concurrent prophylaxis Discontinue other HAE prophylaxis agents
Insufficient documentation Submit complete C1-INH/C4 labs and genetic testing

When to Escalate Beyond Your Plan

Washington Office of the Insurance Commissioner

If your BCBS plan violates Washington insurance laws or fails to follow proper procedures:

Contact: 800-562-6900
Website: insurance.wa.gov
Services: Consumer advocacy, external review coordination, complaint investigation

US HAEA Advocacy Support

For complex cases requiring specialized HAE expertise: Contact: (866) 798-5598
Services: Clinical documentation support, appeals assistance, provider education

When working with these organizations, Counterforce Health can provide additional support by analyzing your specific denial and crafting evidence-based appeals that address your BCBS plan's exact criteria and Washington's procedural requirements.

FAQ

Q: How long does BCBS prior authorization take for Orladeyo in Washington? A: Standard PA review takes 5-10 business days. Request expedited review (72 hours) if delays could jeopardize your health due to uncontrolled HAE attacks.

Q: What if Orladeyo is not on my BCBS formulary? A: File a formulary exception request with clinical justification. Include documentation of medical necessity and why preferred alternatives are inappropriate.

Q: Can I appeal a BCBS denial if I live in Washington? A: Yes. Washington law provides 180 days to file internal appeals, followed by external review through an independent organization if needed.

Q: Does step therapy apply to Orladeyo? A: Some BCBS plans require trying other HAE prophylaxis options first. Document any contraindications or previous failures with alternatives.

Q: What specialty pharmacies dispense Orladeyo for BCBS in Washington? A: Common options include Accredo and other BCBS-contracted specialty pharmacies. Verify your plan's specific network through member services.

Q: Can I use manufacturer copay assistance with Medicare? A: No. Federal law prohibits manufacturer copay cards for Medicare beneficiaries. Explore the Patient Assistance Program for free medication instead.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage determinations. For personalized assistance with appeals and prior authorizations, consider consulting with specialized services like Counterforce Health, which helps patients navigate complex insurance requirements for specialty medications like Orladeyo.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.