By Counterforce Health Team in Orladeyo (berotralstat) —

Get Orladeyo (Berotralstat) Covered by Humana in North Carolina: Complete Guide with Forms and Appeal Steps

Answer Box: Getting Orladeyo (Berotralstat) Covered by Humana in North Carolina

Orladeyo (berotralstat) requires prior authorization from Humana and must be prescribed by an HAE specialist. The fastest path to approval:

  1. Get diagnosed by an in-network allergist/immunologist with confirmed C1-INH testing showing hereditary angioedema
  2. Have your specialist submit prior authorization through Humana's provider portal with complete medical records
  3. If denied, appeal within 65 days and consider North Carolina's external review through Smart NC

Start today: Use Humana's Find Care tool to locate an in-network HAE specialist in North Carolina, then schedule C1-INH testing to confirm your diagnosis.

Table of Contents

Coverage Basics

Is Orladeyo Covered by Humana?

Yes, but with restrictions. Humana requires prior authorization for Orladeyo (berotralstat) across all Medicare Advantage and commercial plans. The medication is typically placed on specialty tiers, meaning higher out-of-pocket costs for patients.

Which Humana Plans Cover Orladeyo?

  • Medicare Advantage: Covered with prior authorization
  • Medicare Part D: Covered with prior authorization (standalone prescription plans)
  • Commercial plans: Coverage varies by employer group but generally requires PA
Note: New Humana Medicare members get a 90-day grace period for medications started before enrollment, but prior authorization review still applies for payment approval.

Prior Authorization Process

Who Submits the Prior Authorization?

Your prescribing physician (typically an allergist or immunologist specializing in hereditary angioedema) must submit the prior authorization request. Patients cannot submit these requests directly.

Step-by-Step: Fastest Path to Approval

  1. Find an HAE specialist using Humana's provider directory - search for "allergy and immunology"
  2. Complete diagnostic testing including C1 esterase inhibitor levels and function
  3. Document attack history with detailed records of HAE episodes requiring treatment
  4. Physician submits PA via Humana's electronic portal with all supporting documentation
  5. Wait for decision (up to 14 days standard, 72 hours if expedited)
  6. If approved, prescription transfers to designated specialty pharmacy
  7. If denied, begin internal appeals process within 65 days

How to Check Authorization Status

  • Online: Log into your Humana member portal
  • Phone: Call the member services number on your insurance card
  • Provider: Your doctor's office can check status through their provider portal

Timeline and Urgency

Standard Timeline

  • Prior authorization decision: Up to 14 days from complete submission
  • Appeal decision: 30 days for pre-service appeals
  • External review: 45 days (standard) or 72 hours (expedited)

When to Request Expedited Review

Request expedited processing if:

  • You're experiencing frequent, severe HAE attacks
  • Delay would seriously jeopardize your health
  • You're transitioning from another effective HAE therapy
Tip: Starting January 2026, Humana commits to one-day decisions for 95% of electronic prior authorization requests.

Medical Necessity Criteria

Coverage Requirements Table

Requirement Details Documentation Needed
Diagnosis Confirmed HAE Type I or II C1-INH levels, genetic testing, or family history
Attack Severity Moderate to severe episodes Medical records documenting attacks
Age 12 years or older Birth certificate or medical records
Prescriber HAE specialist or consultation Board certification in allergy/immunology
Dosing Maximum 150mg once daily Prescription within FDA-approved limits

What Counts as Medical Necessity?

According to Humana's clinical criteria, you must have:

  • Laboratory confirmation of HAE with low C4 and abnormal C1-INH levels
  • Documented attack history requiring emergency care or significantly impacting daily life
  • Failed or inappropriate first-line therapies (if applicable)
  • Prescription by qualified specialist familiar with HAE management

Cost and Copay Information

Medicare Part D Patients

  • No manufacturer copay assistance available due to federal anti-kickback laws
  • High coinsurance typically 25-33% of drug cost
  • Annual cost can exceed $10,000-15,000 out-of-pocket before catastrophic coverage

Alternative Cost Support

  • Charitable foundations: PAN Foundation, other rare disease funds (limited availability)
  • State programs: North Carolina may have additional assistance programs
  • Hospital financial assistance: Some health systems offer charity care programs
Important: Medicare patients cannot use manufacturer copay cards. Explore charitable foundations early, as funding is limited and applications close frequently.

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Address
Insufficient diagnosis Submit complete C1-INH testing results and genetic confirmation
Age under 12 Confirm patient age with documentation
Concurrent prophylaxis Discontinue other HAE prevention therapies
Non-specialist prescriber Transfer care to board-certified allergist/immunologist
Inadequate attack history Provide detailed emergency room records and attack logs

Humana Internal Appeals Process

  1. Level 1: Submit appeal within 65 days of denial notice
  2. Level 2: If Level 1 denied, automatic second-level review
  3. Documentation: Include denial letter, medical records, physician letter

North Carolina External Review

If Humana denials your internal appeals, you can request external review through Smart NC:

  • Timeline: Must request within 120 days of final internal denial
  • Cost: Free to patients
  • Decision: Binding on Humana if coverage is approved
  • Contact: 855-408-1212 for assistance with applications

When navigating complex insurance approvals for specialty medications like Orladeyo, patients and providers often benefit from expert guidance. Counterforce Health helps turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific requirements.

Annual Renewals

When to Reauthorize

Most Humana prior authorizations for Orladeyo are valid for 12 months. Your prescriber should submit renewal requests 30-60 days before expiration to avoid treatment gaps.

What Documentation is Needed for Renewal

  • Updated attack frequency showing benefit from therapy
  • Current lab values if clinically indicated
  • Continued medical necessity letter from prescribing physician
  • Dosing confirmation that medication remains at approved levels

Specialty Pharmacy Requirements

Why Specialty Pharmacy is Required

Orladeyo must be dispensed through Humana's designated specialty pharmacy network due to:

  • High cost requiring special handling
  • Need for patient education and monitoring
  • Complex insurance coordination

What to Expect

  • Prescription transfer: Your local pharmacy will transfer the prescription automatically
  • Patient education: Specialty pharmacist will counsel on proper use
  • Delivery: Medication shipped directly to your home with temperature control
  • Refill coordination: Automatic refill reminders and insurance reauthorization tracking

Troubleshooting Common Issues

Portal Problems

If Humana's online systems are unavailable:

  • Call member services using the number on your insurance card
  • Fax requests to the prior authorization department (verify current fax number)
  • Contact your physician's office to submit via alternative methods

Missing Forms or Documentation

  • Medical records: Request from all previous providers who treated your HAE
  • Lab results: Ensure C1-INH testing includes both quantitative and functional studies
  • Attack logs: Compile detailed records of episodes, treatments, and outcomes
From our advocates: We've seen cases where patients had all the right clinical criteria but their initial submission lacked specific attack frequency documentation. One patient's approval was delayed three months until their specialist provided a detailed letter quantifying episodes per month and emergency department visits. The lesson: comprehensive documentation upfront saves significant time later.

FAQ: Most Common Questions

Q: How long does Humana prior authorization take in North Carolina? A: Standard decisions take up to 14 days, expedited decisions within 72 hours. Starting 2026, electronic submissions will get decisions within one business day for 95% of requests.

Q: What if Orladeyo is non-formulary on my plan? A: You can request a formulary exception through the same prior authorization process, but you'll need stronger medical necessity documentation showing other covered options are inappropriate.

Q: Can I request an expedited appeal? A: Yes, if the standard timeline would jeopardize your health. Your physician must certify the urgency and submit supporting clinical documentation.

Q: Does step therapy apply if I failed treatments outside North Carolina? A: Medical records from any location are valid. Ensure your new North Carolina specialist has complete documentation of previous therapy failures.

Q: What happens if I switch from another Humana plan? A: Existing prior authorizations typically transfer, but confirm with member services. You may need updated documentation if criteria have changed.

Q: Can I appeal to Smart NC if I have Medicare Advantage? A: Yes, North Carolina's external review process applies to Humana Medicare Advantage plans. The decision is binding on Humana.

Q: How do I find an HAE specialist in North Carolina who takes Humana? A: Use Humana's provider finder, search for "allergy and immunology," then call offices to confirm HAE experience. Duke Health and Atrium Health have known HAE specialists.

Q: What if my prescription is denied while I'm having frequent attacks? A: Request expedited appeal and ask your physician about emergency HAE medications (like icatibant) for acute episodes while appealing the Orladeyo denial.

For complex cases requiring detailed appeal strategies, platforms like Counterforce Health specialize in transforming insurance denials into successful approvals by leveraging payer-specific requirements and evidence-based documentation.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on your specific plan terms and medical circumstances. Always consult with your healthcare provider and insurance company for personalized guidance. For assistance with North Carolina insurance appeals, contact Smart NC at 855-408-1212.

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