By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Covered by Humana in Pennsylvania: Complete Prior Authorization Guide

Answer Box: Fastest Path to Approval

Orladeyo (berotralstat) requires prior authorization from Humana Medicare Advantage plans, typically placed in Tier 5 (Specialty) with coverage through designated specialty pharmacies. Start by having your HAE specialist submit a complete PA packet including confirmed HAE diagnosis (low C4 and C1-INH levels on ≥2 occasions), attack frequency documentation, and prior therapy trials. Submit via Humana's provider portal or fax to 877-486-2621. Standard decisions take 7 days; expedited reviews 72 hours. If denied, Pennsylvania residents can appeal through Humana's internal process, then escalate to Pennsylvania's external review program within 4 months—which overturns roughly 50% of denials.

Table of Contents

  1. Before You Start: Verify Your Coverage
  2. Gather What You Need
  3. Submit the Request
  4. Follow-Up and Timelines
  5. If You're Asked for More Info
  6. If Denied: Appeal Your Case
  7. Renewal and Re-Authorization
  8. Costs and Patient Support
  9. Pennsylvania-Specific Resources
  10. Frequently Asked Questions

Before You Start: Verify Your Coverage

Check Your Plan Type and Formulary Status

First, confirm you have a Humana Medicare Advantage or Part D plan that covers prescription drugs. Orladeyo is typically placed in Tier 5 (Specialty Tier) on Humana formularies, requiring:

  • Prior authorization
  • Specialty pharmacy dispensing
  • Higher cost-sharing (coinsurance vs. copay)
Tip: Log into MyHumana or call the number on your ID card to verify your specific plan's formulary and tier placement.

Confirm Your Prescriber Qualifications

Humana and most payers require Orladeyo to be prescribed by or in consultation with:

  • Board-certified allergist/immunologist
  • Hematologist with HAE experience
  • Geneticist familiar with complement disorders
  • Physician with documented HAE management experience

If your current doctor isn't a specialist, ask for a referral or consultation notes from an HAE specialist to include with your PA request.

Gather What You Need

Core Documentation Checklist

HAE Diagnosis Confirmation:

  • Lab results showing low C4 levels on ≥2 separate occasions (at least 3 months apart)
  • C1-esterase inhibitor (C1-INH) antigen and functional levels
  • Normal C1q to rule out acquired angioedema
  • For HAE with normal C1-INH: genetic testing results (F12, PLG, KNG1 mutations)

Clinical History:

  • Attack frequency and severity logs (past 6 months minimum)
  • Emergency department visits or hospitalizations
  • Prior therapy trials with dates, dosing, duration, and reasons for discontinuation
  • Current medications and contraindications

Prescriber Information:

  • Medical license and specialty credentials
  • Medical necessity letter with clinical rationale
  • Contact information for peer-to-peer review if needed

Medical Necessity Letter Components

Your specialist should include:

  1. Confirmed HAE diagnosis with specific type (I, II, or normal C1-INH)
  2. Attack pattern: "Patient experiences X attacks per month affecting [locations], requiring Y emergency treatments"
  3. Prior therapies tried: Include specific medications, doses, duration, and outcomes
  4. Why Orladeyo is appropriate: Oral convenience, efficacy data, patient preference
  5. Treatment goals: Reduce attack frequency, improve quality of life, prevent life-threatening episodes

Submit the Request

Humana Submission Methods

Online Portal (Preferred):

Fax Submission:

  • General PA fax: 877-486-2621
  • Include cover sheet with patient ID and drug name
  • Request fax confirmation

Phone for Urgent Cases:

  • Provider line: 800-555-2546 (Mon-Fri 8am-8pm local time)
  • Use for expedited requests when patient health is at risk

Complete Request Packet

Submit these together for fastest processing:

  • Humana PA form (completed by prescriber)
  • Medical necessity letter
  • Lab results (C4, C1-INH levels with dates and reference ranges)
  • Attack diary or clinical notes documenting frequency
  • Prior therapy documentation
  • Prescription with NDC, quantity, and day supply

Follow-Up and Timelines

Standard Processing Times

Request Type Humana Timeline When to Follow Up
Standard PA 7 calendar days Day 5 if no response
Expedited PA 72 hours Day 2 if urgent
Payment decisions 60 days Day 45

Follow-Up Script for Patients

"Hi, I'm calling to check on the status of my prior authorization for Orladeyo. My member ID is [number], and the request was submitted on [date]. Can you tell me the current status and expected decision date?"

Document: Reference number, representative name, and next follow-up date.

If You're Asked for More Info

Common Information Requests

Additional Clinical Documentation:

  • More detailed attack logs with dates, locations, and severity
  • Emergency department records or hospitalization notes
  • Specialist consultation reports

Prior Therapy Clarification:

  • Specific dates and duration of previous HAE medications
  • Documented reasons for discontinuation (side effects, inefficacy)
  • Contraindications to preferred formulary alternatives

Responding Quickly

Submit additional information within 24-48 hours to avoid delays. Use the same submission method (portal/fax) and reference your original PA number.

If Denied: Appeal Your Case

Common Denial Reasons and Solutions

Denial Reason How to Address
Insufficient diagnosis documentation Submit complete lab panel with dates and reference ranges
Lack of prior therapy trials Provide detailed medication history with specific reasons for failure
Not prescribed by specialist Include consultation notes or transfer care to HAE specialist
Age restriction (<12 years) Confirm patient age ≥12 years in medical records

Humana Appeal Process

Level 1: Coverage Determination Appeal

  • File within 65 days of denial notice
  • Submit via provider portal or mail
  • Include denial letter and additional supporting evidence
  • Decision timeline: 7 days standard, 72 hours expedited

Level 2: Reconsideration

  • File within 65 days of Level 1 denial
  • Same process and timelines as Level 1
  • Independent Humana reviewer

Pennsylvania External Review Program

If Humana denies your appeal, Pennsylvania residents have a powerful option: the state's Independent External Review Program.

Key Benefits:

  • About 50% of appeals are overturned
  • Binding on Humana—they must cover if approved
  • No cost to patients

How to File:

  1. Complete Humana's internal appeals (Levels 1-2)
  2. Request external review within 4 months of final denial
  3. Submit online at pa.gov or mail forms
  4. Independent medical reviewers decide within 45 days
From Our Advocates: We've seen Pennsylvania's external review program particularly effective for rare disease medications like Orladeyo. The independent physicians often have HAE expertise that internal payer reviewers lack, leading to coverage approvals when medical necessity is clearly documented.

Renewal and Re-Authorization

When to Start Renewal

Begin renewal process 90 days before current authorization expires to avoid treatment gaps.

Renewal Documentation

Include updated information:

  • Attack frequency since starting Orladeyo
  • Any emergency department visits or hospitalizations
  • Treatment adherence and tolerance
  • Continued medical necessity from prescriber

Most HAE medications require annual reauthorization with evidence of ongoing benefit.

Costs and Patient Support

Humana Coverage Details

  • Tier 5 coinsurance: Typically 25-33% after deductible
  • Specialty pharmacy required: Humana Specialty Pharmacy or network partner
  • 2025 Part D changes: $2,000 annual out-of-pocket cap

Patient Assistance Options

BioCryst Patient Support:

  • Orladeyo patient assistance program (verify eligibility and current offerings)
  • Copay assistance for commercially insured patients
  • Free drug program for qualifying uninsured patients

Additional Resources:

  • HAE patient organizations for support and advocacy
  • Pennsylvania pharmaceutical assistance programs for low-income residents

Pennsylvania-Specific Resources

State Insurance Help

  • Pennsylvania Insurance Department: 1-877-881-6388
  • SHIP (Senior Health Insurance Program): Free Medicare counseling at shiphelp.org
  • Pennsylvania Health Law Project: Legal assistance for complex appeals

External Review Contact

  • PA Insurance Department External Review: insurance.pa.gov
  • Submit online or mail to address on state website
  • Free assistance available through consumer services

Frequently Asked Questions

Q: How long does Humana prior authorization take for Orladeyo in Pennsylvania? A: Standard requests: 7 calendar days. Expedited requests (when health is at risk): 72 hours. Submit complete documentation for fastest processing.

Q: What if Orladeyo isn't on Humana's formulary? A: Request a formulary exception with medical necessity documentation. Include evidence that formulary alternatives are inappropriate or have failed.

Q: Can I get an expedited appeal if denied? A: Yes, if delay would seriously jeopardize your health. Mark appeals as "expedited" and provide clinical justification for urgency.

Q: Does Pennsylvania's external review cost anything? A: No, Pennsylvania's external review program is free for patients. The state covers all costs of independent medical review.

Q: What happens if I start Orladeyo before approval? A: Contact Humana immediately to request retroactive coverage. Submit receipts and medical necessity documentation. Success varies by plan and circumstances.

Q: How often do I need reauthorization? A: Typically annually. Some plans may require 6-month initial approvals. Start renewal 90 days before expiration.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex medications like Orladeyo. Our platform helps patients, clinicians, and specialty pharmacies navigate prior authorization requirements by analyzing denial letters, plan policies, and clinical notes to create point-by-point rebuttals aligned with each payer's specific rules and timelines.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance processes and is not medical advice. Coverage decisions depend on individual plan terms, medical circumstances, and current policies. Always consult with your healthcare provider about treatment decisions and verify current requirements with Humana and Pennsylvania regulators. For personalized assistance with appeals and prior authorizations, consider consulting with Counterforce Health or other qualified patient advocacy services.

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