By Counterforce Health Team in Orladeyo (berotralstat) —

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

Answer Box: Getting Orladeyo Covered by Humana in New Jersey

Orladeyo (berotralstat) requires prior authorization from Humana as a Tier 4 specialty medication for hereditary angioedema (HAE) prophylaxis. The fastest path to approval: (1) Confirm HAE diagnosis with C1-INH lab results, (2) Have an allergist/immunologist submit complete documentation through Humana's provider portal, and (3) Include prior therapy failures and medical necessity justification. Humana responds within 1 business day for 95% of complete electronic requests. If denied, New Jersey residents have strong appeal rights through the state's IHCAP external review program.

Table of Contents

What This Guide Covers

This guide helps New Jersey residents navigate Humana's prior authorization process for Orladeyo (berotralstat), a once-daily oral medication for preventing hereditary angioedema (HAE) attacks. Whether you have Humana Medicare Advantage, commercial coverage, or Medicaid managed care, you'll find specific steps, required forms, and New Jersey's unique patient protections.

Who this helps: HAE patients age 12 and older, their caregivers, and healthcare providers seeking Humana coverage for long-term HAE prophylaxis.

Note: This guide focuses on prophylactic use of Orladeyo. The medication is not approved for acute HAE attack treatment.

Before You Start: Plan Verification

Confirm Your Coverage Type

First, determine which Humana plan you have:

  • Medicare Advantage (Part C): Most common for seniors; includes medical and often prescription coverage
  • Medicare Part D: Prescription-only coverage that may require specialty pharmacy dispensing
  • Commercial/Employer Plans: Group or individual marketplace coverage
  • Medicaid Managed Care: State-contracted Humana plans
Tip: Your member ID card shows your plan type. Medicare Advantage cards typically include "Medicare" in the plan name.

Verify Orladeyo's Formulary Status

Orladeyo is classified as a Tier 4 specialty medication across Humana plans, requiring prior authorization. Check your specific formulary at Humana's drug lookup tool to confirm coverage and estimated costs.

Confirm In-Network Providers

Prior authorization requests from HAE specialists (allergists, immunologists) process faster than those from primary care providers. Verify your prescriber is in-network using Humana's provider directory.

Gather Required Documentation

HAE Diagnosis Confirmation

Laboratory Evidence Required:

  • C1-INH (C1 esterase inhibitor) antigenic and functional levels showing deficiency on two separate occasions
  • C4 complement levels (typically low during and between attacks)
  • Detailed patient history documenting angioedema episodes

Alternative Diagnosis Paths:

  • Genetic testing results for HAE with normal C1-INH (mutations in F12, KNG1, ANGPT1, PLG, HS3ST6, or MYOF genes)
  • Family history documentation if hereditary pattern is evident

Treatment History Documentation

Prior Therapy Requirements:

  • Specific HAE medications previously tried (C1-INH products like Cinryze or Haegarda, lanadelumab/Takhzyro)
  • Documented reasons for discontinuation (ineffective, intolerable side effects, contraindications)
  • Attack frequency data before and during previous treatments
  • On-demand rescue medication usage patterns

Clinical Justification

Medical Necessity Elements:

  • Current attack frequency and severity impacting quality of life
  • Rationale for oral prophylaxis over injectable alternatives
  • Specialist consultation notes supporting Orladeyo specifically
  • Safety considerations and monitoring plan
From our advocates: We've seen prior authorizations approved faster when the specialist's letter directly addresses why injectable prophylaxis options aren't suitable—whether due to needle phobia, travel requirements, or injection site reactions. Be specific about individual patient factors rather than general preferences.

Submit Your Prior Authorization Request

Submission Methods

Electronic Portal (Fastest): Humana commits to responding within 1 business day for 95% of complete electronic prior authorization requests submitted through their provider portal.

Alternative Methods:

  • Fax: 1-877-486-2621 (verify with your specific plan)
  • Phone submission through provider services
  • Mail to address specified on your plan documents

Clean Request Packet Checklist

Essential Documents:

  • ✓ Completed Humana prior authorization form
  • ✓ Prescriber's medical necessity letter
  • ✓ HAE diagnosis confirmation (labs or genetic testing)
  • ✓ Prior therapy documentation
  • ✓ Current prescription with NDC, strength, and quantity
  • ✓ Patient demographics and insurance information

Specialty Pharmacy Routing

For Tier 4 medications like Orladeyo, Humana may require dispensing through CenterWell Specialty Pharmacy. Confirm pharmacy requirements during the prior authorization process to avoid delays.

Follow-Up and Tracking

When to Follow Up

  • Day 2-3: If electronic submission, call to confirm receipt
  • Day 5-7: For fax/mail submissions, verify processing has begun
  • Day 10: If no response, escalate to supervisor level

Sample Follow-Up Script

"Hello, I'm calling about prior authorization request #[reference number] for Orladeyo submitted on [date] for patient [name], DOB [date]. Can you provide a status update and expected decision timeline?"

Document: Keep records of all call reference numbers, representative names, and promised callback dates.

Typical Timelines in New Jersey

Standard Processing Times

Humana's Commitments:

  • Electronic submissions: 1 business day for 95% of complete requests
  • Standard prior authorization: 3-7 business days
  • Expedited reviews: Within 72 hours for urgent medical situations

What Speeds Decisions:

  • Complete documentation submitted electronically
  • Specialist (allergist/immunologist) as prescriber
  • Clear medical necessity with specific clinical details
  • Prior authorization submitted before prescription fill

What Slows Decisions:

  • Incomplete clinical documentation
  • Primary care prescriber without specialist consultation
  • Missing prior therapy failure documentation
  • Requests for off-label or non-standard dosing

If You Need to Provide More Information

Common Information Requests

Medical Necessity Clarifications:

  • More detailed attack history with dates and severity
  • Specific contraindications to alternative therapies
  • Laboratory values with reference ranges and dates
  • Specialist consultation notes if not initially provided

Handling Additional Requests:

  1. Respond within the timeframe specified (typically 5-10 business days)
  2. Provide exactly what's requested—no more, no less
  3. Resubmit through the same channel as original request
  4. Follow up within 48 hours to confirm receipt

Literature and Guidelines

When requested, include relevant clinical guidelines:

  • FDA labeling for Orladeyo (berotralstat)
  • World Allergy Organization (WAO) HAE management guidelines
  • Hereditary Angioedema Association treatment recommendations

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason Solution
Insufficient HAE diagnosis Submit C1-INH lab results or genetic testing
Lack of specialist involvement Obtain allergist/immunologist consultation
No prior therapy failures Document previous treatments and outcomes
Age restriction Confirm patient is ≥12 years old per FDA labeling
Concurrent prophylaxis Clarify discontinuation of other HAE preventive therapies

First-Level Appeal Snapshot

Timeline: 65 days from denial notice for Medicare Advantage; varies for commercial plans Success Rate: 81.7% of appealed prior authorization denials are partially or fully overturned nationally Key Strategy: Address the specific denial reason with additional documentation

Peer-to-Peer Review

Request a peer-to-peer (P2P) review where your prescribing physician speaks directly with Humana's medical director. This often resolves denials faster than written appeals.

Renewal and Re-authorization

When to Resubmit

Orladeyo authorizations typically require renewal every 6 months. Calendar the renewal 30-45 days before expiration to avoid treatment gaps.

Renewal Documentation

Required Elements:

  • Updated attack frequency data showing ≥50% reduction
  • Decreased rescue medication usage
  • Adherence confirmation from prescriber
  • Any changes in clinical status or concurrent medications
  • Continued medical necessity justification

Appeals Process for New Jersey

Internal Appeals with Humana

Medicare Advantage (Part C):

  • Timeline: 65 days from denial notice
  • Decision: Within 30 days (pre-service) or 60 days (post-service)
  • Expedited: 72 hours if delay could harm health

Commercial Plans:

  • Follow plan-specific timelines in your Evidence of Coverage
  • Typically 30-180 days to file, 15-30 days for decision

New Jersey External Review (IHCAP)

After exhausting Humana's internal appeals, New Jersey residents can access the Independent Health Care Appeals Program (IHCAP) managed by Maximus Federal Services.

Eligibility Requirements:

  • Completed all internal appeal levels with your plan
  • Denial based on medical necessity or similar coverage issue
  • NJ-regulated insurance plan (not self-funded employer plans)

Timeline:

  • File within: 4 months (180 days) from final internal denial
  • Preliminary review: 5 business days
  • Final decision: Within 45 days of complete submission
  • Expedited: Much faster for urgent cases

How to Submit: Submit directly to Maximus (not NJ Department of Banking and Insurance first). Contact IHCAP at 1-888-393-1062 for forms and guidance.

Cost: Free to patients—insurers pay all review costs

Important: If the external reviewer overturns Humana's denial, the insurer must comply and cover Orladeyo. This decision is legally binding under New Jersey statute N.J.S.A. 26:2S-11.

Costs and Patient Assistance

Orladeyo Pricing

Wholesale Acquisition Cost: Approximately $44,484 per 28-day supply (effective January 1, 2025). Patient out-of-pocket costs vary significantly based on plan design and assistance programs.

Financial Assistance Options

BioCryst Patient Support: Visit Orladeyo.com for manufacturer copay assistance and patient support programs. Eligibility restrictions may apply.

Foundation Assistance:

  • Patient Advocate Foundation
  • HealthWell Foundation
  • National Organization for Rare Disorders (NORD)

State Programs: New Jersey residents may qualify for additional assistance through state pharmaceutical programs. Contact the NJ Department of Human Services for eligibility information.

For comprehensive support navigating insurance denials and appeals, Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned with payer requirements.

Quick Reference Checklist

Before Submitting:

  • Verify Humana plan type and Orladeyo formulary status
  • Confirm HAE diagnosis with C1-INH labs or genetic testing
  • Document prior therapy failures and contraindications
  • Obtain specialist consultation (allergist/immunologist preferred)
  • Gather complete medical records and attack history

Submission:

  • Use electronic portal for fastest processing
  • Include all required documents in initial packet
  • Keep copies and track reference numbers
  • Follow up within 2-3 business days

If Problems Arise:

  • Respond to information requests within specified timeframes
  • Request peer-to-peer review for complex cases
  • File appeals within required deadlines
  • Consider New Jersey external review if fully denied

FAQ

How long does Humana prior authorization take in New Jersey? Humana responds within 1 business day for 95% of complete electronic submissions. Standard processing takes 3-7 business days, with expedited reviews available within 72 hours for urgent cases.

What if Orladeyo is non-formulary on my plan? Even if non-formulary, you can request a formulary exception based on medical necessity. Document why formulary alternatives are inappropriate or contraindicated.

Can I request an expedited appeal in New Jersey? Yes, both Humana and New Jersey's external review process offer expedited timelines when delays could seriously harm your health. Your physician must support the urgency request.

Does step therapy apply to Orladeyo? Humana may require documentation of prior HAE therapy failures before approving Orladeyo. This isn't traditional step therapy but rather evidence of medical necessity.

What happens if I move from another state to New Jersey? Your existing Orladeyo authorization should transfer, but confirm with Humana. New Jersey's appeal protections apply regardless of where your initial treatment began.

Can my pharmacy help with the prior authorization? Specialty pharmacies often assist with prior authorization submissions and can coordinate with your prescriber. However, clinical documentation must come from your healthcare provider.

How much will Orladeyo cost with Humana coverage? Costs vary by plan design. As a Tier 4 specialty medication, expect higher copays or coinsurance. Check your plan's formulary for specific cost-sharing amounts.

What if Humana requires me to use their specialty pharmacy? Many Humana plans require Tier 4 medications to be dispensed through CenterWell Specialty Pharmacy. This requirement is typically disclosed during prior authorization approval.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for specific coverage decisions. Policy details and contact information may change—verify current information with official sources before taking action. For personalized assistance with insurance appeals and prior authorizations, Counterforce Health provides comprehensive support for patients and healthcare providers.

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