By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Covered by Humana in Texas: Appeals, Forms, and State Protections

Quick Answer: Getting Orladeyo Covered by Humana in Texas

Orladeyo (berotralstat) requires prior authorization from Humana in Texas. The fastest path to approval involves: (1) having your HAE specialist submit a comprehensive PA request with C1-INH testing, prior therapy documentation, and medical necessity letter, (2) using Humana's electronic portal or Texas-specific forms for submission, and (3) leveraging Texas step therapy override protections if first-line therapies failed. If denied, you have 65 days to appeal and can request an expedited external review through the Texas Department of Insurance for life-threatening conditions. Start today by contacting your prescriber to gather HAE documentation and initiate the PA process.

Table of Contents

Understanding Texas Rules for Orladeyo Coverage

Texas provides some of the strongest patient protections in the country for specialty drug coverage, and these rules directly impact how Humana handles Orladeyo (berotralstat) requests. Understanding how state and federal regulations interact is crucial for getting your HAE medication approved.

How Texas Rules Apply to Humana Plans:

  • Medicare Advantage plans follow federal Medicare rules but must comply with Texas external review protections
  • State-regulated commercial plans (marked "TDI" or "DOI" on your insurance card) get full Texas step therapy and appeals protections
  • Self-funded employer plans (ERISA) are exempt from most state protections but still follow federal guidelines

The key advantage in Texas is that if you're on a state-regulated plan, you have strong step therapy override rights and access to independent external review through the Texas Department of Insurance.

Humana's Prior Authorization Requirements

Based on current Humana policies, all Orladeyo (berotralstat) requests require prior authorization regardless of your plan type in Texas. Here's what Humana typically requires:

Coverage Criteria for Orladeyo

  • Confirmed HAE diagnosis with appropriate testing (C1-INH levels, genetic testing, or clinical criteria)
  • Age requirement: Patient must be ≥12 years old (FDA-approved age)
  • Prescriber qualification: Treatment managed by or in consultation with an allergist/immunologist
  • Medical necessity documentation showing why Orladeyo is appropriate over alternatives

Required Documentation

  • HAE diagnosis confirmation within the last 2 years
  • C1-INH quantitative and functional testing results
  • Documentation of HAE attack frequency and severity
  • Previous therapy trials and outcomes (if applicable)
  • Prescriber attestation of medical necessity

You can submit requests through Humana's provider portal or by using their Texas-specific prior authorization forms.

Step-by-Step: Fastest Path to Approval

Timeline: 2-7 days for standard requests, 24-72 hours for expedited

Step 1: Gather Essential Documentation (Patient + Prescriber)

  • Insurance card and member ID
  • Complete HAE diagnostic workup (C1-INH testing, genetic results if available)
  • Documentation of HAE attacks (frequency, severity, impact on daily life)
  • List of previous HAE treatments tried and their outcomes

Step 2: Prescriber Submits Comprehensive PA Request

Your allergist/immunologist should submit through Humana's electronic portal with:

  • Completed prior authorization form
  • Medical necessity letter (see template below)
  • Supporting clinical documentation
  • Lab results and diagnostic tests

Step 3: Request Expedited Review if Appropriate

If you're currently having frequent HAE attacks or at risk of life-threatening episodes, ask your prescriber to mark the request as expedited. Humana must respond within 24-72 hours for urgent requests.

Step 4: Monitor Status and Follow Up

  • Standard requests: Humana responds within 72 hours
  • Check status through member portal or by calling the number on your ID card
  • If no response within stated timeframes, contact Humana directly

Step 5: If Denied, File Appeal Immediately

You have 65 days from the denial date to file an appeal. Don't wait—gather additional documentation and submit your redetermination request promptly.

Texas Step Therapy Override Protections

Texas law provides powerful protections if Humana requires you to try other HAE medications before approving Orladeyo. Under Texas Insurance Code Chapter 1369, you can request a step therapy override if:

Override Criteria

  • Previous failure: You've already tried and failed the required first-line therapy
  • Contraindication: The required drug is likely to cause adverse reactions or harm
  • Ineffectiveness: Based on your clinical history, the required drug would be ineffective
  • Treatment delay: The step therapy would delay effective treatment or harm adherence

How to Request an Override

  1. Your prescriber completes the standard exception request form
  2. Provide clinical documentation supporting one of the override criteria
  3. Submit within the required timeframe (varies by plan type)
  4. Timeline: Plans must respond within 24 hours (urgent) or 72 hours (standard)
Note: If Humana fails to respond within the required timeline, the override is automatically granted under Texas law.

Appeals Process and Timelines

If your initial Orladeyo request is denied, Texas provides a structured appeals process with strict timelines that work in your favor.

Internal Appeals (Redetermination)

  • Deadline: 65 days from denial date
  • Timeline: Humana must respond within specific timeframes based on urgency
  • Required: Must complete internal appeal before external review
  • Submission: Through Humana's member portal or by mail/fax

What to Include in Your Appeal

  • Copy of original denial letter
  • Additional medical documentation
  • Updated prescriber letter addressing denial reasons
  • Any new test results or clinical information
  • Reference to specific Texas protections if applicable

Expedited Appeals

For life-threatening conditions or ongoing treatment, you can request expedited processing:

  • Timeline: 24-72 hours for decision
  • Criteria: Delay in treatment could seriously jeopardize your health
  • Concurrent filing: Can file expedited external review simultaneously

External Review Through Texas DOI

Texas provides an independent safety net through the Texas Department of Insurance Independent Review Organization (IRO) process. This is particularly valuable for specialty drugs like Orladeyo.

When You Can Request External Review

  • After completing internal appeals process
  • Immediately if the denial involves ongoing treatment or life-threatening conditions
  • When the denial is based on medical necessity or experimental/investigational determinations

IRO Process Timeline

  • Standard review: 20 days for decision
  • Expedited review: 3 calendar days for life-threatening conditions
  • Binding decision: If the IRO approves coverage, Humana must comply

How to File for External Review

  1. Complete Texas IRO request form LHL009
  2. Submit to Humana's Utilization Review Agent with supporting documents
  3. Humana forwards to TDI for IRO assignment
  4. Cost: Humana pays the IRO fee, not you

Medical Necessity Documentation

A strong medical necessity letter is often the difference between approval and denial. Here's what should be included:

Essential Components

  • Patient demographics and insurance information
  • HAE diagnosis confirmation with specific test results
  • Attack history: frequency, severity, triggers, impact on quality of life
  • Previous treatments: what was tried, outcomes, reasons for discontinuation
  • Clinical rationale: why Orladeyo is medically necessary for this patient
  • Supporting evidence: FDA labeling, clinical guidelines, peer-reviewed studies

Key Phrases for Texas Appeals

When referencing Texas protections, include language like:

  • "Under Texas Insurance Code Section 1369.0546, this patient qualifies for step therapy override due to..."
  • "Previous therapy failure documented, meeting Texas criteria for medical exception..."
  • "Treatment delay would jeopardize patient health, qualifying for expedited review under Texas law..."
Clinician Corner: Counterforce Health helps automate the creation of evidence-backed medical necessity letters by analyzing denial reasons and crafting point-by-point rebuttals aligned with payer-specific requirements and state protections.

Common Denial Reasons and Solutions

Denial Reason Solution Documentation Needed
Not medically necessary Submit comprehensive medical necessity letter HAE attack history, impact on daily life, clinical rationale
Step therapy required File Texas step therapy override Previous therapy failures, contraindications, or ineffectiveness
Age restriction Verify patient meets FDA requirements Birth certificate, medical records confirming age ≥12
Insufficient diagnosis Provide complete HAE workup C1-INH testing, genetic results, specialist consultation
Prescriber qualification Ensure allergist/immunologist involvement Specialist consultation notes, referral documentation
Concurrent prophylaxis Clarify treatment plan Discontinuation of other prophylactic agents, treatment timeline

Cost Support and Patient Assistance

Even with insurance approval, Orladeyo's cost can be significant. Multiple assistance programs can help:

Manufacturer Support

BioCryst Pharmaceuticals offers patient assistance programs (verify current offerings on their official website or through your specialty pharmacy).

Foundation Assistance

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

State Programs

Texas residents may qualify for additional state-sponsored assistance programs for rare disease medications.

When to Escalate to State Regulators

If standard appeals fail or you encounter procedural violations, Texas provides multiple escalation paths:

Texas Department of Insurance

  • Consumer hotline: 1-800-252-3439
  • File complaints for procedural violations or unfair denials
  • IRO information line: 1-866-554-4926

Office of Public Insurance Counsel (OPIC)

  • Help line: 1-877-611-6742
  • Provides guidance on appealing denied claims
  • Offers detailed appeals process information

When to Contact Regulators

  • Humana violates Texas timeline requirements
  • Denial reasons appear inconsistent with state law
  • Procedural rights are not honored
  • External review process is improperly denied

Counterforce Health's platform can help identify when regulatory escalation is appropriate by analyzing denial patterns and procedural compliance issues across similar cases.

Frequently Asked Questions

How long does Humana prior authorization take for Orladeyo in Texas? Standard requests: 72 hours after receiving prescriber documentation. Expedited requests: 24 hours for urgent cases. Texas law requires automatic approval if timelines aren't met.

What if Orladeyo is not on Humana's formulary? You can request a formulary exception with prescriber support. Medicare Part D plans must respond within 72 hours (standard) or 24 hours (expedited) with proper documentation.

Can I get a temporary supply while waiting for approval? If you're in a transition period (new enrollment, discharge, level of care change), Humana may provide up to a 31-day supply while the exception request is processed.

Does Texas step therapy protection apply to Medicare Advantage? Texas external review protections apply, but federal Medicare rules generally preempt state step therapy laws. However, you still have Medicare appeals rights and can request expedited processing.

What counts as "life-threatening" for expedited review? Severe, frequent HAE attacks that could compromise airway or cause significant morbidity typically qualify. Your prescriber must document the urgency in the request.

How much does Orladeyo cost without insurance? The wholesale acquisition cost (WAC) is approximately $44,484 per 28-day supply as of 2025. Patient assistance programs can significantly reduce out-of-pocket costs.

Can I appeal if I'm denied due to age restrictions? Orladeyo is FDA-approved for patients ≥12 years. If you meet this requirement but were denied for age, file an appeal with documentation proving you meet FDA criteria.

What happens if my appeal is denied by Humana? You can request external review through the Texas Department of Insurance IRO process. This provides an independent, binding decision that Humana must follow if coverage is approved.

This article provides educational information about insurance coverage and appeals processes. It is not medical advice. Always consult with your healthcare provider about treatment decisions and work with qualified professionals for insurance appeals. For official forms and current requirements, visit the Texas Department of Insurance website and your plan's member portal.

About the Author: This guide was developed with insights from healthcare coverage specialists who help patients navigate complex prior authorization requirements. Counterforce Health provides tools and expertise to help patients, clinicians, and specialty pharmacies turn insurance denials into successful, evidence-backed appeals by analyzing payer policies and crafting targeted responses that meet both clinical and administrative requirements.

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