By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (berotralstat) Covered by Humana in California: Appeals, Forms & Financial Aid

Answer Box: Getting Orladeyo (berotralstat) Covered by Humana in California

Orladeyo (berotralstat) requires prior authorization from Humana and is typically placed on specialty tier (Tier 4). For California residents, the fastest path to approval involves: (1) Having your HAE specialist submit comprehensive PA documentation including C1-INH levels and prior therapy failures, (2) Using Humana's CenterWell Specialty Pharmacy for dispensing, and (3) If denied, filing an internal appeal within 65 days followed by California's Independent Medical Review (IMR) if needed. Start today by confirming your plan's formulary status and gathering your complete HAE treatment history.

Table of Contents

  1. What Drives Orladeyo (berotralstat) Costs with Humana
  2. Benefit Investigation: What to Ask Humana
  3. Financial Assistance Options
  4. Prior Authorization Requirements
  5. Appeals Process in California
  6. Specialty Pharmacy Requirements
  7. Annual Renewal Planning
  8. Scripts for Key Conversations
  9. Common Denial Reasons & Solutions
  10. FAQ

What Drives Orladeyo (berotralstat) Costs with Humana

Understanding Humana's benefit design helps you navigate coverage more effectively. Orladeyo is classified as a specialty medication, which means higher cost-sharing and specific dispensing requirements.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required before coverage Humana provider portal Humana PA Resources
Formulary Tier Specialty Tier 4 Plan drug list Humana Drug Lists
Specialty Pharmacy Must use network specialty pharmacy CenterWell or approved network CenterWell Specialty
Age Requirement 12 years or older FDA labeling requirement FDA Label Information
Diagnosis Documentation Confirmed HAE with lab tests C1-INH levels, genetic testing Humana PA Criteria

The wholesale acquisition cost (WAC) for Orladeyo is approximately $44,484 per 28-day supply as of 2025, making it one of the most expensive oral medications for hereditary angioedema prevention.

Benefit Investigation: What to Ask Humana

Before starting the approval process, gather specific information about your coverage:

Call Humana Member Services (number on your insurance card) and ask:

  • Is Orladeyo on my plan's formulary?
  • What tier is it placed on, and what's my copay/coinsurance?
  • Is prior authorization required?
  • Which specialty pharmacies are in-network?
  • Are there quantity limits or step therapy requirements?
  • What's the appeals process if denied?

Document everything: Get representative names, reference numbers, and confirmation in writing when possible.

Financial Assistance Options

Manufacturer Support

Orladeyo Empower Patient Services offers comprehensive support including:

  • Insurance navigation and PA assistance
  • Financial assistance evaluation
  • Medication delivery coordination

Commercial Insurance Patients: May be eligible for $0 copay assistance through the manufacturer's copay card program. Contact Empower Patient Services at 866-536-7693.

Medicare/Medicaid Patients: Federal law prohibits manufacturer copay assistance, but other support services are available including appeals assistance and care coordination.

Charitable Foundations

Note: Foundation assistance for HAE medications is extremely limited as of 2025, with most programs maintaining waitlists rather than active enrollment.

Key foundations to contact:

  • Accessia Health: Currently not accepting new HAE applications but maintains waitlists
  • The Assistance Fund: Similar waitlist status for HAE medications

Even if closed, register for waitlists as funding can reopen unexpectedly.

From Our Advocates

We've seen patients successfully navigate denials by maintaining detailed records of all prior therapies and their outcomes. One composite case involved a patient who was initially denied but won on appeal by providing comprehensive documentation of three failed prophylaxis attempts, including specific dates, dosages, and adverse effects. The key was having their HAE specialist write a detailed letter explaining why Orladeyo was the only remaining option.

Prior Authorization Requirements

Humana requires comprehensive documentation for Orladeyo approval. Your prescriber must submit:

Required Documentation Checklist

Medical Necessity:

  • Confirmed HAE diagnosis with laboratory evidence
  • C1-INH functional and quantitative levels
  • C4 complement levels
  • Genetic testing results (if applicable)

Treatment History:

  • Detailed record of HAE attack frequency and severity
  • Documentation of all prior prophylaxis therapies tried
  • Specific reasons for discontinuation (ineffectiveness, intolerance, contraindications)
  • Duration of each prior treatment

Prescriber Requirements:

  • Must be an allergist, immunologist, or HAE specialist
  • Or consultation with HAE specialist documented

Patient Factors:

  • Age 12 or older
  • Not for acute treatment of attacks
  • Not concurrent with other prophylaxis therapies

Submission Process

Submit PA requests through:

  • Humana Provider Portal (preferred method)
  • Fax: Use forms available on provider portal
  • Phone: For urgent requests requiring expedited review

Timelines:

  • Standard requests: 72 hours after complete submission
  • Expedited requests: 24 hours for urgent medical situations

Appeals Process in California

California offers robust patient protections for insurance denials through a two-step process:

Step 1: Internal Appeal with Humana

Timeline: Must file within 65 days of denial notice

How to File:

  • Online through Humana member portal
  • Phone: Number on your insurance card
  • Mail: Address provided in denial letter

Required Information:

  • Member ID and policy number
  • Copy of denial letter
  • Additional medical documentation
  • Prescriber's letter of medical necessity

Step 2: California Independent Medical Review (IMR)

If Humana upholds the denial, California residents can request an Independent Medical Review through the Department of Managed Health Care (DMHC).

Key Benefits of California IMR:

  • No cost to patient
  • Binding decision - Humana must comply if overturned
  • High success rate for medically necessary treatments
  • Independent physician experts review your case

How to Request IMR:

  • DMHC Help Center: 888-466-2219
  • Online: healthhelp.ca.gov
  • Timeline: 45 days for standard review, 72 hours for expedited

Required Documents:

  • Completed IMR application
  • Copy of Humana's final denial
  • All medical records supporting the request
  • Prescriber's statement of medical necessity

Specialty Pharmacy Requirements

Orladeyo must be dispensed through Humana's specialty pharmacy network. Regular retail pharmacies cannot fill these prescriptions.

Approved Options

CenterWell Specialty Pharmacy (Humana's preferred):

  • Mail-order delivery available
  • Up to 90-day supplies
  • Integrated with Humana systems for seamless PA processing

Other Network Specialty Pharmacies:

  • Verify participation through Humana provider portal
  • May have different supply limitations

Coordination Tips

  • Timing: Allow 7-10 business days for first fill
  • Refills: Set up automatic refills to avoid gaps
  • Travel: Coordinate with pharmacy for vacation supplies
  • Storage: Orladeyo requires room temperature storage

Counterforce Health specializes in helping patients navigate complex specialty drug approvals by turning insurance denials into targeted, evidence-backed appeals. Their platform can assist with the documentation and appeal process for medications like Orladeyo.

Annual Renewal Planning

Important: PA approvals typically last 12 months and require renewal.

Renewal Reminders

60 days before expiration:

  • Contact prescriber to initiate renewal
  • Schedule updated lab work if required
  • Document any changes in attack frequency or severity

30 days before expiration:

  • Confirm renewal submission with Humana
  • Coordinate with specialty pharmacy for continued supply

Plan Changes:

  • Review formulary annually during open enrollment
  • Confirm continued network participation of specialists and pharmacies
  • Understand any changes to cost-sharing

Scripts for Key Conversations

Calling Humana Member Services

"Hi, I'm calling about prior authorization for Orladeyo, generic name berotralstat, for hereditary angioedema. My member ID is [number]. Can you tell me the current status of my PA request submitted on [date]? If it's been denied, I'd like to understand the specific reasons and start the appeals process."

Requesting Expedited Review

"This is an expedited request for Orladeyo approval. My patient has severe hereditary angioedema with frequent attacks that are impacting their quality of life and ability to work. We've documented failures with [list prior therapies]. Please process this as urgent given the medical necessity."

Pharmacy Coordination

"I'm calling to coordinate an Orladeyo prescription that requires specialty pharmacy dispensing. The prior authorization has been approved by Humana. Can you confirm you're in-network and walk me through the delivery process?"

Common Denial Reasons & Solutions

Denial Reason How to Overturn Required Documentation
Insufficient diagnosis documentation Submit complete lab workup C1-INH levels, C4, genetic testing
Lack of prior therapy trials Document step therapy failures Detailed treatment history with outcomes
Age under 12 years Confirm patient age Birth certificate or medical records
Request for acute treatment Clarify prophylaxis indication Letter explaining preventive use
Non-specialist prescriber Obtain specialist consultation Referral letter or co-signature
Concurrent prophylaxis therapy Discontinue other agents Documentation of therapy changes

For each denial, Counterforce Health can help identify the specific denial basis and draft point-by-point rebuttals aligned with Humana's own coverage policies.

FAQ

How long does Humana prior authorization take for Orladeyo in California? Standard PA requests are processed within 72 hours of complete submission. Expedited requests for urgent medical situations are processed within 24 hours.

What if Orladeyo is not on my Humana formulary? You can request a formulary exception with supporting medical documentation. If denied, California's IMR process provides an independent review with binding decisions.

Can I request an expedited appeal in California? Yes, both Humana internal appeals and California IMR offer expedited processes for urgent medical situations, typically decided within 72 hours.

Does step therapy apply to Orladeyo with Humana? While not formal step therapy, Humana requires documentation of prior prophylaxis therapy failures before approving Orladeyo.

What specialist do I need for Orladeyo approval? An allergist, immunologist, or HAE specialist should prescribe Orladeyo. If your current doctor isn't a specialist, obtain a consultation or referral.

How much will Orladeyo cost with Humana coverage? As a specialty tier medication, expect significant cost-sharing. Exact amounts depend on your specific plan design. Contact member services for precise copay/coinsurance amounts.

What happens if I move out of California during treatment? Your Humana coverage continues, but you'll lose access to California's IMR process. Check your new state's external review options.

Can I appeal multiple times if denied? Yes, you can file internal appeals with new information and proceed to IMR if Humana maintains the denial. Each level offers fresh review opportunities.

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 personalized guidance. Coverage policies and requirements may change. For immediate assistance with insurance appeals and coverage determination, contact the California Department of Managed Health Care Help Center at 888-466-2219.

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