By Counterforce Health Team in Orladeyo (berotralstat) —

How to Get Orladeyo (Berotralstat) Covered by Humana in Washington: Timeline, Appeals & Forms

Answer Box: Getting Orladeyo Covered by Humana in Washington

Orladeyo (berotralstat) is typically covered by Humana as a specialty tier drug requiring prior authorization for hereditary angioedema (HAE) prophylaxis. The fastest path to approval involves: 1) Confirming HAE diagnosis with lab results (C1-INH levels/function), 2) Submitting complete prior authorization through Humana's provider portal with specialist documentation, and 3) Following up within 72 hours if additional information is requested. Appeals through Washington's Independent Review Organization (IRO) are available if denied. Start by gathering your HAE diagnostic labs and contacting your prescribing specialist today.

Table of Contents

What Affects Orladeyo Approval Timing

Several factors influence how quickly Humana approves Orladeyo (berotralstat) for HAE prophylaxis in Washington:

Benefit Type Complexity: Orladeyo requires specialty pharmacy dispensing and appears on Humana's specialty tier (Tier 4) with prior authorization requirements. This adds 3-5 business days compared to standard formulary drugs.

Documentation Completeness: The most critical factor is having comprehensive HAE diagnostic documentation. Humana requires confirmed diagnosis through C1-INH levels/function testing or genetic confirmation, which many initial submissions lack.

Prescriber Specialization: Requests from allergists, immunologists, or HAE specialists typically process faster than those from primary care providers, as reviewers expect specialty involvement for rare disease management.

Note: Humana has committed to reducing prior authorization requirements by one-third by 2026, but specialty medications like Orladeyo will likely maintain current review processes.

Pre-Submission Preparation (0-2 Days)

Essential Documentation Checklist

Before submitting your Orladeyo prior authorization, gather these required documents:

HAE Diagnosis Confirmation:

  • C1-INH (C1 esterase inhibitor) levels and functional testing results
  • C4 complement levels
  • Detailed patient history of angioedema attacks
  • Genetic testing results if applicable (F12, KNG1, ANGPT1, PLG, HS3ST6, or MYOF mutations)

Treatment History:

  • Prior HAE therapies tried, failed, or contraindicated
  • Documentation of attack frequency before treatment
  • Any adverse reactions to alternative therapies (Takhzyro, Haegarda, C1-INH products)

Clinical Documentation:

  • Recent clinic notes from HAE specialist
  • EKG results if patient has cardiac risk factors (QT prolongation monitoring)
  • Current medication list and dosing rationale

Coding and Administrative Details

Ensure your request includes proper medical coding:

  • ICD-10: D84.1 (Hereditary angioedema)
  • NDC: Verify current Orladeyo NDC number
  • Prescriber NPI and specialty designation

Submission to Initial Review (1-5 Days)

Humana's Review Process

Humana processes specialty drug prior authorizations through their provider portal or designated fax lines. For employer plans, documentation is typically faxed to 1-877-486-2621 (verify with your specific plan).

What Reviewers Check First:

  1. HAE diagnosis confirmation in medical records
  2. Prescriber qualifications and specialty
  3. Prior therapy documentation or contraindications
  4. Dosing appropriateness (once daily with food per FDA labeling)

Washington State Requirements: While Humana operates under federal Medicare guidelines, Washington's consumer protection laws ensure you receive clear denial explanations and appeal rights information with any adverse determination.

Expected Timeline

  • Electronic submissions: 1-3 business days for initial review
  • Fax submissions: 3-5 business days
  • Expedited requests: 72 hours for urgent medical situations

Additional Information Requests (1-7 Days)

If Humana requests additional information, respond promptly to avoid delays:

Common Information Requests:

  • More detailed attack frequency documentation
  • Specialist consultation notes
  • Lab result clarification
  • Prior therapy failure documentation

How to Respond Quickly:

  • Use the same submission method (portal vs. fax)
  • Reference the original prior authorization number
  • Include a cover letter summarizing the additional information provided
  • Follow up within 48 hours to confirm receipt
Tip: Keep a digital folder with all HAE-related medical records for quick access during the approval process.

Decision Window & Outcomes

Typical Approval Outcomes

Approved: Full authorization for specialty pharmacy dispensing, typically for 6-month periods with quantity limits (28 capsules per 28 days).

Conditional Approval: May require specific pharmacy network usage or additional monitoring requirements.

Denied: Most denials relate to insufficient HAE diagnosis documentation or lack of specialist involvement.

Reading Your Approval Letter

Approved authorizations will specify:

  • Authorized quantity and days supply
  • Required specialty pharmacy network
  • Authorization expiration date
  • Any special conditions or monitoring requirements

If Denied: Washington Appeals Process

Washington residents have robust appeal rights when Humana denies Orladeyo coverage:

Internal Appeals (First Step)

Submit internal appeal to Humana within 60 days of denial:

  • Use Humana's standard appeal form
  • Include additional clinical documentation
  • Request peer-to-peer review with HAE specialist if available

External Review Through IRO

If internal appeals fail, Washington law provides access to Independent Review Organization (IRO) external review:

Timeline: IRO must decide within 15 days of receiving complete information, or 20 days from referral (whichever is earlier). Expedited reviews: 72 hours.

How to Request: Submit written request to Humana referencing the denial, or contact the Washington Insurance Commissioner's office at 1-800-562-6900.

Binding Decision: IRO decisions are legally binding on Humana. If overturned, Humana must provide coverage.

When to Escalate

Contact Washington's Insurance Commissioner if:

  • Humana fails to meet appeal deadlines
  • Required appeal information isn't provided
  • You suspect procedural violations

Renewal Cycles & Ongoing Authorization

Six-Month Renewal Process

Orladeyo authorizations typically require renewal every 6 months. To ensure continuity:

Required Documentation for Renewal:

  • Updated attack frequency data (≥50% reduction expected)
  • Decreased rescue medication usage
  • Adherence confirmation from prescriber
  • Updated clinical notes demonstrating ongoing benefit

Timeline: Submit renewal documentation at least 30 days before expiration to avoid treatment interruption.

What Speeds Renewals

  • Consistent specialty pharmacy usage
  • Well-documented attack reduction
  • Regular monitoring and follow-up visits
  • No safety concerns or adverse events

Timeline Visual: Approval Milestones

Phase Timeline Key Actions Success Factors
Preparation 0-2 days Gather HAE labs, specialist notes Complete diagnostic documentation
Submission 1-5 days Submit via portal/fax Electronic submission preferred
Review 3-7 days Humana medical review Specialist prescriber, clear diagnosis
Decision 7-14 days Approval/denial notification Respond quickly to information requests
Appeal (if needed) 15-45 days Internal + external review Additional clinical evidence

Time-Saving Tips for Faster Approval

Portal Usage Best Practices

  • Use Humana's electronic prior authorization portal when available
  • Upload all documents as single, clear PDF files
  • Include cover letter summarizing medical necessity

Bundled Evidence Strategy

Submit comprehensive documentation upfront:

  • All HAE diagnostic labs in one file
  • Complete treatment history timeline
  • Specialist consultation notes with clear recommendations

Direct Specialty Routing

Work with HAE specialists familiar with Humana's requirements. They often have established workflows and relationships with utilization management teams.

From Our Advocates: "We've seen the fastest Orladeyo approvals when allergists include a one-page summary highlighting the patient's HAE diagnosis, prior therapy failures, and why oral prophylaxis is medically necessary. This composite approach helps reviewers quickly identify key approval criteria."

Clinician Corner: Medical Necessity Letter Essentials

When writing medical necessity letters for Orladeyo, include these key elements:

Problem Statement: Clear HAE diagnosis with attack frequency and severity Prior Treatments: Document trials of C1-INH products, lanadelumab, or contraindications Clinical Rationale: Why oral prophylaxis is appropriate for this patient Guideline Citations: Reference FDA labeling and HAE management guidelines Monitoring Plan: Safety monitoring including cardiac assessment if indicated

Coverage at a Glance

Requirement Details Source
Prior Authorization Required for all Humana plans Humana formulary
Formulary Tier Tier 4 (Specialty) 2025 Drug Guide
Quantity Limit 28 capsules per 28 days Humana policy
Specialty Pharmacy Required network pharmacy Humana Specialty Rx
Age Requirement ≥12 years for HAE prophylaxis FDA labeling
Renewal Frequency Every 6 months Standard specialty drug policy

About Counterforce Health: Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by creating targeted, evidence-backed prior authorization requests. Our platform analyzes denial patterns and generates comprehensive appeals that address payer-specific requirements, helping ensure patients get access to necessary medications like Orladeyo.

When navigating complex prior authorization processes, having expert support can make the difference between approval and denial. Counterforce Health's evidence-based approach helps streamline the approval process by identifying exactly what documentation payers need and presenting it in the format they expect.

Frequently Asked Questions

How long does Humana prior authorization take for Orladeyo in Washington? Standard prior authorizations take 3-7 business days, with expedited reviews available within 72 hours for urgent medical situations.

What if Orladeyo is non-formulary on my Humana plan? You can request a formulary exception with clinical documentation supporting medical necessity over covered alternatives.

Can I request an expedited appeal if denied? Yes, expedited appeals are available for urgent medical situations, with decisions required within 72 hours.

Does step therapy apply for HAE medications? Many plans require trying other HAE prophylaxis options first, but exceptions are available for contraindications or prior failures.

What are my rights if Humana denies my appeal? Washington residents can request external review through an Independent Review Organization (IRO), which provides binding decisions.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage and appeal processes may vary by plan and individual circumstances. Always consult with your healthcare provider and insurance plan directly for specific coverage decisions. For assistance with insurance appeals in Washington, contact the Insurance Commissioner's Consumer Advocacy line at 1-800-562-6900.

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