By Counterforce Health Team in Garadacimab (anti-FXIIa) — FDA-approved 2025 —

How to Get Garadacimab (Andembry) Approved by Humana in Pennsylvania: Complete Prior Authorization Guide

Quick Answer: Your Path to Garadacimab Coverage

Garadacimab (Andembry) requires prior authorization from Humana in Pennsylvania, with mandatory step therapy through preferred HAE prophylaxis medications first. You'll need confirmed HAE diagnosis, documented failure of Haegarda or Takhzyro, and specialty pharmacy coordination. If denied, Pennsylvania's external review program has a 50% overturn rate. Start today: Gather your HAE attack logs, previous therapy records, and contact your specialist to initiate the prior authorization through CenterWell Specialty Pharmacy.

Table of Contents

What This Guide Covers

This guide helps Pennsylvania residents with Humana Medicare Advantage or commercial plans get garadacimab (Andembry) approved for hereditary angioedema (HAE) prophylaxis. CSL Behring's first-in-class anti-FXIIa monoclonal antibody received FDA approval in June 2025, but faces tight prior authorization requirements due to its specialty status and cost.

Who this helps:

  • HAE patients whose current prophylaxis isn't controlling attacks adequately
  • Clinicians navigating Humana's step therapy requirements
  • Patients facing initial denials who need appeal guidance

Expected outcomes: With proper documentation and persistence, most medically appropriate requests get approved—either initially or through appeals. Pennsylvania's new external review program provides an additional safety net with strong patient success rates.

Before You Start: Verify Your Coverage

Check Your Plan Type

Humana Medicare Advantage: Garadacimab falls under Part B (medical benefit) as a specialty injectable. Prior authorization is required, and you'll use CenterWell Specialty Pharmacy for dispensing.

Humana Commercial Plans: Coverage varies by employer group. Check your Summary of Benefits to confirm specialty drug coverage and annual maximums.

Confirm Network Status

Garadacimab must be filled through Humana's specialty pharmacy network, primarily:

  • CenterWell Specialty Pharmacy (preferred)
  • Accredo
  • Acaria Health
  • Across Specialty Pharmacy
Note: These are mail-order pharmacies with home delivery—no walk-in locations in Pennsylvania for garadacimab pickup.

Formulary Position

Garadacimab is non-formulary on most Humana plans, requiring a formulary exception with robust medical necessity documentation.

Step Therapy Requirements

Before Humana will consider garadacimab, you must document trials of preferred HAE prophylaxis medications:

Required First-Line Agents Status Documentation Needed
Haegarda (C1-INH, subcutaneous) Preferred Trial duration, response, side effects
Takhzyro (lanadelumab) Step therapy required Same as above
Orladeyo (berotralstat) Plan-dependent May be required on some designs

Exception pathways:

  • Documented contraindications to preferred agents
  • Previous therapy failure despite adequate trial duration
  • Drug interactions making garadacimab the only appropriate option
Tip: Keep detailed logs of attack frequency, severity, and quality of life impact during each therapy trial. This becomes crucial evidence for your exception request.

Gather Required Documentation

Clinical Evidence Checklist

✓ HAE Diagnosis Confirmation:

  • Laboratory results showing low C4 complement and C1-INH levels
  • ICD-10 code D84.1 (Defects in the complement system)
  • Genetic testing results if available

✓ Attack History:

  • Detailed logs for ≥6 months showing frequency and severity
  • Emergency department visits or hospitalizations
  • Impact on work, school, or daily activities

✓ Prior Therapy Documentation:

  • Complete list of previous HAE medications tried
  • Dates of treatment, dosing, and duration
  • Specific reasons for discontinuation (lack of efficacy, side effects, contraindications)
  • Supporting clinical notes from your HAE specialist

✓ Prescriber Information:

  • Must be an HAE specialist (immunology, allergy, or hematology)
  • Current medical license and specialty credentials
  • Contact information for peer-to-peer review if requested

REMS Program Requirements

Garadacimab requires Risk Evaluation and Mitigation Strategies (REMS) compliance:

  • Patient and/or caregiver training in preparation and self-injection
  • Safe storage, preparation, and disposal protocols
  • Adverse effects recognition and emergency procedures

Your specialty pharmacy will coordinate this training before the first dose.

Submit Your Prior Authorization

Step-by-Step Submission Process

1. Obtain Prior Authorization Form

2. Complete Documentation Package Include all clinical evidence from the checklist above, plus:

  • Completed prior authorization form
  • Prescriber attestation letter
  • Chart notes supporting medical necessity
  • Laboratory results confirming HAE diagnosis

3. Submit to Humana

  • Fax: 1-888-447-3430 (Medication Intake Team)
  • Phone: 1-800-523-0023 (Clinical intake team)
  • Submit all documents together to avoid delays

4. Coordinate with Specialty Pharmacy Contact CenterWell Specialty Pharmacy to ensure they're ready to dispense once approval comes through.

Clean Request Packet Tips

  • Use clear, legible copies of all documents
  • Include a cover sheet listing all attached items
  • Number pages and include patient name/DOB on each page
  • Highlight key clinical information (attack frequency, prior therapy failures)

Follow-Up and Timelines

Standard Review Timelines

Medicare Advantage (Part B):

  • Standard pre-service decisions: 30 days
  • Payment decisions: 60 days
  • Expedited reviews: 72 hours (if health is jeopardized)

Commercial Plans:

  • Standard review: 15 business days
  • Expedited review: 72 hours

When and How to Follow Up

Week 1: Confirm receipt of your submission

  • Call Humana member services: 1-800-281-6918
  • Get a reference number and expected decision date

Week 2: Check status if no decision received

  • Ask specifically about any missing documentation
  • Request expedited review if clinically appropriate

Sample Follow-Up Script: "I'm calling about prior authorization request #[reference number] for garadacimab for my HAE. Can you tell me the status and if any additional information is needed?"

If You're Asked for More Information

Common Requests and Responses

Medical Necessity Clarification:

  • Provide additional attack logs or emergency department records
  • Submit peer-reviewed literature supporting garadacimab use
  • Include quality of life assessments showing functional impairment

Step Therapy Documentation:

  • Compile pharmacy records showing fills and dates for previous HAE medications
  • Get prescriber notes documenting specific reasons for therapy changes
  • Include any allergy or contraindication documentation

Literature to Include

If Your Request is Denied

Understanding Denial Codes

Common denial reasons:

  • Insufficient documentation of HAE diagnosis
  • Lack of documented failure of preferred agents
  • Missing REMS program compliance documentation
  • Step therapy requirements not met

First-Level Appeal Process

Timeline: 65 days from denial notice to file internal appeal

Required documents:

  • Original denial letter
  • Additional clinical evidence addressing denial reason
  • Updated prescriber letter emphasizing medical necessity

Submission: Same fax/portal as original request, clearly marked "APPEAL"

Peer-to-Peer Review

Request a clinical conversation between your HAE specialist and Humana's medical director:

  • Usually scheduled within 1-2 business days of request
  • Allows real-time discussion of clinical rationale
  • Often resolves complex cases more efficiently than written appeals

Pennsylvania External Review Process

If Humana's internal appeal is unsuccessful, Pennsylvania offers robust external review rights with strong patient success rates.

Eligibility and Process

Who qualifies: Pennsylvania residents with commercial insurance (not self-funded employer plans)

Timeline: Request within 4 months of final denial letter

Success rate: Over 50% of external reviews result in coverage approval

How to Request External Review

  1. Submit request via Pennsylvania Insurance Department website
  2. Include documentation: Final denial letter, medical records, prescriber support letter
  3. Add supporting evidence within 15 days of IRO assignment
  4. Receive decision within 45 days (72 hours for expedited reviews)

The decision is binding on Humana—if approved, they must provide coverage immediately.

From our advocates: We've seen several HAE patients succeed in Pennsylvania external reviews by emphasizing the unique mechanism of action of garadacimab and its role when other prophylaxis options have failed. The independent medical reviewers often have specialized knowledge that internal insurance reviewers may lack.

Renewal and Re-authorization

When to Start Renewal Process

Begin 60-90 days before your current authorization expires. Humana typically approves garadacimab for 6-12 month periods.

What to Include in Renewal Requests

  • Updated attack logs showing continued need
  • Any changes in clinical status or other therapies
  • Confirmation of continued REMS compliance
  • Prescriber attestation of ongoing medical necessity

Calendar Reminders

Set alerts for:

  • 90 days before expiration (start renewal process)
  • 30 days before expiration (follow up if no decision)
  • Expiration date (ensure no gap in coverage)

FAQ

Q: How long does Humana prior authorization take in Pennsylvania? A: Standard review is 30 days for Medicare Advantage, 15 business days for commercial plans. Expedited reviews are completed within 72 hours if health is at risk.

Q: What if garadacimab is non-formulary on my plan? A: You'll need a formulary exception with robust medical necessity documentation. The process is the same as prior authorization but requires stronger clinical justification.

Q: Can I request an expedited appeal? A: Yes, if delays would jeopardize your health. HAE patients with frequent, severe attacks often qualify for expedited review.

Q: Does step therapy apply if I tried preferred agents outside Pennsylvania? A: Yes, documented trials from any state typically count toward step therapy requirements. Ensure you have complete pharmacy and medical records.

Q: What's the cost of garadacimab with Humana coverage? A: Costs vary by plan. Check your specialty drug tier copay or coinsurance. CSL Behring offers patient support programs that may help with out-of-pocket costs.

Q: Can I appeal if I'm on a self-funded employer plan? A: Self-funded plans follow ERISA rules, not Pennsylvania insurance law. You'd appeal through your employer's process, not the state external review program.

Printable Checklist

Before You Start

  • Verify Humana plan type and specialty drug coverage
  • Confirm in-network specialty pharmacy (CenterWell preferred)
  • Check current formulary status for garadacimab

Documentation to Gather

  • HAE diagnosis confirmation (labs, ICD-10 D84.1)
  • Attack logs (≥6 months, frequency and severity)
  • Prior therapy records (dates, responses, discontinuation reasons)
  • HAE specialist prescriber information
  • REMS training completion documentation

Submission Steps

  • Download Humana prior authorization form
  • Complete clinical documentation package
  • Fax to 1-888-447-3430 or submit via provider portal
  • Get reference number and expected decision date
  • Coordinate with CenterWell Specialty Pharmacy

If Denied

  • Review denial reason and gather additional evidence
  • File internal appeal within 65 days
  • Consider peer-to-peer review request
  • If still denied, request Pennsylvania external review within 4 months

Getting specialized medication coverage can feel overwhelming, but you're not alone in this process. Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into targeted, evidence-backed appeals. The platform analyzes denial letters and plan policies to create point-by-point rebuttals aligned with each payer's specific requirements, pulling the right clinical evidence and regulatory citations to strengthen your case.

For immediate assistance with your garadacimab appeal, consider working with Counterforce Health's specialized team, which understands Humana's specific workflows and has experience with HAE medication approvals in Pennsylvania.

Sources & Further Reading

Disclaimer: This guide provides educational information and is not medical advice. Always consult with your healthcare provider about treatment decisions. Insurance coverage policies change frequently—verify current requirements with Humana directly. For additional help with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department Consumer Services at the link provided.

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