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

How to Get Garadacimab (Andembry) Covered by Humana in Florida: Formulary Alternatives, Appeals, and Prior Authorization Guide

Answer Box: Getting Garadacimab Covered by Humana in Florida

Garadacimab (Andembry) is not on Humana's 2025 formulary, requiring a formulary exception with medical necessity documentation. Your fastest path: (1) Try preferred alternatives like Haegarda or Cinryze first if medically appropriate, (2) Document failure/intolerance to alternatives, then (3) Submit formulary exception with specialist letter citing anti-FXIIa necessity. Humana must decide within 72 hours of receiving your prescriber's supporting statement. Start by calling Humana Clinical Pharmacy Review at 800-555-2546.

Table of Contents

When Formulary Alternatives Make Sense

Humana's 2025 Medicare Advantage formulary doesn't include garadacimab (Andembry), but covers several proven HAE prophylaxis alternatives. Consider trying formulary options first if:

  • You're newly diagnosed with HAE and haven't tried other prophylactics
  • Cost is a primary concern (preferred alternatives have lower copays)
  • Your HAE is currently well-controlled on existing therapy
  • You can tolerate more frequent dosing schedules

Skip alternatives and go straight to formulary exception if:

  • You've documented failure or intolerance to C1-INH therapies
  • You need monthly dosing due to adherence challenges
  • Your specialist recommends anti-FXIIa mechanism specifically
  • You're experiencing breakthrough attacks on current therapy
Note: All HAE prophylaxis medications require confirmed HAE diagnosis with low functional C1 esterase inhibitor levels (<50% of normal) or genetic testing for HAE type III.

Humana's Preferred HAE Prophylaxis Options

Coverage at a Glance

Drug Formulary Status Route/Frequency Typical Copay Tier Prior Auth Required
Haegarda Preferred SC, twice weekly Tier 3-4 Yes
Cinryze Non-preferred IV, every 3-4 days Tier 4-5 Yes
Takhzyro Preferred (step therapy) SC, every 2-4 weeks Tier 4-5 Yes
Orladeyo Preferred (step therapy) Oral daily Tier 4-5 Yes
Garadacimab Non-formulary SC, monthly Exception required Yes

Source: Humana 2025 Part B Step Therapy List

Diagnosis Requirements for All Options

Your prescriber must document:

  • Lab confirmation: Functional C1-INH <50% of normal (HAE types I/II) or genetic testing showing pathogenic variants in F12, angiopoietin-1, plasminogen, KNG1, HS3ST6, or MYOF genes (HAE type III)
  • Clinical criteria: Recurrent laryngeal edema, non-urticarial subcutaneous angioedema lasting >12 hours, or self-remitting abdominal pain >6 hours
  • Attack history: Documentation of moderate to severe HAE attacks requiring treatment

Pros and Cons Overview

Haegarda (C1-INH Subcutaneous) - Most Preferred

Pros: Lower copay as preferred drug; established safety profile; home self-administration; FDA-approved for 6+ years Cons: Twice-weekly dosing; requires cold storage; higher injection volume than other options

Best for: Newly diagnosed patients, those prioritizing cost, patients comfortable with frequent dosing

Cinryze (C1-INH Intravenous)

Pros: Flexible dosing schedule; well-established efficacy; can be given at home or infusion center Cons: Higher copay as non-preferred; requires IV access; may need infusion center visits

Best for: Patients with difficult SC access, those preferring less frequent home dosing

Takhzyro (Lanadelumab) - Step Therapy Required

Pros: Less frequent dosing (every 2-4 weeks); room temperature storage; potential for dose reduction after 6 months if attack-free Cons: Requires documented failure of preferred alternatives; higher cost; newer long-term safety data

Best for: Patients who've failed C1-INH therapies, those prioritizing convenience

Orladeyo (Berotralstat) - Step Therapy Required

Pros: Only oral HAE prophylaxis option; daily dosing familiar to patients Cons: Requires documented failure of preferred alternatives; potential liver enzyme elevation; daily adherence required

Best for: Patients preferring oral therapy, those with injection site reactions to other options

Formulary Exception Strategy

Step-by-Step: Requesting Garadacimab Exception

Step 1: Gather Required Documentation

  • HAE diagnosis confirmation (C1-INH levels or genetic testing)
  • Attack logs showing frequency and severity
  • Documentation of prior therapy trials and outcomes
  • Emergency room records or hospitalizations due to HAE
  • Specialist letter supporting garadacimab necessity

Step 2: Prescriber Submits Supporting Statement Your HAE specialist or prescribing physician must submit a supporting statement demonstrating that garadacimab is medically necessary because:

  • All covered Part D drugs would be less effective for your condition
  • Covered alternatives have caused or are likely to cause adverse effects
  • You require the specific anti-FXIIa mechanism of action

Step 3: Submit to Humana

  • Phone: 800-555-2546 (Clinical Pharmacy Review)
  • Online: Through Humana provider portal
  • Timeline: 72-hour decision once supporting statement received
  • Expedited: Request if medically urgent

Medical Necessity Letter Checklist

Your prescriber's letter should include:

  • Confirmed HAE diagnosis with lab values/genetic testing
  • Current attack frequency and severity
  • Prior therapies tried, duration, and reasons for failure/intolerance
  • Clinical rationale for anti-FXIIa therapy specifically
  • References to FDA approval and clinical trial data
  • Planned dosing and monitoring schedule
From our advocates: We've seen the strongest exception approvals when prescribers include specific attack logs (dates, severity, treatments needed) and clearly document why C1-INH therapies aren't suitable—whether due to frequent breakthrough attacks, injection site reactions, or adherence challenges with more frequent dosing schedules.

Appeals Process in Florida

If Your Exception is Denied

Internal Appeal (First Level)

  • Deadline: 65 days from denial notice
  • Timeline: Humana has 30 days for standard appeals, 72 hours for expedited
  • How to file: Call member services, submit online, or mail written appeal
  • Required: Copy of denial letter, additional medical documentation

External Review (Second Level)

  • When available: After internal appeal denial or if Humana fails to follow proper procedures
  • Deadline: 4 months after final internal denial
  • Process: Florida Department of Financial Services contracts with independent medical reviewers
  • Cost: Free to consumers
  • Timeline: 72 hours for expedited urgent cases, 30 days standard

Florida-Specific Resources

Florida Department of Financial Services

  • Consumer Helpline: 877-693-5236 (877-MY-FL-CFO)
  • Online complaints: MyFloridaCFO.com
  • External review requests: Submit through DFS Consumer Services Division

When to Escalate to State Regulators:

  • Humana misses appeal deadlines
  • Denial appears inconsistent with medical evidence
  • You're not receiving required notices or forms
  • Emergency medication access is delayed

Switching Between HAE Medications

No Washout Period Required

Transitions between HAE prophylaxis medications typically don't require washout periods, but coordination is essential:

Provider Coordination:

  • Schedule transition during stable period (avoid known triggers)
  • Ensure on-demand treatments (icatibant, ecallantide) are available
  • Plan monthly monitoring calls for first 3 months
  • Time switches away from dental procedures or stressful periods

Insurance Coordination:

  • Submit new prior authorization before current supply runs out
  • Request overlap coverage if transitioning between different mechanisms
  • Coordinate with specialty pharmacy for dual dispensing during transition
  • Keep documentation of medical necessity for new therapy

Pharmacy Logistics:

  • Specialty pharmacy coordination for both injectable and oral options
  • Cold storage requirements for C1-INH products
  • Training on new self-administration techniques if applicable
  • Supply chain planning for consistent access

Monitoring During Transitions

Track these metrics during medication switches:

  • Monthly HAE attack frequency and severity
  • Use of on-demand treatments
  • Injection site reactions or other adverse effects
  • Quality of life measures and treatment satisfaction

Counterforce Health helps patients and providers navigate complex insurance requirements for specialty medications like HAE prophylaxis options, turning denials into targeted appeals with the right clinical documentation and payer-specific evidence.

Re-trying for Garadacimab Later

Building Your Case for Future Appeals

If your initial garadacimab exception is denied, document the following while trying alternatives:

Attack Documentation:

  • Keep detailed attack logs with dates, severity (1-10 scale), duration
  • Record emergency treatments used and their effectiveness
  • Note any hospitalizations or emergency room visits
  • Track missed work/school days due to HAE

Treatment Response Documentation:

  • Injection site reactions or administration difficulties
  • Adherence challenges with frequent dosing
  • Quality of life impacts from current therapy
  • Any dose escalations needed for breakthrough attacks

Clinical Progression:

  • Regular C1-INH levels or other relevant lab monitoring
  • Specialist assessments of disease control
  • Any changes in attack triggers or patterns
  • Response to stress, illness, or procedures

When to Resubmit

Consider resubmitting a garadacimab exception after:

  • 6+ months of documented inadequate control on alternatives
  • Significant adverse effects requiring therapy discontinuation
  • New clinical evidence or guidelines supporting anti-FXIIa therapy
  • Changes in your medical condition affecting treatment response

FAQ

How long does Humana prior authorization take in Florida? Standard PA decisions take up to 72 hours once Humana receives your prescriber's supporting statement. Expedited reviews can be completed within 24 hours if medically appropriate.

What if garadacimab is completely non-formulary? You can request a formulary exception to add it to your coverage with appropriate cost-sharing. The medical necessity standards are the same as for tier exceptions.

Can I request an expedited appeal in Florida? Yes, if your condition is urgent or could seriously jeopardize your health. Both internal and external appeals can be expedited, with decisions required within 72 hours.

Does step therapy apply if I've failed HAE medications outside Florida? Yes, documented failures from other states count toward step therapy requirements. Ensure your new Florida prescriber has complete records of prior treatments and outcomes.

What counts as "failure" of alternative HAE therapies? Inadequate attack reduction (typically still having >1 moderate-severe attack per month), intolerable side effects, adherence problems due to dosing frequency, or contraindications to continued therapy.

Are there patient assistance programs for HAE medications? Most manufacturers offer patient support programs, but Medicare patients have limited options due to federal regulations. CSL Behring's patient support may help with prior authorization assistance and care coordination.

How do I get help with the appeals process in Florida? Contact Florida's Insurance Consumer Helpline at 877-693-5236 or file a complaint online. Counterforce Health also provides specialized assistance with insurance appeals for complex specialty medications.

What if I'm traveling and need medication access? Coordinate with your specialty pharmacy for travel supplies and emergency prescriptions. Keep copies of your prescription, diagnosis documentation, and insurance cards when traveling.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and is not medical advice. Always consult with your healthcare provider about treatment decisions and insurance coverage options. Insurance policies and coverage criteria can change; verify current requirements with your insurer and healthcare team.

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.