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

Lowering Out-of-Pocket for Garadacimab with Humana in Michigan: Copay, Tiering & Assistance Programs

Answer Box: Getting Garadacimab Covered by Humana in Michigan

Garadacimab (Andembry) is non-formulary on Humana plans, requiring a formulary exception with step therapy documentation. Michigan patients must first try preferred HAE prophylaxis (Haegarda, Takhzyro) or document contraindications. Submit prior authorization through CenterWell Specialty Pharmacy with HAE diagnosis confirmation (C1-INH/C4 labs), attack logs, and specialist prescription. If denied, file internal appeal within 65 days, then external review with Michigan DIFS within 127 days. First step: Contact your HAE specialist to compile medical necessity documentation and initiate Humana's formulary exception process.

Table of Contents

  1. What Drives Garadacimab Costs
  2. Benefit Investigation: Questions to Ask
  3. Copay Assistance and Support Programs
  4. Formulary Exceptions and Step Therapy
  5. Specialty Pharmacy Coordination
  6. Appeals Process for Michigan Patients
  7. Annual Renewal and Budget Planning
  8. Conversation Scripts and Templates

What Drives Garadacimab Costs

Understanding Humana's benefit design helps predict your out-of-pocket costs for Garadacimab (Andembry), CSL Behring's new HAE prophylaxis treatment approved in June 2025.

Formulary Tier Placement

Garadacimab is not on Humana's 2025 Medicare Advantage specialty drug formulary, placing it in non-formulary status requiring formulary exceptions. Humana's preferred HAE prophylaxis alternatives include:

  • Haegarda (C1-INH): Preferred tier
  • Cinryze (C1-INH): Non-preferred but covered
  • Takhzyro (lanadelumab): Step therapy required
  • Orladeyo (berotralstat): Step therapy required

Cost Structure Impact

Coverage Status Patient Responsibility Prior Auth Required Timeline
Non-formulary 100% until exception approved Yes, with medical necessity 72 hours standard
Exception approved Specialty tier copay (typically $47-$150) Annual reauthorization 24 hours expedited

Source: Humana Medicare formulary guidelines

Benefit Investigation: Questions to Ask

Before starting Garadacimab, gather this information from Humana member services (1-800-833-2364):

Essential Coverage Questions

  1. "Is Garadacimab (NDC 44206-0571-01) covered on my specific plan?"
  2. "What's my specialty tier copay after formulary exception approval?"
  3. "Does my plan require step therapy for HAE prophylaxis medications?"
  4. "Which specialty pharmacies are in-network for Garadacimab dispensing?"
  5. "What's my plan's medical necessity criteria for HAE treatments?"

Information to Record

  • Policy/member ID number
  • Plan type (Medicare Advantage vs. commercial)
  • Specialty pharmacy benefits administrator
  • Prior authorization fax number for submissions
  • Annual out-of-pocket maximum
Tip: Request written confirmation of coverage details via MyHumana portal for your records.

Copay Assistance and Support Programs

CSL Behring Connect Programs

CSL Behring offers copay assistance for commercially insured patients with specific eligibility requirements:

Eligibility Requirements:

  • Commercial health insurance coverage (Medicare/Medicaid patients excluded)
  • U.S. resident (excluding Puerto Rico)
  • Valid on-label prescription for Garadacimab
  • Insurance policy allows copay assistance participation

Program Benefits:

  • Reduces out-of-pocket costs for deductibles, copays, and coinsurance
  • Cannot exceed annual program maximums
  • Not combinable with other CSL Behring discount programs

How to Enroll:

  • Call 888-508-6978 for enrollment
  • Pharmacy can request benefits at dispensing
  • Patient reimbursement available with proof of payment

Alternative Financial Assistance

For patients ineligible for manufacturer programs:

  • Patient Access Network (PAN) Foundation: Provides grants for rare disease treatments
  • HealthWell Foundation: Offers copay assistance for HAE medications
  • Good Days (formerly Chronic Disease Fund): Financial assistance for specialty drugs
  • State pharmaceutical assistance programs: Michigan-specific options through DIFS

Note: Medicare patients cannot use manufacturer copay cards but may qualify for foundation grants.

Formulary Exceptions and Step Therapy

Step Therapy Requirements

Humana requires step therapy for HAE prophylaxis, meaning patients must try preferred alternatives before Garadacimab approval:

Preferred Alternatives to Try First:

  1. Lanadelumab (Takhzyro) - First-line monoclonal antibody
  2. Berotralstat (Orladeyo) - Oral kallikrein inhibitor
  3. C1-INH replacement (Haegarda/Cinryze) - Plan-dependent preference

Medical Necessity Documentation

Your HAE specialist must provide comprehensive documentation including:

Required Clinical Evidence:

  • Confirmed HAE diagnosis with lab results (C1-INH levels, C4 complement)
  • Attack frequency and severity logs (minimum 6 months)
  • Prior therapy trials with documented failure/intolerance
  • ICD-10 diagnosis codes (D84.1 for HAE)
  • Prescriber specialty credentials verification

Step Therapy Exception Criteria:

  • Medical contraindication to preferred agents
  • Previous treatment failure despite adequate trial
  • Drug interaction concerns with preferred options
  • Patient-specific factors requiring Garadacimab
From Our Advocates: "Document everything meticulously. We've seen formulary exceptions approved when specialists provide detailed attack logs showing inadequate response to preferred therapies, even when the trial period was shorter than typical requirements."

Specialty Pharmacy Coordination

CenterWell Specialty Pharmacy

Humana's owned specialty pharmacy handles Garadacimab dispensing in Michigan:

Services Provided:

  • Home delivery throughout Michigan
  • Clinical support and education
  • Prior authorization coordination
  • REMS program compliance assistance
  • Refill management and adherence monitoring

Contact Information:

  • Phone: 1-800-486-2668 (TTY: 711)
  • Online: CenterWell patient portal
  • Provider fax for prescriptions and PA forms

Coordination Tips

  1. Verify network status before first fill using Humana's pharmacy finder
  2. Coordinate REMS training - Garadacimab requires Risk Evaluation and Mitigation Strategies compliance
  3. Plan delivery timing - Allow 7-10 business days for first shipment
  4. Set up auto-refill to ensure continuous therapy
  5. Maintain temperature-controlled storage per manufacturer guidelines

Appeals Process for Michigan Patients

Internal Appeals with Humana

If your formulary exception is denied, Michigan patients have specific appeal rights:

Timeline and Process:

  • File within: 65 days of denial notice
  • Standard review: 30 days for medical services, 7 days for Part D drugs
  • Expedited review: 72 hours when health is at risk
  • Required documents: Denial letter, medical records, prescriber letter

Michigan External Review Process

Michigan's Department of Insurance and Financial Services (DIFS) provides independent review:

Key Details:

  • Deadline: 127 days after final internal denial
  • Process: File via DIFS online portal or paper form
  • Timeline: 60 days maximum (72 hours for expedited)
  • Cost: No fee to patients
  • Decision: Binding on insurance company

Required Documentation:

  • Completed external review request form
  • Copy of internal appeal denial
  • All relevant medical records
  • Prescriber statement of medical necessity

Contact DIFS:

  • Phone: 877-999-6442 (toll-free)
  • Online: Michigan.gov/DIFS external review portal
  • Email: [email protected]
Note: Michigan's 127-day deadline is longer than the federal 120-day standard, providing extra time for thorough preparation.

Annual Renewal and Budget Planning

What Changes Each Year

Coverage Variables:

  • Formulary tier placement may shift
  • Prior authorization criteria updates
  • Copay amounts and deductibles reset
  • Specialty pharmacy network changes
  • Step therapy requirements modifications

Planning Strategies

  1. Review annual notice of changes from Humana each October
  2. Confirm continued coverage 60 days before plan year end
  3. Update prior authorization if required annually
  4. Budget for January deductible reset - specialty tier drugs often have high deductibles
  5. Compare plan options during open enrollment if coverage becomes unfavorable

Budget Considerations:

  • Specialty tier copays: $47-$150 per month typical
  • Annual deductible: $2,000-$8,000 for specialty drugs
  • Out-of-pocket maximum: $8,850 (2025 Medicare Advantage limit)

Conversation Scripts and Templates

Calling Humana Member Services

Opening Script: "I need information about coverage for Garadacimab, also called Andembry, for hereditary angioedema prophylaxis. The NDC is 44206-0571-01. Can you tell me if this requires prior authorization and what my copay would be after approval?"

Follow-up Questions:

  • "What documentation does my doctor need to submit?"
  • "How long does the prior authorization review take?"
  • "If denied, what's the appeals process timeline?"
  • "Which specialty pharmacies can dispense this medication?"

Provider Peer-to-Peer Request

Email Template for Clinic Staff:

Subject: Urgent Peer-to-Peer Review Request - Garadacimab Prior Authorization

"We're requesting a peer-to-peer review for [patient name, DOB, member ID] regarding denied prior authorization for Garadacimab (Andembry) for HAE prophylaxis. Our specialist needs to discuss the medical necessity with your medical director. Please schedule within 72 hours per our patient's clinical needs. Fax confirmation to [clinic fax]."

Requesting Clinical Documentation

Template for Patients:

"I'm appealing my insurance denial for Garadacimab. Please provide copies of: my HAE diagnosis labs (C1-INH, C4 levels), attack frequency logs from the past year, documentation of previous HAE treatments tried, and a medical necessity letter explaining why Garadacimab is required for my specific case."

About Counterforce Health: We help patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals by providing evidence-backed, payer-specific guidance. Our platform identifies denial reasons and creates targeted rebuttals using FDA labeling, peer-reviewed studies, and specialty guidelines aligned to each plan's coverage policies.

Need help with your Garadacimab appeal? Counterforce Health specializes in HAE medication coverage challenges and can provide personalized appeal strategies for Michigan patients facing Humana denials.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan and individual circumstances. Always consult your healthcare provider and insurance company for personalized guidance. For questions about Michigan insurance regulations, contact DIFS at 877-999-6442.

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