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

How to Get Garadacimab (Andembry) Covered by UnitedHealthcare in New York: PA Requirements, Appeals, and Cost-Saving Strategies

Answer Box: Getting Garadacimab Covered by UnitedHealthcare in New York

Garadacimab (Andembry) requires prior authorization from UnitedHealthcare's OptumRx with step therapy requirements. You must document failed or contraindicated HAE prophylaxis treatments before approval. First step today: Contact your HAE specialist to gather documentation of prior therapy failures and confirm your HAE diagnosis with lab results (low C4, C1-INH levels). Submit PA through the OptumRx Provider Portal with complete clinical documentation. If denied, New York residents have strong appeal rights through the state's external review process within 4 months of final denial.

Table of Contents

  1. What Drives Garadacimab Costs
  2. Benefit Investigation Checklist
  3. Prior Authorization Requirements
  4. Assistance Programs and Copay Support
  5. Appeals Process for New York Residents
  6. Pharmacy Choice and Coordination
  7. Annual Renewal Planning
  8. Conversation Scripts
  9. FAQ

What Drives Garadacimab Costs

Garadacimab (Andembry) is a first-in-class specialty biologic for hereditary angioedema (HAE) prophylaxis, approved by the FDA in June 2025. As a newly launched monoclonal antibody, it faces typical specialty drug coverage challenges with UnitedHealthcare.

Key Cost Factors:

  • Specialty tier placement: Likely tier 4 or 5 with higher coinsurance (verify with your specific plan)
  • Prior authorization requirement: Mandatory for all UnitedHealthcare plans through OptumRx
  • Step therapy: Must document failure of preferred HAE treatments
  • REMS program: Provider certification and patient enrollment required
Note: UnitedHealthcare's marketplace plans in New York have shown above-average denial rates (~33% for in-network claims), making thorough documentation critical.

Benefit Investigation Checklist

Before starting treatment, gather this information from UnitedHealthcare:

Call Member Services (1-800-711-4555) and ask:

  • What is Garadacimab's formulary tier on my plan?
  • What is my coinsurance/copay for tier 4/5 specialty drugs?
  • Is prior authorization required?
  • What step therapy requirements apply to HAE prophylaxis?
  • What is my annual out-of-pocket maximum?
  • Which specialty pharmacies are preferred?

Document everything with representative name, date, and reference number.

Prior Authorization Requirements

UnitedHealthcare requires comprehensive documentation for Garadacimab approval:

Required Clinical Documentation

HAE Diagnosis Confirmation:

  • Laboratory evidence: Low C4 levels, low or dysfunctional C1-INH
  • Specialist prescription (hematologist, allergist, or immunologist)
  • Attack frequency documentation (typically 2+ attacks per month)

Step Therapy Documentation:

  • Dates of prior HAE prophylaxis therapies
  • Reason for discontinuation (inefficacy, adverse effects, contraindication)
  • Clinical evidence of failure or intolerance
  • Preferred agents typically include: C1-INH therapies (Berinert, Cinryze, Haegarda), Takhzyro (lanadelumab), Orladeyo (berotralstat)

REMS Compliance:

  • Provider certification in Garadacimab REMS program
  • Patient enrollment documentation

Submission Process

  1. Submit via OptumRx Provider Portal for fastest processing (1-5 business days)
  2. Include all supporting documents in initial submission
  3. Use PreCheck MyScript tool to verify specific plan requirements
  4. Follow up within 72 hours if no acknowledgment received

Assistance Programs and Copay Support

CSL Behring Patient Support Programs

Commercial Insurance Copay Card:

  • Eligible patients with private insurance (not Medicare/Medicaid)
  • Apply through ANDEMBRY Connect℠ at 844-423-4273
  • No income requirements for copay assistance

Patient Assistance Program (Uninsured/Underinsured):

  • Free medication for eligible patients
  • Income limits typically 300-500% of federal poverty level
  • Requires detailed application with income verification

Independent Foundation Grants

While Garadacimab-specific programs may be limited due to its recent approval, consider these rare disease assistance organizations:

  • HealthWell Foundation
  • PAN Foundation
  • Patient Access Network Foundation
From our advocates: "Start the manufacturer assistance application early—even before your first denial. CSL Behring's support team can often expedite processing if you have urgent clinical needs and provide guidance on gathering the right documentation for both insurance appeals and their assistance programs."

Appeals Process for New York Residents

New York offers robust patient protection through its external appeal process administered by the Department of Financial Services (DFS).

Internal Appeals (UnitedHealthcare)

Timeline: Must file within 180 days of initial denial Process: Submit through member portal or by mail Documentation: Include all clinical evidence and specialist letters

External Appeals (New York DFS)

Timeline: Must file within 4 months of final internal denial Cost: $25 fee (waived for Medicaid or financial hardship) Decision timeline: 30 days standard, 72 hours expedited

Required Documentation for DFS:

  • Completed external appeal application
  • Copy of UnitedHealthcare's final denial letter
  • HAE diagnosis confirmation
  • Evidence of prior treatment failures
  • Specialist medical necessity letter
  • Attack frequency logs and clinical impact documentation

Submit to DFS:

  • Fax: 800-332-2729
  • Online: DFS External Appeal Portal
  • Mail: Check current DFS address
Tip: New York's external appeal database includes searchable prior decisions that can help strengthen your case with relevant medical literature citations.

For free assistance, contact Community Health Advocates at 888-614-5400.

Pharmacy Coordination

Specialty Pharmacy Requirements

Garadacimab requires specialty pharmacy dispensing due to:

  • REMS program requirements
  • Cold chain storage needs
  • Patient education requirements

UnitedHealthcare Preferred Specialty Pharmacies:

  • OptumRx Specialty Pharmacy
  • Verify current preferred network with member services

Coordination Tips

  1. Confirm pharmacy benefits before first fill
  2. Coordinate with REMS training requirements
  3. Plan refill timing to avoid gaps in therapy
  4. Maintain communication between prescriber, pharmacy, and patient support programs

Annual Renewal Planning

Reauthorization Requirements

  • Frequency: Typically every 12 months
  • Documentation needed: Evidence of ongoing clinical response
  • Timeline: Submit 30-60 days before current authorization expires

Plan Changes to Monitor

  • Formulary updates: Tier placement may change annually
  • Step therapy modifications: New preferred agents may be added
  • Cost-sharing adjustments: Deductibles and coinsurance reset January 1st

Set calendar reminders for:

  • PA renewal submission (60 days prior to expiration)
  • Annual enrollment period review (October-December)
  • Manufacturer assistance program renewal

Conversation Scripts

Calling UnitedHealthcare Member Services

"I'm calling about prior authorization for Garadacimab, also known as Andembry, for hereditary angioedema. Can you tell me the current status of PA request [reference number]? I also need to confirm what clinical documentation is still needed and the expected decision timeline."

Requesting Peer-to-Peer Review

"We're requesting a peer-to-peer review for our Garadacimab prior authorization. The patient has documented HAE with frequent attacks despite trials of [list prior medications]. Can we schedule a clinical discussion with your medical director who covers rare diseases or hematology?"

Pharmacy Coordination Call

"I'm coordinating care for a patient starting Garadacimab. Can you confirm you're enrolled in the REMS program, verify the patient's insurance benefits, and provide an estimated timeline for first shipment once PA is approved?"

FAQ

How long does UnitedHealthcare PA take for Garadacimab in New York? Standard PA processing is 1-5 business days through OptumRx. Expedited reviews (72 hours) are available for urgent clinical needs.

What if Garadacimab is non-formulary on my plan? Non-formulary medications can still be covered through medical necessity appeals. Document why preferred alternatives are inappropriate and include specialist support.

Can I request expedited appeal if attacks are frequent? Yes. New York allows expedited external appeals (72 hours) if delay would seriously jeopardize health. Include physician letter stating urgency.

Does step therapy apply if I tried medications in another state? Yes, but you must provide complete documentation from out-of-state providers, including dates, dosing, and reasons for discontinuation.

What happens if my specialist isn't in UnitedHealthcare's network? Out-of-network specialist prescriptions may still be covered if no in-network HAE specialist is available within reasonable distance. Request single case agreement.

How do I find HAE specialists covered by UnitedHealthcare in New York? Use the provider directory at uhc.com or call member services. Look for hematologists, allergists, or immunologists with HAE experience.

Counterforce Health helps patients navigate complex prior authorization and appeal processes for specialty medications like Garadacimab. Our platform analyzes denial letters and creates evidence-backed appeals tailored to each payer's specific requirements, turning insurance obstacles into successful coverage outcomes.

When facing insurance denials for critical HAE treatments, having the right documentation and appeal strategy can make the difference between coverage and continued out-of-pocket costs. Counterforce Health specializes in transforming clinical evidence into compelling insurance appeals that meet payer-specific criteria and regulatory requirements.

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 with your healthcare provider and insurance company for personalized guidance. For official New York insurance regulations and appeals procedures, visit the New York State Department of Financial Services website.

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