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

How to Get Garadacimab (Andembry) Covered by UnitedHealthcare in Ohio: Complete Prior Authorization and Appeals Guide

Quick Answer: To get Garadacimab (Andembry) covered by UnitedHealthcare in Ohio, you'll need prior authorization through OptumRx with documented HAE diagnosis and step therapy compliance. If denied, Ohio allows two internal appeals plus external review within 180 days. Start by gathering your HAE diagnosis confirmation, prior therapy records, and calling UnitedHealthcare at 1-800-711-4555 to verify your plan's specific requirements.

Table of Contents

  1. Understanding Your Coverage
  2. Prior Authorization Requirements
  3. Common Denial Reasons & How to Fix Them
  4. Appeals Process in Ohio
  5. Cost-Saving Options
  6. When to Escalate
  7. Templates and Scripts
  8. Frequently Asked Questions

Understanding Your Coverage

Garadacimab (brand name Andembry) is a first-in-class monoclonal antibody approved by the FDA in June 2025 for hereditary angioedema (HAE) prophylaxis in adults. As a specialty biologic, UnitedHealthcare requires prior authorization through their pharmacy benefit manager, OptumRx.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all plans OptumRx Provider Portal UHC PA Requirements
Step Therapy Must try preferred HAE drugs first Plan formulary UHC HAE Policy
Specialty Tier Likely Tier 4/5 with high copay Member portal or EOB Verify with plan
REMS Compliance Provider must be certified FDA REMS database FDA REMS

Call UnitedHealthcare Member Services at 1-800-711-4555 to verify your specific plan's formulary status and copay requirements.

Prior Authorization Requirements

UnitedHealthcare requires comprehensive documentation for Garadacimab approval. Here's what your healthcare provider must submit:

Clinical Documentation Checklist

Confirmed HAE Diagnosis:

  • Laboratory evidence: Low C4 levels, low or dysfunctional C1-INH
  • ICD-10 code: D84.1 (Defects in complement system)
  • Specialist prescription (allergist, immunologist, or hematologist)

Step Therapy Documentation:

  • Dates of prior HAE prophylaxis therapies tried
  • Documented failure, intolerance, or contraindication to:
    • Plasma-derived C1-INH (Cinryze, Haegarda)
    • Lanadelumab (Takhzyro)
    • Berotralstat (Orladeyo)
  • Clinical evidence (persistent attacks, adverse events, lab results)

Clinical Justification:

  • HAE attack frequency (typically ≥2 attacks per month)
  • Severity and impact on quality of life
  • Treatment goals and expected outcomes

REMS Compliance:

  • Provider certification in Garadacimab REMS program
  • Patient enrollment documentation
  • Administration and monitoring plan
Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters and crafting point-by-point rebuttals aligned to each plan's specific rules. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for medications like Garadacimab.

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
Lack of confirmed HAE diagnosis Submit complete lab workup C4, C1-INH levels, genetic testing if available
Step therapy not completed Document prior therapy failures Dates, doses, reasons for discontinuation
Missing REMS documentation Provider must complete certification REMS enrollment confirmation
"Not medically necessary" Strengthen clinical justification Attack frequency logs, quality of life impact
Non-formulary status Request formulary exception Medical necessity letter with guideline citations

Step-by-Step: Fastest Path to Approval

  1. Verify Coverage (Patient): Call UnitedHealthcare at 1-800-711-4555 to confirm formulary status and PA requirements
  2. Gather Documentation (Clinic): Collect HAE diagnosis confirmation, prior therapy records, and attack frequency logs
  3. Complete REMS (Provider): Enroll in Garadacimab REMS program if not already certified
  4. Submit PA (Provider): Use OptumRx Provider Portal for fastest processing (1-5 business days)
  5. Follow Up (Clinic): Check status within 72 hours if no acknowledgment received
  6. Appeal if Denied (Patient/Provider): File internal appeal within required timeframe
  7. External Review (Patient): Request Ohio external review if internal appeals fail

Appeals Process in Ohio

Ohio provides robust consumer protections for insurance appeals, including external review through independent medical experts.

Internal Appeals with UnitedHealthcare

First-Level Appeal:

  • Timeline: Must file within 180 days of denial
  • Review Period: UnitedHealthcare has 30 days for standard review, 72 hours for urgent
  • How to File: UnitedHealthcare member portal, mail, or fax
  • What to Include: Medical necessity letter, clinical notes, guideline citations

Second-Level Appeal:

  • Timeline: File within 60 days of first-level denial
  • Review Period: 30 days for standard, 72 hours for urgent
  • Reviewer: Different clinical reviewer than first level

Ohio External Review

If UnitedHealthcare denies your internal appeals, Ohio law provides an independent external review process.

Key Details:

  • Deadline: 180 days from final internal denial
  • Timeline: 30 days for standard review, 72 hours for expedited
  • Cost: Free to patients
  • Reviewer: Independent Review Organization (IRO) with medical experts
  • Decision: Binding on UnitedHealthcare if overturned

How to Request:

  1. Submit written request to UnitedHealthcare (they forward to Ohio Department of Insurance)
  2. Include all supporting documentation
  3. Ohio DOI assigns an IRO for review
  4. IRO renders binding decision

For help with external review, contact the Ohio Department of Insurance Consumer Hotline at 1-800-686-1526.

Cost-Saving Options

Even with insurance approval, Garadacimab can be expensive. Multiple assistance programs can help reduce your out-of-pocket costs.

CSL Behring Patient Support

ANDEMBRY Connect℠ Program:

  • Copay Assistance: Reduces copay, coinsurance, and deductibles for commercially insured patients
  • Patient Assistance: Free medication for uninsured/underinsured patients meeting income requirements
  • Contact: 1-844-423-4273
  • Exclusions: Medicare and Medicaid patients cannot use copay cards due to federal regulations

Foundation Grants

For patients who can't use manufacturer copay programs:

  • HealthWell Foundation: HAE-specific grants
  • PAN Foundation: Rare disease support
  • Good Days: Chronic disease assistance
  • Patient Access Network Foundation: Specialty drug copay help
From Our Advocates: "We've seen patients successfully combine foundation grants with manufacturer assistance programs to reduce their monthly Garadacimab costs from over $3,000 to under $50. The key is applying to multiple programs simultaneously and reapplying annually during open enrollment periods."

When to Escalate

If your appeals are unsuccessful or you encounter procedural problems, escalation options include:

Ohio Department of Insurance:

  • Consumer Hotline: 1-800-686-1526
  • Website: insurance.ohio.gov
  • Services: Complaint filing, external review assistance, regulatory enforcement

Federal Resources (for ERISA plans):

  • Department of Labor: 1-866-444-3272
  • CMS: For Medicare Advantage plans

Templates and Scripts

Patient Phone Script for UnitedHealthcare

"Hi, I'm calling to verify coverage for Garadacimab, also called Andembry, for hereditary angioedema. My member ID is [ID number]. Can you tell me:

  • Is this medication on my plan's formulary?
  • What tier is it on and what's my copay?
  • Is prior authorization required?
  • Are there step therapy requirements?
  • Which specialty pharmacy must I use?"

Medical Necessity Letter Template

Subject: Prior Authorization Request for Garadacimab (Andembry) - [Patient Name], DOB: [Date], Member ID: [ID]

Clinical Summary:

  • Confirmed HAE Type I/II diagnosis with [specific lab values]
  • Current attack frequency: [X attacks per month]
  • Prior therapies attempted and outcomes:
    • [Drug 1]: [dates, reason for discontinuation]
    • [Drug 2]: [dates, reason for discontinuation]

Medical Necessity Justification: Based on [cite relevant guidelines], Garadacimab is medically necessary because:

  1. Patient has documented HAE with inadequate control on preferred agents
  2. [Specific contraindications or failures to other therapies]
  3. Expected to reduce attack frequency and improve quality of life

Requested Action: Approve Garadacimab 150mg subcutaneous monthly per FDA labeling

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take in Ohio? A: Standard PA reviews take 1-5 business days for complete submissions via OptumRx Provider Portal. Expedited reviews for urgent cases are completed within 24-72 hours.

Q: What if Garadacimab is non-formulary on my plan? A: You can request a formulary exception by demonstrating medical necessity. This requires documentation that preferred alternatives are inappropriate for your specific case.

Q: Can I request an expedited appeal? A: Yes, if delays in treatment could seriously jeopardize your health. Both UnitedHealthcare internal appeals and Ohio external reviews offer expedited timelines (72 hours vs. 30 days).

Q: Does step therapy apply if I tried other HAE drugs outside Ohio? A: Yes, prior therapy documentation from any state counts toward step therapy requirements. Ensure your provider includes complete records in the PA submission.

Q: What happens if my external review is denied? A: External review decisions are binding on UnitedHealthcare, but if denied, you retain rights to file regulatory complaints or seek legal remedies. The external review is typically the final administrative step.

Q: Are there any Ohio-specific patient assistance programs? A: Ohio doesn't have HAE-specific state programs, but residents are eligible for all manufacturer and foundation assistance programs available nationwide.

Q: How do I find a specialty pharmacy that stocks Garadacimab? A: UnitedHealthcare typically requires use of OptumRx specialty pharmacy or their preferred network. Call member services to confirm which pharmacies can dispense Garadacimab under your plan.

Q: What should I do if UnitedHealthcare requests peer-to-peer review? A: Your prescribing physician should schedule the call within one business day. Prepare talking points about your HAE diagnosis, prior therapy failures, and why Garadacimab is medically necessary for your specific case.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage and appeals processes. It is not medical advice and should not replace consultation with your healthcare provider. Coverage policies and requirements may vary by plan and change over time. Always verify current requirements with your insurer and consult with qualified healthcare professionals about your treatment options.

For personalized assistance with prior authorization and appeals, Counterforce Health helps patients navigate complex insurance requirements and turn denials into successful approvals through evidence-based appeals strategies.

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