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

Getting Garadacimab (ANDEMBRY) Covered by Cigna in California: Complete 2025 Prior Authorization Guide

Quick Answer: Getting Garadacimab Covered by Cigna in California

Yes, Cigna covers garadacimab (ANDEMBRY®) for hereditary angioedema prophylaxis in California, but prior authorization is required. The fastest path: gather HAE diagnosis labs (C4, C1-INH levels), document failed prior therapies, complete REMS training, and submit through Express Scripts' portal. If denied, file an internal appeal within 180 days, then request California's Independent Medical Review (IMR) for a 50-68% chance of overturn. Start today: Call your prescriber to begin gathering required documentation and initiate the PA process.

Table of Contents

Coverage Basics

Is Garadacimab Covered by Cigna?

Garadacimab (ANDEMBRY®) is covered by Cigna for hereditary angioedema prophylaxis in patients 12 years and older, following FDA approval in June 2025. However, it requires prior authorization through Express Scripts and is subject to step therapy requirements.

Which Cigna Plans Cover It?

Most Cigna commercial plans, Medicare Advantage plans, and employer-sponsored plans include garadacimab on their specialty formulary. Coverage varies by specific plan design, so verify your benefits by calling the number on your insurance card or checking your plan's formulary.

Coverage Type Typical Tier PA Required Step Therapy
Commercial Specialty Tier Yes Yes
Medicare Advantage Tier 5 Yes Yes
Employer Plans Varies Yes Usually

Prior Authorization Process

Who Submits the PA Request?

Your prescribing physician (typically an allergist/immunologist or hematologist) must submit the prior authorization request. Patients cannot submit PA requests directly to Cigna.

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient + Clinic): Collect HAE diagnosis labs, attack history, and prior therapy records
  2. Complete REMS Training (Patient): Enroll in CSL Behring's REMS program at ANDEMBRY.com
  3. Submit PA Request (Prescriber): Use Express Scripts' ExpressPAth portal or fax to 866-233-7151
  4. Track Status (Patient/Clinic): Monitor through ExpressPAth or call 1-800-753-2851
  5. Respond to Requests (Clinic): Provide additional information within 14 days if requested
  6. Receive Decision (Patient): Cigna responds within 5-10 business days for standard requests
  7. Fill Prescription (Patient): If approved, prescription transfers to Accredo specialty pharmacy

Required Forms and Submission Methods

  • Electronic: ExpressPAth portal (fastest)
  • Fax: Use Accredo HAE referral form, fax to 866-233-7151
  • Phone: 1-800-753-2851 for Express Scripts PA support

Timeline and Urgency

Standard Processing Times

Cigna processes completed prior authorization requests within 5-10 business days. Incomplete requests may take longer if additional information is needed.

Expedited Reviews

For urgent medical situations, prescribers can request expedited review by:

  • Marking the PA request as "urgent" or "expedited"
  • Providing clinical justification for urgency
  • Documenting potential harm from delayed treatment

Emergency situations (immediate threat to life or health) do not require prior authorization—medication can be dispensed immediately.

Medical Necessity Criteria

Required Documentation for HAE Diagnosis

Your prescriber must provide:

Requirement Specific Documentation Source
HAE Diagnosis C4 levels (low), C1-INH antigenic and functional levels (low) Cigna HAE Policy
Attack History Frequency, severity, location of attacks; ED visits/hospitalizations Clinical records
Specialist Prescriber Allergist/immunologist or hematologist credentials Provider enrollment
REMS Compliance Training completion certificate CSL Behring REMS program

Step Therapy Requirements

Cigna requires documentation of inadequate response, intolerance, or contraindication to preferred HAE therapies:

  • C1-INH products (Haegarda, Cinryze)
  • Lanadelumab (Takhzyro)
  • Berotralstat (Orladeyo)
Clinician Corner: Your medical necessity letter should specify why factor XIIa inhibition is clinically indicated over alternatives, referencing FDA labeling and HAE treatment guidelines. Include specific details about prior therapy failures, contraindications, or patient-specific factors favoring garadacimab.

Cost and Financial Assistance

Insurance Coverage Costs

Garadacimab is typically placed on specialty tiers with higher cost-sharing:

  • Commercial plans: 20-40% coinsurance after deductible
  • Medicare Advantage: $100-400+ monthly copay in coverage gap
  • Out-of-pocket maximums apply per plan terms

CSL Behring Patient Support Programs

CSL Behring offers comprehensive assistance for eligible patients:

  • Copay Assistance Program: Reduces out-of-pocket costs for commercially insured patients
  • Patient Assistance Program: Free medication for uninsured/underinsured patients meeting income criteria
  • CSL Behring Assurance Program: Bridge therapy during insurance transitions

How to Apply: Visit CSL Behring Support Programs or call 1-877-275-2753.

Counterforce Health helps patients navigate insurance denials by creating targeted, evidence-backed appeals that align with payer policies. The platform identifies denial reasons and drafts point-by-point rebuttals using the right clinical evidence and procedural requirements.

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Lack of HAE diagnosis Submit complete lab results C4, C1-INH antigenic/functional levels on 2+ occasions
Step therapy not met Document prior therapy failures Detailed treatment history with outcomes/intolerances
REMS not documented Provide training certificate CSL Behring REMS completion proof
Medical necessity Strengthen clinical justification Specialist letter citing guidelines and patient-specific factors

California Appeals Process

California offers robust appeal rights through dual regulatory oversight:

Internal Appeals with Cigna

  • Timeline: File within 180 days of denial
  • Process: Submit through Cigna member portal or mail written appeal
  • Documentation: Include denial letter, medical records, prescriber statement

Independent Medical Review (IMR)

California's external review process has high success rates for specialty medications:

  • Success Rate: 50-68% of denials overturned for rare disease treatments
  • Timeline: File within 6 months of final internal denial
  • Cost: Free to patients
  • Process: Submit through DMHC website or call 888-466-2219
From Our Advocates: We've seen HAE medication denials successfully overturned when appeals include comprehensive attack logs, detailed prior therapy documentation, and specialist letters citing current treatment guidelines. The key is demonstrating medical necessity with concrete clinical evidence rather than general statements.

Specialty Pharmacy Requirements

Why Garadacimab Requires Specialty Pharmacy

Garadacimab must be dispensed through Cigna's specialty pharmacy network (primarily Accredo) due to:

  • REMS program requirements
  • Cold-chain storage needs
  • Patient education and injection training
  • Ongoing monitoring requirements

Working with Accredo

Once approved, your prescription automatically transfers to Accredo:

  • Contact: 1-800-803-2523
  • Delivery: Temperature-controlled shipping to your home
  • Training: Injection technique and device education
  • Refills: Automatic coordination with your prescriber

Troubleshooting Common Issues

Portal and System Problems

  • ExpressPAth down: Call 1-800-753-2851 for phone submission
  • Missing forms: Download HAE referral form from Accredo website
  • Status unclear: Use PA tracking number or call Express Scripts directly

Documentation Issues

  • Labs incomplete: Ensure both C1-INH antigenic AND functional levels included
  • Prior therapy vague: Provide specific medication names, doses, duration, and reason for discontinuation
  • REMS missing: Complete training at ANDEMBRY.com before PA submission

FAQ

How long does Cigna prior authorization take for garadacimab in California? Standard processing is 5-10 business days. Expedited reviews are available for urgent medical situations.

What if garadacimab is non-formulary on my Cigna plan? Request a formulary exception through your prescriber. If denied, appeal through internal and IMR processes.

Can I request an expedited appeal in California? Yes, both Cigna internal appeals and California IMR offer expedited timelines for urgent medical situations.

Does step therapy apply if I failed HAE medications outside California? Yes, prior therapy documentation from any location counts toward step therapy requirements.

What happens if my REMS training expires? You must complete refresher training through CSL Behring before prescription refills.

How much will garadacimab cost with Cigna coverage? Costs vary by plan but typically involve specialty tier cost-sharing (20-40% coinsurance). CSL Behring offers copay assistance programs.

Can I appeal to California regulators if Cigna denies my claim? Yes, California's Independent Medical Review (IMR) provides external review with high overturn rates for medically necessary specialty medications.

What if my prescriber isn't familiar with the PA process? Share this guide and Cigna's provider resources. Counterforce Health also helps clinicians navigate complex prior authorization requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical advice. Always consult with your healthcare provider and insurance plan for personalized guidance. Coverage policies and requirements may change. For assistance with complex insurance issues, contact the California Department of Managed Health Care at 888-466-2219 or visit healthhelp.ca.gov.

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