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

Resources to Get Garadacimab Covered by Aetna CVS Health in New York: Forms, Portals & Appeals Guide

Answer Box: Getting Started

To get Garadacimab covered by Aetna CVS Health in New York: First, verify your plan requires prior authorization (most specialty plans do). Submit a complete PA request through the Availity provider portal with HAE diagnosis confirmation, prior treatment failures, and specialist consultation notes. If denied, file an internal appeal within 180 days, then request New York's external review through the Department of Financial Services. Start the process 2-3 weeks before your planned treatment date to avoid delays.

Table of Contents

  1. Start Here: Verify Your Plan and Coverage
  2. Required Forms and Documentation
  3. Submission Portals and Online Access
  4. Fax Numbers and Mailing Addresses
  5. CVS Specialty Pharmacy Enrollment
  6. Support Phone Numbers and Contacts
  7. New York State Appeals and Consumer Help
  8. When to Update Your Resources

Start Here: Verify Your Plan and Coverage

Before starting your Garadacimab approval process, confirm these basics:

Check Your Formulary Status

  • Log into your Aetna member portal or call the number on your ID card
  • Look up "Garadacimab" or search by therapeutic class (HAE prophylaxis)
  • Note the formulary tier and any restrictions listed

Confirm Prior Authorization Requirements Most Aetna plans require PA for specialty HAE medications. Check Aetna's 2025 Precertification List for current requirements.

Verify Your Specialist Garadacimab typically requires prescription by or consultation with an immunologist, allergist, or HAE specialist. Ensure your prescriber meets this requirement.

Tip: If Garadacimab isn't yet listed in Aetna's PA guides, this may indicate it's still under formulary review. Contact Aetna pharmacy services directly for the most current status.

Required Forms and Documentation

Prior Authorization Request Form

Primary Document: Use Aetna's specialty medication PA form, available through the healthcare professional forms portal.

Required Clinical Information:

  • Confirmed HAE diagnosis with lab results (C1-INH levels, genetic testing if applicable)
  • ICD-10 diagnosis code (typically D84.1 for hereditary angioedema)
  • Documentation of prior treatment failures or contraindications
  • Prescriber specialty certification
  • Detailed treatment plan and monitoring schedule

Step Therapy Override Documentation

If requesting a non-preferred agent, include:

  • Evidence of failure/intolerance to preferred HAE prophylaxis medications
  • Clinical rationale why step therapy is not appropriate
  • Supporting literature or guidelines

Medical Necessity Letter Checklist

Your prescriber should include:

  • Patient's specific HAE subtype and severity
  • Frequency and severity of breakthrough attacks
  • Previous prophylaxis trials and outcomes
  • Why Garadacimab is clinically superior for this patient
  • Expected treatment duration and monitoring plan

Submission Portals and Online Access

Availity Provider Portal (Primary Method)

Access: www.availity.com

  • Register for an account if you don't have one
  • Navigate to "Prior Authorization" section
  • Select "Aetna" as the payer
  • Upload all required documents in a single submission

Timeline: Submit at least 2 weeks before planned treatment start date to avoid delays.

Alternative Submission Methods

For Commercial Plans:

  • Fax: 1-877-269-9916
  • Submit complete forms with all supporting documentation

For Medicare Advantage:

  • Fax: 1-844-268-7263
  • Include Medicare-specific documentation requirements
Note: Electronic submission through Availity typically processes faster than fax submissions.

Fax Numbers and Mailing Addresses

Aetna Prior Authorization Contacts

Plan Type Fax Number Phone Support
Commercial Plans 1-877-269-9916 1-888-632-3862
Medicare Advantage 1-844-268-7263 1-800-624-0756

Cover Sheet Best Practices

Include on every fax:

  • Patient name and member ID
  • Prescriber name and NPI
  • Drug name: "Garadacimab (anti-FXIIa)"
  • Request type: "Prior Authorization - HAE Prophylaxis"
  • Total number of pages
  • Contact information for follow-up

CVS Specialty Pharmacy Enrollment

Step-by-Step Enrollment Process

1. Download Enrollment Form

2. Required Information

  • Patient demographics and insurance details
  • Complete prescriber information (name, NPI, DEA, license)
  • Clinical details (diagnosis, allergies, current medications)
  • Injection training needs assessment

3. Submit Completed Form

4. Coordinate Prior Authorization CVS Specialty will help coordinate PA submission with Aetna using your enrollment documentation.

Transfer from Another Pharmacy

If transferring existing HAE therapy:

  • Contact CVS Specialty at 1-800-237-2767
  • Provide current pharmacy information
  • Request prescription transfer coordination
  • Ensure no gaps in therapy during transition

Support Phone Numbers and Contacts

Aetna Member Services

Primary Contact: Number on your Aetna ID card General Member Services: 1-800-872-3862 (M-F, 8 AM-6 PM ET) Pharmacy Services: 1-888-792-3862 (M-F, 7 AM-11 PM ET)

What to Ask When You Call

For Prior Authorization Status:

  • "What's the status of my Garadacimab PA request?"
  • "What additional information is needed?"
  • "Can you provide the reference number for tracking?"

For Denials:

  • "What was the specific reason for denial?"
  • "What documentation would support an appeal?"
  • "Can you connect me to case management for HAE?"

Provider Relations Support

Prescribers can access dedicated support through the same member services numbers by identifying themselves as healthcare providers.

New York State Appeals and Consumer Help

Internal Appeals with Aetna

Timeline: File within 180 days of denial notice Process: Submit through member portal or mail written appeal Standard Review: 30-45 days for decision Expedited Review: 72 hours for urgent medical situations

New York External Review

When to Use: After Aetna's final internal denial Timeline: Request within 4 months of final adverse determination Process: File through NY Department of Financial Services Cost: $25 maximum (waived for financial hardship or Medicaid) Decision Timeline:

  • Standard: 45 days
  • Expedited: 72 hours (24 hours for urgent drug denials)

Consumer Assistance Resources

Community Health Advocates (CHA)

  • Phone: 888-614-5400
  • Free assistance with insurance appeals in New York
  • Help with documentation and filing procedures

NY Department of Financial Services

  • Online portal for external appeals
  • Consumer assistance hotline
  • Searchable database of past appeal decisions
From Our Advocates: "We've seen HAE patients succeed in New York external appeals by providing comprehensive documentation of attack frequency, prior treatment failures, and specialist recommendations. The key is showing medical necessity through objective clinical data, not just patient symptoms."

When to Update Your Resources

Annual Updates Required

January: Check new formulary guidelines and PA requirements Plan Renewal: Verify continued coverage and any new restrictions Drug Updates: Monitor for new HAE therapies or formulary changes

Quarterly Checks

  • Review Aetna's precertification lists for changes
  • Update contact information and portal access
  • Check for new patient assistance programs

As Needed

  • After any plan changes or provider switches
  • Following FDA label updates or new indications
  • When experiencing coverage issues or delays

Costs and Financial Assistance

Manufacturer Support Programs

Check with CSL Behring for:

  • Patient assistance programs
  • Copay support options
  • Free drug programs for qualifying patients

Third-Party Resources

  • Patient Advocate Foundation: Copay relief for chronic conditions
  • HealthWell Foundation: Financial assistance for specialty medications
  • National Organization for Rare Disorders (NORD): HAE-specific support programs

Common Denial Reasons and Solutions

Denial Reason Required Documentation Where to Submit
Lack of HAE confirmation Lab results, genetic testing, specialist consultation PA appeal with clinical records
Step therapy not completed Prior treatment records, failure/intolerance documentation Step therapy override request
Not medically necessary Attack frequency, severity data, treatment goals Medical necessity letter from specialist
REMS requirements not met Training certification, administration plan Updated PA with REMS documentation

Frequently Asked Questions

How long does Aetna PA take for Garadacimab in New York? Standard review is 30-45 days. Expedited review (for urgent cases) is typically 72 hours.

What if Garadacimab is non-formulary on my plan? Request a formulary exception with medical necessity documentation and specialist support.

Can I request an expedited appeal? Yes, if delay would seriously jeopardize your health. Document the urgency and submit through expedited channels.

Does step therapy apply if I've tried treatments outside New York? Yes, document all prior treatments regardless of location. Include pharmacy records and provider notes.

What's the difference between internal and external appeals? Internal appeals are reviewed by Aetna. External appeals are reviewed by independent medical experts through New York DFS.

Resources for Success

Having the right resources and documentation significantly improves your chances of getting Garadacimab approved. Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to create targeted, evidence-backed responses that align with each payer's specific requirements.

The platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes by identifying the exact denial basis and crafting point-by-point rebuttals supported by FDA labeling, peer-reviewed studies, and specialty guidelines. For HAE patients facing coverage challenges, this targeted approach can be the difference between prolonged delays and timely access to life-changing therapy.

Sources and 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 specific coverage decisions. Coverage policies and procedures may change; verify current requirements with official sources before submitting requests.

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