By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (lisocabtagene maraleucel) Covered by Aetna CVS Health in Georgia: Forms, Appeals, and Success Strategies

Quick Answer: Getting Breyanzi Covered by Aetna CVS Health in Georgia

Breyanzi (lisocabtagene maraleucel) requires prior authorization from Aetna CVS Health. Submit your request through the Availity provider portal or fax the completed PA form to 1-877-269-9916. You'll need documentation showing FDA-approved large B-cell lymphoma diagnosis, prior therapy failures, and ECOG performance status <3. If denied, file an internal appeal within 180 days, then request Georgia's external review within 60 days of the final denial. Contact CVS Specialty Pharmacy at 1-888-632-3862 to coordinate enrollment and delivery.

First step today: Verify your Aetna plan covers specialty drugs and download the prior authorization form.

Table of Contents

Coverage Requirements at a Glance

Requirement Details Where to Find It Source
Prior Authorization Mandatory for all plans Aetna PA Form 2024 Precert List
Eligible Diagnosis Large B-cell lymphoma subtypes Clinical Policy Bulletin #986 Aetna Medical Policy
Age Requirement ≥18 years old Clinical documentation FDA Label Requirements
Performance Status ECOG <3 documented Provider assessment CPB #986
Prior Therapy Refractory/relapsed after chemoimmunotherapy Treatment records Medical Necessity Criteria
REMS Certification Treatment at certified facility Facility verification FDA REMS Program

Step-by-Step: Fastest Path to Approval

1. Verify Plan Coverage (Patient/Clinic - Day 1)

Check that your Aetna plan includes specialty drug benefits. Call member services at the number on your insurance card or log into your member portal. Ask specifically about CAR-T therapy coverage and any plan-specific requirements.

2. Gather Required Documentation (Clinic - Days 1-3)

Collect all medical records showing:

  • Confirmed LBCL diagnosis with pathology report
  • Prior chemotherapy regimens and response/failure dates
  • Current ECOG performance status assessment
  • Recent labs showing adequate organ function
  • Confirmation of REMS-certified treatment facility

3. Submit Prior Authorization (Provider - Day 4)

Complete the Aetna prior authorization form and submit via:

  • Preferred: Availity portal for electronic submission
  • Alternative: Fax to 1-877-269-9916

Timeline: Submit at least 2 weeks before planned treatment.

4. Follow Up (Clinic - Days 10-14)

Aetna typically responds within 30-45 days for standard requests, 72 hours for expedited. Track status through Availity or call provider services at 1-888-632-3862.

5. If Approved: Coordinate with CVS Specialty (Days 15-21)

Contact CVS Specialty Pharmacy at 1-888-632-3862 to begin enrollment and coordinate product delivery to your certified treatment center.

6. If Denied: File Internal Appeal (Within 180 days)

Submit appeal documentation through the same channels, including additional clinical evidence and peer-reviewed literature supporting medical necessity.

7. External Review Option (Within 60 days of final denial)

If internal appeal fails, file for Georgia's external review through the Georgia Department of Insurance.

Forms and Submission Portals

Primary Submission Methods

Electronic (Preferred):

  • Availity Portal: Register at no cost for real-time PA submissions and status tracking
  • Upload medical records and supporting documentation directly
  • Includes urgency indicators for life-threatening situations

Fax Submission:

Tip: Electronic submissions through Availity typically receive faster processing and real-time status updates compared to fax submissions.

Required Documentation Checklist

  • Completed prior authorization form
  • Current clinical notes and treatment history
  • Pathology report confirming LBCL diagnosis
  • Documentation of prior therapy failures
  • ECOG performance status assessment
  • Laboratory results showing organ function
  • Confirmation of REMS-certified facility

Common Denial Reasons and Solutions

Denial Reason How to Address Supporting Documentation
"Not FDA-approved indication" Verify LBCL subtype matches approved indications FDA label and pathology report
"Inadequate prior therapy documentation" Provide detailed treatment timeline Complete chemotherapy records with dates and responses
"Performance status not documented" Submit current ECOG assessment Recent physician evaluation with ECOG score
"Facility not REMS-certified" Confirm treatment center certification REMS facility verification letter
"Experimental/investigational" Cite FDA approval and guidelines NCCN guidelines and clinical policy references

Appeals Process in Georgia

Internal Appeals with Aetna CVS Health

  • Deadline: 180 days from denial date
  • Submission: Same portals as initial PA request
  • Timeline: 30-45 days for standard appeals, 72 hours for expedited
  • Required: New clinical evidence or peer-to-peer review request

Georgia External Review

Georgia law provides a powerful second opinion process for wrongful denials.

Eligibility: Available after internal appeal denial or for urgent situations where delay would seriously jeopardize health.

Deadline: 60 days from final internal appeal denial - this is Georgia's statutory requirement.

Process:

  1. Request external review application from your insurer or Georgia DOI
  2. Submit completed application with supporting documents
  3. Georgia DOI assigns independent medical reviewers
  4. Decision rendered within 30 business days (72 hours for expedited)
  5. Binding decision: If approved, Aetna must cover the treatment

Contact Georgia DOI Consumer Services:

Note: Georgia's external review is free for consumers and has successfully overturned many specialty drug denials when proper medical evidence is provided.

CVS Specialty Pharmacy Enrollment

Breyanzi must be obtained through CVS Specialty Pharmacy once approved.

Enrollment Process

  1. Provider Enrollment: Complete CVS Specialty enrollment form
  2. Submit Documentation:
    • Phone: 1-800-237-2767
    • Fax: 1-800-323-2445
    • Alternative fax: 1-855-330-1720

Required Information

  • Patient demographics and insurance details
  • Confirmed LBCL diagnosis
  • Treatment facility information and REMS certification
  • Prescriber information and NPI

Coordination Services

CVS Specialty coordinates product delivery to your certified CAR-T treatment center and assists with:

  • Insurance benefit verification
  • Prior authorization support
  • Patient assistance program enrollment
  • Delivery scheduling and cold-chain management

For questions or status updates: 1-888-632-3862 (commercial plans) or 1-800-624-0756 (Medicare)

Costs and Patient Assistance

Typical Costs

  • List Price: Approximately $447,000-$487,000 per treatment
  • Total Treatment Cost: Often exceeds $500,000 including facility fees and monitoring

Financial Assistance Options

  • Manufacturer Support: Contact Bristol Myers Squibb patient assistance programs
  • CVS Specialty: Helps facilitate copay assistance and foundation grants
  • Georgia Resources: Limited state programs; primarily federal and manufacturer assistance

Patient assistance often covers:

  • Copay reduction for insured patients
  • Free drug programs for uninsured patients meeting income criteria
  • Travel and lodging assistance for treatment

Contact CVS Specialty at 1-800-237-2767 to explore all available assistance programs.

When to Contact Georgia Regulators

Contact the Georgia Department of Insurance if you experience:

  • Delays beyond stated timeframes
  • Requests for non-standard documentation
  • Repeated denials despite meeting coverage criteria
  • Difficulty accessing the external review process

Georgia DOI Consumer Services:

  • Phone: 1-800-656-2298
  • Website: oci.georgia.gov
  • Complaint form: Available online for formal complaints

Additional Consumer Support:

  • Georgians for a Healthy Future: Nonprofit providing appeals guidance
  • Georgia Legal Services: Assistance with complex appeals cases

Frequently Asked Questions

How long does Aetna CVS Health prior authorization take? Standard requests: 30-45 days. Expedited requests for urgent situations: 72 hours. Submit at least 2 weeks before planned treatment.

What if Breyanzi is non-formulary on my plan? Request a formulary exception using the same prior authorization process. Provide medical necessity documentation and evidence that formulary alternatives are inappropriate.

Can I request an expedited appeal in Georgia? Yes. For life-threatening conditions or situations where delay would seriously jeopardize health, both Aetna and Georgia's external review offer expedited processes (typically 72 hours).

Does step therapy apply if I've failed treatments outside Georgia? Treatment records from any location are valid. Ensure all prior therapy documentation is included in your submission, regardless of where treatment occurred.

What happens if my CAR-T center isn't in Aetna's network? Request an out-of-network exception. Given the limited number of REMS-certified CAR-T centers, insurers often approve exceptions when no in-network facility is available within reasonable distance.

How do I know if my treatment facility is REMS-certified? Ask your treatment center directly or verify through the FDA REMS program database. Only certified facilities can administer Breyanzi.

Counterforce Health helps patients, clinicians, and specialty pharmacies turn insurance denials into successful appeals. Our platform analyzes denial letters, identifies the specific denial basis, and creates targeted, evidence-backed rebuttals aligned to each plan's requirements. We pull the right clinical evidence—from FDA labeling to peer-reviewed studies—and weave it into appeals that meet procedural requirements while tracking deadlines and required documentation. For complex CAR-T therapy appeals like Breyanzi, having the right evidence presented in the right format can make the difference between denial and approval.

Appeals can feel overwhelming, especially when dealing with expensive specialty treatments like CAR-T therapy. But Georgia's consumer protection laws provide strong safeguards, and with proper documentation and persistence, many denials are successfully overturned. The key is understanding each step of the process and acting within the required timeframes.

Whether you're navigating your first prior authorization or appealing a denial, remember that Counterforce Health can help streamline the process by ensuring your appeals include all necessary clinical evidence and meet payer-specific requirements. Don't let administrative barriers delay access to life-saving treatment.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with your insurer and consult with your healthcare provider about treatment decisions. For personalized assistance with appeals, consider consulting with patient advocacy organizations or legal professionals specializing in healthcare coverage.

Sources and Further Reading:

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