By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (lisocabtagene maraleucel) Covered by Cigna in Georgia: Prior Authorization Guide and Appeal Strategies

Answer Box: Getting Breyanzi Covered by Cigna in Georgia

Eligibility: Adults with relapsed/refractory large B-cell lymphoma after ≥2 prior therapies, or CLL/SLL after ≥2 lines including BTK/BCL2 inhibitors. Fastest path: Submit prior authorization through Express Scripts Accredo with complete pathology reports, treatment history, and REMS certification. First step today: Call Express Scripts Accredo at 1-800-256-7575 to initiate coverage verification and PA process. Georgia advantage: External review available through GA Department of Insurance within 60 days if denied.

Table of Contents

  1. Cigna's Coverage Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy & Medical Exceptions
  4. Quantity and Administration Limits
  5. Required Diagnostics & Documentation
  6. Site of Care & Specialty Pharmacy
  7. Evidence for Medical Necessity
  8. Sample Medical Necessity Letter
  9. Appeals Process in Georgia
  10. Common Denial Reasons & Solutions
  11. Costs & Patient Assistance
  12. FAQ

Cigna's Coverage Policy Overview

Cigna covers Breyanzi (lisocabtagene maraleucel) under medical benefit with prior authorization required for all plan types—HMO, PPO, and Medicare Advantage. The coverage is governed by Cigna's Coverage Position Criteria IP0130, updated September 2024.

Key Policy Points:

  • Prior authorization mandatory for the drug itself
  • Administration codes (38225-38228) no longer require PA as of January 2025
  • Must be administered at REMS-certified facilities
  • Managed through Express Scripts Accredo specialty pharmacy

Coverage at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for drug Complete PA form via Accredo Cigna Policy IP0130
Formulary Status Covered when criteria met Medical necessity documentation Express Scripts Formulary
Site of Care REMS-certified centers only Facility certification proof Breyanzi Treatment Centers
Age Requirement ≥18 years Date of birth verification FDA Label
Appeals Deadline 180 days internal, 60 days external Denial letter date GA Insurance Code

FDA Indication Requirements

Breyanzi is FDA-approved for specific B-cell malignancies with strict criteria that Cigna follows closely.

Covered Indications:

Large B-Cell Lymphoma (LBCL)

  • Relapsed/refractory LBCL after ≥2 prior systemic therapies
  • Includes: DLBCL, primary mediastinal LBCL, high-grade B-cell lymphoma, follicular lymphoma grade 3B
  • Second-line therapy for transplant-ineligible patients or those relapsing within 12 months

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

  • Relapsed/refractory CLL/SLL after ≥2 prior therapies
  • Must have received BTK inhibitor and BCL2 inhibitor
  • Accelerated approval indication (subject to confirmatory trials)

Classic Follicular Lymphoma

  • Adults after ≥2 prior systemic therapies
  • Grade 1-3A follicular lymphoma
Note: Off-label uses are generally not covered and require extensive clinical justification with peer-reviewed literature support.

Step Therapy & Medical Exceptions

Cigna requires documentation of prior therapies but doesn't impose additional step therapy beyond FDA labeling requirements.

Required Prior Treatments:

  • LBCL: Minimum 2 prior systemic therapies (typically includes anti-CD20 monoclonal antibody and anthracycline-based chemotherapy)
  • CLL/SLL: Minimum 2 prior therapies including BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) and BCL2 inhibitor (venetoclax)

Medical Exception Pathways:

  • Document treatment failures with specific dates and outcomes
  • Include contraindications to standard therapies
  • Provide evidence of disease progression or intolerance
Tip: Treatment history from any location counts toward step therapy requirements. Gather records from all treating facilities.

Quantity and Administration Limits

Dosing Requirements:

  • LBCL: 50-110 × 10⁶ CAR-positive viable T cells
  • CLL/SLL: 90-110 × 10⁶ CAR-positive viable T cells
  • Single infusion after lymphodepleting chemotherapy

Coverage Limitations:

  • One treatment course per indication
  • Repeat administration may be considered with clinical justification
  • Must be weight-based dosing per FDA label

Required Diagnostics & Documentation

Essential Clinical Documentation

Pathology Requirements:

  • Tissue biopsy confirming diagnosis
  • Immunohistochemistry showing CD19 expression
  • Cytogenetics and molecular studies if available

Performance Status:

  • ECOG performance status ≤2 (preferably 0-1)
  • Adequate organ function per protocol criteria
  • No active CNS involvement

Laboratory Values:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Liver function tests
  • Coagulation studies
  • Infectious disease screening (HIV, Hepatitis B/C, CMV)

Documentation Timeline

  • Labs must be ≤30 days old at time of PA submission
  • Imaging studies ≤60 days old
  • Pathology can be from initial diagnosis if confirmed relapse/progression

Site of Care & Specialty Pharmacy

Approved Treatment Centers in Georgia

Breyanzi must be administered at REMS-certified facilities contracted with Cigna:

Major Centers:

  • Northside Hospital (Atlanta) - Full CAR-T program
  • Children's Healthcare of Atlanta (Egleston and Scottish Rite) - Pediatric/young adult
  • Emory University Hospital - Academic medical center program
Important: Verify current certification status at Breyanzi Treatment Center Locator before scheduling.

Express Scripts Accredo Process

All Breyanzi orders must go through Accredo:

  1. Initial Contact: 1-800-256-7575
  2. Benefit Verification: Accredo confirms coverage
  3. Prior Authorization: Submitted to Cigna on your behalf
  4. Coordination: Delivery to treatment center upon approval

Evidence for Medical Necessity

Guidelines Support

NCCN Guidelines (Version 1.2025):

  • Category 1 recommendation for relapsed/refractory LBCL
  • Preferred option for transplant-ineligible patients
  • Listed for CLL/SLL after BTK and BCL2 inhibitor failure

Supporting Literature:

  • TRANSCEND NHL 001 trial data (LBCL indication)
  • TRANSCEND CLL 004 trial data (CLL/SLL indication)
  • Real-world evidence studies showing efficacy

Key Citations to Include

Sample Medical Necessity Letter

Template Structure:

"[Patient] is a [age]-year-old with relapsed/refractory [specific diagnosis] who meets FDA-approved criteria for Breyanzi (lisocabtagene maraleucel). The patient has received [number] prior lines of therapy including [list specific regimens with dates and outcomes]. Current disease status shows [progression/refractoriness] as evidenced by [imaging/labs/clinical findings dated within 60 days].

Per NCCN Guidelines Version 1.2025, CAR-T therapy is a Category 1 recommendation for this clinical scenario. The patient has adequate performance status (ECOG [0-2]) and organ function for treatment. Treatment will be administered at [REMS-certified facility name], which is contracted with Cigna and experienced in CAR-T therapy management.

Alternative therapies are not appropriate because [specific contraindications/prior failures]. The requested dose of [specific cell count] aligns with FDA labeling and clinical protocols."

Appeals Process in Georgia

Step-by-Step Appeals Guide

Internal Appeal (First Level):

  1. Timeline: File within 180 days of denial
  2. Submission: Cigna Provider Portal or written request
  3. Documents: Denial letter, additional clinical evidence, peer-reviewed studies
  4. Decision: Within 30 days (72 hours if expedited)

External Review (Georgia DOI):

  1. Timeline: Within 60 days of final internal denial
  2. Submission: Georgia Insurance Department form
  3. Cost: Free to consumer
  4. Decision: Within 30 business days (72 hours if urgent)
From our advocates: "We've seen success when appeals include specific NCCN guideline citations and detailed documentation of why alternative therapies failed. The key is showing this isn't experimental—it's FDA-approved standard of care for the patient's specific situation."

Required Appeal Documents

  • Original denial letter
  • Complete medical records
  • Pathology reports
  • Treatment history with outcomes
  • Current imaging/labs
  • Physician letter of medical necessity
  • NCCN or other guideline citations

Common Denial Reasons & Solutions

Denial Reason Solution Strategy Documentation Needed
"Not medically necessary" Cite NCCN Category 1 recommendation Guidelines, FDA label, efficacy data
"Experimental/investigational" Emphasize FDA approval status FDA approval letter, package insert
Insufficient prior therapies Document all previous treatments Pharmacy records, infusion logs, physician notes
Performance status concerns Provide current functional assessment Recent ECOG score, physician evaluation
Site of care issues Confirm REMS certification Facility credentials, Cigna contract status

Costs & Patient Assistance

Estimated Costs:

  • List price: ~$477,000-$487,000 (2024-2025 data)
  • Total treatment cost: Often exceeds $600,000 with hospitalization

Financial Assistance:

  • Bristol Myers Squibb Patient Assistance: BMS Access Support
  • Leukemia & Lymphoma Society: Copay assistance programs
  • National Cancer Institute: Clinical trial opportunities

Georgia-Specific Resources

  • Georgia Cancer Coalition: State-funded support programs
  • Georgians for a Healthy Future: Consumer advocacy and guidance

FAQ

How long does Cigna prior authorization take in Georgia? Standard PA decisions within 5-10 business days; expedited reviews within 72 hours for urgent cases.

What if Breyanzi is non-formulary on my plan? Submit formulary exception request with clinical justification. Most Cigna plans cover Breyanzi when medical necessity criteria are met.

Can I request an expedited appeal? Yes, if delay poses serious health risks. Must provide clinical documentation supporting urgency.

Does step therapy apply if I failed treatments outside Georgia? No, treatment history from any location counts toward step therapy requirements.

What happens if my treatment center isn't Cigna-contracted? Request out-of-network exception if no in-network REMS-certified center is available within reasonable distance.

How much will I pay out-of-pocket? Varies by plan; typically subject to specialty drug copay/coinsurance. Patient assistance programs can help reduce costs.

When navigating insurance coverage for breakthrough therapies like Breyanzi, having expert support can make the difference between approval and denial. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft compelling rebuttals aligned with payer requirements. Their platform helps patients, clinicians, and specialty pharmacies get prescription drugs approved by identifying specific denial reasons and drafting point-by-point responses with the right clinical evidence and regulatory citations.

For Georgia residents facing Cigna denials, the state's external review process provides a powerful second chance. With proper documentation and strategic appeals, many patients successfully obtain coverage for this life-saving CAR-T therapy. Remember, Counterforce Health can provide additional support in navigating complex prior authorization requirements and appeal processes.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current criteria with your insurer and consult healthcare providers for medical decisions. For personalized assistance with Georgia insurance appeals, contact the Georgia Department of Insurance Consumer Services at 1-800-656-2298.

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