By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (lisocabtagene maraleucel) Covered by Cigna in New Jersey: Prior Authorization, Appeals, and Medical Necessity Requirements

Answer Box: Getting Breyanzi Covered by Cigna in New Jersey

Cigna covers Breyanzi (lisocabtagene maraleucel) for FDA-approved indications with prior authorization required. Key eligibility: adults with relapsed/refractory large B-cell lymphoma after ≥2 prior lines, or CLL/SLL after ≥2 lines including BTK and BCL-2 inhibitors. Fastest path to approval: Have your oncologist submit PA through Cigna's provider portal with complete documentation of diagnosis, prior therapies, and FDA indication match. If denied, file internal appeal within 180 days, then pursue New Jersey's Independent Health Care Appeals Program (IHCAP) through Maximus Federal Services.

Take action today: Call Cigna member services to verify your specific plan's formulary status and PA requirements for Breyanzi.

Table of Contents

  1. Cigna's Coverage Policy Overview
  2. FDA Indication Requirements
  3. Step Therapy and Medical Exceptions
  4. Required Diagnostics and Documentation
  5. Site of Care Requirements
  6. Medical Necessity Evidence
  7. Common Denial Reasons and Solutions
  8. New Jersey Appeals Process
  9. Coverage Requirements at a Glance
  10. FAQ

Cigna's Coverage Policy Overview

Cigna Healthcare covers Breyanzi under its medical benefit for specific relapsed or refractory lymphomas after prior systemic therapies. The drug requires prior authorization across all plan types—HMO, PPO, and Medicare Advantage—with coverage managed through Express Scripts/Accredo specialty pharmacy networks.

Key Policy Details:

  • Coverage effective January 23, 2026 on Cigna's prescription drug formulary
  • Prior authorization required for all indications
  • Covered as one-time administration per FDA dosing guidelines
  • Must be administered at certified CAR-T treatment centers

For New Jersey Cigna Healthcare Garden State plan members specifically, there's an important restriction: you must use in-network providers with service locations in New Jersey only. Care provided outside New Jersey will be denied, leaving you responsible for out-of-pocket costs.

FDA Indication Requirements

Cigna strictly follows FDA-approved indications for Breyanzi coverage. Your oncologist must document that you meet specific criteria:

Large B-Cell Lymphoma (LBCL)

  • Age: ≥18 years
  • Eligible subtypes: Diffuse LBCL arising from indolent lymphoma, high-grade B-cell lymphoma, primary mediastinal LBCL, follicular lymphoma grade 3B
  • Treatment history: After ≥2 prior lines of systemic therapy OR after first-line treatment failure if ineligible for stem cell transplant
  • Disease status: Relapsed or refractory disease with progression on last regimen

Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

  • Age: Adults
  • Treatment history: After ≥2 prior lines including both a BTK inhibitor (like ibrutinib) and a BCL-2 inhibitor (like venetoclax)
  • Disease status: Relapsed or refractory
Note: Primary CNS lymphoma is specifically excluded from coverage.

Step Therapy and Medical Exceptions

Unlike many specialty drugs, Breyanzi doesn't typically require step therapy since it's reserved for patients who have already failed multiple prior treatments. However, Cigna requires clear documentation of:

Prior Treatment Failures:

  • Complete records of each prior therapy line
  • Documentation of disease progression or intolerance
  • Specific timeframes showing relapse ≤12 months post-complete response for LBCL second-line eligibility

Medical Exception Pathways: If you don't meet standard criteria, your oncologist can request exceptions by documenting:

  • Contraindications to standard therapies
  • Inability to tolerate required prior treatments
  • Clinical circumstances making alternative approaches inappropriate

Required Diagnostics and Documentation

Your medical team must provide comprehensive documentation to support medical necessity:

Clinical Documentation Checklist

  • Pathology reports confirming LBCL histology/subtype via biopsy
  • Disease staging with current imaging (PET/CT scans)
  • Performance status assessment (ECOG score)
  • Prior therapy records with dates, regimens, and outcomes
  • Laboratory values confirming adequate organ function
  • Infection screening results (no active infections)

Timing Requirements

  • Imaging must be recent (typically within 30-60 days)
  • Lab values should be current (within 2 weeks of submission)
  • Prior therapy documentation must show clear progression dates

Site of Care Requirements

Breyanzi must be administered at FDA-authorized, certified treatment centers capable of managing severe side effects. In New Jersey, only two major adult programs are certified:

Certified New Jersey CAR-T Centers

Center Location Key Features
John Theurer Cancer Center Hackensack University Medical Center First NJ certified site; FACT-accredited; >6,500 stem cell transplants
Rutgers Cancer Institute Robert Wood Johnson University Hospital, New Brunswick NCI-designated Comprehensive Cancer Center; FACT-certified BMT program

Important for Cigna Garden State plan members: Verify that your chosen center is in-network, as out-of-state care is not covered.

Center Requirements

All certified centers must have:

  • FACT accreditation for cellular therapy
  • 24/7 ICU access for CRS management
  • Specialized multidisciplinary teams
  • REMS program enrollment
  • Capability for close monitoring during first 3 weeks post-infusion

Medical Necessity Evidence

Strong medical necessity documentation significantly improves approval odds. Appeals with comprehensive clinical documentation achieve 76% approval rates versus 27% for incomplete submissions.

Guidelines to Cite

Your oncologist should reference:

  • NCCN Guidelines with specific page numbers and category designations (Category 1 or 2A recommendations achieve 68% approval)
  • FDA approval documentation with specific indication details
  • Peer-reviewed literature demonstrating efficacy for your specific condition
  • ASCO guidelines relevant to your treatment scenario

Evidence Quality Impact

  • Appeals citing Cigna Medical Coverage Policies verbatim: 76-82% overturn rates
  • Appeals with NCCN Category 1 citations: 68% approval
  • Appeals with comprehensive regulatory documentation: 71% approval
  • Generic medical necessity statements: 44% approval

Common Denial Reasons and Solutions

Denial Reason How to Overturn Required Documentation
Doesn't meet line of therapy Provide detailed prior treatment records Complete therapy timeline with progression dates
Inadequate BTK/BCL-2 exposure (CLL) Document specific inhibitor trials Pharmacy records, treatment notes, progression imaging
Non-eligible histology Submit pathology review Second pathology opinion, molecular testing results
Center not certified Switch to certified facility Referral to John Theurer or Rutgers Cancer Institute
Insufficient documentation Comprehensive resubmission All items from diagnostics checklist above

New Jersey Appeals Process

If Cigna denies your Breyanzi request, New Jersey offers excellent appeal rights through the Independent Health Care Appeals Program (IHCAP).

Internal Appeals (Required First)

Timeline: 180 days from denial date Process:

  1. Submit Level 1 appeal to Cigna National Appeals Unit
  2. If denied, file Level 2 appeal within 60 days
  3. Cigna responds within 30 days (pre-service) or 60 days (post-service)

External Review Through IHCAP

Eligibility: After completing internal appeals Timeline: 4 months (180 days) from final internal denial Process: Submit directly to Maximus Federal Services (contracted by NJ)

IHCAP Success Factors:

  • About 50% of external appeals nationwide favor consumers
  • Independent physician reviewers with appropriate specialty expertise
  • Binding decisions that insurers must follow
  • No cost to patients (insurers pay all review fees)

Contact Information:

  • IHCAP Hotline: 1-888-393-1062
  • NJ DOBI Consumer Hotline: 1-800-446-7467
From our advocates: We've seen cases where Cigna initially denied Breyanzi for "insufficient line of therapy documentation," but when the oncologist provided a detailed timeline showing clear progression after rituximab-containing regimens, the internal appeal was approved within 15 days. The key was organizing prior treatment records chronologically with specific progression dates.

Coverage Requirements at a Glance

Requirement Details Documentation Needed Source
Prior Authorization Required for all plans Complete PA form via provider portal Cigna Policy IP_0130
Age Requirement ≥18 years Birth certificate or ID FDA Label
LBCL Criteria ≥2 prior lines OR 2L after transplant-ineligible Treatment records, progression imaging Cigna Policy IP_0130
CLL/SLL Criteria ≥2 lines including BTK + BCL-2 inhibitors Pharmacy records, treatment notes Cigna Policy IP_0130
Site of Care Certified CAR-T center only Center certification verification Bristol Myers Squibb Locator
Appeals Deadline 180 days from denial Denial letter, EOB NJ IHCAP

Frequently Asked Questions

How long does Cigna prior authorization take for Breyanzi? Cigna typically responds within 15 business days for standard requests, or 72 hours for expedited reviews when medically urgent. Incomplete submissions may extend this timeline.

What if Breyanzi is non-formulary on my plan? Even if non-formulary, Cigna must cover FDA-approved indications when medically necessary. Request a formulary exception with your oncologist's clinical rationale.

Can I request an expedited appeal in New Jersey? Yes, both Cigna internal appeals and IHCAP external reviews offer expedited pathways when delays could cause serious harm. Include physician certification of urgency.

Does step therapy apply if I failed treatments outside New Jersey? No, Cigna recognizes prior treatments regardless of where they were administered, as long as you have proper documentation of failure or intolerance.

What's the average cost of Breyanzi treatment? The drug's wholesale acquisition cost is approximately $447,000-$487,000, with total treatment costs potentially higher when including site-of-care and toxicity management expenses.

How do I find a certified CAR-T center in New Jersey? Use Bristol Myers Squibb's treatment center locator or contact John Theurer Cancer Center or Rutgers Cancer Institute directly.

Getting insurance approval for advanced cancer treatments shouldn't add stress to an already challenging journey. Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to craft point-by-point rebuttals aligned with each payer's specific requirements. The platform pulls the right citations—FDA labeling, peer-reviewed studies, and specialty guidelines—while tracking deadlines and procedural requirements to help patients, clinicians, and specialty pharmacies get prescription drugs approved more efficiently.

For personalized guidance on your specific situation, consider working with experienced advocates who understand both Cigna's policies and New Jersey's appeal processes. Remember, Counterforce Health can help streamline this complex process by creating professionally crafted appeals that meet payer-specific workflows and procedural requirements.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions depend on individual plan details and medical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For official New Jersey appeals information, contact the NJ Department of Banking and Insurance at 1-800-446-7467.

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