By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

Blue Cross Blue Shield North Carolina's Coverage Criteria for Breyanzi (Lisocabtagene Maraleucel): What Counts as "Medically Necessary"?

Answer Box: Getting Breyanzi Covered by BCBS North Carolina

Eligibility: Breyanzi requires prior authorization from Blue Cross Blue Shield of North Carolina for specific B-cell lymphomas after multiple treatment lines. Fastest path: Have your oncologist submit a PA request through the Blue e provider portal with complete documentation of diagnosis, prior therapies, and treatment failures. First step today: Contact BCBS NC customer service at the number on your member ID card to verify your plan's specialty drug coverage and confirm current PA requirements. Appeals follow a 180-day internal process, with external review available through Smart NC within 120 days of final denial.

Table of Contents

  1. BCBS North Carolina Policy Overview
  2. FDA-Approved Indications and Requirements
  3. Step Therapy and Medical Exceptions
  4. Quantity and Frequency Limits
  5. Required Diagnostics and Documentation
  6. Site of Care Requirements
  7. Evidence to Support Medical Necessity
  8. Sample Medical Necessity Narrative
  9. Appeals Process for Denials
  10. Common Denial Reasons and Solutions
  11. FAQ

BCBS North Carolina Policy Overview

Blue Cross Blue Shield of North Carolina covers Breyanzi (lisocabtagene maraleucel) for eligible patients with specific B-cell lymphomas, but prior authorization is required across all plan types. Coverage is provided for one treatment course consisting of a single dose and may not be renewed.

The policy applies to:

  • Commercial HMO and PPO plans
  • Medicare Advantage plans
  • State Health Plan members
  • ACA marketplace plans

Key Policy Elements:

  • Maximum quantity limit: one carton containing 1 to 4 vials
  • Coverage limited to approved indications
  • REMS-certified facility requirement
  • Extensive prior authorization documentation needed
Note: Specific coverage details may vary by individual plan. Always verify current requirements through the BCBS NC drug search tool or by contacting customer service.

FDA-Approved Indications and Requirements

Breyanzi is FDA-approved for multiple B-cell malignancies with specific line-of-therapy requirements:

Large B-Cell Lymphomas

Eligible subtypes:

  • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
  • High-grade B-cell lymphoma
  • Primary mediastinal large B-cell lymphoma
  • Follicular lymphoma grade 3B

Treatment scenarios:

  • After one prior line: Refractory to first-line chemoimmunotherapy OR relapsed after first-line therapy and ineligible for stem cell transplant
  • After two or more prior lines: Relapsed or refractory disease

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

Requirements:

  • At least 2 prior lines of therapy
  • Must include both: BTK inhibitor AND BCL-2 inhibitor
  • Relapsed or refractory disease status

Coverage Exclusions

BCBS North Carolina specifically excludes coverage for:

  • Primary central nervous system lymphoma
  • Patients under 18 years old
  • Previous CAR-T therapy recipients

Step Therapy and Medical Exceptions

Required Prior Therapies

For LBCL (first-line failures):

  • Standard chemoimmunotherapy regimen (e.g., R-CHOP, R-EPOCH)
  • Documentation of refractory disease or early relapse
  • Evidence of transplant ineligibility (age, comorbidities, or organ function)

For CLL/SLL:

  • BTK inhibitor therapy with documented progression or intolerance
  • BCL-2 inhibitor therapy with documented progression or intolerance
  • Clear documentation of both drug classes attempted

Medical Exception Pathways

Exceptions to standard step therapy may be granted for:

  • Contraindications: Document specific medical reasons why required therapies cannot be used
  • Previous intolerance: Include details of adverse events, dose reductions, or discontinuations
  • Rapid progression: Evidence of aggressive disease requiring immediate CAR-T therapy

Documentation requirements:

  • Provider attestation of medical necessity
  • Clinical notes detailing prior therapy outcomes
  • Laboratory or imaging evidence of treatment failure

Quantity and Frequency Limits

BCBS North Carolina enforces strict quantity limits for Breyanzi:

Parameter Limit Clinical Rationale
Doses per lifetime 1 treatment course Single-dose therapy per FDA labeling
Vials per course 1-4 vials Based on patient weight and cell count
CAR-T cells 50-110 × 10⁶ Varies by indication and prior lines
Renewal eligibility Not applicable One-time treatment

Dosing Specifications

  • LBCL (after 1 line): 90-110 × 10⁶ CAR-positive viable T cells
  • LBCL (after 2+ lines): 50-110 × 10⁶ CAR-positive viable T cells
  • CLL/SLL: 90-110 × 10⁶ CAR-positive viable T cells

Required Diagnostics and Documentation

Pre-Authorization Diagnostics

Essential laboratory work:

  • Complete blood count with differential
  • Comprehensive metabolic panel
  • Hepatitis B surface antigen and core antibody
  • HIV testing (if clinically indicated)
  • Performance status assessment (ECOG 0-2)

Imaging requirements:

  • Staging CT or PET/CT within 4 weeks
  • CNS imaging if clinically indicated
  • Bone marrow biopsy (for CLL/SLL)

Clinical Documentation Checklist

✓ Pathology report confirming eligible lymphoma subtype
✓ Prior therapy records with dates, regimens, and outcomes
✓ Disease progression documentation (imaging, labs, clinical notes)
✓ Performance status assessment with provider attestation
✓ Facility certification confirmation for REMS compliance

Site of Care Requirements

REMS Program Compliance

All Breyanzi administration must occur at REMS-certified facilities that meet specific requirements:

  • Immediate tocilizumab access for cytokine release syndrome management
  • Trained medical staff in CAR-T therapy administration and toxicity management
  • 24/7 critical care capabilities for monitoring and intervention
  • Certified treatment center status with manufacturer

North Carolina CAR-T Centers

Major certified facilities include:

Important: BCBS North Carolina will only cover Breyanzi when administered at properly certified facilities. Verify certification status before scheduling treatment.

Evidence to Support Medical Necessity

Clinical Guidelines and References

Primary sources for medical necessity:

  • FDA prescribing information for approved indications
  • NCCN Guidelines for B-Cell Lymphomas (current version)
  • ASH Clinical Practice Guidelines for CAR-T therapy
  • Peer-reviewed efficacy data from TRANSCEND trials

Key Clinical Evidence Points

For LBCL patients:

  • 73% overall response rate in TRANSCEND studies
  • 54% complete response rate after ≥2 prior therapies
  • Durable responses: 65% maintained CR ≥6 months

For CLL/SLL patients:

  • Accelerated approval based on response rates
  • Specific requirement for BTK and BCL-2 inhibitor failures
  • Limited alternative options after dual class failure

Sample Medical Necessity Narrative

Clinician Corner: Medical Necessity Template

"This [age]-year-old patient with [specific lymphoma subtype] has relapsed/refractory disease after [number] prior lines of therapy, including [list specific regimens with dates]. Prior treatments included [BTK inhibitor name] discontinued due to [reason] and [BCL-2 inhibitor name] with documented progression on [date]. Current disease status shows [progression evidence from imaging/labs]. The patient has adequate performance status (ECOG [score]) and organ function for CAR-T therapy. Breyanzi is FDA-approved for this indication and represents the most appropriate treatment option given [specific clinical rationale]. Treatment will be administered at [REMS-certified facility name] with appropriate monitoring protocols."

Appeals Process for Denials

Internal Appeals Timeline

BCBS North Carolina internal appeals process:

Level Timeline Submission Method Required Documents
First Level 30 days standard, 72 hours expedited Blue e provider portal PA request, clinical notes, denial letter
Second Level 30 days standard, 72 hours expedited Fax: 919-287-8709 All prior documents plus additional evidence

Filing deadlines:

  • Providers: 90 calendar days from denial
  • Members: 180 days from denial letter date

External Review Through Smart NC

If internal appeals fail, North Carolina offers external review through Smart NC:

Process details:

  • Filing deadline: 120 days after final internal denial
  • Standard review: 45 days for decision
  • Expedited review: 72 hours for urgent cases
  • Success rate: Approximately 50% of specialty drug denials overturned

Contact Smart NC: 855-408-1212 for free advocacy assistance

Common Denial Reasons and Solutions

Denial Reason Solution Strategy Required Documentation
Insufficient prior therapy Document all previous treatments with dates and outcomes Pharmacy records, infusion logs, provider notes
Missing BTK/BCL-2 inhibitor history Provide detailed records of both drug classes Prescription history, treatment summaries
Facility not REMS-certified Confirm certification status and provide documentation REMS certificate, facility credentialing
Inadequate performance status Submit current ECOG assessment with clinical rationale Recent clinic notes, functional assessments
Experimental/investigational Cite FDA approval and on-label use FDA labeling, NCCN guidelines
From our advocates: "We've seen many Breyanzi denials overturned when providers submit comprehensive prior therapy documentation, especially for CLL patients. The key is clearly demonstrating that both BTK and BCL-2 inhibitor classes have been tried and failed. Including pharmacy benefit records alongside clinical notes significantly strengthens these appeals."

FAQ

How long does BCBS North Carolina prior authorization take? Standard PA requests receive a decision within 15 business days. Expedited requests for urgent cases are processed within 72 hours.

What if Breyanzi is not on my formulary? Breyanzi may require formulary exception requests. Your provider can submit a non-formulary appeal with medical necessity documentation through the standard PA process.

Can I request an expedited appeal? Yes, expedited appeals are available if delaying treatment would seriously jeopardize your health. Both internal and external reviews offer expedited tracks.

Does step therapy apply if I failed treatments in another state? BCBS North Carolina typically accepts prior therapy documentation from other states, but ensure complete records transfer to your new provider.

What happens if my appeal is denied? After exhausting internal appeals, you can pursue external review through Smart NC. This independent process has overturned approximately 50% of specialty drug denials.

Are there financial assistance options? Bristol Myers Squibb offers patient assistance programs. Contact their patient support services or visit www.counterforcehealth.org for comprehensive coverage assistance.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like CAR-T treatments. Our platform analyzes denial letters, identifies the specific coverage gaps, and generates evidence-backed appeals that address payer concerns point-by-point. For patients navigating Breyanzi coverage challenges with BCBS North Carolina, we provide the clinical documentation and payer-specific strategies that significantly improve approval rates.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies change frequently, and individual circumstances vary. Always consult with your healthcare provider and insurance plan for the most current requirements. For additional assistance with insurance appeals in North Carolina, contact Smart NC at 855-408-1212.

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