By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (lisocabtagene maraleucel) Covered by Cigna in Pennsylvania: Complete Prior Authorization and Appeals Guide

Answer Box: Fastest Path to Breyanzi Coverage with Cigna in Pennsylvania

To get Breyanzi (lisocabtagene maraleucel) covered by Cigna in Pennsylvania: (1) Have your CAR-T center submit prior authorization through Cigna's LifeSOURCE transplant program with complete documentation of diagnosis, prior therapy failures, and facility certification; (2) If denied, request peer-to-peer review within 180 days; (3) Use Pennsylvania's Independent External Review Program within 4 months of final denial—this state program has overturned about 50% of insurance denials in 2024. Start today: Contact your CAR-T center's financial counselor to initiate the prior authorization process through Cigna's provider portal.

Table of Contents

Patient Profile: Who Needs This Guide

This guide is for patients diagnosed with relapsed or refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who meet Breyanzi eligibility criteria and have Cigna insurance in Pennsylvania.

Breyanzi is FDA-approved for:

  • Adults with LBCL after ≥2 lines of therapy (including DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B)
  • Adults with CLL/SLL after ≥2 prior lines including a BTK inhibitor and BCL-2 inhibitor

The typical patient profile includes:

  • Age 18+ (median age in trials: 59-74 years)
  • ECOG Performance Status 0-1
  • Adequate organ function (LVEF ≥40%, creatinine clearance ≥30 mL/min)
  • Treatment at a FACT-accredited CAR-T center
Note: Breyanzi costs approximately $447,000-$487,000 per dose, making insurance coverage essential for most patients.

Pre-Authorization Preparation

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Required for all Cigna plans Cigna provider portal Cigna CAR-T Policies
Formulary Status Typically medical benefit Plan documents Cigna member portal
Treatment Center FACT-accredited facility required CAR-T center credentials FDA CAR-T Centers
Prior Therapy Documentation Complete treatment history Medical records Oncology notes
Appeals Deadline 180 days internal, 4 months external Denial letter Pennsylvania Insurance Department

Essential Documentation Checklist

Before starting the prior authorization process, gather:

Patient Information

  • Cigna member ID and plan type (commercial/Medicare Advantage)
  • Complete demographics and contact information
  • Insurance card front and back copies

Clinical Documentation

  • Pathology reports confirming CD19-positive B-cell malignancy
  • Imaging studies (PET/CT) showing current disease status
  • Laboratory results: CBC, comprehensive metabolic panel, LDH
  • ECOG performance status assessment
  • Cardiac function (LVEF) and organ function tests

Treatment History

  • Detailed chronology of all prior therapies
  • Start/stop dates for each treatment line
  • Best response achieved and reason for discontinuation
  • Documentation of disease progression or intolerance

Facility Credentials

  • Confirmation of FACT accreditation or Cigna-contracted status
  • Treating physician specialty certification (hematology/oncology)
  • CAR-T program capabilities statement

Submission Process

Step-by-Step: Fastest Path to Approval

  1. Contact Cigna LifeSOURCE Transplant Program
    • Who does it: CAR-T center financial counselor
    • Timeline: Initiate within 1-2 business days of treatment decision
    • Portal: Cigna provider portal or direct LifeSOURCE contact
  2. Submit Complete Prior Authorization Packet
    • Required documents: PA form, clinical summary, treatment history, facility credentials
    • Timeline: 72 hours for standard review, 24 hours for expedited
    • Tip: Include all documentation upfront to avoid delays
  3. Medical Necessity Letter Components
    • FDA-approved indication confirmation
    • Prior therapy failures with specific regimens and dates
    • Current disease status and urgency of treatment
    • Guidelines support (NCCN Category 1/2A recommendations)
  4. Facility Verification
    • Confirm CAR-T center is Cigna-contracted
    • Include FACT accreditation documentation
    • Provide physician NPI and specialty certification
  5. Coding and Billing Setup
    • Request authorization under medical benefit
    • Include anticipated HCPCS codes for the product
    • Plan for lymphodepleting chemotherapy coverage

Initial Outcome Scenarios

Approval Scenario

If approved, Cigna typically provides:

  • Authorization valid for 180 days for chronic conditions
  • Coverage for the complete CAR-T episode including:
    • Leukapheresis procedure
    • Lymphodepleting chemotherapy
    • Breyanzi infusion
    • Inpatient monitoring and toxicity management

Common Denial Reasons & Fixes

Denial Reason How to Overturn Required Documents
Insufficient prior therapies Document ≥2 lines with specific regimens Treatment chronology with dates and responses
Non-qualified treatment center Confirm FACT accreditation Facility certification letter
Off-label use Cite FDA approval and NCCN guidelines Prescribing information and guideline excerpts
Medical necessity questioned Provide peer-reviewed evidence Literature supporting CAR-T for refractory disease

Appeal Strategies

Peer-to-Peer Review Process

When requesting a peer-to-peer review with Cigna:

Talking Points for Oncologists:

  • "This patient has relapsed/refractory [diagnosis] after [X] lines of therapy, meeting FDA-approved Breyanzi indications"
  • "NCCN Guidelines list CAR-T as Category 1 recommendation for this clinical scenario"
  • "Delay risks disease progression that may render the patient ineligible for curative therapy"
  • "Our center is FACT-accredited with experience in CAR-T toxicity management"

Key Evidence to Reference:

  • FDA prescribing information for Breyanzi
  • NCCN Guidelines for B-cell lymphomas or CLL/SLL
  • Clinical trial data (PILOT, TRANSFORM, TRANSCEND CLL 004)
  • Real-world evidence supporting efficacy and safety

Internal Appeals Process

If the peer-to-peer review is unsuccessful:

  1. File Internal Appeal (within 180 days of denial)
    • Submit through Cigna member or provider portal
    • Include additional clinical evidence and specialist letters
    • Request expedited review if clinically urgent
  2. Second-Level Internal Review
    • Available if first-level appeal is denied
    • Reviewed by different medical director
    • Additional opportunity to submit new evidence

Pennsylvania External Review Process

Pennsylvania's Independent External Review Program offers strong patient protections with a 50-53% overturn rate for eligible cases.

Timeline and Process

Standard External Review:

  • Filing deadline: 4 months after Final Adverse Benefit Determination
  • Eligibility decision: Within 5 business days
  • IRO assignment: Within 1 business day of eligibility confirmation
  • Additional evidence window: 15 days from IRO assignment
  • Final decision: Within 45 days of IRO assignment
  • Total timeline: Usually under 60 days

Expedited External Review (for urgent cases):

  • When to use: Life-threatening situations or serious health risks
  • Requirements: Physician Certification Form attesting to urgency
  • Timeline: 72 hours for final decision
  • Implementation: Insurer must comply within 24 hours

How to File External Review

  1. Online submission (fastest): Pennsylvania Insurance Department portal
  2. Required documents:
    • Final Adverse Benefit Determination letter
    • Insurance card copy
    • Medical necessity letter from oncologist
    • Supporting clinical evidence and guidelines
    • Physician Certification Form (if expedited)
From our advocates: We've seen CAR-T denials overturned when families submitted comprehensive packages including NCCN guideline excerpts, FDA approval documentation, and detailed letters from CAR-T specialists explaining why standard chemotherapy options were exhausted. The key is addressing the specific denial rationale with authoritative medical evidence.

Resolution and Next Steps

After Approval

Once Breyanzi is approved:

  • Immediate actions: Schedule leukapheresis and treatment planning
  • Coordination: Work with CAR-T center to confirm authorization details
  • Monitoring: Track any authorization expiration dates

If External Review Fails

  • Consult with health law attorney for potential legal remedies
  • Explore manufacturer patient assistance programs
  • Consider clinical trial enrollment if available
  • Contact Counterforce Health for specialized appeals support

What We'd Do Differently

Key Lessons for Success:

  1. Start Early: Begin prior authorization process as soon as CAR-T eligibility is confirmed
  2. Complete Documentation: Submit all required documents in the initial packet to avoid delays
  3. Leverage Specialists: Have the CAR-T center's experienced staff handle submissions
  4. Know Your Rights: Understand Pennsylvania's external review timeline and requirements
  5. Build Relationships: Maintain communication with Cigna case managers throughout the process

Common Mistakes to Avoid:

  • Incomplete treatment history documentation
  • Missing facility accreditation verification
  • Waiting until the last minute to file appeals
  • Not requesting expedited review for urgent cases

Templates and Checklists

Medical Necessity Letter Template

"[Patient Name] is a [age]-year-old with relapsed/refractory [diagnosis] who has received [number] prior lines of systemic therapy including [list specific regimens]. Current disease status shows [describe progression/refractoriness]. The patient meets FDA-approved criteria for Breyanzi and NCCN Guidelines support CAR-T therapy as a Category [1/2A] recommendation. Treatment delay risks disease progression that may preclude curative therapy."

Prior Authorization Checklist

  • Cigna PA form completed
  • Clinical summary with diagnosis and ICD-10 codes
  • Complete treatment history with dates and responses
  • Current imaging and laboratory results
  • ECOG performance status and organ function assessment
  • Facility FACT accreditation documentation
  • Physician specialty certification
  • Medical necessity letter with guidelines citations

FAQ

How long does Cigna prior authorization take for Breyanzi in Pennsylvania? Standard reviews take 72 hours (3 business days), while expedited requests are processed within 24 hours for urgent medical situations.

What if Breyanzi is non-formulary on my Cigna plan? CAR-T therapies are typically covered under the medical benefit rather than pharmacy benefit. Your CAR-T center will work with Cigna to ensure proper benefit routing.

Can I request an expedited appeal in Pennsylvania? Yes, Pennsylvania offers expedited external review for life-threatening situations. You'll need a Physician Certification Form from your oncologist confirming the urgency.

Does step therapy apply to CAR-T therapy? Cigna typically requires documentation of prior therapy failures rather than formal step therapy protocols, given that CAR-T is indicated after multiple prior lines.

What happens if I paid out-of-pocket during the appeal? If Pennsylvania's external review overturns the denial, Cigna must provide retroactive coverage including reimbursement for treatments you paid for during the appeal process.

How successful are external reviews for CAR-T therapy in Pennsylvania? While specific CAR-T data isn't published, Pennsylvania's external review program has overturned approximately 50% of eligible denials overall, with higher success rates when comprehensive medical evidence is provided.

About Counterforce Health

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals for complex therapies like CAR-T. Our platform helps patients, clinicians, and specialty pharmacies navigate prior authorization requirements and appeal processes by identifying denial reasons and crafting point-by-point rebuttals aligned with payer policies and clinical guidelines.

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage decisions depend on individual plan terms and clinical circumstances. Always consult with your healthcare team and insurance plan for specific guidance. For additional support with insurance appeals in Pennsylvania, contact the Pennsylvania Insurance Department Consumer Services at the phone number listed on their website.

Sources & Further Reading:

Powered by Counterforce Health—AI that turns drug denials into evidence-based appeals patients and clinicians can submit today.