By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

Work With Your Doctor to Get Breyanzi (Lisocabtagene Maraleucel) Approved by UnitedHealthcare in Florida: Complete Provider Collaboration Guide

Quick Answer: Getting Breyanzi Approved in Florida

Breyanzi (lisocabtagene maraleucel) requires UnitedHealthcare prior authorization for relapsed/refractory large B-cell lymphoma or CLL/SLL after ≥2 prior therapies. Your oncologist must submit documentation showing progression after standard treatments, confirm CD19 positivity, and demonstrate you meet FDA labeling criteria. Treatment must occur at a UHC-designated CAR-T center with FACT accreditation. First step today: Contact your oncologist to schedule a pre-authorization planning visit and request your complete treatment history records. If denied, Florida allows internal appeals within 60 days, then external review through the Florida Office of Insurance Regulation within 4 months.

Table of Contents

  1. Set Your Goal: Understanding Approval Requirements
  2. Prepare for Your Provider Visit
  3. Build Your Evidence Kit
  4. Medical Necessity Letter Structure
  5. Support Your Doctor's Peer-to-Peer Review
  6. After Your Visit: Documentation Strategy
  7. Respectful Persistence: Follow-Up Timeline
  8. Appeals Process in Florida
  9. Cost Assistance Programs
  10. FAQ: Common Questions

Set Your Goal: Understanding Approval Requirements

Coverage Requirements at a Glance

Requirement What It Means Where to Verify
Prior Authorization Required for all CAR-T therapies UHC PA Requirements
Designated Center FACT-accredited CAR-T facility UHC CAR-T Portal
Prior Therapies ≥2 lines for LBCL; BTK + BCL2 inhibitors for CLL FDA Label
Performance Status ECOG 0-1 typically required UHC Clinical Guidelines
Appeals Timeline 60 days internal, 4 months external Florida DFS

Your Partnership Strategy

Success requires active collaboration between you and your oncology team. UnitedHealthcare's approval rate for CAR-T therapies improves significantly when submissions include complete documentation and meet all clinical criteria upfront.

Counterforce Health specializes in turning insurance denials into targeted appeals by analyzing payer policies and clinical evidence. Their platform helps patients and providers navigate complex prior authorization requirements for specialty therapies like Breyanzi, ensuring submissions align with UnitedHealthcare's specific approval criteria.

Prepare for Your Provider Visit

Essential Information to Gather

Treatment History Timeline:

  • Exact dates of all prior therapies (chemotherapy, targeted therapy, immunotherapy)
  • Response to each treatment (complete response, partial response, progression)
  • Reasons for discontinuation (progression, toxicity, intolerance)
  • Imaging dates showing disease progression

For Large B-Cell Lymphoma:

  • Initial diagnosis date and biopsy results
  • Staging information (Ann Arbor stage, IPI score)
  • Prior regimens: R-CHOP, R-ICE, or other standard combinations
  • Transplant eligibility assessment

For CLL/SLL:

  • Documentation of BTK inhibitor therapy (ibrutinib, acalabrutinib, zanubrutinib)
  • BCL2 inhibitor exposure (venetoclax)
  • FISH cytogenetics (del17p, TP53 mutations if applicable)

Questions to Ask Your Doctor

  1. "Do you have experience submitting Breyanzi prior authorizations to UnitedHealthcare?"
  2. "Is our treatment center FACT-accredited for CAR-T therapy?"
  3. "Can you provide a timeline for the PA submission and expected approval?"
  4. "What backup plans do we have if the initial request is denied?"

Build Your Evidence Kit

Clinical Documentation Checklist

Diagnostic Confirmation:

  • Pathology report confirming large B-cell lymphoma or CLL/SLL
  • Flow cytometry showing CD19 positivity
  • Staging scans (PET-CT, CT chest/abdomen/pelvis)
  • Bone marrow biopsy (if applicable)

Treatment History:

  • Chemotherapy administration records
  • Response assessments (imaging reports, lab values)
  • Toxicity documentation and dose modifications
  • Progression documentation with imaging

Current Status:

  • Recent labs (CBC, comprehensive metabolic panel, LDH)
  • Performance status assessment (ECOG scale)
  • Organ function tests (cardiac, pulmonary, renal)
  • Infection screening results

Published Guidelines Support

Your oncologist should reference current treatment guidelines in the medical necessity letter:

  • NCCN Guidelines for B-Cell Lymphomas (latest version)
  • NCCN Guidelines for Chronic Lymphocytic Leukemia (for CLL/SLL)
  • FDA prescribing information for Breyanzi
  • FACT-JACIE International Standards for cellular therapy programs

Medical Necessity Letter Structure

Key Components Your Doctor Should Include

Patient Demographics and Diagnosis:

[Patient Name], [Age]-year-old with relapsed/refractory [specific lymphoma subtype]
Initial diagnosis: [Date] with biopsy confirming [histology]
ICD-10: C83.3x (diffuse large B-cell lymphoma) or C91.1x (CLL)

Prior Treatment History:

Line 1: R-CHOP x 6 cycles ([dates]) - achieved [response], progressed [date]
Line 2: R-ICE x 3 cycles ([dates]) - [response], [reason for discontinuation]
[Additional lines as applicable]

Clinical Rationale:

Patient meets FDA labeling criteria for Breyanzi:
- Relapsed/refractory disease after ≥2 prior therapies
- CD19-positive disease confirmed by flow cytometry
- Adequate performance status (ECOG 0-1)
- Appropriate candidate for intensive therapy

Treatment Plan:

Planned lymphodepletion with fludarabine/cyclophosphamide
Breyanzi infusion at [FACT-accredited center name]
Post-infusion monitoring per REMS requirements

Support Your Doctor's Peer-to-Peer Review

If Initial PA is Denied

UnitedHealthcare offers peer-to-peer review within 14 days of denial. This allows your oncologist to discuss your case directly with a UHC medical director.

How You Can Help:

  • Provide flexible scheduling for the P2P call
  • Prepare a one-page summary of your case for your doctor's reference
  • Offer to be available during the call if the medical director has questions

Sample Patient Summary for P2P:

Key Points for [Patient Name]:
- Diagnosis: [Specific lymphoma type], diagnosed [date]
- Prior therapies: [List with dates and outcomes]
- Current status: Progressive disease, ECOG 0-1
- Meets all FDA criteria for Breyanzi
- Treatment planned at [FACT-accredited center]

After Your Visit: Documentation Strategy

What to Save and Track

From Your Provider:

  • Copy of the prior authorization submission
  • Expected timeline for UnitedHealthcare response
  • Contact information for PA status checks
  • Backup treatment options if denied

Portal Communications:

  • Screenshot confirmation of PA submission
  • Any additional requests from UnitedHealthcare
  • Status updates and determination letters

Personal Records:

  • Visit summary with treatment plan
  • Insurance verification confirmation
  • Financial counselor contact information

Follow-Up Schedule

  • Week 1: Confirm PA submission with provider office
  • Week 2: Check status via UHC Provider Portal
  • Week 3: If no response, provider should call UnitedHealthcare
  • Week 4+: Consider expedited review if medically urgent

Respectful Persistence: Follow-Up Timeline

Communication Cadence

With Your Provider's Office:

  • Weekly check-ins during PA review period
  • Immediate notification if you receive any insurance communications
  • Monthly updates on treatment planning and scheduling

Escalation Protocol:

  1. Day 21: If no PA decision, request provider call UnitedHealthcare
  2. Day 30: Consider expedited review if disease progression
  3. Day 45: Prepare appeal documentation if denial expected
  4. Day 60: File internal appeal if denied

When to Request Expedited Review

Contact your provider immediately if you experience:

  • Rapid disease progression
  • New symptoms requiring urgent treatment
  • Complications from current therapy requiring change

Expedited reviews can be completed within 72 hours for urgent medical situations.

Appeals Process in Florida

UnitedHealthcare Internal Appeals

Timeline: 60 days from denial notice

Required Documents:

  • Original denial letter
  • Updated medical necessity letter
  • Additional clinical evidence
  • Peer-reviewed literature supporting treatment

Submission Methods:

  • UHC Provider Portal (preferred)
  • Fax: (verify current number with UnitedHealthcare)
  • Mail: Address on denial letter

Florida External Review

If internal appeals are unsuccessful, Florida law provides external review through independent medical experts.

Timeline: 4 months from final internal denial Process: Submit request to Florida Office of Insurance Regulation Decision: Binding on UnitedHealthcare if approved Cost: Free to patients

Required for External Review:

  • Exhausted UnitedHealthcare internal appeals
  • Denial involves medical necessity determination
  • Treatment is FDA-approved (Breyanzi qualifies)
From Our Advocates: We've seen cases where patients initially denied for Breyanzi were approved after external review when the independent physician reviewer agreed the treatment met FDA criteria and was medically necessary. The key was comprehensive documentation of prior therapy failures and current disease status. External review provides an important safety net when insurance companies disagree with treating physicians.

Cost Assistance Programs

Bristol Myers Squibb Support

Patient Assistance Program:

Co-pay Assistance:

  • Commercial insurance patients may qualify
  • Reduces out-of-pocket costs significantly
  • Not available for government insurance

Additional Resources

  • Leukemia & Lymphoma Society: Financial assistance grants
  • CancerCare: Co-payment assistance program
  • HealthWell Foundation: Disease-specific grants
  • Good Days: Chronic disease assistance

Counterforce Health's platform can help identify which assistance programs align with your specific insurance situation and treatment timeline, ensuring you don't miss application deadlines while pursuing coverage approval.

FAQ: Common Questions

Q: How long does UnitedHealthcare prior authorization take for Breyanzi? A: Standard review is typically 3-5 business days, though complex cases may take up to 14 days. Expedited reviews for urgent cases are completed within 72 hours.

Q: What if my treatment center isn't UnitedHealthcare-designated? A: Breyanzi must be administered at a FACT-accredited CAR-T center in UnitedHealthcare's network. Your oncologist can help identify the nearest approved facility.

Q: Can I appeal if UnitedHealthcare says Breyanzi is experimental? A: Yes. Breyanzi is FDA-approved for specific indications. Appeals should emphasize FDA approval and include current prescribing information demonstrating your diagnosis meets labeled criteria.

Q: Does step therapy apply to CAR-T therapies? A: UnitedHealthcare typically requires documentation of prior therapy failures rather than specific step therapy protocols for CAR-T, given the advanced nature of eligible diseases.

Q: What if I need treatment urgently? A: Request expedited prior authorization and appeal processes. Document medical urgency with recent imaging showing progression and physician assessment of time sensitivity.

Q: How much does Breyanzi cost? A: The wholesale acquisition cost is approximately $447,000-$487,000, with additional costs for administration and monitoring. Total treatment costs often exceed $500,000.

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 circumstances, policy terms, and medical necessity determinations. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional support with insurance appeals and prior authorizations, visit Counterforce Health for specialized assistance with complex coverage challenges.

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