By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi Covered by UnitedHealthcare in New York: Complete Prior Authorization Guide

Answer Box: Getting Breyanzi Covered by UnitedHealthcare in New York

Breyanzi (lisocabtagene maraleucel) requires prior authorization from UnitedHealthcare across all plans in New York. Coverage depends on meeting FDA-approved criteria for relapsed/refractory large B-cell lymphoma or chronic lymphocytic leukemia, plus plan-specific step therapy requirements.

Your fastest path to approval:

  1. Submit complete PA request via UnitedHealthcare Provider Portal with diagnosis, prior therapies, performance status, and organ function labs
  2. If denied, file internal appeal within 180 days with point-by-point clinical evidence
  3. Use New York's external review through the Department of Financial Services if internal appeals fail

Start today: Contact your oncologist to gather required documentation and verify your treatment center is REMS-certified for CAR-T therapy administration.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timeline and Urgency
  4. Clinical Criteria and Documentation
  5. Out-of-Pocket Costs
  6. Denials and Appeals
  7. New York External Review Rights
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. FAQ: Most Common Questions

Coverage Basics

Is Breyanzi Covered by UnitedHealthcare?

Yes, UnitedHealthcare covers Breyanzi (lisocabtagene maraleucel) under the medical benefit for FDA-approved indications, but prior authorization is mandatory across all plan types in New York—commercial, Medicare Advantage, and Medicaid managed care.

Which Plans Require PA?

According to UnitedHealthcare's 2025 PA requirements, all plans require prior authorization for Breyanzi, including:

  • Commercial employer plans
  • Marketplace (ACA) plans
  • Medicare Advantage plans
  • Medicaid managed care plans

Coverage at a Glance

Requirement What It Means Where to Find It
Prior Authorization Must get approval before treatment UHC Provider Portal
Step Therapy Must try/fail other treatments first Plan-specific PA policy
REMS Certification Treatment center must be certified FDA REMS program database
Medical Necessity Must meet FDA-approved criteria FDA prescribing information
Performance Status ECOG 0-2 typically required Clinical documentation

Prior Authorization Process

Step-by-Step: Fastest Path to Approval

1. Verify Coverage and Benefits

  • Who: Patient or clinic staff
  • What: Call UnitedHealthcare member services
  • Timeline: Same day
  • Source: Member ID card phone number

2. Gather Required Documentation

  • Who: Oncology team
  • What: Diagnosis, staging, prior therapies, labs, performance status
  • Timeline: 1-2 days
  • Key requirement: All documentation must be current (typically within 30 days)

3. Submit PA Request

  • Who: Healthcare provider
  • What: Complete PA form via UnitedHealthcare Provider Portal
  • Timeline: Submit immediately when complete
  • Support: OptumRx PA phone support at 888-397-8129

4. Track Status

  • Who: Provider or patient
  • What: Check portal or call for updates
  • Timeline: Standard review within 72 hours of complete submission
  • Expedited: 24 hours for urgent cases

5. Respond to Requests

  • Who: Healthcare provider
  • What: Provide any additional information requested
  • Timeline: Respond within 24-48 hours to avoid delays

Who Submits the Prior Authorization?

Your oncologist or their staff must submit the PA request. Patients cannot submit directly, but you can:

  • Ensure your provider has all necessary documentation
  • Follow up on submission status
  • Request expedited review if medically urgent

Timeline and Urgency

Standard Review Timelines

  • Complete submission to determination: 72 hours
  • Expedited review: 24 hours (for urgent medical situations)
  • Additional information requests: Can extend timeline by 5-10 business days

When to Request Expedited Review

Mark your request as "expedited" if:

  • Patient's condition is rapidly progressing
  • Delay could seriously jeopardize health
  • Standard timeline would compromise treatment effectiveness
Tip: Include a detailed clinical rationale explaining why expedited review is medically necessary.

Clinical Criteria and Documentation

Required Documentation Checklist

Diagnosis and Staging:

  • Pathology report confirming LBCL or CLL subtype
  • Staging studies (CT/PET scans, bone marrow biopsy)
  • ICD-10 diagnosis codes

Prior Treatment History:

  • Documentation of ≥2 prior lines of therapy for LBCL
  • For CLL: Prior BTK inhibitor and BCL2 inhibitor exposure
  • Dates, dosing, duration, and reason for discontinuation
  • Evidence of refractory or relapsed disease

Performance and Organ Function:

  • ECOG performance status (typically 0-2 required)
  • Laboratory values: CBC, comprehensive metabolic panel, liver function
  • Cardiac function assessment (ECHO or MUGA)
  • Pulmonary function if indicated

Treatment Center Certification:

  • Confirmation of REMS-certified facility
  • Evidence of CAR-T administration capability
Clinician Corner: Your medical necessity letter should address each PA criterion point-by-point, cite relevant FDA labeling sections, and include supporting literature from major oncology guidelines (NCCN, ASH, etc.).

Common Denial Reasons and Fixes

Denial Reason How to Fix Required Documentation
Insufficient prior therapy Document all previous treatments Treatment timeline with outcomes
Missing performance status Submit current ECOG assessment Dated clinical note with score
Inadequate organ function Provide recent lab values Labs within 30 days
Non-certified facility Transfer to REMS center Facility certification proof
Missing pathology Submit diagnostic reports Pathology with subtype confirmation

Out-of-Pocket Costs

Understanding Your Costs

Medicare Advantage Plans:

  • Typically 20% coinsurance after deductible
  • Annual out-of-pocket maximum applies (varies by plan)

Commercial Plans:

  • Varies by plan design and deductible status
  • May require facility copay plus procedure coinsurance

Medicaid Plans:

  • Minimal to no out-of-pocket costs for eligible members
  • Prior authorization still required

Cost Assistance Options

Bristol Myers Squibb Patient Support:

  • Cell Therapy 360 provides comprehensive support
  • Financial assistance programs available
  • Verify eligibility with manufacturer

Foundation Grants:

  • Leukemia & Lymphoma Society
  • Patient Advocate Foundation
  • CancerCare Co-Payment Assistance

Denials and Appeals

Internal Appeals Process

Level 1 Internal Appeal:

  • Deadline: 180 days from denial date
  • How to file: UnitedHealthcare Provider Portal or written request
  • Timeline: 30 days for standard, 72 hours for expedited
  • Required: Point-by-point response to denial reasons

Level 2 Internal Appeal:

  • Available if Level 1 is denied
  • Same deadlines and submission methods
  • Independent medical review by different reviewers

Peer-to-Peer Review

Before or during appeals, request a peer-to-peer review where your oncologist speaks directly with UnitedHealthcare's medical director. This often resolves coverage issues faster than written appeals.

How to request:

  • Call OptumRx at 888-397-8129
  • Request peer-to-peer review
  • Provide preferred times for oncologist availability

New York External Review Rights

When Internal Appeals Fail

New York provides robust external review rights through the Department of Financial Services (DFS). This is your strongest appeal option when UnitedHealthcare maintains their denial after internal appeals.

External Review Process

Eligibility:

  • Must complete UnitedHealthcare's internal appeals first
  • Have 4 months after final internal denial to file
  • Treatment must be denied as "not medically necessary" or "experimental"

How to File:

  • Submit request through DFS Portal (verify current link)
  • Mail or fax forms to DFS
  • Include all medical records and denial letters

Timeline:

  • Standard: Decision within 45 days
  • Expedited: 72 hours for urgent cases
  • Drug denials: 24 hours for urgent medication needs

Cost: Maximum $25 filing fee (waived for Medicaid or financial hardship)

New York's Consumer Advantages

  • Binding decisions: If external reviewer approves coverage, UnitedHealthcare must pay
  • Fee refund: Get your $25 back if you win
  • Expert review: Independent medical experts evaluate your case
  • Public database: Past decisions help guide future appeals
Note: New York's external review law is among the strongest in the nation, with high overturn rates for cancer treatment denials when proper clinical evidence is provided.

Specialty Pharmacy Requirements

CAR-T Distribution Network

Breyanzi requires specialized handling and administration at certified treatment centers. Your insurance may specify:

  • Designated specialty pharmacies for procurement
  • Certified infusion centers for administration
  • Network requirements that affect coverage

Action steps:

  • Verify your treatment center is in-network with UnitedHealthcare
  • Confirm the center's specialty pharmacy relationships
  • Check if OptumRx has specific distribution requirements
Important: Contact UnitedHealthcare and your treatment center to confirm current network status, as these relationships change frequently.

Troubleshooting Common Issues

Portal and Submission Problems

Provider Portal Down:

  • Use fax backup numbers (verify current numbers with UHC)
  • Call OptumRx support at 888-397-8129
  • Document submission attempts for appeal purposes

Missing Forms:

  • Download current forms from UnitedHealthcare Provider Portal
  • Verify you're using the correct form for your patient's plan type
  • Call provider services if forms are unavailable online

Communication Issues

No Response to PA:

  • Call to confirm receipt of submission
  • Verify all required fields were completed
  • Request status update and expected timeline

Conflicting Information:

  • Document all phone calls (date, time, representative name)
  • Request written confirmation of verbal approvals
  • Escalate to supervisor if information conflicts

FAQ: Most Common Questions

How long does UnitedHealthcare PA take for Breyanzi in New York? Standard review is 72 hours from complete submission. Expedited review for urgent cases is 24 hours. Additional information requests can extend the timeline.

What if Breyanzi is non-formulary on my plan? Even non-formulary drugs can be covered with proper prior authorization and medical necessity documentation. Focus on meeting clinical criteria and documenting failed alternatives.

Can I request an expedited appeal in New York? Yes, both UnitedHealthcare internal appeals and New York external reviews offer expedited processes for urgent medical situations. Include clinical justification for urgency.

Does step therapy apply if I failed treatments outside New York? Yes, prior treatment history from any location counts toward step therapy requirements. Ensure complete documentation of all prior therapies and outcomes.

What happens if my treatment center isn't REMS-certified? Coverage will be denied. You'll need to transfer care to a certified CAR-T center. Use the FDA REMS database to find certified facilities in your area.

How do I get help with appeals in New York? Contact Community Health Advocates at 888-614-5400 for free assistance with insurance appeals. They can help you navigate both internal and external review processes.

Counterforce Health specializes in turning insurance denials into successful appeals by crafting evidence-backed, point-by-point rebuttals that align with each plan's specific requirements. Our platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization processes and appeals for specialty medications like CAR-T therapies.

When to Escalate Beyond Appeals

If standard appeals fail, consider:

State Insurance Complaints:

  • File complaint with New York Department of Financial Services
  • Document pattern of improper denials
  • Request regulatory intervention

Congressional Representatives:

  • Contact your representatives for Medicare Advantage issues
  • Provide detailed case summary and timeline
  • Request assistance with federal oversight agencies

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage policies change frequently. Always verify current requirements with UnitedHealthcare and consult with your healthcare team for medical decisions. For personalized assistance with prior authorizations and appeals, consider working with specialized advocacy services like Counterforce Health.

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