By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

Breyanzi (Lisocabtagene Maraleucel) Approval with UnitedHealthcare in Michigan: Answers to the Most Common Questions

Answer Box: Getting Breyanzi Covered by UnitedHealthcare in Michigan

Breyanzi (lisocabtagene maraleucel) requires prior authorization from UnitedHealthcare for all Michigan plans. Your oncologist must submit documentation proving you meet FDA criteria: relapsed/refractory large B-cell lymphoma after ≥2 lines, or CLL/SLL after BTK and BCL-2 inhibitor failure. Treatment must occur at a REMS-certified CAR-T center with tocilizumab available.

First step today: Have your clinic verify your UnitedHealthcare plan covers CAR-T therapy and confirm your treatment center is in-network with Optum Transplant Solutions. Standard approval takes up to 15 business days; expedited decisions within 72 hours for urgent cases.

Table of Contents

  1. Coverage Basics
  2. Prior Authorization Process
  3. Timing and Urgency
  4. Clinical Criteria
  5. Costs and Coverage
  6. Denials and Appeals
  7. Renewals and Monitoring
  8. Specialty Pharmacy Requirements
  9. Troubleshooting Common Issues
  10. Key Terms Glossary

Coverage Basics

Is Breyanzi Covered by UnitedHealthcare in Michigan?

Yes, but with strict requirements. UnitedHealthcare treats CAR-T therapy like a transplant benefit, managed through Optum Transplant Solutions. Coverage applies to:

  • Commercial plans (employer-sponsored)
  • Medicare Advantage plans
  • Medicaid/Community Plan (Michigan)
  • Marketplace (ACA) plans

Self-funded employer plans may have different rules—check your plan documents or call member services.

Which Indications Are Covered?

UnitedHealthcare covers Breyanzi for FDA-approved indications:

  • Large B-cell lymphoma (DLBCL and related subtypes) after ≥2 prior systemic therapies
  • Chronic lymphocytic leukemia/small lymphocytic lymphoma after ≥2 lines including BTK and BCL-2 inhibitors
  • Mantle cell lymphoma after ≥2 lines including a BTK inhibitor
  • Follicular lymphoma (grade 3B) and other eligible B-cell lymphomas per current label

Off-label use requires strong evidence from CMS-approved compendia and case-by-case review.

Prior Authorization Process

Who Submits the Prior Authorization?

Your oncologist or treatment center submits the PA request through:

  • UnitedHealthcare Provider Portal (preferred method)
  • Phone: Call Optum Transplant Solutions (number provided in denial letters)
  • Fax: As directed in UnitedHealthcare policy documents

Patients cannot submit CAR-T prior authorizations directly due to the complexity and transplant-benefit classification.

Required Documentation Checklist

Document Details Source
Pathology Report Confirms CD19+ B-cell lymphoma subtype Hospital/clinic records
Prior Therapy Summary Complete treatment history with dates, responses, progression Oncology notes
Performance Status ECOG 0-2 documented in recent visit Clinic visit note
Recent Labs CBC, CMP, viral studies (HIV, HBV, HCV) within 30 days Laboratory reports
Imaging PET/CT or CT showing active disease Radiology reports
REMS Certification Confirmation treatment center is FDA-certified Facility documentation

Step-by-Step Submission Process

  1. Verify Network Status - Confirm your treatment center contracts with Optum Transplant Solutions
  2. Gather Clinical Records - Collect all required documentation (see checklist above)
  3. Complete PA Form - Oncologist submits through UnitedHealthcare Provider Portal
  4. Submit Supporting Documents - Attach pathology, labs, imaging, and medical necessity letter
  5. Track Status - Monitor through provider portal or call member services
  6. Respond to Requests - Provide additional information within 14 days if requested
  7. Receive Decision - Standard: 15 business days; Expedited: 72 hours

Timing and Urgency

How Long Does Prior Authorization Take?

  • Standard Review: Up to 15 business days from complete submission
  • Expedited Review: 72 hours when delay would jeopardize health
  • Incomplete Submissions: Additional 14 days to provide missing information

When to Request Expedited Review

Request urgent processing when:

  • Disease is rapidly progressing
  • Bridging therapy is failing
  • Treatment window is narrowing due to performance status decline
  • Risk of transformation or blast crisis

Your oncologist must provide written justification for why waiting could seriously jeopardize your health.

Clinical Criteria

What Counts as Step Therapy for Breyanzi?

For Large B-Cell Lymphoma:

  • ≥2 prior systemic therapies (chemotherapy, immunotherapy, targeted agents)
  • Documentation of relapse or refractoriness
  • Transplant ineligibility or post-transplant relapse (if applicable)

For CLL/SLL:

  • Prior BTK inhibitor (ibrutinib, acalabrutinib, or zanubrutinib) with progression or intolerance
  • Prior BCL-2 inhibitor (venetoclax) with progression or intolerance
  • ≥2 total prior lines of therapy

For Mantle Cell Lymphoma:

  • ≥2 prior systemic therapies including a BTK inhibitor
  • Documented progression or intolerance to prior treatments

Required Lab Values and Assessments

While specific thresholds aren't publicly detailed, UnitedHealthcare typically requires:

  • Performance Status: ECOG 0-2 (documented in clinic note)
  • Organ Function: Adequate cardiac, pulmonary, hepatic, and renal function
  • Infection Screening: Negative or controlled HIV, hepatitis B/C
  • Disease Assessment: Measurable disease on recent imaging
  • Age: ≥18 years for adult indications
Tip: Missing ECOG documentation is a common denial reason. Ensure your oncologist explicitly states your performance status in recent visit notes.

Costs and Coverage

What Will I Pay for Breyanzi?

Costs vary significantly by plan type and coverage phase. Breyanzi's list price is approximately $447,000-$487,000, but your out-of-pocket costs depend on:

Medicare Advantage Plans:

  • Specialty drugs typically fall into Tier 4/5
  • Coinsurance: 25-33% until reaching out-of-pocket maximum
  • 2025 out-of-pocket max: $3,300-$8,850
  • Low-Income Subsidy (LIS): $4.50-$12.15 copay

Commercial/Marketplace Plans:

  • Varies by formulary tier and deductible
  • Often subject to prior deductible and coinsurance
  • Annual out-of-pocket maximums apply

Cost-Saving Resources:

Denials and Appeals

Common Denial Reasons and Solutions

Denial Reason How to Address Required Evidence
Insufficient prior therapy Document all previous treatments with dates and outcomes Complete treatment timeline
Missing BTK/BCL-2 history Provide records of ibrutinib, venetoclax, or other required agents Pharmacy records, oncology notes
Performance status concerns Submit recent ECOG assessment and functional status Current clinic visit note
Experimental/investigational Cite FDA approval and current label FDA prescribing information
Site of care issues Confirm REMS certification and network status Facility certification letter

UnitedHealthcare Internal Appeal Process

Timeline: 180 days from denial notice to file internal appeal

How to Appeal:

  1. Gather Evidence - Collect denial letter, medical records, and supporting literature
  2. Write Medical Necessity Letter - Have oncologist address each denial reason specifically
  3. Submit Appeal - Use UnitedHealthcare Provider Portal or follow denial letter instructions
  4. Request Peer-to-Peer - Ask for physician-to-physician review with UnitedHealthcare medical director
  5. Track Status - Monitor through provider portal or member services

Expedited Appeals: 72-hour decision when delay poses health risks

Michigan External Review Process

After exhausting UnitedHealthcare's internal appeals, you can request independent review through Michigan Department of Insurance and Financial Services (DIFS).

Timeline: 127 days from final UnitedHealthcare denial to request external review

Process:

  1. Complete DIFS External Review Form - Available online or by calling 877-999-6442
  2. Submit Required Documents - Include all denial letters, medical records, and plan documents
  3. DIFS Review - Independent medical experts evaluate the case
  4. Binding Decision - Standard: 60 days; Expedited: 72 hours for urgent cases
Note: DIFS external review is available for most fully-insured plans but not self-funded employer plans.

Renewals and Monitoring

When Do I Need Re-Authorization?

Breyanzi is typically a one-time treatment, so ongoing prior authorization isn't usually required. However, you may need new approvals for:

  • Monitoring visits and labs at the CAR-T center
  • Management of side effects (CRS, neurologic events)
  • Additional CAR-T doses (rare, usually not approved)
  • Subsequent treatments if Breyanzi doesn't work or disease returns

Your treatment team will coordinate any necessary approvals for follow-up care.

Specialty Pharmacy Requirements

Why Was My Case Transferred to Optum Transplant?

UnitedHealthcare classifies CAR-T as a transplant service rather than a standard specialty drug. This means:

  • Optum Transplant Solutions manages the authorization and care coordination
  • REMS-certified centers handle the actual drug preparation and infusion
  • Specialty pharmacy may coordinate the cell collection and manufacturing logistics

This isn't a transfer—it's the standard pathway for all CAR-T therapies under UnitedHealthcare.

Troubleshooting Common Issues

Provider Portal Problems

Portal Down or Access Issues:

  • Call UnitedHealthcare Provider Services: 1-800-842-2658
  • Use backup fax submission (number in your provider manual)
  • Request phone-based prior authorization if system is unavailable

Missing Forms or Documentation

Can't Find Required Forms:

  • Check UnitedHealthcare Provider Portal under "Prior Authorization"
  • Call Optum Transplant Solutions directly (number provided after initial submission)
  • Contact your treatment center's financial counselor for assistance

Network and Coverage Questions

Unsure About Coverage:

  • Call member services number on your insurance card
  • Verify both medical coverage and transplant benefits
  • Confirm your treatment center's network status with Optum

From Our Advocates

We've seen cases where patients were initially denied because their oncologist submitted through the standard drug PA pathway instead of the transplant benefit. Once the clinic resubmitted through Optum Transplant Solutions with complete documentation, approval came within the standard timeframe. The key is understanding that CAR-T isn't treated like a typical infusion drug—it requires the transplant-level review process.

Key Terms Glossary

Prior Authorization (PA): Insurance approval required before receiving treatment

Step Therapy: Requirement to try specific treatments before accessing others

Medical Necessity Letter: Physician documentation explaining why treatment is required

Peer-to-Peer (P2P): Phone consultation between your doctor and insurance medical director

REMS: Risk Evaluation and Mitigation Strategy - FDA safety program for certain drugs

ECOG Performance Status: Scale (0-4) measuring how disease affects daily activities

BTK Inhibitor: Targeted therapy for B-cell cancers (e.g., ibrutinib, acalabrutinib)

BCL-2 Inhibitor: Targeted therapy that promotes cancer cell death (e.g., venetoclax)

Cytokine Release Syndrome (CRS): Common side effect of CAR-T therapy requiring monitoring

External Review: Independent evaluation of insurance denials by state-appointed experts

About Counterforce Health

Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like CAR-T. Our platform analyzes denial letters, identifies the specific criteria insurers use, and helps build evidence-backed appeals that address each payer's requirements. For patients and providers navigating UnitedHealthcare's CAR-T approval process, we provide targeted guidance on documentation, medical necessity letters, and appeal strategies.

Whether you're facing an initial denial or need help strengthening your prior authorization submission, Counterforce Health can help you understand exactly what UnitedHealthcare requires and how to present your case most effectively.

Sources & Further Reading

Disclaimer: This guide provides educational information about insurance processes and should not be considered medical advice. Treatment decisions should always be made in consultation with qualified healthcare providers. Insurance policies and procedures may change—verify current requirements with UnitedHealthcare and your treatment team. For personalized assistance with insurance issues in Michigan, contact the Michigan Department of Insurance and Financial Services at 877-999-6442.

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