By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

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

Quick Answer: Getting Breyanzi Approved by UnitedHealthcare in California

Breyanzi (lisocabtagene maraleucel) requires prior authorization from UnitedHealthcare before administration. To get approval: (1) Submit a complete PA request through the UnitedHealthcare Provider Portal with diagnosis documentation, prior therapy records, and REMS facility certification; (2) Allow 72 hours for standard review or request expedited processing for urgent cases; (3) If denied, file an internal appeal within 180 days, then pursue California's Independent Medical Review (IMR) through the DMHC. Success depends on meeting FDA-approved indications and step therapy requirements. Start by verifying your plan's formulary status and gathering complete medical records.

Table of Contents

  1. What This Guide Covers
  2. Before You Start: Plan Verification
  3. Gather Required Documentation
  4. Submit Your Prior Authorization Request
  5. Follow-Up and Timeline Expectations
  6. Handling Requests for Additional Information
  7. If Your Request Is Denied
  8. Appeals Process in California
  9. Renewal and Re-Authorization
  10. Quick Reference Checklist
  11. Frequently Asked Questions

What This Guide Covers

This guide helps patients, caregivers, and healthcare providers navigate UnitedHealthcare's prior authorization process for Breyanzi (lisocabtagene maraleucel), a CAR-T cell therapy for certain blood cancers. Whether you're dealing with large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL), we'll walk you through each step to maximize your chances of approval.

Who this helps:

  • Patients prescribed Breyanzi by their oncologist
  • Healthcare providers submitting PA requests
  • Caregivers advocating for coverage
  • Anyone facing a UnitedHealthcare denial in California

Expected outcomes: With complete documentation and proper submission, most medically appropriate requests receive approval within 72 hours. Denials can often be overturned through California's robust appeals process, which has favorable success rates for specialty therapies.

Before You Start: Plan Verification

Confirm Your Coverage Details

Step 1: Check your plan type

  • Log into your UnitedHealthcare member portal or call the number on your insurance card
  • Verify whether you have commercial, Medicare Advantage, or Medicaid coverage
  • Note: Different plan types have varying PA requirements and timelines

Step 2: Verify network status

  • Ensure your treating facility is credentialed for CAR-T therapy administration
  • Confirm the infusion center participates in UnitedHealthcare's specialty network
  • REMS-certified facilities are required for Breyanzi administration

Step 3: Check formulary status

  • Breyanzi typically requires prior authorization across all UnitedHealthcare plans
  • Review your plan's specialty drug formulary for any specific restrictions
  • Note any quantity limits or site-of-care requirements
Tip: UnitedHealthcare's step therapy requirements for Medicare Advantage began January 1, 2025, but existing patients with prior claims may be exempt.

Gather Required Documentation

Medical Necessity Criteria Checklist

Diagnosis Requirements:

  • Confirmed diagnosis of LBCL, CLL, or SLL with pathology report
  • Appropriate ICD-10 codes documented in medical records
  • Age verification (18 years or older for FDA-approved indications)

Prior Therapy Documentation:

  • Complete treatment history showing at least 2 prior systemic therapies
  • For CLL/SLL: Evidence of BTK inhibitor trial (ibrutinib, acalabrutinib, zanubrutinib)
  • For CLL/SLL: Documentation of BCL-2 inhibitor use (venetoclax)
  • For LBCL: Evidence of refractoriness or relapse within 12 months of first-line therapy

Clinical Status:

  • Current performance status assessment
  • Laboratory values confirming eligibility
  • Contraindications to alternative therapies (if applicable)
  • No prior CAR-T therapy (or current CD19-positive disease if previously treated)

Facility Requirements:

  • REMS program certification for administering facility
  • Documentation of trained staff for managing cytokine release syndrome
  • Proof of capability to handle neurologic toxicities

Key Documents to Collect

  • Insurance card and member ID
  • Complete medical records and pathology reports
  • Prior authorization form from UnitedHealthcare
  • Physician's detailed medical necessity letter
  • Laboratory results and imaging studies
  • Documentation of prior treatment failures or intolerances

Submit Your Prior Authorization Request

UnitedHealthcare Submission Process

Primary Method: Online Portal

  1. Access the UnitedHealthcare Provider Portal
  2. Navigate to "Prior Authorization and Notification" section
  3. Select "Specialty Pharmacy Transactions" tile
  4. Complete the Breyanzi-specific PA form with all required clinical data

Alternative Methods:

  • Phone support: 888-397-8129 (OptumRx prior authorization line)
  • For urgent cases, clearly mark "EXPEDITED REVIEW REQUESTED"

Submission Checklist

  • Completed PA form with all required fields
  • Detailed diagnosis and staging information
  • Comprehensive prior therapy history
  • Medical necessity letter from prescribing physician
  • REMS facility certification documentation
  • Laboratory values and performance status
  • Insurance verification and member information
Note: Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals by analyzing denial letters, plan policies, and clinical notes to draft point-by-point rebuttals aligned to each plan's specific rules.

Follow-Up and Timeline Expectations

Standard Processing Times

UnitedHealthcare Timelines:

  • Standard prior authorization: 72 hours from complete submission
  • Expedited review: 24 hours for urgent medical situations
  • Incomplete submissions may take longer pending additional information

When to Follow Up:

  • Day 3: If no response to standard request
  • Day 1: If no response to expedited request
  • Immediately: If additional information is requested

Sample Follow-Up Script

"Hello, I'm calling to check the status of a prior authorization request for Breyanzi submitted on [date]. The member ID is [number] and the reference number is [if available]. This is for a time-sensitive CAR-T therapy. Can you provide an update on the review status?"

Document everything:

  • Date and time of calls
  • Representative name and reference numbers
  • Status updates and next steps
  • Any additional requirements mentioned

Handling Requests for Additional Information

Common Information Requests

Clinical Clarifications:

  • More detailed prior therapy documentation
  • Specific contraindications to alternative treatments
  • Updated laboratory values or imaging
  • Performance status assessments

Administrative Requirements:

  • REMS facility verification
  • Provider credentialing confirmation
  • Billing and coding clarification (J-codes, HCPCS)

Response Strategy

Act quickly: Most payers allow 14 days to submit additional information Be comprehensive: Address all questions thoroughly to avoid further delays Include supporting literature: Attach relevant clinical guidelines or FDA labeling when appropriate

If Your Request Is Denied

Common Denial Reasons and Solutions

Denial Reason How to Address Required Documentation
"Not meeting step therapy requirements" Document prior therapy failures or contraindications Treatment records, adverse event notes
"Experimental/investigational" Cite FDA approval and clinical guidelines FDA label, NCCN guidelines
"Not medically necessary" Provide detailed clinical rationale Physician letter, supporting literature
"Facility not qualified" Verify REMS certification REMS program documentation

First-Level Appeal Process

Timeline: File within 180 days of denial notice Method: UnitedHealthcare Provider Portal or written appeal Required: Original denial letter, additional clinical evidence, medical necessity argument

Key Appeal Elements:

  • Point-by-point response to denial reasons
  • Updated clinical information
  • Peer-reviewed literature supporting Breyanzi use
  • Physician attestation of medical necessity

Appeals Process in California

Internal Appeals with UnitedHealthcare

Step 1: Standard Internal Appeal

  • File within 180 days of denial
  • Submit through provider portal or by mail
  • Include all supporting documentation
  • Expect response within 30 days (standard) or 72 hours (expedited)

Step 2: Peer-to-Peer Review

  • Request a discussion between your oncologist and UnitedHealthcare's medical director
  • Schedule through provider services
  • Prepare clinical talking points and supporting evidence

California Independent Medical Review (IMR)

If internal appeals fail, California residents have strong external review rights through the Department of Managed Health Care (DMHC).

IMR Process:

  1. File IMR Application: Submit to DMHC within required timeframe
  2. Required Documentation: Health plan denial letter, physician certification, supporting literature
  3. Timeline: 30 days for standard review, 3-7 days for expedited cases
  4. Outcome: If approved, UnitedHealthcare must authorize treatment within 5 days

IMR Success Factors:

  • Complete medical documentation
  • Strong physician support letter
  • Evidence of medical necessity
  • Demonstration that Breyanzi is likely more beneficial than alternatives
From our advocates: We've seen complex CAR-T denials successfully overturned through California's IMR process when the clinical team provided comprehensive documentation showing the patient met FDA criteria and had exhausted appropriate prior therapies. The key was presenting a clear narrative that connected the patient's specific clinical situation to established treatment guidelines.

DMHC Contact Information:

  • Phone: 888-466-2219 (Help Center)
  • Website: healthhelp.ca.gov
  • Online IMR application available in multiple languages

Renewal and Re-Authorization

Ongoing Coverage Considerations

When to Reapply:

  • Breyanzi is typically a one-time infusion, but monitoring may require separate authorizations
  • Supportive care medications may need individual PA requests
  • Follow-up treatments or complications may trigger new reviews

Documentation for Renewals:

  • Treatment response data
  • Ongoing medical necessity
  • Updated clinical status
  • Any changes in patient condition

Quick Reference Checklist

Before Submitting PA Request

  • Verify UnitedHealthcare plan type and network status
  • Confirm treating facility is REMS-certified
  • Collect complete medical records and prior therapy documentation
  • Obtain detailed physician medical necessity letter
  • Check current formulary status and any restrictions

During Review Process

  • Submit complete application through provider portal
  • Follow up within appropriate timeframes
  • Respond promptly to requests for additional information
  • Document all communications with reference numbers

If Denied

  • Review denial letter carefully for specific reasons
  • Gather additional supporting evidence
  • File internal appeal within 180 days
  • Consider peer-to-peer review
  • Prepare for California IMR if needed

Frequently Asked Questions

Q: How long does UnitedHealthcare prior authorization take for Breyanzi in California? A: Standard requests are processed within 72 hours of complete submission. Expedited requests for urgent situations are reviewed within 24 hours.

Q: What if Breyanzi is not on my plan's formulary? A: Even if not listed, Breyanzi may still be covered with prior authorization. Submit a complete PA request with strong medical necessity documentation.

Q: Can I request an expedited appeal if my condition is urgent? A: Yes. California law requires expedited review for urgent medical situations. Mark your request clearly and provide physician documentation of urgency.

Q: Does step therapy apply if I received prior treatments outside California? A: Treatment history from any location counts toward step therapy requirements. Provide complete documentation of all prior therapies regardless of where they were administered.

Q: What's the difference between DMHC and CDI for appeals? A: Most UnitedHealthcare plans fall under DMHC oversight (HMOs and managed care). CDI typically regulates traditional indemnity plans. Check your plan documents or call DMHC to confirm.

Q: How much does the IMR process cost? A: There is no fee for patients to request an IMR in California. The health plan bears the cost of the independent review.

Q: What happens if UnitedHealthcare doesn't respond to my PA request on time? A: If UnitedHealthcare fails to respond within required timeframes, you may be able to proceed with treatment and seek reimbursement. Contact the DMHC Help Center for guidance.

Q: Can I appeal a denial even if I don't live in California? A: This guide covers California-specific rights. If you have UnitedHealthcare coverage but live elsewhere, contact your state insurance department for local appeal procedures.

When navigating complex insurance approvals for specialty therapies like Breyanzi, having expert support can make the difference between approval and denial. Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals, analyzing denial letters and plan policies to identify the specific denial basis and draft point-by-point rebuttals aligned to each plan's requirements.

Sources & Further Reading

Disclaimer: This guide provides general information about insurance coverage processes and should not be considered medical or legal advice. Coverage decisions depend on individual circumstances, plan benefits, and medical necessity. Always consult with your healthcare provider about treatment options and contact your insurance plan directly for specific coverage information. For assistance with appeals or coverage denials, consider consulting with qualified patient advocates or legal professionals familiar with California insurance law.

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