By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (Lisocabtagene Maraleucel) Covered by Cigna in California: Complete Requirements Guide

Quick Answer: Getting Breyanzi Covered by Cigna in California

To get Breyanzi (lisocabtagene maraleucel) covered by Cigna in California, you'll need prior authorization through their specialty pharmacy partner Express Scripts/Accredo. The fastest path: (1) Submit complete PA documentation including FDA-approved indication criteria, prior therapy failures, and REMS certification, (2) If denied, file internal appeal within 180 days with medical necessity letter, (3) Request California DMHC Independent Medical Review if still denied. Start by calling Cigna at 1-800-882-4462 to confirm your specific plan requirements and obtain the current PA form.

First step today: Verify your Cigna plan covers specialty drugs and confirm whether you need to use Accredo specialty pharmacy.

Table of Contents

Who Should Use This Guide

This guide is for patients diagnosed with relapsed/refractory large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) whose oncologist has recommended Breyanzi CAR-T therapy. You'll also find this useful if you're a caregiver, clinic staff member, or patient advocate helping navigate Cigna's approval process.

Expected outcome: With complete documentation meeting FDA criteria, most medically appropriate Breyanzi requests get approved. If initially denied, California's robust appeals system provides strong patient protections, with Independent Medical Review overturn rates of 20-30% for medical necessity denials.

Member & Plan Basics

Coverage Requirements

Requirement Details How to Verify
Active Cigna Coverage Current enrollment in commercial, Medicare Advantage, or ACA marketplace plan Check member ID card, call 1-800-882-4462
Specialty Drug Coverage Most Cigna plans cover FDA-approved CAR-T therapies Review plan documents or call customer service
Prior Authorization Required Yes, for all CAR-T therapies including Breyanzi Cigna precertification requirements
Specialty Pharmacy Express Scripts/Accredo typically required Verify through Cigna member portal
Note: Self-funded employer plans may have different requirements. Check your Summary Plan Description or contact HR.

Clinical Criteria for Approval

Breyanzi must meet FDA-approved indications for coverage consideration:

Large B-Cell Lymphoma (LBCL)

  • Adults with DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B
  • One of these criteria:
    • Refractory to first-line chemoimmunotherapy OR relapsed within 12 months of first-line therapy
    • Refractory/relapsed after first-line therapy AND ineligible for stem cell transplant due to age/comorbidities
    • Relapsed/refractory disease after ≥2 prior lines of systemic therapy

CLL/Small Lymphocytic Lymphoma

  • Adults with relapsed/refractory CLL/SLL after ≥2 prior therapies
  • Must include both: BTK inhibitor AND BCL-2 inhibitor
Important: Breyanzi is NOT indicated for primary CNS lymphoma.

Coding Requirements

ICD-10 Diagnosis Codes

  • DLBCL: C83.3
  • High-grade B-cell lymphoma: C85.29 or C85.89
  • Primary mediastinal large B-cell lymphoma: C85.2
  • Follicular lymphoma grade 3B: C82.2
  • CLL: C91.10 (not in remission) or C91.12 (in relapse)
  • Small lymphocytic lymphoma: C83.0

HCPCS J-Code

  • J9358: Injection, lisocabtagene maraleucel, up to 0.1 x 10^8 CAR-positive viable T cells, including leukapheresis and dose preparation procedures, per therapeutic dose

Documentation Packet

Required Clinical Documentation

  1. Pathology report confirming specific lymphoma subtype
  2. Treatment history with drug names, dates, responses, and reasons for discontinuation
  3. Current imaging (PET/CT within 30 days) showing active disease
  4. Performance status (ECOG 0-2) documented in recent clinic note
  5. Laboratory results (CBC, comprehensive metabolic panel, hepatic function, cardiac assessment)
  6. Infection screening results per institutional protocol

Medical Necessity Letter Components

Your oncologist's letter should include:

  • Specific FDA indication being met
  • Prior therapy failures with dates and outcomes
  • Current disease status and treatment goals
  • Why Breyanzi is most appropriate option
  • Treatment center REMS certification
  • Patient's ability to tolerate CAR-T therapy
Clinician Tip: Reference NCCN Guidelines for B-cell lymphomas or CLL/SLL to support medical necessity arguments.

Submission Process

Step-by-Step Submission

  1. Obtain current PA form from Cigna provider portal or call 1-800-882-4462
  2. Complete form with all required fields (incomplete forms cause delays)
  3. Attach documentation packet (see above list)
  4. Submit via:
    • Electronic: CoverMyMeds, ExpressPAth, or Cigna portal
    • Fax: 1-866-873-8279 (verify current number)
    • Phone: 1-800-882-4462 for urgent cases

Timeline Expectations

  • Standard review: 5-15 business days
  • Expedited review: 72 hours (requires clinical urgency documentation)
  • Additional information requests: May extend timeline by 5-10 days

Specialty Pharmacy Routing

Most Cigna plans require Breyanzi to be obtained through Express Scripts/Accredo specialty pharmacy:

  1. After PA approval, Cigna will route prescription to designated specialty pharmacy
  2. Pharmacy coordination: Accredo will contact treatment center to coordinate leukapheresis and manufacturing timeline
  3. Shipment verification: Confirm delivery details and cold-chain handling requirements

Contact Accredo at 1-800-803-2523 for specialty pharmacy questions.

After Submission: What to Expect

Tracking Your Request

  • Confirmation number: Save for all follow-up calls
  • Status checks: Call weekly if no decision within expected timeframe
  • Documentation requests: Respond within 24-48 hours to avoid delays

Possible Outcomes

  • Approved: Proceed with treatment planning
  • Approved with modifications: Review any quantity or site-of-care restrictions
  • Denied: Move immediately to appeals process (don't wait)

Common Denial Reasons & How to Fix Them

Denial Reason How to Overturn Required Documentation
"Not FDA-approved indication" Provide specific label citation FDA prescribing information highlighting exact indication
"Insufficient prior therapies" Document each prior regimen Detailed treatment history with dates, drugs, outcomes
"Not medically necessary" Submit peer-reviewed evidence Medical necessity letter citing clinical guidelines
"Experimental/investigational" Reference FDA approval date FDA approval letter and current prescribing information
"Site of care not appropriate" Verify REMS certification Treatment center REMS documentation

Appeals Process in California

California provides strong patient protections through the Department of Managed Health Care (DMHC).

Internal Appeal (First Step)

  • Timeline: File within 180 days of denial
  • Process: Submit appeal letter with additional clinical evidence
  • Decision: Cigna has 30 days to respond (7 days for urgent cases)

Independent Medical Review (IMR)

If internal appeal fails, California residents can request IMR through DMHC:

  1. File IMR application within 6 months of final denial
  2. Independent physician review of medical necessity
  3. Decision timeline: 30 days standard, 7 days urgent
  4. Binding decision: If IMR approves, Cigna must cover treatment
Success rates: California IMR overturn rates are 20-30% for medical necessity denials, often higher for rare disease treatments with strong clinical evidence.

File IMR online: DMHC website or call 1-888-466-2219 for assistance.

Counterforce Health specializes in turning insurance denials into targeted, evidence-backed appeals. Their platform analyzes denial letters and plan policies to draft point-by-point rebuttals aligned with payer requirements, helping patients and clinicians navigate complex approval processes more effectively.

Costs & Patient Assistance

Estimated Costs

  • Breyanzi list price: ~$477,000-$487,000 (2024-2025)
  • Total treatment cost: Often exceeds $500,000 including hospitalization and toxicity management

Financial Assistance Options

  • Bristol Myers Squibb Patient Assistance: BMS Access Support
  • Copay assistance: May be available for commercially insured patients
  • California state programs: Check eligibility for additional coverage through Covered California

Printable Checklist

Before Starting:

  • Verify active Cigna coverage
  • Confirm specialty pharmacy requirements
  • Gather insurance card and member ID

Clinical Documentation:

  • Pathology report confirming eligible lymphoma subtype
  • Complete treatment history (≥2 prior lines for CLL/SLL)
  • BTK and BCL-2 inhibitor documentation (CLL/SLL only)
  • Current imaging showing active disease
  • ECOG performance status (0-2)
  • Recent lab results (CBC, chemistry, liver, cardiac)
  • Infection screening results

Submission:

  • Complete PA form with all fields
  • Medical necessity letter from oncologist
  • Submit via preferred method (electronic/fax/phone)
  • Save confirmation number
  • Schedule follow-up call in 1 week

If Denied:

  • File internal appeal within 180 days
  • Prepare for California IMR if needed
  • Contact Counterforce Health for appeal assistance

From our advocates: We've seen patients initially denied for "insufficient prior therapies" successfully appeal by providing detailed pharmacy records showing exact dates of BTK and BCL-2 inhibitor trials, along with oncology notes documenting disease progression. The key is comprehensive documentation that leaves no room for interpretation about meeting FDA criteria.

FAQ

How long does Cigna prior authorization take for Breyanzi in California? Standard PA decisions take 5-15 business days. Expedited reviews (with clinical urgency documentation) are completed within 72 hours.

What if Breyanzi is not on my Cigna formulary? Even non-formulary drugs can be covered through formulary exceptions. Submit PA with strong medical necessity documentation and be prepared to appeal if initially denied.

Can I request an expedited appeal in California? Yes, both Cigna internal appeals and California DMHC Independent Medical Review offer expedited processes for urgent medical situations.

Does step therapy apply to CAR-T therapies like Breyanzi? Cigna doesn't typically require step therapy for CAR-T therapies, but you must demonstrate appropriate prior treatment failures per FDA labeling.

What happens if my appeal is denied by Cigna? California residents can request Independent Medical Review through DMHC, which provides binding decisions from independent physician reviewers.

Sources & Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage varies by plan, and requirements may change. Always verify current policies with your insurer and consult your healthcare team for medical decisions. For personalized assistance with insurance appeals, consider consulting with Counterforce Health or other qualified patient advocacy services.

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