How to Get Breyanzi (Lisocabtagene Maraleucel) Approved by Cigna in Ohio: Complete Prior Authorization Guide
Answer Box: Getting Breyanzi Approved by Cigna in Ohio
Breyanzi (lisocabtagene maraleucel) requires prior authorization from Cigna for both LBCL and CLL/SLL patients in Ohio. Submit electronically via CoverMyMeds or EviCore by Evernorth with complete treatment history, diagnosis documentation, and proof of prior BTK/BCL2 inhibitor failure for CLL patients. Standard review takes 5-14 business days; expedited review 24-72 hours for urgent cases. If denied, Ohio residents have 180 days to file internal appeals, then can request binding external review through the Ohio Department of Insurance.
First step today: Verify your plan type (commercial vs. Medicare vs. Medicaid) and confirm your CAR-T center is Cigna LifeSOURCE network certified.
Table of Contents
- What This Guide Covers
- Before You Start: Plan Verification
- Coverage Requirements at a Glance
- Gather Required Documentation
- Submit Your Prior Authorization Request
- Follow-Up and Timeline Management
- If You're Asked for More Information
- If Your Request is Denied
- Ohio External Review Process
- Common Denial Reasons and Solutions
- Cost Support and Patient Assistance
- FAQ
What This Guide Covers
This comprehensive guide helps Ohio patients and their healthcare teams navigate Cigna's prior authorization process for Breyanzi (lisocabtagene maraleucel), a CAR-T cell therapy approved for certain blood cancers. Whether you're dealing with large B-cell lymphoma (LBCL) or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), this guide provides the specific forms, timelines, and appeal strategies you need.
Who this helps:
- Patients with Cigna coverage in Ohio
- Oncologists and their staff submitting prior authorizations
- Patient advocates and family members navigating appeals
- CAR-T centers coordinating with Cigna's specialty networks
Before You Start: Plan Verification
1. Confirm Your Plan Type
Your appeal rights and timelines depend on your specific Cigna plan:
- Commercial/ACA plans: Follow Ohio state insurance laws for appeals
- Medicare Advantage: Federal appeal timelines (65 days to file)
- Medicaid managed care: Ohio Medicaid appeal process
- Self-funded ERISA plans: May use federal external review
Check your insurance card or call Cigna member services at 1-800-244-6224 to confirm.
2. Verify Network Status
Breyanzi must be administered at a Cigna LifeSOURCE network center with FACT IEC accreditation. Out-of-network administration typically requires additional approvals and may result in higher costs.
3. Check Benefit Coverage
Breyanzi is covered under Cigna's medical benefit (not pharmacy) and falls under the Gene Therapy and Advanced Cellular Therapy Program.
Coverage Requirements at a Glance
| Requirement | LBCL Patients | CLL/SLL Patients | Source |
|---|---|---|---|
| Prior Authorization | Required | Required | Cigna Policy IP0130 |
| Prior Lines of Therapy | ≥1 line (refractory/early relapse) or ≥2 lines | ≥2 lines including BTK + BCL2 inhibitors | Cigna IP0130 |
| Performance Status | ECOG 0-2 typically required | ECOG 0-2 typically required | Standard practice |
| Site of Care | FACT IEC-accredited center | FACT IEC-accredited center | LifeSOURCE requirements |
| Age Requirement | ≥18 years | ≥18 years | FDA label |
| Review Timeline | 5-14 business days (standard) | 5-14 business days (standard) | Cigna policy |
Gather Required Documentation
Clinical Documentation Checklist
For all patients:
- Pathology report confirming CD19+ LBCL or CLL/SLL
- Complete treatment history with dates, regimens, and outcomes
- Recent imaging showing active disease
- Laboratory results (CBC, CMP, hepatic panel within 30 days)
- ECOG performance status documentation
- Infection screening (HBV, HCV, HIV)
- Cardiac evaluation (ECHO or MUGA)
Additional for CLL/SLL patients:
- Documentation of BTK inhibitor use (ibrutinib, acalabrutinib, zanubrutinib)
- Documentation of BCL2 inhibitor use (venetoclax)
- Evidence of disease progression or intolerance to both drug classes
ICD-10 Codes for Breyanzi
- LBCL: C83.30-C83.39 (diffuse large B-cell lymphoma)
- HGBCL: C85.10-C85.19 (high-grade B-cell lymphoma)
- PMBCL: C85.20-C85.29 (primary mediastinal B-cell lymphoma)
- CLL: C91.10-C91.19 (chronic lymphocytic leukemia)
- SLL: C83.00-C83.09 (small lymphocytic lymphoma)
Submit Your Prior Authorization Request
Step 1: Choose Your Submission Method
Primary options (fastest approval):
- CoverMyMeds: Visit covermymeds.com/main/prior-authorization-forms/cigna/
- EviCore by Evernorth: Register at evicore.com for oncology pathways
- MyAccredoPatients: Access through myaccredopatients.com
Backup methods:
- Phone: 1-800-882-4462 (urgent cases only)
- Fax: Use state-specific forms (verify current fax number)
Step 2: Complete the Request
Required information:
- Patient demographics and Cigna ID
- Prescriber information (NPI, DEA, specialty)
- Diagnosis with ICD-10 codes
- Breyanzi dosing and administration plan
- Complete prior therapy history
- Clinical rationale for medical necessity
Tip: Mark requests as "urgent" if standard review timing would risk patient safety. Include a physician letter explaining why delay could cause harm.
Follow-Up and Timeline Management
Standard Timelines
- Initial review: 5-14 business days for complete requests
- Expedited review: 24-72 hours for urgent cases
- Additional information requests: 72 hours to respond
Sample Follow-Up Script
"This is [name] calling about prior authorization request #[reference number] for Breyanzi submitted on [date]. Can you provide a status update and estimated decision date? If additional information is needed, please specify exactly what's required and the deadline for submission."
Document everything: Keep a log with dates, reference numbers, and staff names for all communications.
If You're Asked for More Information
Cigna may request additional documentation to support medical necessity. Common requests include:
Medical Necessity Letter Components
Your oncologist should include:
- Patient summary: Diagnosis, staging, molecular markers
- Treatment history: All prior regimens with dates, responses, and reasons for discontinuation
- Current status: Disease progression evidence, performance status, organ function
- Rationale: Why Breyanzi is appropriate now, citing NCCN guidelines and FDA labeling
- Urgency: Timeline considerations and risks of delay
Supporting Literature
Include relevant citations from:
- FDA prescribing information for Breyanzi
- NCCN Clinical Practice Guidelines
- Published clinical trial data (TRANSCEND studies)
- Specialty society recommendations (ASH, ASCO)
If Your Request is Denied
Step 1: Request a Peer-to-Peer Review
Within 3 business days of denial, ask your oncologist to request a peer-to-peer discussion with a Cigna medical director. This informal review often resolves denials without formal appeals.
Step 2: File a Level 1 Internal Appeal
Timeline: 180 days from denial date for commercial plans
How to file:
- Use the appeal form included with your denial letter
- Submit via Cigna member portal or fax
- Include all original documentation plus any new evidence
- Request expedited review if clinically urgent
Appeal letter should address:
- Each specific reason for denial cited by Cigna
- How your case meets Cigna Policy IP0130 criteria
- Updated clinical information since initial request
- Expert guidelines supporting treatment
Ohio External Review Process
If Cigna upholds the denial after internal appeals, Ohio residents can request an independent external review through the Ohio Department of Insurance.
Key Details
- Deadline: 180 days from Cigna's final denial
- Cost: Free to patients
- Timeline: 30 days for standard review, 72 hours for expedited
- Decision: Binding on Cigna if overturned
How to File
- Complete the external review form from your denial packet
- Submit through Cigna (they forward to Ohio DOI)
- Include all medical records and appeal correspondence
- Add any new clinical evidence within the 10-business-day window
Note: Even if Cigna claims your case isn't eligible for external review, the Ohio Department of Insurance can independently determine eligibility.
Contact Ohio DOI: 1-800-686-1526 for assistance with external reviews.
Common Denial Reasons and Solutions
| Denial Reason | Solution | Required Documentation |
|---|---|---|
| Insufficient prior therapy | Provide complete treatment timeline | Detailed therapy history with dates, doses, responses |
| Not meeting line requirements | Document BTK + BCL2 use for CLL | Pharmacy records, progress notes showing failure/intolerance |
| Performance status concerns | Update functional assessment | Recent ECOG documentation, physician assessment |
| Site not qualified | Transfer to FACT-certified center | Confirmation of LifeSOURCE network participation |
| Experimental/investigational | Cite FDA approval | FDA label, clinical guidelines, published efficacy data |
Cost Support and Patient Assistance
While pursuing approval, explore these cost support options:
Manufacturer Programs
- Bristol Myers Squibb Patient Assistance: bmspaf.org
- Breyanzi Co-pay Program: For commercially insured patients (verify eligibility)
Foundation Support
- Leukemia & Lymphoma Society: lls.org/support/financial-support
- Patient Access Network Foundation: panfoundation.org
- Good Days: mygooddays.org
Ohio-Specific Resources
- UHCAN Ohio: Consumer advocacy for health coverage issues
- Ohio Department of Insurance: Consumer services for coverage disputes
Counterforce Health: Expert Appeal Support
Counterforce Health specializes in turning insurance denials into successful appeals for complex therapies like CAR-T treatments. The platform analyzes denial letters, identifies specific policy gaps, and creates evidence-backed appeals tailored to each payer's requirements. For patients facing Cigna denials in Ohio, this targeted approach can significantly improve approval odds by ensuring appeals directly address Cigna's IP0130 policy criteria and Ohio's external review standards.
FAQ
How long does Cigna prior authorization take for Breyanzi in Ohio? Standard review takes 5-14 business days for complete requests. Expedited review (24-72 hours) is available when delays would seriously jeopardize health.
What if Breyanzi isn't on Cigna's formulary? Breyanzi is typically covered under medical benefits, not pharmacy formularies. Coverage follows Cigna's Gene Therapy and Advanced Cellular Therapy Program policies.
Can I request expedited appeal in Ohio? Yes, both Cigna internal appeals and Ohio external reviews offer expedited timelines (72 hours) when clinical urgency is documented.
What counts as prior therapy failure for CLL patients? For CLL/SLL, Cigna requires documented use of both a BTK inhibitor (like ibrutinib) and BCL2 inhibitor (like venetoclax) with evidence of progression, intolerance, or contraindication.
Does my CAR-T center need special Cigna approval? Yes, centers must be part of the Cigna LifeSOURCE network with FACT IEC accreditation. Treatment at non-network centers typically requires additional approvals.
What happens if Ohio external review overturns the denial? The decision is binding on Cigna, and they must cover the treatment according to the external reviewer's determination.
Sources & Further Reading
- Cigna Policy IP0130 - Breyanzi Coverage Criteria
- Ohio Department of Insurance - External Review Process
- Cigna LifeSOURCE Network Directory
- CoverMyMeds Prior Authorization Portal
- EviCore by Evernorth - Oncology Pathways
- FDA Breyanzi Prescribing Information
Disclaimer: This guide provides general information about insurance processes and should not be considered medical or legal advice. Always consult with your healthcare team and insurance representatives for guidance specific to your situation. Coverage policies and procedures may change; verify current requirements with official sources.
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