By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

Getting Breyanzi (Lisocabtagene Maraleucel) Covered by Aetna CVS Health in Ohio: Prior Authorization, Appeals, and Cost-Saving Strategies

Answer Box: Getting Breyanzi Covered by Aetna CVS Health in Ohio

Breyanzi (lisocabtagene maraleucel) requires mandatory prior authorization from Aetna CVS Health before coverage. To qualify, you need confirmed relapsed/refractory large B-cell lymphoma after ≥2 prior therapies, ECOG performance status 0-2, and treatment at a certified CAR-T center. First step today: Have your oncologist gather pathology reports, treatment history, and recent imaging, then submit PA through Aetna's Availity portal or fax to 1-877-269-9916. If denied, Ohio residents have 180 days for internal appeals and external review through the Ohio Department of Insurance.

Table of Contents

  1. Understanding Breyanzi Coverage Requirements
  2. Prior Authorization Process with Aetna CVS Health
  3. Managing Out-of-Pocket Costs
  4. Appeals Process in Ohio
  5. Specialty Pharmacy Coordination
  6. Common Denial Reasons and Solutions
  7. Scripts and Templates
  8. FAQ

Understanding Breyanzi Coverage Requirements

Breyanzi is a CAR-T cell therapy with a list price of approximately $447,000-$487,000, making insurance approval critical for patient access. Aetna CVS Health covers this FDA-approved treatment for specific blood cancers when strict criteria are met.

Coverage at a Glance

Requirement What It Means Where to Find It Source
Prior Authorization Mandatory approval before treatment Aetna PA List Aetna 2025 PA List
Eligible Diagnosis LBCL subtypes only Pathology report Aetna Policy 0986
Prior Therapies ≥2 lines with documented failure Treatment records FDA Label
Performance Status ECOG 0-2 only Clinical assessment Aetna Policy
Treatment Center CAR-T certified facility Facility confirmation REMS Requirements

Eligibility Criteria

Diagnosis Requirements:

  • Confirmed relapsed or refractory large B-cell lymphoma (LBCL), including:
    • Diffuse large B-cell lymphoma (DLBCL) not otherwise specified
    • High-grade B-cell lymphoma
    • Primary mediastinal large B-cell lymphoma
    • Grade 3B follicular lymphoma

Treatment History:

  • Failed ≥2 lines of systemic therapy with documented progression or intolerance
  • Complete records of prior treatment names, dates, and outcomes

Patient Status:

  • Age 18 or older
  • ECOG performance status 0, 1, or 2
  • Adequate organ function and infection screening

Facility Requirements:

  • Treatment at CAR-T certified center
  • Tocilizumab availability and ICU access on-site

Prior Authorization Process with Aetna CVS Health

Step-by-Step: Fastest Path to Approval

  1. Gather Documentation (Patient/Clinic)
    • Pathology report confirming LBCL subtype (within 30 days)
    • Recent PET/CT imaging showing active disease
    • Complete treatment history with dates and outcomes
    • Timeline: 1-2 days to compile
  2. Submit Prior Authorization (Clinic)
    • Use Aetna Availity portal or fax to 1-877-269-9916
    • Include all required clinical documentation
    • Timeline: Same day submission possible
  3. Insurance Review (Aetna)
    • Standard review: 30-45 business days
    • Expedited review: 72 hours for urgent cases
    • Timeline: Varies by urgency
  4. Approval or Denial (Aetna)
    • Approval: Proceed to treatment scheduling
    • Denial: Begin appeal process immediately
    • Timeline: Per review timeline above

Required Documentation Checklist

Clinical Records (within 30 days):

  • Pathology report confirming eligible LBCL subtype
  • Recent imaging (PET/CT) showing active disease
  • ECOG performance status documentation
  • Complete blood count and comprehensive metabolic panel
  • Hepatitis B/C and HIV screening results

Treatment History:

  • Names, dates, and outcomes of all prior therapies
  • Documentation of progression or intolerance to previous treatments
  • Reason for transplant ineligibility (if applicable)

Facility Confirmation:

  • Proof that treatment center is CAR-T certified
  • Confirmation of tocilizumab availability

Managing Out-of-Pocket Costs

The high cost of Breyanzi makes understanding your benefit design and assistance options crucial for affordability.

Understanding Your Benefits

Key Questions to Ask Aetna:

  • What is my specialty tier copay or coinsurance?
  • Does my plan have a specialty drug maximum out-of-pocket?
  • Am I subject to deductible before coverage begins?
  • Are there quantity limits or site-of-care restrictions?

Information to Record:

  • Policy number and group ID
  • Specialty pharmacy network requirements
  • Prior authorization reference number
  • Customer service representative name and date

Patient Assistance Programs

Bristol Myers Squibb Cell Therapy 360

  • Eligibility: Commercial insurance required (excludes Medicare, Medicaid, TRICARE, VA)
  • Coverage: Out-of-pocket expenses for Breyanzi only
  • Contact: 1-888-805-4555 (Option 1 or Press 2 then Option 3)
  • Additional Support: Transportation, lodging, meal assistance available
From Our Advocates: One patient's family found that calling Cell Therapy 360 before starting the PA process helped coordinate both insurance approval and financial assistance applications simultaneously, reducing overall timeline stress. While outcomes vary, early engagement with support programs often streamlines the process.

Alternative Assistance for Government-Insured Patients

  • BMS Access Support: 1-800-861-0048
  • Referrals to independent charitable foundations
  • Separate eligibility criteria and evaluation processes

Formulary Exception Strategies

If Breyanzi is non-formulary on your specific plan:

  1. Request formulary exception with medical necessity documentation
  2. Demonstrate lack of suitable alternatives on formulary
  3. Provide supporting literature for clinical benefit
  4. Emphasize urgency of progressive disease

Appeals Process in Ohio

Ohio provides robust consumer protections for health insurance appeals, including external review rights that can overturn insurer denials.

Appeals Playbook for Aetna CVS Health in Ohio

Level Timeline How to File Required Forms Source
Internal Appeal 180 days from denial Aetna member portal or mail Written request with supporting docs Aetna Appeals Process
External Review 180 days from final denial Through health plan to ODI ODI External Review Form Ohio Dept of Insurance
Expedited Review 72 hours (urgent cases) Same as above, mark urgent Same form, medical urgency docs ODI External Review

Ohio External Review Process

Timeline Requirements:

  • Request deadline: 180 days from final internal denial
  • Standard review: 30 days for IRO decision
  • Expedited review: 72 hours for urgent cases
  • Information submission: 10 business days to provide additional docs

Contact Information:

Key Advantages in Ohio:

  • No cost to patient for external review
  • Independent Review Organizations (IROs) with medical expertise
  • Binding decisions on insurers when appeals are won
  • ODI can independently determine eligibility if insurer disputes it

When to Escalate

Contact the Ohio Department of Insurance if:

  • Aetna delays response beyond required timelines
  • You're told external review isn't available for your case
  • Procedural violations occur during the appeal process
  • You need help understanding your appeal rights

Specialty Pharmacy Coordination

CVS Specialty Pharmacy handles Breyanzi dispensing and coordinates with insurance for coverage approval.

Enrollment Process

Contact Numbers:

  • Commercial plans: 1-888-632-3862
  • Medicare plans: 1-800-624-0756

Services Provided:

  • Insurance benefit verification
  • Prior authorization support
  • Patient assistance program enrollment
  • Cold-chain delivery coordination to treatment center

Dispensing and Logistics

Breyanzi requires specialized handling:

  • Ships directly to certified treatment center in liquid nitrogen storage
  • 2-hour maximum from thaw to patient administration
  • Treatment center must have tocilizumab and ICU access immediately available

Counterforce Health helps patients navigate complex specialty drug approvals by turning insurance denials into targeted, evidence-backed appeals. The platform identifies denial reasons and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements.

Common Denial Reasons and Solutions

Denial Reason How to Overturn Documents Needed
Non-eligible LBCL subtype Submit updated pathology review Current pathology report with specific LBCL classification
Insufficient prior therapy Document all treatment failures Complete treatment timeline with progression dates
ECOG status not documented Provide current performance assessment Recent ECOG evaluation by oncologist
Non-certified treatment center Confirm facility credentials CAR-T certification documentation
"Experimental/investigational" Cite FDA approval and guidelines FDA label, NCCN guidelines, payer policy

Scripts and Templates

Patient Phone Script for Aetna CVS Health

"Hello, I'm calling about prior authorization for Breyanzi, lisocabtagene maraleucel, for my large B-cell lymphoma. My policy number is [X] and my doctor submitted the PA on [date]. Can you tell me the status and what additional information might be needed? I'd also like to understand my out-of-pocket costs once approved."

Clinic Staff Script for Peer-to-Peer Request

"I'm requesting a peer-to-peer review for [patient name] regarding denial of Breyanzi coverage. This patient has relapsed DLBCL after two prior therapies with documented progression. The medical necessity is clear based on FDA labeling and NCCN guidelines. When can we schedule the clinical review?"

Email Template for Documentation Requests

"Subject: Urgent - Breyanzi PA Documentation Request

Dear [Provider],

We need the following documents within 48 hours for [patient]'s Breyanzi prior authorization:

  • Current pathology report confirming LBCL subtype
  • Recent PET/CT showing active disease
  • ECOG performance status assessment
  • Complete prior treatment summary

Please fax to [number] or upload to patient portal. Contact me with any questions.

Thank you, [Name and contact]"

FAQ

How long does Aetna CVS Health prior authorization take for Breyanzi in Ohio? Standard review takes 30-45 business days. Expedited review is available within 72 hours for urgent medical situations with appropriate clinical documentation.

What if Breyanzi is non-formulary on my Aetna plan? Request a formulary exception by demonstrating medical necessity, lack of suitable alternatives, and providing clinical evidence supporting Breyanzi's benefit for your specific situation.

Can I request an expedited appeal in Ohio? Yes, expedited appeals are available for urgent medical situations. Both Aetna internal appeals and Ohio external reviews offer expedited timelines (72 hours) when delay would jeopardize your health.

Does step therapy apply to Breyanzi coverage? No, step therapy doesn't apply since Breyanzi is reserved for patients who have already failed multiple prior therapies as part of the FDA-approved indication.

What happens if my appeal is denied by the external review organization? While the external review decision is binding on your insurer, you retain the right to pursue other remedies such as legal action or regulatory complaints through the Ohio Department of Insurance.

How do I coordinate between CVS Specialty and my treatment center? CVS Specialty coordinates directly with certified CAR-T centers for delivery. Your treatment center will work with CVS on timing, storage, and preparation requirements.

Are there financial assistance options if I have Medicare or Medicaid? Bristol Myers Squibb's copay assistance program excludes government insurance, but BMS Access Support (1-800-861-0048) can refer you to independent charitable foundations that may provide assistance.

What documentation should I keep during the appeals process? Maintain copies of all correspondence, denial letters, appeal submissions, medical records, and notes from phone calls including dates, representative names, and reference numbers.

When navigating complex insurance approvals for expensive therapies like Breyanzi, having expert support can make the difference between approval and denial. Counterforce Health specializes in transforming insurance denials into successful appeals by identifying specific denial reasons and crafting evidence-based responses that align with payer policies.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Coverage policies and requirements may change. Always verify current information with your insurance company and healthcare providers. For personalized assistance with Ohio insurance appeals, contact the Ohio Department of Insurance at 800-686-1526.

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