By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (lisocabtagene maraleucel) Covered by Aetna (CVS Health) in Pennsylvania: Renewal Forms, Timelines & Appeal Strategies

Answer Box: Getting Breyanzi Renewed with Aetna (CVS Health) in Pennsylvania

Renewing Breyanzi (lisocabtagene maraleucel) coverage with Aetna (CVS Health) requires submitting renewal documentation at least 2 weeks before your scheduled treatment. Key steps: 1) Complete the Aetna specialty drug prior authorization form, 2) Provide updated clinical notes showing disease status and treatment response, 3) Submit via the Availity provider portal or fax to 1-877-269-9916. If denied, Pennsylvania's new external review program has overturned about 50% of insurance denials in 2024. Start your renewal process early—Aetna typically takes 30-45 days for standard decisions.

Table of Contents

When to Start Your Renewal

Renewal Triggers

Breyanzi is a one-time CAR-T cell therapy, so traditional "renewals" don't apply. However, you may need coverage renewal or reauthorization for:

  • Follow-up monitoring and labs required post-infusion
  • Supportive care medications for managing side effects
  • Imaging studies to assess treatment response
  • Emergency readmissions for cytokine release syndrome or neurologic events
Note: With the FDA's removal of REMS requirements in June 2025, monitoring requirements have been streamlined to at least 7 days of daily assessment, reducing some coverage complexities.

Early Warning Signs to Act

Start the reauthorization process if you experience:

  • Denial of coverage for post-CAR-T monitoring
  • Changes to your Aetna plan formulary
  • Transition between insurance plans
  • Need for additional treatments due to disease progression

Required Documentation Update

Core Evidence Package

For any Breyanzi-related coverage requests with Aetna (CVS Health), ensure your clinical team provides:

Disease Status Documentation:

  • Current pathology confirming eligible lymphoma subtype
  • Staging imaging (PET/CT) showing disease extent
  • Performance status assessment (ECOG 0-2 required)
  • Organ function tests meeting safety criteria

Prior Treatment History:

  • Documentation of ≥2 prior systemic therapies for LBCL
  • For CLL/SLL: evidence of BTK inhibitor and BCL2 inhibitor failure
  • Specific drug names, dates, and reasons for discontinuation
  • Imaging showing progression or inadequate response

Current Clinical Assessment:

  • Recent oncologist visit notes (within 30 days)
  • Updated lab values and infection screening
  • Assessment of treatment goals and expected outcomes

Treatment Center Verification

Confirm your facility meets requirements:

  • Ability to manage cytokine release syndrome and neurotoxicity
  • On-site or immediate access to tocilizumab
  • ICU capabilities for emergency management
Clinician Corner: The medical necessity letter should emphasize FDA-approved indications, document specific prior therapy failures with dates and imaging, and reference current NCCN guidelines supporting CAR-T therapy in the patient's clinical scenario.

Renewal Submission Process

Step-by-Step Submission

  1. Obtain Current Forms
  2. Complete Documentation
    • Have your oncologist complete the clinical sections
    • Attach all required supporting documents
    • Include a detailed medical necessity letter
  3. Submit Early
    • Submit at least 2 weeks before needed treatment
    • Use Availity provider portal for fastest processing
    • Fax backup to specialty pharmacy line: 1-877-269-9916
  4. Follow Up
    • Track submission through Aetna provider portal
    • Contact CVS Specialty Pharmacy (1-888-632-3862) for status updates

Timeline & Decision Windows

Standard Processing

Submission Method Initial Review Standard Decision Expedited Decision
Availity Portal 2-3 business days 30-45 days 72 hours
Fax Submission 3-5 business days 30-45 days 72 hours
Mail 5-7 business days 30-45 days N/A

Expedited Reviews

Request expedited processing if:

  • Patient has rapidly progressive disease
  • Treatment delay poses immediate health risk
  • Current therapy is failing quickly

Include physician attestation of urgency with expedited requests.

If Coverage Lapses

Immediate Actions

If Aetna denies or delays coverage:

  1. Contact CVS Specialty immediately (1-888-632-3862)
  2. Request peer-to-peer review with medical director
  3. File internal appeal within 180 days of denial
  4. Explore patient assistance through Bristol Myers Squibb's Cell Therapy 360 program

Bridging Options

While appeals are pending, discuss with your oncologist:

  • Supportive care for disease control
  • Clinical trial enrollment
  • Alternative therapies covered by your plan
Important: Never delay emergency care due to coverage concerns. CAR-T complications require immediate medical attention regardless of insurance status.

Pennsylvania Appeals Process

Internal Appeals with Aetna

Timeline: 180 days from denial date Process:

  1. Submit written appeal with additional documentation
  2. Include updated medical records and peer-reviewed literature
  3. Request independent medical review if initially denied

Pennsylvania External Review

Pennsylvania's new Independent External Review Program, launched in January 2024, offers significant advantages:

Success Rate: Approximately 50% of appeals are overturned Timeline: 4 months to file after final internal denial Process:

  1. Complete internal appeals first
  2. Submit request to Pennsylvania Insurance Department
  3. Independent review organization makes binding decision

Expedited Review: Available for urgent cases (72-hour decisions)

From our advocates: One patient's Breyanzi denial was initially upheld by Aetna's internal review, citing "investigational" status despite FDA approval. The Pennsylvania external review overturned this decision within 6 weeks, noting the insurer failed to properly consider current FDA labeling and NCCN guidelines. The key was submitting comprehensive documentation including recent clinical trial data and specialty society recommendations.

For assistance, contact Pennsylvania Insurance Department Consumer Services: (877) 881-6388

Annual Plan Changes to Monitor

2024-2025 Formulary Updates

Aetna regularly updates coverage policies. Key changes affecting CAR-T therapies:

Monitor These Areas:

When Changes Occur:

  • Mid-year changes possible for new drugs or biosimilars
  • Annual updates typically effective January 1
  • Members may not receive advance notification of all changes

Verification Steps

Before each treatment cycle:

  1. Check current formulary status
  2. Verify prior authorization requirements
  3. Confirm network provider status
  4. Review any new exclusions or restrictions

Personal Renewal Tracker

Documentation Checklist

Use this tracker to organize your renewal materials:

Clinical Documents:

  • Current pathology report
  • Recent imaging studies (PET/CT)
  • Updated lab results
  • Oncologist visit notes (last 30 days)
  • Performance status assessment

Insurance Documents:

  • Current insurance card
  • Prior authorization form (2025 version)
  • Medical necessity letter
  • Previous approval letters
  • Any denial letters

Submission Tracking:

  • Submission date: ___________
  • Confirmation number: ___________
  • Follow-up date scheduled: ___________
  • Decision received: ___________

Key Contacts

Keep these numbers readily available:

  • Aetna Customer Service: (verify with member ID card)
  • CVS Specialty Pharmacy: 1-888-632-3862
  • Pennsylvania Insurance Department: (877) 881-6388
  • Your Oncology Team: ___________
  • Treatment Center Financial Counselor: ___________

FAQ

How long does Aetna (CVS Health) prior authorization take for Breyanzi in Pennsylvania? Standard decisions take 30-45 days, but expedited reviews for urgent cases are completed within 72 hours. Submit at least 2 weeks before needed treatment to avoid delays.

What if Breyanzi is non-formulary on my Aetna plan? Request a formulary exception by providing medical necessity documentation. If denied, you can appeal through Aetna's internal process and then Pennsylvania's external review program.

Can I request an expedited appeal in Pennsylvania? Yes, both Aetna's internal process and Pennsylvania's external review offer expedited timelines (typically 72 hours) for cases involving immediate health risks.

Does step therapy apply to CAR-T therapies like Breyanzi? Generally no, since CAR-T is typically reserved for relapsed/refractory disease after multiple prior therapies. However, insurers may require documentation of specific prior treatment failures.

What happens if I need emergency care after Breyanzi infusion? Emergency care is covered regardless of prior authorization status. Focus on getting immediate medical attention for symptoms like fever, confusion, or difficulty breathing.

How does Pennsylvania's external review compare to other states? Pennsylvania's program, launched in 2024, has shown a 50% success rate for overturning denials—significantly higher than many other states' processes.

Are there financial assistance programs for Breyanzi? Yes, Bristol Myers Squibb offers the Cell Therapy 360 program providing insurance verification, appeals support, and patient assistance for eligible individuals.

What documentation is most important for approval? The medical necessity letter from your oncologist is crucial. It should detail your specific diagnosis, prior treatment failures, current disease status, and why Breyanzi is the appropriate next step.

Counterforce Health helps patients, clinicians, and specialty pharmacies get prescription drugs approved by turning insurance denials into targeted, evidence-backed appeals. Our platform identifies denial reasons and drafts point-by-point rebuttals using the right clinical evidence and payer-specific requirements. Learn more about our services.

Sources & Further Reading

Disclaimer: This guide provides educational information only and is not medical advice. Coverage decisions depend on individual circumstances and current policy terms. Always consult with your healthcare team and insurance provider for personalized guidance. For additional support with insurance appeals and coverage issues, Counterforce Health specializes in helping patients navigate complex prior authorization and appeals processes.

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