By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

Getting Breyanzi (Lisocabtagene Maraleucel) Covered by Aetna CVS Health in Washington: Complete Prior Authorization and Appeals Guide

Quick Answer: Breyanzi (lisocabtagene maraleucel) requires prior authorization from Aetna CVS Health for all plan types. Submit complete documentation via Availity portal or fax 1-877-269-9916. If denied, file internal appeal within 180 days, then request external review through Washington's Office of Insurance Commissioner within 4 months. Success depends on comprehensive clinical documentation and meeting FDA-approved indications.

Table of Contents

Patient Profile: Understanding Breyanzi Eligibility

Meet Sarah, a 58-year-old Washington resident with relapsed/refractory large B-cell lymphoma (LBCL) after two prior lines of therapy. Her oncologist at Seattle Cancer Care Alliance believes Breyanzi CAR-T therapy offers her best chance for durable remission.

Sarah has Aetna CVS Health coverage through her employer's group plan. Her diagnosis includes:

  • Diffuse large B-cell lymphoma (DLBCL), confirmed by pathology
  • Disease progression after R-CHOP and R-ICE regimens
  • ECOG performance status of 1
  • Adequate organ function for CAR-T therapy

Key Eligibility Criteria for Breyanzi

According to Aetna's Clinical Policy Bulletin #986, patients must meet these requirements:

Requirement Details Documentation Needed
Age ≥18 years Birth certificate or ID
Diagnosis FDA-approved LBCL subtypes or CLL/SLL Pathology report
Prior Therapy ≥2 lines for LBCL; BTK + BCL2 inhibitors for CLL Treatment records
Performance Status ECOG 0-2 preferred Recent clinical assessment
Facility REMS-certified CAR-T center Center certification
Note: Breyanzi is not approved for primary CNS lymphoma or patients who previously received CAR-T therapy.

Pre-Authorization Preparation

Sarah's oncology team spent two weeks gathering comprehensive documentation before submitting to Aetna CVS Health.

Essential Documentation Checklist

Clinical Records (within 30 days):

  • Pathology report confirming DLBCL subtype
  • Recent PET/CT showing active disease
  • Complete blood count and comprehensive metabolic panel
  • Hepatitis B/C and HIV screening results
  • Cardiac and pulmonary function assessments

Treatment History:

  • Detailed summary of R-CHOP (6 cycles, partial response, then progression)
  • R-ICE salvage therapy (3 cycles, refractory disease)
  • Explanation of autologous stem cell transplant ineligibility
  • Documentation of disease progression with imaging

Medical Necessity Letter Components: Sarah's oncologist drafted a comprehensive letter addressing:

  • Specific DLBCL subtype and stage
  • Failed prior therapies with dates and outcomes
  • Clinical rationale for choosing Breyanzi over alternatives
  • Performance status supporting CAR-T eligibility
  • Treatment center's REMS certification status
Tip: Counterforce Health helps clinicians create targeted, evidence-backed appeals by analyzing denial letters and payer policies to draft point-by-point rebuttals aligned to plan requirements.

Submission Process

Sarah's team submitted the prior authorization through multiple channels to ensure receipt.

Step-by-Step Submission

1. Portal Submission (Primary Method)

  • Logged into Availity provider portal
  • Completed Aetna-specific Breyanzi PA form
  • Uploaded all supporting documentation
  • Received confirmation number for tracking

2. Backup Fax Submission

  • Faxed complete packet to 1-877-269-9916
  • Included cover sheet with patient demographics
  • Sent delivery confirmation receipt

3. CVS Specialty Pharmacy Coordination

  • Called 1-888-632-3862 to initiate enrollment
  • Confirmed patient insurance verification
  • Scheduled distribution pending PA approval

Timeline Expectations

According to Aetna's standard process:

  • Standard review: 30-45 business days
  • Expedited review: 72 hours (with urgent medical need certification)
  • Additional information requests: 14-day response window

Initial Outcome: Approval or Denial

Sarah's case was initially denied after 35 days. The denial letter cited:

  • "Insufficient documentation of treatment failure to R-ICE"
  • "Lack of clear contraindication to autologous transplant"
  • "Request for additional imaging to confirm active disease"

Common Denial Reasons

Denial Reason Frequency Solution Strategy
Incomplete treatment history High Detailed therapy records with dates/outcomes
Missing facility certification Medium REMS center documentation
Inadequate performance status Medium Recent ECOG assessment
Prior CAR-T receipt Low Explicit statement of no prior CAR-T

Appeals Process in Washington

Washington state provides robust consumer protections for insurance appeals through the Office of Insurance Commissioner (OIC).

Internal Appeal (First Level)

Sarah's oncologist filed the internal appeal within the 180-day deadline, addressing each denial point:

Response Strategy:

  • Provided detailed R-ICE treatment notes showing clear progression
  • Obtained transplant oncologist's letter documenting ineligibility
  • Submitted updated PET scan confirming active disease
  • Included peer-reviewed literature supporting Breyanzi efficacy

Timeline: Aetna has 45 business days to respond to internal appeals.

External Review Process

If the internal appeal fails, Washington residents can request external review through an Independent Review Organization (IRO).

Key Steps:

  1. File within 4 months of final internal denial
  2. Contact Washington OIC at 800-562-6900 for guidance
  3. Submit complete file including all medical records and correspondence
  4. IRO assignment by the Insurance Commissioner
  5. Decision timeline: 30 days standard, 72 hours expedited
Washington Advantage: The state's external review process is binding on insurers and uses independent medical specialists to evaluate denials.

From Our Advocates

"We've seen Washington patients successfully overturn Aetna CAR-T denials by leveraging the state's strong external review process. The key is comprehensive documentation and understanding that Washington's IRO reviewers often include academic oncologists familiar with cutting-edge therapies. This composite experience shows the value of persistence and proper preparation."

Resolution and Lessons Learned

Sarah's internal appeal was approved after 42 days. The additional documentation clearly demonstrated treatment failure and transplant ineligibility, satisfying Aetna's medical necessity criteria.

Success Factors

What worked:

  • Comprehensive response to each denial point
  • Updated clinical data within submission timeframe
  • Clear documentation of prior treatment failures
  • Specialist letters supporting medical necessity

Approval terms:

  • Coverage approved for single Breyanzi infusion
  • Required administration at REMS-certified facility
  • 30-day post-infusion monitoring coverage included
  • Total approved amount: $487,000 (2024 WAC pricing)

Counterforce Health specializes in turning insurance denials into targeted appeals by identifying the specific denial basis—whether PA criteria, step therapy, or "not medically necessary"—and crafting evidence-backed rebuttals that align with each plan's own rules and procedural requirements.

What We'd Do Differently

Preparation improvements:

  • Submit PA request 6-8 weeks before intended treatment date
  • Proactively obtain transplant ineligibility documentation
  • Schedule peer-to-peer review immediately upon denial
  • Prepare expedited appeal materials in advance

Documentation enhancements:

  • Include treatment timeline flowchart for clarity
  • Provide imaging comparison showing progression
  • Add quality of life assessments supporting urgency
  • Reference specific Aetna policy language in medical necessity letter

Templates and Checklists

Pre-Submission Checklist

Patient Information:

  • Insurance card copy (front/back)
  • Photo ID
  • Prior authorization form completed
  • Patient consent for treatment

Clinical Documentation:

  • Pathology report (within 6 months)
  • Recent imaging (within 30 days)
  • Laboratory results (within 30 days)
  • Performance status assessment
  • Treatment history summary
  • Medical necessity letter

Administrative Requirements:

  • REMS facility certification
  • Provider NPI and credentials
  • Submission confirmation receipt
  • Follow-up tracking system

Appeal Preparation Template

Internal Appeal Components:

  1. Cover letter addressing specific denial reasons
  2. Updated medical records filling documentation gaps
  3. Specialist consultations supporting medical necessity
  4. Literature citations from peer-reviewed sources
  5. Patient impact statement describing urgency

FAQ

How long does Aetna CVS Health prior authorization take for Breyanzi in Washington? Standard review takes 30-45 business days. Expedited review (with urgent medical certification) provides decisions within 72 hours.

What if Breyanzi is non-formulary on my Aetna plan? Request a formulary exception with documentation of medical necessity and lack of covered alternatives. Include peer-reviewed evidence supporting efficacy.

Can I request an expedited appeal in Washington? Yes, if delay threatens life or health. Provide physician certification of urgent medical need for 72-hour decision timeline.

Does step therapy apply to CAR-T therapies? Typically no, as CAR-T therapies are reserved for relapsed/refractory disease after multiple prior lines. Document all failed therapies clearly.

What are my rights if Aetna denies my appeal? Washington residents can request external review through the Office of Insurance Commissioner. This independent review is binding on insurers.

How much does Breyanzi cost without insurance? The wholesale acquisition cost (WAC) is approximately $477,000-$487,000, with total treatment costs potentially exceeding $500,000 including administration and monitoring.

Can I get help with the appeals process? Yes, contact the Washington Office of Insurance Commissioner at 800-562-6900 for free consumer assistance with appeals and external review requests.

What happens if I miss an appeal deadline? Washington allows 180 days for internal appeals and 4 months for external review. Contact the OIC immediately if you've missed a deadline, as exceptions may be possible in certain circumstances.

Sources and Further Reading

Disclaimer: This information is for educational purposes only and does not constitute medical or legal advice. Insurance coverage decisions vary by individual plan and clinical circumstances. Always consult with your healthcare provider and insurance company for guidance specific to your situation. For additional support with appeals in Washington, contact the Office of Insurance Commissioner's Consumer Advocacy line at 800-562-6900.

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