By Counterforce Health Team in Breyanzi (lisocabtagene maraleucel) —

How to Get Breyanzi (Lisocabtagene Maraleucel) Covered by Aetna CVS Health in California: Complete Prior Authorization and Appeals Guide

Answer Box: Getting Breyanzi Approved by Aetna CVS Health in California

Breyanzi (lisocabtagene maraleucel) requires mandatory prior authorization from Aetna CVS Health under their medical benefit, with standard decisions taking 30-45 days. Submit via Availity provider portal or fax to 1-877-269-9916 at least 2 weeks before treatment. If denied, California patients can appeal internally within 180 days, then request an Independent Medical Review (IMR) through DMHC with a ~73% success rate for medically necessary treatments.

First step today: Verify your Aetna plan type and download the current PA form through your oncologist's Availity portal or call CVS Specialty at 1-888-632-3862.

Table of Contents

What This Guide Covers

This guide helps California patients and their healthcare teams navigate Aetna CVS Health's prior authorization process for Breyanzi (lisocabtagene maraleucel), a CAR-T cell therapy for certain blood cancers. Whether you're facing large B-cell lymphoma (LBCL) after multiple treatments or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that hasn't responded to BTK and BCL2 inhibitors, this step-by-step approach can help you secure coverage.

With Breyanzi's list price around $477,000-$487,000 and total treatment costs often exceeding $500,000, getting insurance approval is crucial. California's consumer-friendly insurance regulations provide strong appeal rights if you're initially denied.

Counterforce Health specializes in turning insurance denials into successful appeals by analyzing denial letters, plan policies, and clinical notes to craft targeted, evidence-backed rebuttals. Their platform helps patients, clinicians, and specialty pharmacies navigate complex prior authorization requirements for specialty medications like CAR-T therapies.

Before You Start: Verify Your Coverage

Coverage Classification

Breyanzi is covered under Aetna's medical benefit, not pharmacy benefit, following Clinical Policy Bulletin #986 for CAR-T therapies. This means your oncology team will handle the authorization, not your retail pharmacy.

Plan Type Verification

Call the member services number on your insurance card to confirm:

  • Your plan type (HMO, PPO, Medicare Advantage)
  • Whether you need referrals for specialty care
  • Your medical benefit deductible and out-of-pocket maximum
  • Whether your treatment center is in-network

Required Facility Certification

Breyanzi must be administered at a REMS-certified CAR-T center. Verify your treatment facility is certified and in-network with Aetna before starting the PA process.

Gather What You Need

Essential Documentation Checklist

Diagnosis and Staging:

  • Pathology report confirming LBCL subtype or CLL/SLL diagnosis
  • Recent PET/CT imaging showing active disease
  • Flow cytometry confirming CD19-positive status
  • ICD-10 codes with current remission status

Treatment History:

  • Complete records of ≥2 prior therapy lines for LBCL
  • For CLL/SLL: documentation of BTK inhibitor and BCL2 inhibitor use
  • Dates, dosing, duration, and response/failure for each regimen
  • Reasons for discontinuation (progression, intolerance, contraindications)

Current Clinical Status:

  • ECOG performance status assessment (must be 0-2)
  • Complete blood count and comprehensive metabolic panel
  • Hepatitis B/C and HIV screening results
  • Cardiac function assessment (ECHO or MUGA)
  • Pulmonary function tests if indicated

Required Forms:

  • Aetna CVS Health PA form (2025 version)
  • Medical necessity letter from prescriber
  • REMS-certified facility verification letter

Submit Your Prior Authorization Request

Submission Methods

Primary Method: Availity Portal

  • Log in through your provider's Availity account
  • Upload all required documents as a complete packet
  • Track submission status in real-time

Alternative: Fax Submission

  • Fax to: 1-877-269-9916
  • Include cover sheet with patient name, DOB, and member ID
  • Send as one complete packet to avoid delays

Timing Your Submission

Submit at least 2 weeks before planned treatment to allow for standard 30-45 day processing. For urgent cases where delay could cause serious harm, request expedited review (72-hour decision timeline).

Tip: Coordinate with CVS Specialty Pharmacy (1-888-632-3862) early in the process. They'll handle Breyanzi enrollment and delivery once PA is approved.

Follow-Up and Timeline Expectations

Standard Processing Times

Review Type Timeline When to Use
Standard 30-45 days Most cases
Expedited 72 hours Serious harm risk
Urgent 24 hours Life-threatening delay

Follow-Up Schedule

Week 1: Confirm receipt via Availity portal or call Aetna at the number on your member card.

Week 2: If no update, call to verify all documents were received and ask for estimated decision date.

Week 3: For standard reviews approaching 30 days, request status update and escalate if needed.

Sample Call Script

"Hi, I'm calling to check the status of a prior authorization request for Breyanzi submitted on [date] for member [name], ID [number]. Can you tell me if all required documents were received and when I can expect a decision?"

If You're Asked for More Information

Aetna may request additional documentation during review. Common requests include:

Medical Necessity Clarification:

  • More detailed treatment history with specific response criteria
  • Laboratory values showing disease progression
  • Specialist consultation notes supporting CAR-T recommendation

Administrative Requirements:

  • Updated facility certification
  • Corrected ICD-10 or CPT codes
  • Patient consent forms

Respond to these requests within 10 business days to avoid processing delays. Submit additional information through the same portal or fax used for the original request.

If Your Request is Denied

Common Denial Reasons and Solutions

Denial Reason Solution
"Not medically necessary" Submit detailed treatment history, NCCN guidelines, FDA label citations
"Missing CD19 positivity" Provide flow cytometry report confirming CD19+ status
"Non-certified facility" Verify REMS certification or transfer to certified center
"Insufficient prior therapy" Document specific failures with dates and response criteria

Peer-to-Peer Review

Before filing a formal appeal, request a peer-to-peer review with Aetna's medical director. This allows your oncologist to directly discuss medical necessity and may resolve coverage issues without a formal appeal.

California Appeals Process

California provides robust appeal rights through the Department of Managed Health Care (DMHC) for most HMO and managed care plans.

Internal Appeal (First Level)

Timeline: File within 180 days of denial notice Process: Submit through Aetna member portal or mail Decision: 30 days (expedited appeals ≤72 hours) Include: All denial letters, medical records, specialist recommendations, peer-reviewed evidence

Independent Medical Review (IMR)

If your internal appeal is denied, California residents can request an IMR through DMHC.

Timeline: Apply within 6 months of final internal denial Cost: Free to patients Success Rate: Approximately 73% overturn rate for medically necessary services Decision Timeline: 45 days standard, 7 days expedited

How to Apply:

  • Online: healthhelp.ca.gov
  • Phone: 888-466-2219 (24/7)
  • Mail or fax applications also accepted

Required Documents:

  • All denial and appeal letters
  • Complete medical records
  • Specialist attestation of medical necessity
  • Clinical guidelines (NCCN, FDA labeling)
  • Evidence of disease severity/progression
Note: Plans must authorize or pay for approved services within 5 working days of an IMR decision favoring the member.

For plans regulated by the California Department of Insurance (CDI), a similar external review process exists. Call the CDI Consumer Hotline at 800-927-4357 for guidance.

Financial Assistance Options

Bristol Myers Squibb Support Programs

Cell Therapy 360®

  • Phone: 888-805-4555 (24/7)
  • Coverage: Copay assistance for commercially insured patients
  • Exclusions: Medicare, Medicaid, TRICARE, VA, other government programs
  • Additional Support: Transportation, lodging assistance for treatment

BMS Access Support

  • Phone: 1-800-861-0048 (8 AM-8 PM ET, Mon-Fri)
  • Services: Copay programs, foundation referrals, financial counseling

Independent Foundations

For patients with government insurance or insufficient commercial coverage, Bristol Myers Squibb Patient Assistance Foundation may provide free medication for qualifying low-income patients.

Counterforce Health can also help identify additional foundation grants and coordinate appeals that maximize your chances of coverage approval, reducing the need for out-of-pocket payment.

Renewal and Re-Authorization

Breyanzi is typically a one-time treatment, so renewal is uncommon. However, if re-treatment is medically necessary:

Calendar Reminder: Submit re-authorization requests 60 days before planned treatment Required Evidence: Documentation of initial response, current disease status, medical necessity for repeat treatment Updated Requirements: Current labs, imaging, performance status assessment

Quick Reference Checklist

Before Submission:

  • Verify Aetna plan type and facility network status
  • Confirm REMS-certified treatment center
  • Gather pathology report with CD19+ confirmation
  • Document ≥2 prior therapy failures (LBCL) or BTK/BCL2 inhibitor use (CLL/SLL)
  • Obtain current labs, imaging, and performance status

Submission Packet:

  • Completed Aetna PA form
  • Medical necessity letter from oncologist
  • Complete treatment history with dates and outcomes
  • Recent PET/CT and laboratory results
  • REMS facility certification letter

After Submission:

  • Confirm receipt within 3-5 business days
  • Follow up weekly for status updates
  • Respond to information requests within 10 days
  • Coordinate with CVS Specialty Pharmacy upon approval

FAQ

How long does Aetna CVS Health PA take in California? Standard prior authorization takes 30-45 days. Expedited reviews for urgent cases are decided within 72 hours.

What if Breyanzi is non-formulary on my plan? Since Breyanzi is covered under the medical benefit, formulary status is less relevant. Submit a medical necessity request with your PA application.

Can I request an expedited appeal in California? Yes, if delay could cause serious harm to your health. Both internal appeals and IMRs have expedited timelines (72 hours and 7 days, respectively).

Does step therapy apply to CAR-T therapies? Step therapy requirements vary by plan, but CAR-T therapies are typically reserved for patients who have already failed multiple prior treatments, which often satisfies step therapy requirements.

What happens if my treatment center isn't REMS-certified? You'll need to transfer care to a certified facility or help your current center obtain certification before treatment can proceed.

How much will I pay out-of-pocket? With commercial insurance and manufacturer copay assistance, many patients pay minimal out-of-pocket costs. Medicare and Medicaid patients should explore foundation grants and hospital financial assistance programs.

Can I appeal if I have Medicare Advantage through Aetna? Yes, Medicare Advantage appeals follow similar timelines but may have additional federal protections. The California IMR process also applies to most Medicare Advantage plans.

What documentation strengthens my appeal? Include detailed treatment history, current clinical guidelines (NCCN), FDA labeling supporting your indication, and a compelling medical necessity letter from your specialist.

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 plan for guidance specific to your situation. Insurance policies and procedures may change; verify current requirements with official sources.

Sources & Further Reading

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