Breyanzi denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for breyanzi are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why Cigna Denied Breyanzi: Step Therapy

Step-therapy (or "fail-first") denials for Breyanzi (lisocabtagene maraleucel) mean Cigna is requiring you to try — and fail — additional prior lines of therapy before it will authorize Breyanzi. For a CAR-T cell therapy that is FDA-approved specifically for patients who have already failed multiple prior lines of treatment, this denial often reflects a misapplication of step-therapy logic, a policy that does not align with the FDA-approved indication, or a claim that a specific additional therapy should have been tried first.

Step-therapy denials for Breyanzi are among the most commonly appealed and reversed CAR-T denials, because the FDA approval itself presupposes a defined prior-therapy requirement that you may already satisfy.

## Why This Denial Is Appealable

The FDA-approved indication for Breyanzi already incorporates a prior-therapy requirement — meaning the label itself functions as a clinically validated step-therapy protocol. Cigna's policy requiring additional steps beyond the FDA label's requirements must be justified by evidence that the additional step is clinically superior. If Cigna cannot point to credible clinical support for the additional step, the denial is vulnerable under both ERISA's arbitrary-and-capricious standard and ACA external review. Many states also have step-therapy exception laws that require insurers to grant exceptions when the required step is contraindicated, previously tried, or clinically inappropriate.

## Federal Appeal Framework

• Step-therapy exception request: File this in parallel with the internal appeal — federal and many state laws require a formal exception process, and it may resolve faster than a full appeal.
• Internal appeal (ERISA §503 / ACA §2719): File within 180 days of denial. Expedited review available within 72 hours if clinically urgent.
• External review (ACA §2719): Available after exhausting internal appeals, generally within 4 months. IROs reviewing step-therapy denials for CAR-T regularly evaluate whether the required additional step was clinically supported. Binding on Cigna.
• Expedited review: Request in writing if disease progression makes delay dangerous — deteriorating performance status is directly relevant here.

## Documentation to Gather

• Complete prior-treatment history with start/stop dates, regimens, best response, and documented reasons for discontinuation of each line — this is the core of your step-therapy appeal
• Oncologist letter specifically addressing: (a) why your prior-therapy history satisfies the FDA label's requirements, (b) why the additional step Cigna requires is not clinically appropriate for your specific situation, and (c) why further delay risks harm
• FDA prescribing information for Breyanzi — the approved indication's prior-therapy criteria; your treatment history should map to each one
• Cigna's step-therapy policy for Breyanzi — identify the exact additional step required; your oncologist must address it directly
• Step-therapy exception criteria from the policy — many plans list specific grounds (prior failure, contraindication, clinical urgency); map your facts to each ground
• Performance status and disease status documentation — deteriorating status is a clinical argument for urgency and against further delay

## Criteria-Mapping Structure

| Step Cigna Requires | Your Response | |---|---| | Additional therapy Cigna specified | [Name the therapy; state whether previously tried (with outcome) or why it is clinically inappropriate] | | FDA prior-therapy requirement (label) | [Map your treatment history to each prior-line requirement in the Breyanzi label] | | Exception grounds (policy-listed) | [Match your clinical facts to each exception category — failure, contraindication, urgency, or clinical inappropriateness] | | Risk of further delay | [Oncologist statement on disease trajectory and why delay is harmful] | | Guideline support | [Relevant hematology guideline organization's position on Breyanzi's place in the treatment sequence] |

An appeal that demonstrates your treatment history already satisfies the FDA-approved prior-therapy requirement — and that Cigna's additional step has no credible clinical basis for your specific situation — is the strongest foundation for overturning a step-therapy denial for Breyanzi.