Breyanzi denied as not FDA-approved for this use 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: Not FDA-Approved

A denial stating that Breyanzi (lisocabtagene maraleucel) is "not FDA-approved" — when Breyanzi holds full FDA approval for defined indications — is almost certainly either a claims-processing error, a policy that has not been updated to reflect a recent FDA action, or an assertion that the specific indication for which you are being treated falls outside the currently approved label.

This is one of the most factually straightforward denials to appeal: the FDA's approval is a matter of public record, and your appeal can cite it directly.

## Why This Denial Is Appealable

FDA approval is the baseline standard courts, regulators, and independent review organizations use to assess whether a therapy has achieved sufficient regulatory recognition to be covered. If your oncologist is prescribing Breyanzi for an FDA-approved indication, the "not FDA-approved" denial is factually incorrect on its face. IROs reviewing this type of denial have a clear, objective standard to apply, and reversals are common when the record is complete.

If the denial is based on an off-label use — meaning Breyanzi is being prescribed outside its current FDA-approved indications — the appeal strategy shifts to demonstrating support in compendia (such as those recognized by Medicare and state insurance laws) and in the relevant clinical guideline organization's recommendations.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): File within 180 days of denial. Standard pre-service appeals decided within 30 days; expedited within 72 hours. Attach the FDA approval documentation directly to your appeal letter.
• External review (ACA §2719): Available after exhausting internal appeals, generally within 4 months. IRO reviewers are required to consider FDA-approved status as a primary factor. Binding on Cigna.
• Expedited external review: Available for serious/life-threatening conditions — request explicitly if disease urgency warrants it.

## Documentation to Gather

• FDA prescribing information for Breyanzi — the current label showing the exact approved indication(s), including any supplemental approvals; attach as an exhibit to your appeal
• Oncologist letter confirming that Breyanzi is being prescribed for a currently FDA-approved indication and that all label-specified eligibility criteria are met by your clinical profile
• Denial letter — quote the exact "not FDA-approved" language and the date of the denial; compare against the FDA approval date
• Treatment history establishing that your diagnosis and prior-therapy history match the FDA-approved indication
• If off-label: Compendia citations (e.g., NCCN) showing recognized support for the specific use, plus the oncologist's clinical rationale

## Criteria-Mapping Structure

| Cigna's Denial Basis | Your Rebuttal | |---|---| | Asserted lack of FDA approval | [FDA approval date and indication reference from prescribing label] | | Indication match | [Oncologist confirmation that your diagnosis matches approved indication] | | Prior-therapy eligibility | [Treatment history matching label requirements] | | Policy update lag (if applicable) | [Date of FDA approval vs. date of Cigna policy — note if policy predates approval] | | Off-label use (if applicable) | [Compendia listing; guideline organization recognition; oncologist rationale] |

Leading your appeal with a copy of the FDA approval and a brief oncologist letter confirming on-label use is often sufficient to overturn a "not FDA-approved" denial at the internal stage, without needing to proceed to external review.