Breyanzi denied as not medically necessary 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: Medical Necessity

Cigna's medical necessity denials for Breyanzi (lisocabtagene maraleucel) typically occur because the plan's coverage policy sets out specific clinical criteria — such as diagnosis type, stage, number and type of prior therapies, performance status, and organ function — and Cigna's reviewer concluded that your submitted records did not clearly establish that each criterion is met. Medical necessity is the most common denial type for CAR-T cell therapies and also among the most commonly overturned on appeal when documentation is complete.

The key insight: Cigna is not saying Breyanzi doesn't work — it is saying your file did not prove your case meets the policy's criteria. Your appeal is a documentation exercise as much as a clinical argument.

## Why This Denial Is Appealable

If your oncologist has determined that Breyanzi is medically appropriate and your case meets the FDA-approved indication, a well-documented appeal has a strong track record of success. IROs reviewing CAR-T denials routinely reverse medical-necessity decisions when the clinical record is complete. ERISA requires Cigna to conduct a full-and-fair review, including consideration of all new evidence you submit on appeal.

## Federal Appeal Framework

• Internal appeal (ERISA §503): File within 180 days of denial. Cigna must decide pre-service standard appeals within 30 days; post-service within 60 days; expedited (urgent/concurrent care) within 72 hours.
• External review (ACA §2719): Available after exhausting internal appeals, generally within a 4-month window. An IRO with oncology expertise makes the final, binding determination.
• Expedited review: Request explicitly if disease progression or deteriorating performance status makes delay clinically harmful.

## Documentation to Gather

• Oncologist's detailed medical-necessity letter — this is the single most important document; it should address every criterion in Cigna's coverage policy for Breyanzi by name, with supporting chart references
• Pathology reports confirming diagnosis, histology, and any molecular/cytogenetic markers required by the policy
• Prior treatment records — complete chronological list of prior lines of therapy with start/stop dates, regimens, best response, and reason for discontinuation
• Performance status documentation from recent clinical visits
• Organ function and relevant lab results sufficient to demonstrate eligibility per the FDA label (exact values are for the medical record; the appeal letter should reference them as "within the range specified in the FDA-approved prescribing information")
• Cigna's current medical coverage policy for Breyanzi / CAR-T — obtain the version active at denial; your appeal must address each criterion listed

## Criteria-Mapping Structure

For each requirement in Cigna's Breyanzi coverage policy, document your answer:

| Policy Criterion | Your Evidence | |---|---| | Diagnosis (histology/subtype) | [Pathology report date and finding] | | Relapsed/refractory status | [Number and type of prior lines; dates; responses] | | Performance status requirement | [Most recent documented performance status from chart] | | Organ function / eligibility parameters | [State "within parameters specified in FDA label" + reference lab date] | | Treatment setting / center qualifications | [Treating center's FACT accreditation or equivalent, if required by policy] | | Prescribing physician specialty | [Oncologist credentials and institutional affiliation] |

A denial based on incomplete documentation rather than a genuine clinical disagreement is one of the most reversible denial types — build a complete record and your appeal position is strong.