Carvykti denied for missing prior authorization by Aetna?

Aetna's specific coverage criteria for carvykti 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 Aetna Denied Carvykti for Prior Authorization

Carvykti (ciltacabtagene autoleucel) is a high-cost specialty CAR-T therapy that Aetna universally requires prior authorization before administration. A "prior authorization required" denial occurs when authorization was not obtained before the service, when an authorization request was submitted but denied on clinical grounds, or when authorization expired before the infusion date. For a CAR-T therapy, the prior authorization process involves clinical review of the patient's disease history, prior treatment lines, and performance status against Aetna's clinical policy criteria.

## Why This Denial Is Appealable

If this is a prospective denial — the authorization was requested and denied before the infusion — your appeal is a standard medical-necessity appeal arguing that all policy criteria are met, with a complete documentation package (see below). If this is a retrospective denial because authorization was not obtained before the infusion, the path is more difficult but not closed: review your plan documents for any emergency or urgent exception provisions, and consider whether the clinical urgency of the situation made it impossible to obtain prior authorization in time. Your oncologist's statement about clinical urgency is critical in that scenario.

## Federal Appeal Framework

• Internal appeal: Under ERISA §503 or state insurance law, you have the right to a full-and-fair review. File within the deadline in your denial letter, which is typically 60 to 180 days.
• External review: Under ACA §2719, after exhausting internal appeal you may request independent external review within approximately four months of the final internal denial.
• Expedited review: Given the serious, potentially life-threatening nature of relapsed/refractory multiple myeloma, request expedited processing at every stage — both internal and external. Expedited external review decisions are typically rendered within 72 hours.
• State protections: If your plan is a fully-insured state-regulated plan, check whether your state has additional prior authorization reform protections that apply to oncology or specialty drugs.

## Documentation to Gather

• Complete prior-therapy table: Every prior line of therapy for multiple myeloma, by name as documented in the chart, with start date, end date, response assessment, and reason for discontinuation. This is the single most important document for a CAR-T prior authorization appeal.
• Current disease-status records: Bone marrow biopsy with pathology, serum or urine protein electrophoresis, and most recent imaging, all dated as close to the authorization request as possible.
• Performance status: Explicit ECOG or Karnofsky notation in a recent clinic note.
• Prescribing information reference: Your oncologist should confirm the patient meets Carvykti's FDA-approved indication as stated in the prescribing information and cite the current applicable NCCN guideline category.
• Center certification: Documentation that the treating center is certified to administer Carvykti (a common policy requirement).
• Oncologist authorization letter: A letter that walks through each Aetna prior authorization criterion explicitly and cites the supporting document for each.

## Criteria-Mapping Structure

Request Aetna's current clinical policy bulletin for Carvykti. Build a four-column table: (1) Aetna Prior Authorization Criterion, (2) FDA Label Requirement (referenced, not quoted with numbers), (3) Patient's Chart Finding, (4) Supporting Document and Date. Submit this as the first page of your appeal. For a CAR-T therapy authorization appeal, a complete and well-organized criteria table is the most important structural element — reviewers have seen many incomplete submissions and a thorough, exhibit-linked table substantially increases the probability of approval.