Gene Therapy Casgevy denied as not FDA-approved for this use by Humana?

Humana's specific coverage criteria for gene therapy casgevy 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 Humana Cites "Not FDA-Approved" for Casgevy — and Why That Denial Is Almost Certainly Wrong

Casgevy received FDA approval for sickle cell disease and transfusion-dependent beta-thalassemia. A denial citing "not FDA-approved" for an on-label use of Casgevy is factually incorrect on its face. These denials often result from a coding error, a lag in updating Humana's internal drug database, or a mismatch between the diagnosis code submitted and the FDA-approved indication. Identifying the root cause quickly is essential.

## Why This Denial Is Appealable

An incorrect factual premise is one of the most straightforwardly reversible grounds for appeal. Under ACA §2719 and ERISA §503, plans must provide a full-and-fair review that considers the actual facts. Submitting documentation of FDA approval directly contradicts the stated denial reason and typically results in reversal at the internal level without need for external review.

## Federal Appeal Framework

• Internal appeal — first priority: File immediately, attaching the FDA approval letter and the current prescribing label. Request a written explanation of what the plan means by "not FDA-approved" in this context.
• External review: If internal appeal is denied despite this documentation, request IRO review. An independent reviewer will have no basis to uphold a denial contradicted by the public FDA record.
• Expedited review: Available if delay poses imminent health risk.

## Documentation to Gather

1. FDA approval documentation: Print or attach a copy of the FDA-approved prescribing label and, if available, the FDA approval letter — both are publicly available on the FDA website (Drugs@FDA). 2. On-label indication match: A letter from your hematologist confirming the diagnosis and that the prescribed use is within the FDA-approved indication. 3. Diagnosis records: Lab or genetic confirmation of sickle cell disease or transfusion-dependent beta-thalassemia as applicable. 4. Claim and coding review: Ask your prescribing specialist's billing team to verify that the ICD-10 diagnosis code on the claim matches the FDA-approved indication exactly. 5. Denial letter analysis: Identify whether Humana cited a specific policy number or clinical basis — if the only stated reason is FDA approval status, the rebuttal is straightforward.

## Criteria-Mapping Strategy

For this denial type, the mapping exercise is narrow but must be precise: show that (a) the FDA approved Casgevy, (b) the approved indication matches your diagnosis code, and (c) the prescribed use is not off-label. Attach the prescribing label's "Indications and Usage" section and your hematologist's letter side by side with the denial language. If Humana's denial was based on a database or coding issue, ask for a peer-to-peer call between your hematologist and Humana's medical director before escalating to formal appeal — this often resolves the error within days.