Tafamidis ATTR denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for tafamidis attr 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 May Deny Tafamidis Citing "Not FDA-Approved" — and Why That Is Almost Certainly Wrong

Tafamidis received FDA approval specifically for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults. A denial citing "not FDA-approved" typically reflects one of three administrative errors: (1) the claim was coded with a diagnosis or indication that does not match the approved label; (2) the formulary system flagged the drug pending prior authorization that was not submitted; or (3) a legacy policy entry was applied that predates the approval. This type of denial is among the most correctable on appeal.

## Your Federal Appeal Rights

• ACA §2719 External Review: If the internal appeal fails, you may escalate to an independent external review within approximately four months of the final internal denial — verify the exact deadline on your denial letter.
• ERISA §503: You are entitled to the specific plan language and clinical rationale behind the denial in writing, and to a full-and-fair review with the right to submit rebuttal evidence.
• Expedited Review: Simultaneously requestable for urgent situations; turnaround is typically 72 hours.

## Concrete Appeal Steps and Timeline

1. Pull the FDA prescribing information for tafamidis and confirm the approved indication matches your diagnosis code. 2. Request the denial letter's specific basis — which indication does Aetna claim is not approved? 3. If the denial reflects a coding mismatch, have the prescriber's billing office correct the diagnosis code and resubmit before filing a formal appeal. 4. If Aetna stands by the denial despite correct coding, file a Level 1 internal appeal with the FDA approval documentation attached. 5. If denied again, request external IRO review.

## Documentation to Gather

• FDA label extract: The "Indications and Usage" section of the current FDA-approved prescribing information for tafamidis — this is publicly available at FDA.gov and should be the first attachment on any appeal.
• Diagnosis confirmation: Records establishing ATTR-CM (scintigraphy, biopsy, or genetic testing as appropriate), matching the coded indication.
• Prescriber attestation: A letter confirming the drug is being prescribed within its FDA-approved indication for this patient.
• Claim audit: Verify the NDC and diagnosis code submitted on the original claim are accurate.

## Criteria-Mapping Structure

Your appeal cover letter should contain a single, clear table: the FDA-approved indication as written in the label in column one; the patient's confirmed diagnosis, test results, and ICD code in column two. The goal is to make it impossible for the reviewer to sustain a "not approved" rationale once they see the exact label language alongside the chart confirmation. Include the FDA.gov URL and the approval date so the reviewer can independently verify.