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

Aetna's specific coverage criteria for filspari 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 Issues a "Not FDA-Approved" Denial for Filspari — and How to Correct It

Filspari (sparsentan) has received FDA approval for IgA nephropathy (IgAN). A "not FDA-approved" denial from Aetna almost always reflects a system or policy lag — either the plan's drug database has not yet been updated to reflect the approval, the specific indication being billed was coded in a way the system did not recognize as the approved indication, or an older policy version is being applied. This is among the clearest categories of denial to overturn, because the factual predicate of the denial — that FDA approval is absent — is directly contradicted by publicly available FDA records.

## Your Federal Appeal Rights

• Internal appeal (ACA §2719 / ERISA §503): File within the deadline shown on your denial notice. Lead with the FDA approval documentation as your primary exhibit.
• External review: If internal appeal is denied, escalate to an independent external reviewer. The standard external-review window is approximately four months from the original denial.
• Expedited review: Request expedited processing if kidney disease progression makes delay clinically harmful.

## Documentation to Gather

1. FDA approval documentation — the official FDA prescribing information (package insert) for Filspari, which includes the approval date and approved indication. This is the central document in this appeal. 2. Diagnosis confirmation — biopsy-confirmed IgA nephropathy, demonstrating that the use is on-label for the approved indication. 3. Prescriber medical-necessity letter — confirming that the prescription is for the FDA-approved indication and is medically necessary for this patient. 4. Coding review — ask your prescriber or billing team to confirm the diagnosis and procedure codes submitted match the approved indication precisely; a coding mismatch can trigger this denial type.

## Criteria-Mapping Structure

Request Aetna's clinical policy or the specific denial rationale. Then respond directly:

| Denial Basis | Rebuttal Evidence | |---|---| | Drug lacks FDA approval | [FDA prescribing label — approval date for IgAN indication] | | Use is off-label | [On-label indication confirmed — FDA label + biopsy diagnosis] | | Policy version applied | [Request current policy version and effective date from Aetna] |

Attach the FDA prescribing information as exhibit A with the approval date highlighted. Write a brief cover letter stating the specific factual error in the denial and requesting immediate reconsideration. Most not-FDA-approved denials for genuinely approved drugs resolve at the internal appeal level without requiring external review.