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

Aetna's specific coverage criteria for fostamatinib itp 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 Issue a "Not FDA-Approved" Denial for Fostamatinib in ITP

This denial type is often a coding or administrative error. Fostamatinib (Tavalisse) received FDA approval for chronic ITP in adults, so a denial citing lack of FDA approval most commonly means one of three things: (1) the drug was coded or billed under a different indication that is not FDA-approved; (2) Aetna's system did not recognize the submitted diagnosis code as matching the approved indication; or (3) a reviewer conflated "not on formulary" with "not FDA-approved." In any case, this denial is factually correctable on appeal.

## Why This Denial Is Appealable

FDA approval is publicly verifiable from the agency's own drug database. If your prescriber submitted fostamatinib for the FDA-approved ITP indication and Aetna denied it as unapproved, the appeal simply requires presenting the FDA approval documentation alongside the prescriber's confirmation that the drug is being used within its labeled indication. These factual appeals are among the most straightforward to win.

## Federal Appeal Framework

• Internal appeal: File under ERISA §503 or your state's insurance code within the deadline on your denial notice. Request the specific basis for the "not FDA-approved" finding in writing so you can address it directly.
• External review: Available under ACA §2719 after internal exhaustion; approximately four months to file. An independent reviewer's confirmation that FDA approval exists is binding on the plan.
• Expedited review: Request if your platelet count or bleeding risk makes delay medically dangerous.

## Documentation to Gather

1. FDA approval confirmation — print the FDA-approved labeling and the drug approval page from FDA.gov showing the ITP indication; attach to your appeal. 2. Prescriber letter confirming on-label use — your hematologist states the drug was prescribed for chronic ITP in an adult patient, matching the FDA-approved indication, and that it is not being used off-label. 3. Claim and coding review — ask your prescriber's billing staff to confirm the diagnosis code and drug code submitted align with the FDA-approved indication; correct any discrepancy before or alongside the appeal. 4. Denial letter analysis — request Aetna's clinical rationale in writing; if the stated basis is factually incorrect, your appeal letter should quote it and refute it with the FDA documentation.

## Criteria-Mapping Structure

In your appeal letter, reproduce the exact language of the denial, then place the FDA approval documentation directly beside it. Where Aetna states the drug lacks approval, cite the FDA approval date and indication. Request that Aetna reprocess the claim under the correct coverage category once approval is confirmed.