Fostamatinib ITP denied as experimental or investigational 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 Denied Fostamatinib (for ITP) as Experimental

Aetna's experimental or investigational denial for fostamatinib (Tavalisse) in ITP is highly contestable. Fostamatinib received FDA approval for the treatment of thrombocytopenia in adults with chronic ITP who have had an insufficient response to a prior therapy. If your use falls within that approved indication, an experimental denial is factually inconsistent with the FDA's determination and should be reversed on appeal.

The most common reasons Aetna applies this label despite FDA approval are: the claim was submitted under a diagnosis or indication code that does not match the approved label, Aetna's internal coverage policy has not yet been updated to reflect current FDA status, or the policy applies the experimental designation to a patient population subset that Aetna's criteria do not recognize.

## Federal Appeal Framework

• Internal appeal: File within the timeframe stated on your denial letter. Aetna must decide within 30 days (non-urgent) or 72 hours (expedited). Attach the FDA prescribing label to the appeal package.
• External review (ACA §2719 / ERISA §503): After an internal denial, request independent external review within approximately 4 months. An IRO independent of Aetna reviews the experimental-status question with access to the full clinical record and applicable FDA documentation. Expedited review is available when delay creates a serious health risk — relevant here given the bleeding risks associated with severe thrombocytopenia.

## Documentation to Gather

1. FDA prescribing label: Download the current Prescribing Information for fostamatinib from FDA's Drugs@FDA database. Highlight the approved indication and the patient population criteria (prior therapy requirement) that match your clinical history. 2. Diagnosis and disease history: Physician notes confirming chronic ITP diagnosis, duration, and platelet count history establishing chronicity and inadequate response to prior therapy. 3. Prior-therapy documentation: A dated list of prior ITP treatments with outcomes, confirming that you meet the FDA-approved indication's "insufficient response to a prior therapy" requirement. 4. Hematologist rebuttal letter: A letter from the treating physician rebutting the experimental determination, citing the FDA approval date and indication, and explaining how your case is squarely within the approved use. 5. Guideline support: Reference to the applicable guideline organization (e.g., the American Society of Hematology) that includes fostamatinib among recognized treatment options for persistent or chronic ITP.

## Criteria-Mapping Structure

Obtain the exact language from Aetna's clinical policy bulletin that triggered the experimental finding. For each criterion or exclusion cited, document the counter-evidence from the FDA label, the chart, and the hematologist's letter. Present the rebuttal as a structured table: Aetna's basis for denial in the left column, the specific factual rebuttal in the right column. Submit the FDA prescribing label as Exhibit A.