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

Aetna's specific coverage criteria for soliris mg 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 Soliris (Eculizumab) as Not FDA-Approved

A "not FDA-approved" denial from Aetna typically means one of two things: (1) the reviewer believes the prescribed use of Soliris (eculizumab) does not match any FDA-approved indication, or (2) the plan restricts coverage to on-label uses only and the submitted indication is off-label. Soliris holds FDA approval for several serious rare conditions, so this denial most commonly arises when the diagnosis coding on the claim does not precisely align with an approved indication, or when the drug is being used for a related but technically off-label condition.

This denial is often correctable with proper documentation and, where the use is legitimately off-label, with evidence of guideline support.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): You have the right to a full-and-fair internal review. Most plans allow 180 days from the denial notice.
• External review (ACA §2719): If the internal appeal fails, external review by an independent organization is available. The window is approximately four months from final internal denial. Expedited review is available for urgent medical situations.
• Off-label protections: Many states have laws requiring coverage of off-label oncology and serious-disease uses that are supported by recognized compendia or national specialty society guidelines. Check your state's applicable statute.

## Appeal Process and Timeline

1. Verify the FDA-approved indications for Soliris in the current prescribing label and confirm whether the prescribed use is on-label or off-label. 2. If on-label, confirm that the diagnosis codes submitted on the claim match the approved indication exactly. 3. File a written internal appeal with a corrected claim if there was a coding error, or with guideline and compendia support if the use is off-label. 4. If internally denied, escalate to external review.

## Documentation to Gather

• Diagnosis confirmation: Records establishing the precise diagnosis with ICD-10 coding that matches the FDA-approved indication — or, for off-label use, records demonstrating the clinical rationale and guideline support.
• FDA prescribing label: Reference the current Soliris prescribing information (available from the FDA or the manufacturer) to confirm the exact approved indications. Provide this to Aetna as part of the appeal.
• Prescriber medical-necessity letter: A letter from the treating specialist identifying the precise indication, whether it is on-label or off-label, and — if off-label — citing the relevant professional society guidelines by organization name and noting any compendium listings.
• Prior-treatment history: Documentation of other treatments attempted, relevant to establishing medical necessity.

## Criteria-Mapping Structure

Obtain Aetna's clinical policy for Soliris and its definition of "FDA-approved use." List each approved indication from the prescribing label. Confirm in writing that the patient's documented diagnosis and clinical presentation match one of those indications. If the use is off-label, map the guideline organization's recommendation to the plan's off-label coverage criteria. Ensure the diagnosis coding on all submitted claims is consistent with this mapping before resubmitting.