Soliris MG denied as non-formulary 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 Non-Formulary

A non-formulary denial means Aetna's drug formulary — its approved list of covered medications — does not include Soliris (eculizumab) at a covered tier for your specific plan, or that the drug requires a separate formulary exception process that was not completed. Soliris is an ultra-orphan biologic drug used for rare, serious conditions; it is among the highest-cost medications in the world, and many commercial formularies place it in a specialty tier requiring pre-approval or treat it as non-formulary absent a formulary exception.

This type of denial is frequently overturned through a formulary exception request, which is a defined right under most plan documents.

## Federal Appeal Framework

• Formulary exception request: Before or alongside a formal appeal, submit a formulary exception request. Plans subject to ACA §2719 and most ERISA plans are required to have an exceptions process. Your prescriber must document medical necessity and the inadequacy of formulary alternatives.
• Internal appeal (ERISA §503 / ACA §2719): You may also file a standard internal appeal of the non-formulary denial. Most plans allow 180 days from the denial notice.
• External review (ACA §2719): If internal remedies are exhausted, independent external review is available. The window is approximately four months from final internal denial.

## Appeal Process and Timeline

1. Request Aetna's formulary exception form and the list of formulary alternatives for your condition. 2. Have your prescriber complete the formulary exception request with a medical-necessity letter explaining why formulary alternatives are clinically inappropriate. 3. Simultaneously file a written internal appeal of the non-formulary denial. 4. If both are denied, escalate to external review.

## Documentation to Gather

• Diagnosis confirmation: Documentation of the specific rare condition for which Soliris is prescribed, confirming it falls within an FDA-approved indication.
• Formulary alternatives review: A written assessment from your prescriber of each drug on Aetna's formulary for this condition, explaining — with clinical specifics — why each is contraindicated, inappropriate, or expected to be ineffective based on your individual clinical profile. (Obtain exact contraindication and interaction information from the FDA-approved prescribing labels for those alternatives, not from memory.)
• Prescriber medical-necessity letter: A letter explaining why Soliris is uniquely necessary and why no formulary alternative is an acceptable substitute.
• Chart documentation: Clinical notes and lab data establishing diagnosis, severity, and prior treatment history.

## Criteria-Mapping Structure

Obtain Aetna's formulary exception criteria from the plan's Evidence of Coverage document. For each exception criterion — typically including a requirement to document failure of or contraindication to formulary alternatives — provide a point-by-point answer from the chart. Confirm the specific covered status and tier requirements in Aetna's current published formulary for your plan year, as formulary tier placements change annually.