Soliris MG denied for failing step therapy 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) Under Step Therapy

A step-therapy denial (also called "fail-first") means Aetna requires that you try and fail one or more less costly or preferred medications before it will approve Soliris (eculizumab). For a complement inhibitor treating rare diseases such as PNH, aHUS, gMG, or NMOSD, this type of denial is particularly consequential — and frequently inappropriate — because the conditions Soliris treats may have no true therapeutic equivalent, or because a step-therapy requirement may impose clinically dangerous delays.

Many states have enacted step-therapy override laws that require plans to waive step-therapy requirements when the required first-step drugs are contraindicated, previously failed, or when requiring step therapy would cause clinically significant harm. Federal employees and self-insured ERISA plans may have different protections; confirm which rules apply to your plan.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): File a full-and-fair internal appeal. Most plans allow 180 days from the denial notice.
• Step-therapy override request: Simultaneously with or before the formal appeal, submit a step-therapy override (or "exception") request, which is a separate mechanism in many plans and states. Your prescriber must document the clinical basis for the override.
• External review (ACA §2719): If internal remedies are exhausted, independent external review is available. The window is approximately four months from final internal denial. Expedited review is available when delay would seriously jeopardize your health.

## Appeal Process and Timeline

1. Obtain the step-therapy criteria from Aetna's clinical policy bulletin and identify which drugs are required as prerequisite steps. 2. Review each required step drug with your prescriber to determine whether any override basis applies (previous failure, contraindication, clinical harm from delay). 3. Submit both a step-therapy override request and a written internal appeal simultaneously. 4. If denied, escalate to external review with an urgency argument if clinically warranted.

## Documentation to Gather

• Step-drug history: For each drug required by the step protocol, documentation showing either: prior use with dates and outcome (failure, adverse event, insufficient response); a clinical reason the drug cannot be used for this patient; or a statement from the prescriber that the drug is not appropriate for this specific indication.
• Diagnosis and disease-severity documentation: Records establishing the specific condition and its severity, supporting the argument that delay for step therapy poses clinical risk.
• Prescriber medical-necessity and override letter: A letter from the treating specialist explaining why each step drug is not an appropriate substitute, why proceeding directly to Soliris is medically necessary, and citing the applicable specialist society guidelines by organization name.
• State step-therapy override statute: If your plan is subject to state regulation, identify the applicable state law and include it in the appeal to invoke the override process by right.

## Criteria-Mapping Structure

Obtain Aetna's step-therapy policy for Soliris. List each required step drug. For each, document the override basis from the chart. Map this to the override criteria in the policy or applicable state law. A well-constructed step-therapy appeal demonstrates either prior failure of each required step or a compelling clinical reason why step therapy cannot safely be applied to this patient.