Soliris MG denied for missing prior authorization 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) for Prior Authorization

A prior-authorization (PA) denial means Aetna requires advance approval before covering Soliris (eculizumab), and that approval was either not obtained before the drug was administered or dispensed, or a submitted authorization request was denied because it did not satisfy the plan's clinical criteria. Soliris is a high-cost specialty biologic, and prior authorization is standard practice for this class of drug across virtually all commercial plans.

This type of denial is the most common and the most routinely overturned on appeal when proper documentation is submitted.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): You have the right to a full-and-fair internal review of a PA denial. Most plans allow 180 days from the denial notice.
• Urgent/expedited PA: If treatment is medically urgent, request an expedited prior-authorization review, which must be decided within 72 hours under federal rules for urgent cases.
• External review (ACA §2719): If the internal appeal is denied, independent external review is available. The window is approximately four months from final internal denial.

## Appeal Process and Timeline

1. Request the full denial letter including the specific criteria the submission failed to meet. 2. Obtain Aetna's current clinical criteria for Soliris prior authorization — these are published in Aetna's clinical policy bulletins. 3. Work with your prescriber to compile documentation that addresses every criterion, then resubmit or appeal. 4. If denied on appeal, escalate to external review. Request expedited processing if clinically urgent.

## Documentation to Gather

• Diagnosis confirmation: Specialist records, laboratory findings, and imaging that establish the precise FDA-approved indication — aligned with the ICD-10 codes on the PA request.
• Clinical severity documentation: Chart notes, objective lab trends, and functional assessments demonstrating the severity and activity of the condition.
• Prior-treatment history: A chronological record of all treatments previously tried for this condition, with dates, outcomes, and documented reasons for discontinuation or failure — addressing any step-therapy or formulary-alternative requirements in the PA criteria.
• Prescriber medical-necessity letter: A letter from the treating specialist that maps each PA criterion directly to the clinical record, explaining why Soliris is medically necessary and why the patient meets every coverage requirement.
• Vaccinations and safety monitoring: Confirm that the prescribing label's required pre-treatment steps (e.g., meningococcal vaccination, as noted in the Soliris label — verify the current requirements in the FDA-approved prescribing information) are documented, as plans often require evidence of these as part of PA.

## Criteria-Mapping Structure

Obtain Aetna's clinical policy bulletin for Soliris. Create a table listing every PA criterion in the left column. In the right column, provide the exact chart fact — date, test result, clinical note — that satisfies each criterion. Submit this table with the appeal. Do not leave any criterion blank; an unanswered criterion is the most common reason a PA appeal fails on the first round.