Tepezza TED denied as non-formulary by Aetna?

Aetna's specific coverage criteria for tepezza ted 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 May Issue a Non-Formulary Denial for Tepezza (Thyroid Eye Disease)

Tepezza (teprotumumab-trbw) is a specialty biologic infused in an outpatient setting for thyroid eye disease (TED). Aetna may classify it as non-formulary either because it sits on a specialty or excluded tier of the plan's drug benefit, or because the plan does not cover this class of biologic under the medical benefit without specific prior authorization. Non-formulary denials are not final — both the formulary exception process and the standard appeal pathway remain available, and TED patients have had strong success in demonstrating that no formulary alternative provides the same clinical benefit.

## Federal Appeal Rights

• Formulary exception request: File a formulary exception simultaneously with or before your formal appeal. Aetna is required under ACA §2719 to consider exceptions when the formulary alternative is contraindicated, clinically ineffective, or likely to cause adverse effects for the specific patient.
• Internal appeal: Under ERISA §503 and ACA §2719, you have the right to a full-and-fair internal review of the non-formulary denial. File within the deadline on your denial letter.
• External review: Independent external review is available after final internal denial under most ACA-compliant plans — generally for approximately four months from the date of final denial.
• Expedited review: If your physician certifies that delay would seriously jeopardize your vision or health, request expedited review (72-hour turnaround).

## What to Include in Your Appeal

1. Formulary alternative analysis: Identify every Aetna formulary-preferred TED or orbital inflammatory treatment. Your prescriber should explain in writing why each is clinically inadequate, contraindicated, or not therapeutically equivalent for your specific case. 2. No-therapeutic-equivalent letter: TED is a rare condition with limited treatment options. Your prescriber should state that Tepezza is the only FDA-approved therapy specifically indicated for TED, and that general corticosteroids or other formulary options do not address the same disease pathway. 3. Diagnosis and severity documentation: Ophthalmology and endocrinology records confirming active TED, severity, and clinical activity. 4. FDA label: Include the Tepezza label to establish its unique approved indication. 5. Professional society guidance: Reference applicable guideline recommendations from relevant professional organizations supporting Tepezza as the standard of care for appropriate TED patients.

## Criteria-Mapping Structure

| Formulary Exception / Appeal Criterion | Your Documentation | |---|---| | Active TED diagnosis | Ophthalmology and endocrinology notes | | FDA-unique indication for Tepezza | FDA label | | Formulary alternatives assessed and inadequate | Prescriber letter addressing each alternative | | Clinical urgency / risk of delay | Prescriber letter with severity documentation |

## Next Step

Request Aetna's current formulary tier list and non-formulary exception form from the member portal. Submit the exception request and appeal together — parallel submissions reduce delay in a condition where orbital changes can become permanent without timely intervention.