Tepezza TED denied as experimental or investigational 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 an "Experimental" Denial for Tepezza (Thyroid Eye Disease)

Tepezza (teprotumumab-trbw) received full FDA approval for thyroid eye disease (TED). An "experimental or investigational" denial from Aetna in this context is almost always based on an outdated clinical policy bulletin that has not yet been updated to reflect FDA approval status, or on a claim that lists a specific sub-indication or severity descriptor that Aetna has separately flagged. This category of denial has a strong track record of reversal on appeal because FDA approval establishes that a treatment is, by definition, not experimental for its approved indication.

## Federal Appeal Rights

• Internal appeal: Under ACA §2719 and ERISA §503, you are entitled to a full-and-fair internal review. Many state insurance codes add additional protections for experimental-use denials. Check whether your state law applies to your plan type.
• External review: An independent external reviewer (not employed by Aetna) will review the denial on its merits. This right is available under most ACA-compliant plans for approximately four months after a final internal denial.
• Expedited review: If your treating physician certifies that delay would seriously jeopardize your vision or health, request expedited review — Aetna must respond within 72 hours.

## What to Include in Your Appeal

1. FDA approval documentation: Print the current FDA approval letter and label for Tepezza from the FDA website (fda.gov) and include them. This is often the single most important document in an experimental-use denial appeal. 2. Aetna clinical policy bulletin: Obtain the current version of Aetna's own policy on Tepezza/teprotumumab. If the policy has been updated to acknowledge FDA approval, cite it directly; if it appears outdated, note the discrepancy in your appeal letter. 3. Diagnosis documentation: Ophthalmology and endocrinology records confirming the TED diagnosis, severity, and clinical activity. 4. Prescriber medical-necessity letter: Your treating physician should state that Tepezza is FDA-approved for the patient's specific diagnosis and is the standard of care per applicable professional society guidelines. 5. Professional society guideline support: Reference applicable guidance from relevant professional organizations (e.g., American Thyroid Association) to demonstrate that Tepezza reflects current accepted medical practice.

## Criteria-Mapping Structure

| Aetna Experimental-Use Criterion | Your Documentation | |---|---| | FDA approval status for the indicated use | FDA approval letter and label | | Diagnosis and indication match | Clinical notes, imaging | | Accepted medical practice | Professional society guideline | | Prescriber attestation | Prescriber letter |

## Next Step

Download and date-stamp Aetna's current clinical policy bulletin for Tepezza before filing. If the policy predates FDA approval or has not been updated, reference the policy date gap explicitly in your appeal letter — this often resolves the denial at the internal review level.