Daa Pangenotypic Mavyret denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for daa pangenotypic mavyret 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 "Not FDA-Approved" Denial for Mavyret

This denial category is most commonly triggered by an administrative or coding mismatch rather than a genuine regulatory gap. Mavyret (glecaprevir/pibrentasvir) holds FDA approval for chronic hepatitis C virus (HCV) infection in adults and certain pediatric patients. If Aetna's system flags the claim as "not FDA-approved," the cause is almost always one of the following: the submitted diagnosis or indication code does not map to an FDA-approved use; a clerical error in the prior-authorization submission; or Aetna's automated review logic applied the wrong product category to the claim.

## Why This Denial Is Appealable

An insurer cannot sustain a "not FDA-approved" denial for a drug that holds FDA approval for the submitted indication. This type of denial is highly reversible when the correct FDA labeling and a clean clinical record are submitted together.

## Federal Appeal Framework

• ACA §2719 / ERISA §503: Non-grandfathered plans must offer internal review followed by independent external review.
• Timeline: Internal appeal typically must be filed within 180 days of the denial notice. External review must generally be requested within 4 months of an internal denial.
• Expedited option: If delay would seriously jeopardize your health, request expedited review; decision typically required within 72 hours.

## The Appeal Process

1. Pull the exact denial reason from the Explanation of Benefits and Aetna's clinical rationale letter. 2. Verify with your prescriber that the ICD-10 diagnosis code and J-code or NDC submitted accurately reflect the FDA-approved indication. 3. Attach a copy of the Mavyret FDA-approved prescribing label (available at DailyMed) to the appeal. 4. Submit a corrected prior-authorization request simultaneously if a coding error contributed to the denial. 5. If the internal appeal is denied, proceed to independent external review — an external reviewer applying FDA-approval standards is very likely to overturn this denial.

## Documentation to Gather

• FDA prescribing label: Print the current full prescribing information from DailyMed or the manufacturer; highlight the approved indication that matches your diagnosis.
• Diagnosis confirmation: Lab report confirming active HCV infection and genotype, matching the ICD-10 code submitted.
• Corrected claim or PA forms: Any corrected coding documents, if a submission error contributed to the denial.
• Prescriber attestation: A brief letter confirming the drug is being prescribed within its FDA-approved indication for this patient.

## Criteria-Mapping Structure

Create a side-by-side table: left column lists each element of the FDA-approved indication from the prescribing label; right column shows the patient's corresponding lab, diagnosis, and chart documentation. Pair this with a clean prior-authorization resubmission to close any coding gap that triggered the original denial.