PrEP Apretude LA denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for prep apretude la 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 Apretude (Long-Acting Cabotegravir) as "Not FDA-Approved" — and How to Appeal

Apretude (cabotegravir extended-release injectable suspension) received FDA approval for HIV pre-exposure prophylaxis (PrEP) in December 2021. A denial stating it is not FDA-approved is factually incorrect as applied to its approved indication and is one of the most straightforwardly reversible denial types. The most common cause is an outdated Aetna clinical policy bulletin — one drafted before or shortly after approval that has not yet been updated in the reviewer's queue — or an incorrect application of a policy intended for a different cabotegravir formulation.

## Why This Denial Is Appealable

A denial that mischaracterizes an FDA-approved drug as unapproved cannot be sustained under the plan's own terms, which typically condition coverage on FDA approval for the proposed indication. When the documentation shows the drug is approved and is being used within that approved indication, the denial lacks a factual basis. Independent external reviewers are not bound by Aetna's internal classifications and will apply the correct regulatory standard.

## Your Federal Appeal Rights

• ACA §2719 / ERISA §503 — Non-grandfathered commercial and employer-sponsored plans must provide full-and-fair internal appeal and independent external review.
• External review window — Typically approximately four months from the adverse determination date. Track this carefully.
• Expedited review — If delay creates a serious clinical risk (e.g., ongoing high-risk exposure and delayed PrEP initiation), expedited processing is available and typically resolves within 72 hours.

## Concrete Appeal Steps

1. Obtain the denial letter and the Aetna clinical policy bulletin applied — Note the policy effective date and compare it to the FDA approval date for Apretude. 2. Gather FDA approval documentation — The approval letter and prescribing information are publicly available from the FDA website; include the approval date and approved indication in your appeal. 3. File a Level 1 internal appeal — Cite FDA approval status, note the approved indication, and include your prescriber's confirmation that the drug is being used within that indication. 4. Request a peer-to-peer review — A direct call between your prescriber and Aetna's medical director frequently resolves not-FDA-approved denials before external review is needed. 5. File for independent external review if internal appeals fail.

## Documentation to Gather

• FDA approval reference for Apretude in the PrEP indication — include the FDA approval date and the approved indication statement.
• Aetna clinical policy bulletin for Apretude or long-acting injectable PrEP — obtain the version applied to your claim, note its effective date, and identify any language that predates or mischaracterizes approval status.
• Prescriber letter confirming the drug is being prescribed for its FDA-approved indication and that your clinical situation meets the approved use criteria.
• HIV testing records and clinical history confirming HIV-negative status and active PrEP candidacy.

## Criteria-Mapping Structure

For each criterion Aetna used to classify Apretude as not FDA-approved, write one sentence rebutting it with a verifiable fact — citing the FDA approval date, the approval document reference, or the specific prescribing information language. Present this as a numbered list so every basis for the denial is directly answered.