PrEP Apretude LA denied due to quantity / dose limits 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 Limits the Quantity of Apretude (Cabotegravir LA) — and Why You Can Appeal

Apretude (cabotegravir long-acting injectable) is an FDA-approved HIV pre-exposure prophylaxis (PrEP) medication given by injection on a schedule defined in the FDA-approved prescribing label. Because the injection intervals are fixed by the label and are not monthly, Aetna's standard quantity-limit edits — which are often built around 30- or 90-day supply rules designed for daily oral drugs — can misfire and generate an automatic denial even when a clinician is prescribing exactly within label.

### Why This Is Appealable

A quantity-limit denial on a fixed-schedule injectable is a technical mismatch between the plan's dispensing logic and the drug's FDA-approved dosing schedule, not a determination that the drug is medically unnecessary. Federal law requires that coverage decisions align with the FDA label. Under the Affordable Care Act's preventive-services mandate, qualifying PrEP medications must be covered without cost-sharing; an improperly applied quantity limit that obstructs access may independently violate that mandate.

### Your Federal Appeal Rights

• Internal appeal: You have the right to a full and fair internal review under ERISA §503 (job-based plans) or ACA §2719 (individual/marketplace plans). Submit within the timeframe on your denial notice — typically 180 days.
• External review: If the internal appeal is denied, you may escalate to an Independent Review Organization (IRO) under ACA §2719. The external-review window is generally within four months of the final internal denial.
• Expedited review: If a standard timeline would seriously jeopardize your health, request expedited review — decisions are typically required within 72 hours.

### Documentation to Gather

1. Prescriber letter of medical necessity — should state that the prescribed quantity and interval are required by the FDA-approved label for Apretude, that the patient is an appropriate PrEP candidate per current clinical guidelines (reference the relevant guideline organization, such as the CDC or USPSTF, without quoting specific numbers), and that no daily oral alternative is clinically equivalent for this patient. 2. FDA prescribing label — download from DailyMed and highlight the exact dosing-interval schedule. Attach it directly to your appeal. 3. Aetna's quantity-limit policy — obtain the specific policy number and criteria from Aetna's website or your denial letter. Show line-by-line how the prescribed quantity conforms to, or is necessitated by, the label. 4. Diagnosis and risk-factor documentation — chart notes confirming eligibility for PrEP under the applicable guideline organization's criteria.

### Criteria-Mapping Structure

Copy each quantity-limit requirement listed in Aetna's policy into a table. In the right column, cite the specific chart entry or FDA label section that satisfies it. Attach the completed table as the first page of your appeal letter. This format forces a reviewer to engage with each criterion individually rather than applying a blanket rule.

### Next Step

Request Aetna's complete Clinical Policy Bulletin for Apretude in writing before drafting your appeal. The bulletin will list every criterion; address each one explicitly. If the denial persists after internal appeal, file for external review immediately — an IRO evaluates the claim against the FDA label and accepted medical standards, not just the insurer's internal policy.