Ohtuvayre denied for missing prior authorization by Aetna?

Aetna's specific coverage criteria for ohtuvayre 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 Requires Prior Authorization for Ohtuvayre

Ohtuvayre (ensifentrine) is a newer inhaled COPD maintenance therapy, and like most specialty or brand-only medications, Aetna's formulary requires prior authorization (PA) before the plan will cover it. A PA-required denial does not mean your claim has been reviewed and found unjustified — it means the claim was submitted without the insurer first reviewing and approving coverage. This type of denial is resolved by initiating (or re-submitting) the PA process with complete supporting documentation.

## Why This Denial Is Appealable — and How PA Fits In

If a PA was submitted and denied on clinical grounds, that denial is a coverage determination subject to full appeal rights:

• Internal appeal (ERISA §503 / ACA §2719): You or your provider may appeal a denied PA. The plan must provide a full-and-fair review within regulated timelines.
• External review (ACA §2719): After internal exhaustion, or after 4 months from the denial date, you may request Independent Review Organization (IRO) review. The IRO decision is binding on the plan.
• Expedited review: If standard timelines would seriously jeopardize your health, request expedited PA and expedited appeal simultaneously. Expedited PA decisions are typically required within 72 hours.

If the PA was never submitted, the fix is administrative: your prescriber's office initiates the PA. If the PA was submitted but denied, the fix is a clinical appeal.

## Documentation to Gather for the PA or PA Appeal

1. COPD diagnosis documentation: Spirometry results and clinical notes confirming diagnosis and disease severity classification. 2. Current medication list and treatment history: A dated, annotated list of all COPD therapies tried, with start/stop dates and reason for change or discontinuation. 3. Symptom burden documentation: Chart notes showing persistent symptoms or exacerbations despite current therapy. 4. Prescriber medical-necessity letter: A letter explaining why Ohtuvayre is medically necessary for this patient and why covered alternatives are not clinically equivalent. 5. Aetna's PA criteria: Download Aetna's current Clinical Policy Bulletin for Ohtuvayre and confirm your prescriber's letter addresses every listed criterion explicitly.

## Criteria-Mapping Structure

Obtain the exact PA criteria from Aetna's Clinical Policy Bulletin (aetna.com, search "Clinical Policy Bulletins"). Create a two-column table: left column lists each PA criterion verbatim; right column provides the specific chart fact, date, and document that satisfies it. Submit this table with the PA request or appeal.

## Next Step

Have your prescriber's office call Aetna's PA line (number on the back of your insurance card) to confirm the correct PA form, fax number, and turnaround time. If the PA was previously denied, request the denial reason in writing and the full clinical review notes before drafting the appeal.