Ohtuvayre denied as not FDA-approved for this use 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 May Issue a "Not FDA-Approved" Denial for Ohtuvayre

Ohtuvayre (ensifentrine) received FDA approval as a maintenance treatment for COPD. A denial coded as "not FDA-approved" most commonly occurs for one of three reasons: (1) an administrative coding error where the claim was processed under an incorrect drug or indication code; (2) a plan policy that restricts coverage to indications listed under a specific code set, and the submitted code does not match; or (3) a request for an off-label use that the plan does not separately cover.

If your prescriber is using Ohtuvayre for its FDA-approved COPD maintenance indication, a "not FDA-approved" denial is almost certainly an error and is highly appealable.

## Why This Denial Is Appealable

• Internal appeal (ERISA §503 / ACA §2719): Submit a formal written appeal correcting the factual record. Attach the FDA approval letter or the FDA label showing the approved indication. Plans must conduct a full-and-fair review.
• External review (ACA §2719): Available after internal exhaustion or after 4 months from denial. An Independent Review Organization reviews the clinical and regulatory record de novo.
• Expedited option: If delay would seriously jeopardize your health, request expedited external review (typically 72-hour turnaround).

## Documentation to Gather

1. FDA prescribing information: Print the current FDA-approved prescribing label for Ohtuvayre from DailyMed (dailymed.nlm.nih.gov). Highlight the approved indication and the exact indication language. 2. Correct diagnosis and procedure codes: Ask your prescriber's billing office to confirm that the submitted ICD-10 diagnosis code and NDC/HCPCS code are accurate and match the approved indication. 3. Prescriber letter: A brief letter from your physician confirming that the prescribed use is exactly the FDA-approved indication for COPD maintenance. 4. Denial record: Request the complete clinical review notes underlying the denial — under ERISA you have the right to this record.

## Criteria-Mapping Structure

In your appeal letter, state the legal basis clearly: "The FDA granted approval of ensifentrine (Ohtuvayre) for [the approved indication]. The prescribed use is on-label. The plan's denial reason is factually incorrect." Attach the FDA label as Exhibit A. Attach the corrected claim coding as Exhibit B. Keep the argument narrow and factual — no clinical elaboration needed if the denial rests solely on the regulatory status question.

## Next Step

Call Aetna Member Services before filing a written appeal. A coding correction submitted by your provider's billing office may resolve the denial without a formal appeal process. Document the call (date, representative, reference number) in case a written appeal becomes necessary.