Evenity denied as not FDA-approved for this use by Aetna?

Aetna's specific coverage criteria for evenity 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 Evenity as "Not FDA-Approved"

Evenity (romosozumab) holds full FDA approval for its labeled indication in postmenopausal osteoporosis at high fracture risk. When Aetna issues a "not FDA-approved" denial for Evenity, it almost always reflects one of three situations: (1) the prescription was written for a patient population or an indication that falls outside the precise wording of the FDA-approved label; (2) Aetna's internal policy cites the FDA approval but then adds coverage criteria that the submitted documentation did not satisfy, and the denial letter uses "not FDA-approved" loosely to mean "not covered under our policy for this use"; or (3) an administrative processing error caused the claim to be routed through the wrong denial pathway.

## Why This Denial Is Appealable

Because Evenity has received full FDA approval, a denial premised on lack of FDA approval is factually rebuttable on its face when the drug is being used within its labeled indication. If the real issue is an off-label use, the appeal should address the applicable off-label use standard in your plan document. You are entitled to a full internal appeal under ERISA §503 or your state's insurance law, and to independent external review under ACA §2719 after internal remedies are exhausted, generally within approximately four months of the final internal denial. Expedited review is available for urgent clinical situations.

## Your Appeal Timeline

1. Request the denial letter and Aetna's operative clinical policy for romosozumab, noting the specific FDA-approval language cited. 2. Obtain the current FDA-approved prescribing label for romosozumab and confirm whether the prescribed use is on-label. 3. File a first-level internal appeal within the deadline on your Explanation of Benefits. 4. Escalate to external review if internally denied.

## Documentation to Gather

• FDA prescribing label: A copy of the current FDA-approved labeling for romosozumab confirming the approved indication and patient population.
• Diagnosis and indication alignment: Clinical notes, DXA scan results, and fracture history showing that the prescription is for a diagnosis and patient profile consistent with the FDA-approved labeled indication.
• Prescriber medical-necessity letter: A letter from your prescribing physician confirming that Evenity is being prescribed within its FDA-approved indication, referencing the applicable labeling, and noting support from the relevant professional society guideline (e.g., Endocrine Society or ASBMR).
• Aetna policy effective date check: Confirm whether Aetna's policy version is current relative to the FDA approval date — a stale policy may be the root of the error.

## Criteria-Mapping Structure

Map Aetna's denial language to the actual FDA record:

| Denial Claim | Rebuttal Evidence | |---|---| | Drug lacks FDA approval | Cite FDA approval date and labeled indication | | Use is outside labeled indication | Cite prescriber confirmation of on-label use | | Policy version is current | Cite policy effective date vs. FDA approval date |

A focused, factual rebuttal that cites the FDA-approved prescribing label directly — and confirms the prescription matches the approved indication — is typically sufficient to reverse a not-FDA-approved denial for Evenity.