Evenity denied for failing step therapy 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 Requires Step Therapy for Evenity — and How to Appeal

Evenity (romosozumab) is a bone-forming agent approved for postmenopausal osteoporosis at high fracture risk. Step-therapy denials from Aetna occur when the plan's coverage policy requires documentation that one or more alternative osteoporosis treatments were tried and failed, or were clinically inappropriate, before Evenity will be authorized. This approach is common for high-cost injectables, but step-therapy requirements are legally overridable when clinical circumstances justify going directly to the requested therapy.

## The Federal Appeal Framework

Under ACA §2719, you have the right to internal appeal followed by independent external review (IRO). The external review window is typically four months after exhausting internal remedies. Request an expedited review if waiting poses a significant health risk.

For employer-sponsored self-funded plans, ERISA §503 applies: the plan must provide a full-and-fair review, a written explanation of the denial citing the specific criteria used, and copies of any clinical guidelines relied upon — all on request.

Many states also have step-therapy override laws that require insurers to grant exceptions when a patient tried a required step-therapy drug and it failed, caused an adverse reaction, or is contraindicated based on the patient's individual clinical presentation. Check whether your state's insurance code includes such a provision and cite it explicitly in your appeal.

## Documentation to Gather

• Prior therapy records: Dated pharmacy fill history, clinical notes, and lab or imaging results for every alternative osteoporosis therapy tried, showing start date, dose adjustments, duration, and reason for discontinuation or inadequate response.
• Adverse-reaction or intolerance documentation: If the required step-therapy agent was not tried because of a documented clinical reason, include chart notes, allergist letters, or specialist correspondence explaining why.
• Fracture risk evidence: DXA reports, vertebral imaging, and the treating physician's documented fracture-risk assessment.
• Prescriber's medical-necessity letter: A detailed letter explaining why the patient has either completed required prior steps or meets a clinical exception, citing the FDA-approved labeling for Evenity and applicable osteoporosis guidelines from the relevant professional society (e.g., the applicable guideline from the American Society for Bone and Mineral Research or the Endocrine Society).

## Criteria-Mapping Structure

Create a table that matches each step-therapy requirement in Aetna's policy to the patient's actual chart:

| Aetna Step-Therapy Requirement | Patient Chart Evidence | |---|---| | [Copy verbatim from Aetna's clinical policy for Evenity] | [Exact chart note, date, provider, outcome] |

Obtain Aetna's specific clinical policy document and the FDA prescribing label. Each step listed in the policy should be answered with a corresponding chart entry showing it was completed, failed, or is contraindicated for this individual patient.

## Practical Next Steps

1. Obtain the denial letter citing the exact step-therapy criteria applied. 2. Pull complete medication history and chart notes for all prior osteoporosis therapies. 3. Have the prescriber write a letter directly addressing each step-therapy requirement. 4. File the internal appeal with the criteria-mapping table attached. 5. If denied internally, escalate immediately to independent external review — IRO reviewers frequently overturn step-therapy denials when the prior-therapy record is complete and well-documented.