Anifrolumab denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for anifrolumab 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 Cigna Denies Anifrolumab Under Step Therapy

Step therapy (also called "fail-first") denials require that a patient try one or more less expensive or more established treatments before Cigna will authorize the requested drug. For anifrolumab, Cigna's step therapy protocol for moderate-to-severe SLE typically requires documented trial of conventional immunosuppressant agents and/or other biologics before anifrolumab is approved. A step therapy denial means either (a) the required prior treatments were not documented in the submission, or (b) the plan's records do not reflect adequate trials of those agents.

## Why This Denial Is Appealable

Step therapy denials are frequently overturned when the prescriber's chart documents that the patient has already tried and failed the required agents — a scenario called "step therapy exceptions." Additionally, many states have enacted step therapy override laws requiring plans to grant exceptions when a required drug would be contraindicated, when the patient has already failed the required step, or when the required step would cause clinically significant harm. Even where state law does not apply (ERISA self-funded plans), the federal full-and-fair review process still applies.

## Your Federal and State Appeal Rights

• Step therapy exception request / internal appeal: File a written exception citing the specific step(s) already completed, with chart documentation. Under ERISA §503 and ACA §2719, this is an adverse benefit determination subject to full-and-fair review.
• State step therapy laws: Check whether your state has a step therapy override law — many require the plan to grant an exception within a defined timeframe when the prior-step criteria are met.
• External review: If the internal appeal is denied, independent external review is available. File within approximately four months of the final internal denial. An external reviewer will assess whether the step therapy requirement was applied consistently with medical standards.
• Expedited review: Available if waiting through the standard step would seriously jeopardize health.

## Documentation to Gather

1. Prior treatment history — dated and detailed — for every step Cigna requires: the drug name, start and end dates, doses as prescribed, and the documented clinical outcome (inadequate response defined in the chart, intolerance with description of adverse effects, or prescriber-documented reason the drug was not appropriate). 2. Diagnosis and severity documentation — confirming moderate-to-severe SLE, disease-activity scores, organ involvement, flare frequency. 3. Cigna's step therapy criteria — obtain the exact steps required from Cigna's published coverage policy or PA criteria. Map each completed step to a chart entry. 4. Prescriber medical-necessity letter — explaining why anifrolumab is appropriate now and why the required steps are either completed or not clinically appropriate for this patient, referencing applicable rheumatology guidelines (e.g., ACR guidance) without citing specific numbers. 5. Any step therapy exception criteria — Cigna's policy may list conditions under which exceptions are granted. Address each one directly.

## Criteria-Mapping Structure

List Cigna's required steps in a numbered table. For each step, note whether it was completed (with chart dates and outcomes) or whether a clinical exception applies (with prescriber explanation). Attach visit notes and pharmacy records as exhibits. A complete step-by-step response makes the appeal easy to approve and hard to deny without a detailed written rebuttal.