Nucala denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for nucala 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 Requires Step Therapy for Nucala — and How to Appeal

Nucala (mepolizumab) is a targeted biologic for severe eosinophilic asthma and related conditions. Cigna's step-therapy (also called "fail-first") protocol requires that a member try and fail — or have a documented contraindication to — one or more lower-cost alternatives before the plan will cover Nucala. This type of denial is extremely common for biologics and does not mean your physician made the wrong clinical choice. It means the plan wants documented evidence that the required prior steps were tried.

### Why This Denial Is Appealable

Step-therapy denials can be overturned in several circumstances: you already tried and failed the required step drugs (but the documentation was not included with the original request); a required step drug is medically inappropriate for you; your disease severity makes delay dangerous; or state law includes a step-therapy exception mandate that limits what Cigna can require. Under ERISA §503 and ACA §2719, you are entitled to a full-and-fair internal review and, if that fails, binding independent external review.

### Federal Appeal Framework

• Internal appeal: File within 180 days of the denial. Standard appeals must be decided within 30–60 days; urgent appeals within 72 hours.
• External review: Request within approximately four months of the final internal denial. An Independent Review Organization makes a binding determination.
• Expedited option: Available if delay would seriously endanger your health — invoke it explicitly in writing and note the clinical urgency.

### Documentation to Gather

1. Diagnosis and severity documentation — specialist notes establishing the diagnosis (e.g., severe eosinophilic asthma) and its current severity level as recorded in the chart. 2. Step-drug trial history — for each drug Cigna's policy requires, provide: drug name, start date, end date or ongoing status, doses tried (per your physician's records), and documented reason for discontinuation or inadequate response. 3. Step-drug intolerance or contraindication records — if any required drug could not be used, provide the chart note, adverse-event record, or clinical rationale documented by your prescriber. 4. Prescriber medical-necessity letter — your physician should explain in detail why each required prior step was completed, failed, or is contraindicated, and why Nucala is now medically necessary. 5. Applicable guideline reference — your prescriber can cite the relevant professional society guideline organization (e.g., GINA, ATS/ERS) supporting biologic escalation after inadequate response to standard therapy, without needing to quote specific numbers.

### Criteria-Mapping Structure

Obtain Cigna's published step-therapy protocol for Nucala and map every required step against your documentation:

| Step Required by Cigna Policy | Dates Tried | Outcome Documented in Chart | |---|---|---| | [Step 1 drug per policy] | [Start–End] | [Response or reason stopped] | | [Step 2 drug per policy] | [Start–End] | [Response or reason stopped] |

Address each line explicitly in your appeal letter. A gap in the table — where a step drug was never tried — should be accompanied by a prescriber explanation of why it was medically inappropriate. Including the FDA prescribing label for Nucala to show the step is now clinically supported strengthens the appeal.