Fscig Hyqvia denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for fscig hyqvia 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 Denied HyQvia Under "Step Therapy" — and Why It Is Often Overturned

Cigna's clinical coverage policy for immune globulin therapy typically requires that a patient demonstrate an adequate trial of — or a clinical reason to bypass — an intravenous immunoglobulin (IVIG) formulation before approving subcutaneous HyQvia (immune globulin infusion 10% with recombinant human hyaluronidase). This is called a step-therapy or "fail-first" requirement. The denial does not mean HyQvia is inappropriate; it means Cigna's automated system did not see documented evidence that the required prior step was completed or that a step-therapy exception applies.

## Why This Denial Is Frequently Appealable

Many patients prescribed HyQvia have a legitimate clinical reason to go directly to the subcutaneous route — including prior adverse reactions to IV administration, poor venous access, quality-of-life or logistical factors documented by the prescriber, or a transition from a prior IVIG regimen. Federal and many state step-therapy exception laws require insurers to grant exceptions when the required prior drug is contraindicated, has been tried and failed, or when a specific clinical reason supports bypassing the step. If any of these apply to your situation, the denial is appealable on step-therapy exception grounds.

## Federal Appeal Framework

• Step-therapy exception request — File simultaneously with or before the formal internal appeal. Many states have separate step-therapy exception statutes with short deadlines; check the laws applicable to your plan.
• Internal appeal — Submit within the deadline shown on your Explanation of Benefits (commonly 180 days). Under ERISA §503, request the exact coverage criteria and step-therapy protocol Cigna used.
• ACA §2719 external review — After an adverse internal decision, an Independent Review Organization can review whether Cigna's step-therapy application was consistent with clinical standards. The standard window is approximately four months; confirm the exact date on your denial letter.
• Expedited review — Available if delay would seriously jeopardize your health; typically decided within 72 hours.

## Documentation to Gather

• Prior IVIG history — Dates, formulations, durations, and outcomes of any previous IV immunoglobulin therapy. If you completed the required step, this documentation alone may resolve the denial.
• Step-therapy exception evidence — If you have a clinical reason to bypass the required step, your prescriber should document it explicitly: adverse reactions (with dates and descriptions), venous access issues, or other clinical factors.
• Prescriber medical-necessity letter — A letter addressing the step-therapy protocol directly, confirming either that the required step was completed or that a specific clinical reason warrants an exception, with reference to the FDA prescribing label for HyQvia.
• FDA prescribing label — Attach the current label to establish the approved indication and the clinical basis for subcutaneous administration.
• Cigna coverage policy — Obtain the current policy to identify each step-therapy requirement and address each one individually.

## Criteria-Mapping Structure

| Step-Therapy Requirement | Chart Evidence or Exception Basis | |---|---| | Required prior therapy completed | Dates + prescriber + outcome documented in chart | | OR: Exception criterion met | Specific clinical reason documented by prescriber | | Diagnosis qualifies for immune globulin coverage | Specialist note + diagnosis code | | Each additional policy criterion | Specific chart reference |

A prescriber letter that addresses the step-therapy protocol by name and answers each criterion directly is the single most effective document in this type of appeal.