Evrysdi denied for failing step therapy by Cigna?

Cigna's specific coverage criteria for evrysdi 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 Evrysdi Under Step Therapy

Cigna's step-therapy (also called "fail-first") protocol for SMA medications requires evidence that the patient has previously tried and had an inadequate response to one or more other SMA therapies before Evrysdi (risdiplam) will be approved. Because the SMA therapy landscape includes Spinraza (intrathecal) and Zolgensma (gene therapy, typically for younger patients), Cigna may require documentation of a prior trial or a clinical reason why the step-therapy sequence does not apply to this patient.

Step-therapy denials are highly appealable when the record documents prior treatment failure, or when the mandated prior therapy is clinically inappropriate for the individual.

## Why It Is Appealable

Under ACA §2719, step-therapy protocols are subject to exceptions and full internal appeal. More than 30 states have enacted step-therapy reform laws requiring that plans grant exceptions when step therapy is clinically contraindicated or has already failed; check whether your state's law applies to this plan type. ERISA §503 provides full-and-fair review rights for self-funded plans. The internal appeal window is 180 days from the denial. External review must be filed within four months of the final adverse internal decision. Expedited review is available when the patient's health requires rapid resolution.

## Appeal Process and Timeline

1. Request the specific step-therapy protocol — Cigna must provide the exact sequence of required prior therapies and the documentation it expects. 2. Step-therapy exception request — file alongside or before the formal appeal. Exception grounds include: prior therapy has already been tried and failed, prior therapy is clinically contraindicated, prior therapy is not appropriate for the patient's SMA type or age, or the clinical urgency of the patient's condition makes a trial period medically inappropriate. 3. Internal appeal — file within 180 days. Cigna's standard decision timeline is 30 days for non-urgent pre-service appeals. 4. External review — file within four months of the final adverse internal decision. 5. Peer-to-peer call — have the neurologist request a peer-to-peer discussion with Cigna's medical director; step-therapy exceptions are frequently granted at this level.

## Documentation to Gather

• Prior SMA therapy history — dates initiated, doses adjusted (per prescriber records), objective functional outcomes over time, and reason for discontinuation or transition.
• Clinical rationale for exception — if no prior therapy has been tried, the prescriber must document why the mandated step agent is clinically inappropriate (e.g., anatomical factors precluding intrathecal administration, age outside the indicated range for gene therapy, clinical urgency).
• Objective functional assessments — current and historical standardized motor function evaluations showing the patient's status and trajectory.
• Prescriber's exception letter — addressing each criterion in Cigna's step-therapy exception policy and explaining why Evrysdi is the appropriate first or next line of treatment for this specific patient.
• Applicable SMA guideline reference — note that the prescriber's recommendation aligns with current neuromuscular society guidelines, directing the reviewer to the relevant society's published guidance.

## Criteria-Mapping Structure

Obtain Cigna's step-therapy policy and the list of required prior agents. For each required step, either document the date it was tried and why it failed, or document the specific clinical reason it is not appropriate for this patient. Map each exception criterion in Cigna's exception policy to a chart fact. A step-therapy denial that has a documented prior failure or a clear clinical contraindication to the step agent has a high probability of reversal at the internal appeal or external review stage.