Evrysdi denied due to quantity / dose limits 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 Applied a Quantity Limit to Evrysdi

Quantity-limit (QL) denials for Evrysdi (risdiplam) occur when Cigna's pharmacy benefit system flags a dispensed quantity — typically in bottles of oral solution — as exceeding the plan's authorized supply interval or total quantity per authorization period. Because risdiplam is dosed based on patient weight and age per the FDA-approved label, the prescriber-calculated quantity may legitimately exceed Cigna's default limit, especially for larger patients or when a 90-day supply is requested.

Quantity-limit denials are among the most technically straightforward to appeal because the correct quantity is determined by the FDA-approved dosing table in the prescribing label, not by the plan's default.

## Why It Is Appealable

Under ACA §2719 and ERISA, any adverse benefit determination — including a QL denial — triggers internal appeal and external review rights. Plans that impose quantity limits more restrictive than the FDA-approved dosing instructions must justify that restriction with clinical evidence; they generally cannot. The internal appeal window is 180 days. External review must be filed within four months of the final adverse internal decision. Expedited review is available when health urgency applies.

## Appeal Process and Timeline

1. Request the specific QL applied — Cigna must tell you the quantity limit that triggered the denial and the clinical rationale for it. 2. Prescriber letter with dosing justification — the prescribing neurologist should submit a letter stating that the requested quantity reflects the FDA-approved weight- and age-based dosing in the prescribing label and is not excessive. 3. Internal appeal — file within 180 days. Cigna has 30 days for non-urgent pre-service and 72 hours for urgent appeals. 4. External review — if internal appeal fails, file with the IRO within four months. IROs routinely overturn QL denials that contradict the FDA label's own dosing instructions.

## Documentation to Gather

• Current patient weight and age — from a recent clinical visit note, used by the prescriber to calculate the FDA-label-compliant quantity.
• Prescriber's quantity justification letter — stating that the quantity requested is the minimum necessary for a full supply period based on FDA-approved dosing and the patient's current weight and age, and directing the reviewer to the FDA prescribing label for the dosing table.
• FDA prescribing label — attach a copy from Drugs@FDA showing the dosing calculation method. Do not cite specific numbers in the appeal narrative; instead, direct the reviewer to the label itself.
• Dispensing history — pharmacy records showing prior supply quantities if this is a continuation, to demonstrate consistent prescribing.
• SMA diagnosis and type — brief confirmation that the diagnosis and SMA type are within the approved indication, to preclude any secondary denial.

## Criteria-Mapping Structure

Quantity-limit appeals require a short, precise mapping: (1) Cigna's stated QL — as received in the denial; (2) FDA-label-based quantity — as calculated by the prescriber per the approved dosing method; (3) chart evidence — patient's current weight and age from a recent visit note. The discrepancy between columns 1 and 2 is the core of the appeal. If the prescriber-calculated quantity is within FDA-approved parameters, the plan's lower limit has no clinical basis and should be overturned.