Evrysdi denied as not FDA-approved for this use 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 Issued a Not-FDA-Approved Denial for Evrysdi

A not-FDA-approved denial for Evrysdi (risdiplam) is almost certainly a coding or policy-classification error. Risdiplam holds full FDA approval for the treatment of spinal muscular atrophy (SMA) in adults and children. This type of denial most often arises when the claim was submitted under a diagnosis code or NDC that did not match the approved indication in Cigna's system, when an outdated policy was applied, or when the request was for an age group or SMA subtype that Cigna has not yet updated its policy to reflect following FDA label expansions.

Because the FDA approval is a matter of public record, this is among the most straightforwardly reversible denials.

## Why It Is Appealable

Under ACA §2719, adverse benefit determinations must be based on accurate clinical and regulatory information. A denial that contradicts the FDA-approved status of a drug is facially erroneous. ERISA §503 requires the plan to provide the full claims file and to allow the enrollee to present evidence; the FDA approval letter is definitive rebuttal evidence. 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 clinical urgency exists.

## Appeal Process and Timeline

1. Request the complete denial rationale — ask Cigna to specify which FDA approval status they relied on, which version of the clinical policy was applied, and the reviewing clinician's credentials. 2. Submit a corrected prior-authorization request — in parallel with the appeal, have the prescriber resubmit with the exact FDA-approved indication language, correct NDC, and supporting diagnosis codes. 3. Internal appeal — file within 180 days. Cigna's non-urgent pre-service timeline is 30 days. 4. External review — if the internal appeal is denied, file with the IRO within four months. IROs are required to apply FDA approval status as a baseline; a denial that contradicts an approved label is routinely reversed at this stage.

## Documentation to Gather

• FDA approval documentation — print the current FDA drug label and approval summary from the FDA website (Drugs@FDA). Attach it to the appeal letter.
• Correct NDC and diagnosis codes — confirm the prescriber and pharmacy submitted the correct National Drug Code and ICD-10 diagnosis code for the patient's SMA type.
• Prescribing label indication match — a one-paragraph prescriber letter confirming that the proposed use matches the FDA-approved indication exactly.
• Patient's SMA diagnosis — genetic testing results and neurology evaluation confirming the diagnosis.
• Policy version request — ask Cigna to identify which version of its SMA clinical coverage policy was used; if it predates the FDA approval or a label expansion, document that discrepancy.

## Criteria-Mapping Structure

This appeal is primarily a factual correction, not a clinical argument. The mapping is simple: (1) the FDA approval status — cite the approval date and covered indication; (2) the patient's diagnosis — confirm it falls within the approved indication; (3) the claim submission — confirm the NDC and diagnosis codes were correct. If the denial persists after this correction, escalate immediately to external review, noting that the plan is denying a drug with active FDA approval for a covered indication.