Evrysdi denied as experimental or investigational 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 as Experimental

An experimental or investigational denial signals that Cigna's medical policy has classified Evrysdi (risdiplam) as lacking sufficient evidence to meet its coverage criteria — or that the proposed use falls outside the labeled indication. This classification is surprising given that risdiplam holds full FDA approval for spinal muscular atrophy (SMA), but it can arise when the patient's SMA type, age group, or functional status does not precisely match the population Cigna's internal policy recognizes.

FDA approval is the single most powerful rebuttal to an experimental denial.

## Why It Is Appealable

Federal law creates strong protections here. Under ACA §2719, plans must follow evidence-based criteria and must make their clinical policy publicly available. If Cigna's policy contradicts the FDA-approved label, the denial is facially vulnerable. Under ERISA §503, the plan must provide the full claims file, the clinical criteria applied, and the reviewing clinician's qualifications. The external-review clock runs four months from the final adverse internal decision; an expedited track (typically 72-hour turnaround) applies when delay would seriously jeopardize health.

## Appeal Process and Timeline

1. Obtain Cigna's written denial and request the specific clinical policy version applied, the reviewer's specialty, and the complete claims file. 2. Internal appeal — file within 180 days of the denial notice. Cigna has 30 days for non-urgent pre-service appeals. 3. Escalate to external review if internal appeal fails. File with the IRO within four months of Cigna's final adverse decision. 4. Simultaneous state agency complaint — if the plan is state-regulated, filing a complaint with the state insurance commissioner can accelerate resolution.

## Documentation to Gather

• FDA approval documentation — a copy of the current FDA-approved labeling and approval summary for risdiplam; this directly rebuts an experimental classification for covered indications.
• Diagnosis confirmation — genetic confirmation of SMN1 or SMN2 copy number, neurologist's clinical evaluation, and SMA type determination.
• Functional baseline — recent motor function assessments, respiratory status, and swallowing evaluation with dates.
• Prescriber letter — explicitly stating that the proposed use matches the FDA-approved indication and that the therapy is the standard of care per the applicable neuromuscular society guidelines.
• Published evidence summary — your prescriber or a medical advocate can compile a brief narrative (without citing specific trial statistics) noting that risdiplam's approval was based on a regulatory review of clinical evidence, directing Cigna's reviewer to the FDA label for details.

## Criteria-Mapping Structure

Retrieve Cigna's current SMA clinical coverage policy. List every criterion. Opposite each criterion, write the corresponding chart fact — genetic test result, functional score date and name, clinician's assessment. Where Cigna's policy contradicts the FDA-approved label, flag the discrepancy explicitly in your appeal letter. IROs are required to use the FDA label as a baseline standard; any policy more restrictive than the label without clinical justification is a strong ground for reversal.