Factor 8 Gene Roctavian denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for factor 8 gene roctavian 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 Roctavian (valoctocogene roxaparvovec) — "Not FDA-Approved"

Roctavian received FDA approval for adults with severe hemophilia A who currently use Factor VIII prophylaxis therapy. A denial coded "not FDA-approved" from Cigna is almost always an administrative error: the drug's NDC or HCPCS code did not match an entry in Cigna's system, Cigna's internal coverage policy has not been updated to reflect the FDA approval, or the claim was adjudicated under a policy that predates the approval date. This type of denial is factually correctable and among the most straightforward to overturn on appeal.

## Why This Denial Is Appealable

FDA approval is a matter of public record. If Roctavian was used within its FDA-approved indication, Cigna's factual premise for the denial is incorrect. The appeal strategy is documentation-first: attach the FDA approval letter and the current prescribing label, confirm the billing codes match the approved product, and request that Cigna re-adjudicate under its current coverage policy. A peer-to-peer call between your hematologist and Cigna's medical director — specifically requesting that the reviewer consult the most current version of the gene therapy coverage policy — often resolves this type of denial before a formal written appeal is required.

## Federal Appeal Framework

• Internal appeal: File with Cigna within 180 days of the denial. Attach FDA documentation at the time of filing — do not wait for Cigna to request it.
• Peer-to-peer review: Request this before or concurrently with the written appeal. Ask Cigna to confirm which version of its coverage policy was applied and whether it has been updated since the FDA approval date.
• External review (ACA §2719): If Cigna upholds the denial internally, request independent external review within four months. External reviewers apply the FDA-approved labeling, not the insurer's internal policy version.
• ERISA §503: Employer plan members may demand the specific policy version, the reviewer's qualifications, and the clinical rationale underlying the denial.
• Regulatory complaint: If Cigna's internal policy is demonstrably out of date with the FDA approval, a complaint to your state's insurance commissioner or to CMS may prompt a faster correction.

## Documentation to Gather

1. FDA approval documentation — the FDA approval letter (available on FDA.gov), the current FDA prescribing label for Roctavian, and the FDA product page showing the approval date and indication. 2. Indication matching — a brief prescriber letter confirming the patient's use falls within the FDA-approved indication, with the patient's diagnosis stated. 3. Billing code verification — confirm with the specialty pharmacy or infusion center that the HCPCS code, NDC, and product name submitted on the claim exactly match the FDA-approved product. 4. Cigna's current gene therapy coverage policy — download the most recent version and compare the effective date to the FDA approval date to identify whether Cigna's system has been updated. 5. HTC records — documentation from the hemophilia treatment center confirming the patient's diagnosis, evaluation, and candidacy.

## Criteria-Mapping Structure

For a not-FDA-approved denial, the mapping is straightforward: - Column A: Cigna's stated requirement (FDA approval for the indication). - Column B: FDA approval letter date, indication text from the prescribing label, and confirmation that the patient's use matches the approved indication.

Close the appeal letter by requesting that Cigna confirm in writing whether its coverage policy has been updated to reflect the FDA approval, and by what date it will re-adjudicate the claim.