Factor 8 Gene Roctavian denied as non-formulary 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) — Non-Formulary

Roctavian is an FDA-approved gene therapy for adults with severe hemophilia A. As a recently approved, high-cost specialty biologic, Roctavian may not yet appear on Cigna's drug formulary for your specific plan, or it may be excluded from coverage by plan design. A non-formulary denial does not mean the treatment is inappropriate — it means the plan's standard coverage list does not include it, triggering a formulary exception or medical-necessity override process.

## Why This Denial Is Appealable

Most Cigna plans include a formulary exception process for non-formulary drugs when the formulary alternatives are medically inappropriate for a specific patient. For Roctavian, there is no meaningful therapeutic equivalent on formulary — no other gene therapy for hemophilia A is interchangeable with it, and standard Factor VIII concentrates are categorically different treatments. An appeal that documents the absence of a formulary alternative and the clinical basis for Roctavian specifically should qualify for a formulary exception. Confirm the exception process with Cigna's member services or your plan documents before filing.

## Federal Appeal Framework

• Formulary exception request: File a formulary exception simultaneously with — or before — a formal appeal. This is often a faster path than a standard appeal for non-formulary denials.
• Internal appeal: File within 180 days of the denial. If the formulary exception is denied, appeal that denial as well.
• External review (ACA §2719): After exhausting internal options, request independent external review within four months of the final internal denial. External reviewers evaluate whether Cigna's formulary exclusion, as applied to this patient, meets the plan's coverage terms.
• ERISA §503: Employer plan members may request the specific formulary exception criteria and plan documents governing non-formulary coverage.
• Open enrollment alternative: If the appeal is unsuccessful, review whether a different Cigna plan tier or a non-Cigna plan available at open enrollment includes Roctavian on its formulary.

## Documentation to Gather

1. Formulary exception criteria — download Cigna's formulary exception policy for your plan and identify the specific grounds for an exception (medical necessity, no formulary alternative, contraindication to alternatives). 2. Evidence that no formulary alternative exists — a prescriber letter explicitly stating that no other product on Cigna's formulary is therapeutically equivalent to Roctavian for this patient's diagnosis and treatment goals. 3. Diagnosis and clinical summary — confirmed severe hemophilia A diagnosis, current treatment status, and the clinical rationale for gene therapy. 4. HTC evaluation letter — documentation from a hemophilia treatment center supporting Roctavian candidacy. 5. FDA prescribing label — confirms approved indication and that Roctavian is in a distinct therapeutic category from standard Factor VIII concentrates. 6. Plan document excerpt — the summary plan description (SPD) or evidence of coverage language governing non-formulary exceptions and appeals.

## Criteria-Mapping Structure

For a non-formulary appeal: - Column A: Each formulary exception criterion from Cigna's policy. - Column B: The specific fact that satisfies it — absence of formulary alternative, confirmed diagnosis, HTC candidacy letter.

For a coverage-exclusion appeal: - Column A: The specific plan language excluding Roctavian or gene therapy. - Column B: Any plan language or Cigna policy that creates an exception or override, along with the clinical documentation supporting it.

Attach documents as numbered exhibits. Request a written decision with the specific policy language and clinical rationale used.