Gene Therapy Casgevy denied for missing prior authorization by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for gene therapy casgevy 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.

## UnitedHealthcare Prior Authorization Denial for Casgevy — What It Means and How to Appeal

Casgevy (exagamglogene autotemcel) is a one-time gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia. Because of its clinical complexity and cost, UHC requires prior authorization (PA) before approving coverage. A PA denial — whether for missing information, failure to meet stated clinical criteria, or an administrative gap — is not a final answer. It is the opening round of a structured appeal process you have a legal right to pursue.

## Why Prior Authorization Denials Happen for Gene Therapy

UHC's PA reviewers evaluate whether the submitted clinical documentation maps precisely to each criterion in UHC's published medical/coverage policy for Casgevy. Common reasons for an initial PA denial include: incomplete documentation of prior treatment history, missing specialist attestation, a referring provider rather than a treating specialist submitting the request, or the clinical records not explicitly addressing each criterion UHC requires. None of these gaps are permanent bars to coverage.

## Federal Appeal Framework

• Internal appeal: File within 180 days of the denial. For urgent/expedited requests, UHC must respond within 72 hours; for standard requests, within 30 days.
• External review (ACA §2719): After final internal denial, request independent external review — typically within approximately 4 months of the internal denial. An Independent Review Organization (IRO) evaluates your case without deference to UHC's initial decision.
• ERISA §503: Employer-sponsored plan members are entitled to a full-and-fair review under federal law.
• Expedited review: Available when standard timelines would seriously jeopardize your health; ask for it explicitly in writing.

## Documentation to Gather

1. Complete diagnosis records: Medical records confirming sickle cell disease or transfusion-dependent beta-thalassemia, including genetic/lab confirmation and disease severity documentation. 2. Prior treatment history: Dated records of every prior therapy tried, including duration, dosing history, and documented clinical outcomes or reasons for discontinuation. 3. Specialist letter of medical necessity: Your treating hematologist or specialized gene therapy center should write a letter addressing every criterion in UHC's coverage policy for Casgevy by name. Vague letters are a leading cause of denials. 4. Center qualifications: Documentation that the treatment will be administered at a UHC-recognized center of excellence or specialty program, if required by the policy. 5. FDA label: Attach the current FDA-approved prescribing information to confirm your case falls within the approved indication.

## Criteria-Mapping Structure

Obtain the full text of UHC's current medical/coverage policy for Casgevy (available on UHC's provider/member portal). For each listed criterion:

| UHC Policy Criterion | Chart Evidence Addressing It | |---|---| | Confirmed diagnosis and indication | Lab/genetic records, specialist notes | | Prior therapy requirements | Dated treatment history with outcomes | | Clinical severity or disease burden | Specialist documentation from chart | | Prescriber/site qualifications | Credentials of treating hematologist/center |

Submit your appeal letter mapping every criterion explicitly. Gene therapy PA appeals succeed most often when the prescriber's letter directly echoes the policy's own language.