Gene Therapy Casgevy denied due to quantity / dose limits 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 Quantity Limit Denial for Casgevy — Why It Happens and How to Appeal

Casgevy (exagamglogene autotemcel) is a one-time, single-administration gene therapy. A quantity limit denial for a therapy that is by its very nature administered once is almost always the product of an administrative or claims-system error — a benefit management rule designed for chronic medications being applied incorrectly to a single-course gene therapy. This is among the most defensible denial categories for this product.

## Why This Denial Is Appealable

Quantity limit policies are designed to prevent overutilization of chronic therapies. Applying such a limit to Casgevy — a one-time infusion administered at a specialized center following a conditioning regimen — has no clinical rationale. UHC's own published coverage policy for Casgevy, as well as the FDA-approved prescribing label, describe a single-administration treatment course. Any quantity limit that effectively bars or restricts this single course is inconsistent with the approved product design.

## Federal Appeal Framework

• Internal appeal: Submit within 180 days of the denial. Standard response: 30 days; urgent: 72 hours.
• External review (ACA §2719): After final internal denial, you are entitled to independent external review, generally within approximately 4 months of the denial. An Independent Review Organization reviews the case de novo.
• ERISA §503: For employer-sponsored plans, federal law guarantees a full-and-fair review.
• Expedited review: Request in writing if delay would seriously jeopardize your health.

## Documentation to Gather

1. FDA prescribing label: The current label describes the approved administration schedule. Print and attach it to clarify that Casgevy is a single-course therapy, not a refillable or repeat-dose product. 2. Treatment plan from your specialist: Your treating hematologist or gene therapy program should confirm in writing that only one administration is planned and that the quantity limit denial has no clinical meaning for this product. 3. Denial letter review: Identify the specific benefit management rule or quantity limit policy number cited. Note any mismatch between the policy's apparent intent (chronic-use limits) and the actual product. 4. Diagnosis and severity records: Underlying records supporting the need for this therapy in the first place, in case the reviewer also scrutinizes medical necessity. 5. Prior authorization approval (if any): If a PA was already approved, that approval is evidence that UHC already determined the therapy appropriate — making a separate quantity-limit denial contradictory.

## Criteria-Mapping Structure

In your appeal letter, address the quantity limit directly:

| Issue | Your Rebuttal Evidence | |---|---| | Quantity limit rule applied | FDA label confirming single-administration design | | Clinical rationale for limit | None exists for a one-time gene therapy | | Policy intent vs. product design | UHC coverage policy language; prescribing label | | Consistency with prior PA approval | Attach PA approval letter if applicable |

Request that UHC explain in writing the clinical basis for applying a quantity limit to a single-course gene therapy. This request alone often prompts administrative correction before a formal appeal hearing is needed.