Imlifidase denied as not medically necessary by Aetna?

Aetna's specific coverage criteria for imlifidase 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 Aetna Denies Imlifidase on Medical-Necessity Grounds

Aetna's medical-necessity review for imlifidase centers on whether the patient's clinical profile meets the specific criteria Aetna has established in its clinical policy — typically relating to the patient's degree of immune sensitization, the availability or non-availability of compatible donors through standard allocation, and the transplant center's evaluation and recommendation. When the clinical record submitted with the prior authorization request does not clearly document each of these elements, Aetna's reviewers may find that medical necessity has not been established.

Because imlifidase is used in a time-sensitive transplant setting, prompt and thorough documentation is especially important.

## Your Federal Appeal Rights

• Internal appeal: ACA §2719 and ERISA §503 require Aetna to provide a full-and-fair internal review. Submit your appeal with complete clinical documentation within the deadline on your denial notice.
• External review: After an adverse internal decision, you may request independent external review within approximately four months of the final internal denial. The IRO must be staffed with qualified reviewers in the relevant specialty.
• Expedited review: The transplant context creates urgency that typically qualifies for expedited processing — a decision in 72 hours or fewer. Explicitly request expedited review and document the clinical urgency in writing.

## What to Gather Before You File

1. Aetna's current clinical policy for imlifidase: Download the policy from Aetna's website or request it from Aetna. Every criterion listed must be addressed in your appeal. 2. FDA-approved prescribing information: Confirms the labeled indication and patient-population criteria. Your documentation should show the patient's situation aligns with the label. 3. Sensitization and compatibility records: Panel-reactive antibody testing results and HLA typing that establish the clinical basis for needing IgG clearance prior to transplantation. These are the foundational documents for any imlifidase appeal. 4. Transplant listing and evaluation records: Documentation of the transplant committee evaluation, listing status, and the basis for determining that standard allocation is insufficient for this patient. 5. Transplant program medical-necessity letter: A detailed letter from the transplant nephrologist or program director addressing each of Aetna's policy criteria by name and providing the clinical rationale specific to this patient. 6. Prior treatment and desensitization history: If other desensitization approaches were attempted, document them with dates and outcomes.

## Criteria-Mapping Structure

Obtain Aetna's policy requirements and map the clinical record to each:

| Aetna Requirement | Chart / Record Evidence | Document Reference | |---|---|---| | Confirmed transplant candidacy | Listing committee evaluation | Transplant program records | | Documented high sensitization | PRA / HLA compatibility workup | Lab records (date) | | Limited compatible donor availability | Allocation analysis | Program letter | | Transplant center recommendation | Prescribing physician letter | Letter (date) | | Aligns with FDA-labeled use | Label citation | FDA prescribing information |

A complete, criterion-by-criterion appeal submitted by the transplant team — rather than a general letter — is the most effective format for this type of denial.