Srt Fabry Galafold denied for missing prior authorization by Aetna?

Aetna's specific coverage criteria for srt fabry galafold 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 Requires Prior Authorization for Galafold

Galafold is a specialty drug for a rare disease, and Aetna — like most large commercial insurers — requires prior authorization before it will cover high-cost specialty medications. A prior-authorization-required denial means the claim was processed without a prior authorization on file, or the submitted authorization request was incomplete and was not approved before the prescription was filled.

This type of denial is administrative in nature and is highly correctable. The denial does not reflect a clinical judgment that the drug is inappropriate; it reflects a process gap.

## Your Federal Appeal Rights

Even for administrative prior-authorization denials, ACA §2719 external review and ERISA §503 full-and-fair review rights apply to non-grandfathered plans. If your prescriber submits a complete prior authorization and it is denied on clinical grounds, that clinical denial is fully appealable through the internal and external review process. You have approximately four months from a denial notice to initiate external review. If the patient's condition is deteriorating or urgent, request expedited review.

## Immediate Next Steps

1. Contact the prescriber's office: Confirm whether a prior authorization was submitted and, if so, what the status is. Many PA denials result from an incomplete submission rather than a clinical rejection. 2. Obtain Aetna's current PA criteria: Request the specific clinical criteria Aetna applies to Galafold from the provider services line or from Aetna's published medical policy. This tells you exactly what documentation to gather. 3. Submit or resubmit the PA with complete documentation (see below).

## Documentation for the Prior Authorization

• Diagnosis confirmation: Chart notes and ICD code confirming Fabry disease diagnosis.
• Genetic report: Sequencing results identifying the specific GLA mutation, with amenability determination consistent with the FDA-approved prescribing label.
• Clinical severity: Organ involvement, lab trends, imaging, and symptom documentation from recent clinic visits.
• Treatment history: Prior therapies, dates of use, and clinical outcomes or tolerability issues.
• Prescriber attestation: A medical-necessity letter from the treating specialist addressing each of Aetna's stated PA criteria point by point.

If the PA is denied after a complete submission, that denial triggers full appeal rights. Keep a copy of every submission with timestamps so you have a clear record if you need to escalate to external review.