Tafamidis ATTR denied due to quantity / dose limits by Humana?

Humana's specific coverage criteria for tafamidis attr 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 Humana Imposes Quantity Limits on Tafamidis (ATTR Amyloidosis) — and How to Appeal

Quantity-limit denials for tafamidis typically arise when Humana's dispensing system flags a prescription that does not align with the plan's approved quantity per fill or approved day supply. Because tafamidis is dosed on a fixed daily schedule per the FDA label, this type of denial is frequently a mismatch between how the prescription was written and the specific quantity parameters in Humana's formulary — not a clinical judgment that the drug is inappropriate.

Common triggers include: prescriptions written for a supply period different from the plan's approved interval, incorrect tablet count per the formulary tier, or a pharmacy fill that preceded the plan's refill-too-soon window.

## Your Federal Appeal Rights

• Internal appeal (ACA §2719 / ERISA §503): A quantity-limit denial is a covered adverse benefit determination and carries full internal appeal rights. Request Humana's written explanation of the specific quantity limit applied and the regulatory basis for it.
• External review: If the internal appeal is denied, request independent external review by an IRO. Federal law provides approximately four months from the adverse determination to initiate this. An expedited track is available when delay poses health risk.

## Documentation to Gather

1. FDA-approved prescribing label — obtain the current label from drugs.fda.gov and identify the approved dosing schedule. Your prescriber's prescribed quantity should align with it. Attach this as Exhibit A. 2. Prescriber attestation — your cardiologist should certify in writing that the prescribed quantity corresponds exactly to the FDA-approved dosing regimen and is medically necessary for continuous therapy. 3. Medical-necessity letter — include a statement explaining that interruption of therapy due to quantity restrictions poses clinical risk, and that the quantity prescribed does not exceed what the FDA label supports. 4. Humana's quantity-limit policy — request the exact quantity-limit parameters from Humana in writing. Compare them to the FDA label. If they diverge, document the discrepancy explicitly in your appeal. 5. Prior fill history — if you have previously filled at this quantity without issue, provide that dispensing history.

## Criteria-Mapping Structure

| Humana Quantity-Limit Requirement | Your Documentation | |---|---| | Approved quantity per fill | FDA label dosing schedule (attached) | | Day supply alignment | Prescriber attestation of dosing regimen | | Refill timing compliance | Pharmacy dispensing record | | Medical necessity for quantity | Prescriber letter addressing continuity of care |

If the quantity limit Humana applies is more restrictive than what the FDA label supports for the approved indication, cite that discrepancy directly in your appeal as a basis for an exception.