TNF Inhibitor denied as not FDA-approved for this use by Highmark?

Highmark uses Prime Therapeutics PBM. Adalimumab biosimilar preferred (Cyltezo/Hyrimoz/Yusimry). Step therapy through preferred biosimilar required for new starts; existing patients on Humira may grandfather.

Highmark Continuity of Care provisions — 90-day grandfather for established therapy. Cite Prime Therapeutics PA exception process. ACR 2019 Position Statement opposes non-medical switching of stable patients.

## Why Highmark May Deny a TNF Inhibitor as "Not FDA-Approved"

TNF inhibitors are FDA-approved for several well-defined conditions, but a denial citing "not FDA-approved" from Highmark generally means one of the following: (1) the diagnosis documented in the claim does not match an indication listed in the specific TNF inhibitor's approved labeling; (2) the drug is being used in a patient population (e.g., pediatric versus adult) outside the labeled approval; or (3) there is a documentation mismatch between the claim code and the clinical record. These denials are based on a factual question — FDA approval status — that is publicly verifiable.

## Why This Denial Is Often Appealable

Because FDA approval status is a matter of public record (documented in the prescribing information available at DailyMed and fda.gov), these denials can often be refuted by producing the label itself and showing that the patient's documented diagnosis falls squarely within an approved indication. Coding errors and documentation gaps — where the correct diagnosis is supported clinically but was not accurately captured in the claim — are also correctable on appeal. If the use is genuinely off-label, the appeal can pivot to the evidence basis under applicable plan terms or state law.

## Your Federal Appeal Rights

• Internal appeal: Submit within the deadline in your denial notice. Highmark must decide pre-service non-urgent appeals within 30 days and post-service appeals within 60 days.
• External review (ACA §2719): After a final internal denial, request IRO external review within approximately four months. External reviewers independently assess clinical and factual grounds, and "not FDA-approved" claims are among those most frequently reversed when documentation is complete. The IRO decision is binding on Highmark.
• Expedited review: If the standard timeline would seriously jeopardize your health, request expedited review; decisions are typically issued within 72 hours.
• ERISA §503: Employer-plan members are entitled to a full-and-fair review and access to all documents and criteria used in the denial decision.

## Documentation to Gather

1. Current FDA-approved prescribing information — the full label for the prescribed TNF inhibitor, with the approved indications highlighted. This is your central exhibit. Obtain it from DailyMed (dailymed.nlm.nih.gov) or the manufacturer's website. 2. Confirmed diagnosis documentation — chart notes, specialist assessments, lab results, and imaging that unambiguously establish the diagnosis with the ICD code corresponding to an approved indication. 3. Prescriber medical-necessity letter — a letter from the treating specialist that explicitly references the FDA-approved indication and maps the patient's documented diagnosis to that indication. 4. Applicable professional-society guidance — a reference to guidance from the ACR, AGA, AAD, or other relevant organization affirming use of this drug class for the patient's diagnosis. 5. Highmark's medical policy — obtain the current policy from highmarkbcbs.com to confirm which indications they recognize and to address any additional criteria.

## Criteria-Mapping Strategy

Side-by-side, place the exact indication language from the FDA label alongside the diagnosis language in the clinical record. If they align, that alignment is the substance of the appeal. If there is a coding discrepancy, have the prescriber submit a corrected claim alongside the appeal. Note the date of the prescribing information you are relying on to ensure it is the current approved version, as label updates can affect indication language.