TNF Inhibitor denied as non-formulary 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 "Non-Formulary"

Highmark's formulary — the list of drugs covered under the plan — is updated periodically and organizes drugs into tiers that determine cost-sharing. A TNF inhibitor may be denied as non-formulary because the specific brand or biosimilar prescribed is not on Highmark's current formulary, because it has been moved to a non-preferred or excluded tier, or because a formulary alternative in the same drug class is preferred. This is particularly common in the TNF inhibitor class, where multiple originator biologics and biosimilars now exist.

## Why This Denial Is Often Appealable

Non-formulary denials are appealable on two main grounds. First, a formulary exception can be requested when there is a clinical reason why the patient cannot use the formulary alternative — such as a documented intolerance, prior failure, or clinical contraindication to the preferred agent. Second, if the patient is stable on the currently prescribed TNF inhibitor, a continuity-of-care or step-edit exception may be available. Highmark, like all ACA-compliant and ERISA plans, must provide a meaningful exception process.

## Your Federal Appeal Rights

• Internal appeal / formulary exception request: File a formulary exception at the same time as your internal appeal. Highmark must process the exception request within the same timeframes: 30 days for pre-service non-urgent, 60 days for post-service.
• External review (ACA §2719): If the internal process fails, request IRO external review within approximately four months of the final denial. The IRO independently evaluates whether the denial is clinically appropriate.
• Expedited review: Available when standard timelines would seriously jeopardize health; decisions typically within 72 hours.
• ERISA §503: Employer-plan members may review all documents used in the denial and submit supporting evidence.

## Documentation to Gather

1. Highmark's current formulary — confirm which TNF inhibitor(s) are preferred/formulary and what the stated alternatives are, so the exception request can address the specific alternatives by name. 2. Clinical reason the formulary alternative is insufficient — chart documentation of prior failure on the preferred agent, intolerance, allergy, or another clinical contraindication. This is the core of any formulary exception. 3. Stability documentation — if the patient has been maintained successfully on the non-formulary agent, records of the duration of therapy and clinical response. 4. Prescriber medical-necessity letter — a letter from the treating specialist explaining why the specific non-formulary TNF inhibitor is medically necessary for this patient and why the formulary alternatives are not clinically equivalent or appropriate. 5. FDA-approved prescribing information — relevant to distinguish agents if the formulary alternative has a different indication profile or clinical profile relevant to this patient.

## Criteria-Mapping Strategy

Highmark's formulary exception process requires demonstrating that the formulary alternative would be ineffective or harmful for this patient. Structure the exception request as a direct comparison: for each formulary alternative Highmark lists, cite the specific clinical record entry explaining why it is not appropriate for this individual. Pair each entry with the prescriber's clinical rationale. This format makes it straightforward for the reviewer to confirm that an exception is warranted under Highmark's own stated exception criteria.