Rezdiffra Nash denied as non-formulary by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for rezdiffra nash 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 UHC Denies Rezdiffra for NASH as Non-Formulary — and Why You Can Appeal

Rezdiffra (resmetirom) was FDA-approved in 2024 as the first treatment specifically indicated for MASH (metabolic dysfunction-associated steatohepatitis) with moderate-to-advanced liver fibrosis. Formulary placements for newly approved specialty drugs lag behind clinical adoption, and UnitedHealthcare's commercial plans may not yet list Rezdiffra on a covered tier, or may place it on a specialty tier requiring a prior authorization exception. A non-formulary exception appeal — also called a formulary exception request — can succeed when the prescriber demonstrates that formulary alternatives are clinically inferior or inappropriate for this patient.

For MASH specifically, there are currently no other FDA-approved pharmacologic agents with the same indication, which substantially strengthens the argument that no adequate formulary alternative exists.

## Federal Appeal Framework

• Formulary exception / internal appeal: File a formulary exception request with supporting medical documentation. UHC must decide within 72 hours for urgent requests or 30 days for standard pre-service requests.
• Standard internal appeal: If the formulary exception is denied, file a formal internal appeal within 180 days of the denial notice.
• External review (ACA §2719): After exhausting internal appeals, you have approximately four months to request independent external review. The IRO's determination is binding.
• ERISA §503: For self-funded employer plans, the full-and-fair review standard applies; preserve all written communications and request the administrative record.

## Documentation to Gather

• No adequate formulary alternative: A letter from the prescribing hepatologist or gastroenterologist stating that no currently listed formulary drug has FDA approval for MASH with the patient's confirmed fibrosis stage, and explaining why off-label alternatives are not clinically equivalent.
• Diagnosis and fibrosis staging: Objective confirmation of the MASH diagnosis and fibrosis stage (biopsy or validated non-invasive staging), demonstrating that the patient falls within Rezdiffra's approved indication.
• Prior treatment history: Documentation of metabolic management, lifestyle interventions, and any prior pharmacologic attempts, with outcomes, showing why the patient requires disease-specific pharmacotherapy now.
• FDA label: A copy of Rezdiffra's current FDA-approved prescribing information confirming the indication and supporting the medical-necessity argument.
• Prescriber medical-necessity letter: A letter citing the approved indication, the absence of a formulary equivalent, and the clinical urgency given the patient's fibrosis stage and disease trajectory.

## Criteria-Mapping Structure

Obtain UHC's formulary exception criteria from the plan documents or by calling UHC's pharmacy benefit line. Copy each criterion. For each, document: (1) why no formulary alternative is clinically appropriate (cite the FDA label's specific indication), (2) the clinical consequences of delaying or substituting treatment given the patient's current fibrosis stage, and (3) the prescriber's direct attestation of medical necessity. Formulary exception denials based on "non-preferred tier" rather than true clinical non-coverage are particularly vulnerable to reversal when no therapeutic equivalent exists.