Daa Pangenotypic Mavyret denied as experimental or investigational by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for daa pangenotypic mavyret 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 UnitedHealthcare Issues an "Experimental" Denial for Mavyret

An "experimental or investigational" denial from UnitedHealthcare (UHC) for Mavyret (glecaprevir/pibrentasvir) is almost always triggered by one of two causes: an administrative or coding error that caused UHC's automated system to misclassify the drug or indication, or a coverage policy that has not been updated to reflect a more recently expanded FDA-approved indication (for example, a specific genotype subtype, a pediatric population, or a particular comorbidity profile). In rare cases, the denial may reflect a specific plan exclusion for certain HCV treatment settings.

Mavyret holds full FDA approval for chronic HCV infection across all major genotypes. It is not experimental.

## Why This Denial Is Appealable

An insurer cannot legally sustain an "experimental" denial for a drug with an on-label FDA-approved indication. This is one of the most reversible denial types at external review. External reviewers apply FDA-approval standards and are highly unlikely to uphold an experimental designation for a fully approved drug used within its labeling.

## Federal Appeal Framework

• ACA §2719 / ERISA §503: Experimental denials are subject to full-and-fair internal review and independent external review.
• Timeline: Internal appeal must generally be filed within 180 days of the denial. External review must generally be requested within 4 months of an internal denial.
• Expedited option: If delay would seriously jeopardize health, expedited review is available; decisions typically required within 72 hours.

## The Appeal Process

1. Pull UHC's denial letter and identify the exact language used to classify Mavyret as experimental — note the specific policy section or criterion cited. 2. Obtain the current FDA-approved Mavyret prescribing label from DailyMed and identify the precise approved indication that matches your diagnosis. 3. Obtain UHC's current coverage determination policy for hepatitis C DAAs and compare the policy's definition of "experimental" against Mavyret's FDA approval status. 4. Submit the internal appeal with the FDA label, the clinical record, and a prescriber letter affirming the on-label use. 5. If denied internally, file immediately for independent external review — this denial type is particularly strong for external reversal.

## Documentation to Gather

• FDA prescribing label: Current full prescribing information from DailyMed, highlighting the approved indication matching the patient's diagnosis.
• Diagnosis and genotype confirmation: Lab reports confirming active HCV infection and the specific genotype.
• Prescriber letter: Attests that Mavyret is being prescribed within its FDA-approved indication for this patient and cites the relevant section of the label.
• UHC policy language: A copy of UHC's coverage determination policy with the experimental-definition section highlighted, showing that Mavyret does not meet the policy's own definition of experimental.

## Criteria-Mapping Structure

Build a two-column table: left column reproduces UHC's experimental-drug criteria verbatim; right column provides the specific FDA label text, approval date, and clinical documentation showing Mavyret meets none of those criteria. Include the FDA approval letter or DailyMed summary as an exhibit.