Daa Pangenotypic Mavyret denied due to quantity / dose limits 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 Issued a Quantity-Limit Denial for Mavyret

Quantity-limit (QL) denials for Mavyret (glecaprevir/pibrentasvir) typically arise when the prescribed course duration or pack size exceeds the quantity that UnitedHealthcare's formulary or pharmacy benefit allows per dispensing period. For direct-acting antivirals like Mavyret, treatment duration is clinically determined by factors including hepatitis C genotype, prior treatment history, and the presence and severity of cirrhosis. If your physician has prescribed a course that differs from the plan's default limit, a quantity-limit exception request is the appropriate first step — and an appeal is the backstop if that request is denied.

## Why This Denial Is Appealable

Quantity limits are administrative defaults, not clinical determinations. When the FDA-approved prescribing information and the applicable specialty society guidelines (such as those from AASLD — the American Association for the Study of Liver Diseases) support a treatment duration that exceeds the plan's default limit, that clinical support is the basis for the exception. A quantity-limit denial that conflicts with the FDA label's approved dosing regimen is particularly vulnerable on appeal.

## Federal Appeal Framework

• Quantity-limit exception / internal appeal: Most plans require a formulary exception request before or alongside a formal appeal. File both simultaneously to preserve your timeline.
• ERISA §503 / ACA §2719: Standard internal appeal rights apply. The plan must issue a written decision within the required timeframe.
• External review: Available after a final internal denial. The approximately four-month external review window runs from the date of the final internal determination. Expedited review (often 72 hours) applies when standard timelines would jeopardize your health.

## Concrete Appeal Steps

1. Obtain UHC's published quantity-limit policy for Mavyret — note the exact limit stated. 2. Ask your prescriber to document in writing the prescribed duration and the clinical basis for that duration (genotype, prior treatment status, fibrosis stage) by reference to the FDA label and current AASLD guidelines. 3. Compare the prescribed regimen to the FDA-approved prescribing information; note whether the prescribed quantity falls within a labeled indication. 4. Submit a quantity-limit exception request and a concurrent internal appeal with the prescriber's letter and supporting chart excerpts. 5. If denied, escalate to external review immediately.

## Documentation to Gather

• Diagnosis: confirmed hepatitis C genotype and viral load
• Fibrosis/cirrhosis staging: current liver disease staging study
• Treatment history: documentation of prior HCV treatment or treatment-naive status
• Prescriber letter: explains the prescribed duration with clinical rationale referencing the FDA label and applicable guidelines
• FDA prescribing information: current Mavyret labeling showing the approved treatment duration for your patient's specific clinical scenario

## Criteria-Mapping Structure

List UHC's quantity limit verbatim (the number of days or tablets per period). In the adjacent column, cite the FDA label section that authorizes the prescribed duration for your patient's genotype and treatment history. Then cite the chart entry (date, note, lab) that documents each clinical factor the FDA label references. This direct label-to-chart mapping is the most compelling structure for a quantity-limit appeal.