Daa Pangenotypic Mavyret denied for failing step therapy by Aetna?

Aetna'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 Aetna Applies Step Therapy to Mavyret

Aetna's step-therapy ("fail-first") protocols for hepatitis C direct-acting antivirals may require that a plan-preferred pangenotypic DAA be tried before Mavyret (glecaprevir/pibrentasvir) is authorized — or, alternatively, may require documented prior treatment with an older regimen before any pangenotypic DAA is covered. Step-therapy denials are particularly common when a patient switches plans mid-treatment, when prior treatment history is not captured in Aetna's system, or when the prescriber submits a new start without attaching prior-treatment documentation.

## Why This Denial Is Appealable

All 50 states and the federal government have enacted or apply step-therapy override protections in some form. An override is generally available when: (1) the required step drug is contraindicated or clinically inappropriate for this patient; (2) the patient already failed or is currently on the requested drug; or (3) requiring the step would cause clinically significant delay in a serious, curable disease. Hepatitis C, being progressive and curable, is a strong candidate for step-therapy override.

## Federal Appeal Framework

• ACA §2719 / ERISA §503: Step-therapy denials are subject to full-and-fair internal appeal and independent external review.
• Timeline: Internal appeal must generally be filed within 180 days of the denial. External review is available within approximately 4 months of an internal denial.
• Expedited option: If delay poses serious health risk (e.g., advancing fibrosis or cirrhosis), expedited review is available; decisions typically required within 72 hours.

## The Appeal Process

1. Identify exactly which step drug Aetna requires and why your prescriber considers it unsuitable for this patient. 2. Gather documentation of any prior treatment with the required step drug (or any HCV therapy), including dates, outcomes, and reasons for discontinuation. 3. Have your prescriber write a step-therapy override letter citing the applicable clinical grounds (contraindication, prior failure, clinical inappropriateness, or risk of harmful delay). 4. Submit the internal appeal with the override letter and full clinical package. 5. Invoke your state's step-therapy override law if your plan is subject to state regulation; include a citation to the applicable state statute in your appeal. 6. If denied internally, request independent external review.

## Documentation to Gather

• HCV genotype and viral load: Confirms the diagnosis and informs regimen selection.
• Prior HCV treatment records: Dates, regimens, response, and reason for stopping — or clear documentation of treatment-naive status.
• Liver disease staging: Fibrosis or cirrhosis documentation that supports clinical urgency.
• Contraindication or clinical-inappropriateness rationale: Prescriber documentation explaining why the required step drug cannot be used, referencing the FDA prescribing labels for both drugs.
• Step-therapy override letter: A prescriber letter explicitly invoking the applicable override criteria under Aetna's policy and applicable state or federal law.

## Criteria-Mapping Structure

Create a two-column table: left column lists each of Aetna's step-therapy requirements and each override criterion from Aetna's policy and applicable state law; right column maps each requirement to the specific chart fact, date, and document that satisfies it. A well-organized criterion-by-criterion response is the most effective tool for winning a step-therapy override.