CurrentCignaPolicy CNF119

Hepatitis C – Mavyret Prior Authorization for Preferred Specialty Management Policy - (CNF119)

Prior authorization policy for Mavyret (glecaprevir/pibrentasvir tablets and oral pellets) covering FDA-approved and select evidence-supported uses across acute and chronic HCV genotypes, including dosing durations, pediatric and transplant guidance, and explicit non-covered conditions.

Policy Summary

PayerCigna

PolicyHepatitis C – Mavyret Prior Authorization for Preferred Specialty Management Policy - (CNF119)

Policy CodePolicy CNF119

Change TypeSelected revisions and annual reviews

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; ensure prescriber is a gastroenterologist, hepatologist, infectious diseases physician, transplant physician, or nephrologist (as applicable) and provide required documentation (quantifiable HCV RNA for acute HCV; prior treatment history to determine duration).

SourceLink

POLICY UPDATE CHANGES

Removed 'Life Expectancy Less Than 12 Months Due To Non-Liver Related Comorbidities' from Conditions Not Covered.

Chronic HCV Genotype Unknown/Undetermined: criterion modified so patient may have no cirrhosis OR compensated cirrhosis (previously required no cirrhosis).

Added acute HCV indication approval: Mavyret approved for 8 weeks for acute HCV when criteria met.

Multiple annual reviews noted with 'No criteria changes' (04/02/2025 and 04/01/2026).

16Enumerated Covered Indications (including renal/transplant variants)

3Explicit Not Covered Conditions

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Coverage Summary & FDA-Approved Indications

Initial Therapy Criteria (by Indication)

Initial Approval Conditions (Indications 1–15)

Mavyret is covered as medically necessary when listed criteria for each FDA‑approved indication are met. Approvals are for durations specified per indication.

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Continuation / Completion of Therapy

Not Medically Necessary / Contraindications

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for Mavyret prescriptions. Approvals are provided for specified durations and require the medication to be prescribed by or in consultation with a specialist (gastroenterologist, hepatologist, infectious diseases physician, transplant physician, or nephrologist for renal/transplant cases).

Documentation Required

Clinical documentation to support acute HCV

For acute HCV approval, document a quantifiable HCV RNA and at least one supporting finding: conversion from negative to positive anti-HCV antibody, HCV RNA, or HCV core antigen; prescriber-documented signs/symptoms of acute hepatitis (examples include ALT > 5× ULN and/or jaundice, nausea, fatigue, fever, muscle aches); or recent risk behavior for HCV infection within the prior 6 months. Patient must meet age and cirrhosis criteria and therapy is approved for 8 weeks when criteria are met.

Documentation Required

Prior treatment history required for duration determination

Document prior HCV treatment history and the specific agents/regimens received to determine the required treatment duration (8, 12, or 16 weeks). Prior exposure to NS5A inhibitors, NS3/4A protease inhibitors, Sovaldi (sofosbuvir) combinations, interferon/pegylated interferon ± ribavirin, or other named regimens will affect whether 8, 12, or 16 weeks is indicated.

Billing Rule

Completion of therapy approvals

If a patient has already started Mavyret, approve the remaining weeks needed to complete the indicated course. Example: if the full course is 12 weeks and the patient has received 3 weeks, approve 9 additional weeks to complete therapy.

Applicable Codes

DrugNDCCovered

No codes listed

Clinical Indications / Diagnosis (Hepatitis C)ICD-10Covered

No codes listed

Clinical Evidence

96%SVR12 in acute HCV single-arm study (n=286)

8 weeksApproved treatment duration for acute HCV (study and FDA indication)

June 2025Prescribing information (AbbVie Mavyret PI)

Prescribing information and guideline references support Mavyret as a pangenotypic regimen with high efficacy and short-course options: the AbbVie prescribing information (June 2025) describes glecaprevir (NS3/4A PI) + pibrentasvir (NS5A inhibitor) and details durations based on genotype, prior treatment, cirrhosis, renal impairment, and transplant status; an acute HCV single-arm study (n=286) treated patients for 8 weeks with an overall SVR12 of 96%.

AASLD/IDSA guidance (Dec 19, 2023) recommends treating acute HCV upon diagnosis (quantifiable HCV RNA) and recognizes pangenotypic regimens for situations when genotyping is not available; the guidelines support using regimens recommended for chronic HCV in acute infection and note simplified algorithms where Mavyret can be used without genotyping in many patients.

Key clinical requirements from the policy for acute HCV include patient age ≥ 3 years, quantifiable HCV RNA, and at least one supporting finding (seroconversion, prescriber-documented signs/symptoms of acute hepatitis, or recent risk behavior within the prior 6 months); Mavyret is approved for 8 weeks in eligible acute HCV patients. For chronic HCV, the FDA-labeled durations include 8, 12, or 16 weeks depending on genotype and prior treatment exposure, and special 12-week recommendations apply for many renal impairment and transplant scenarios.

Definitions

PRS: Defined as prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir (Sovaldi) but no prior PI or NS5A inhibitor.

Compensated cirrhosis: Refers to Child-Pugh Class A disease and is eligible for certain Mavyret approvals (e.g., simplified 8-week regimens in some settings).

Revision History

02/28/2024removed

Removed 'Life Expectancy Less Than 12 Months Due To Non-Liver Related Comorbidities' from Conditions Not Covered.

04/03/2024revised

Chronic HCV, Genotype Unknown/Undetermined: criterion modified so patient may have no cirrhosis OR compensated cirrhosis (previously required no cirrhosis).

06/25/2025added

Added acute HCV indication approval: Mavyret approved for 8 weeks for acute HCV when criteria met.