CurrentUnitedHealthcarePolicy 2025 P 2078-13

UnitedHealthcare Pharmacy Clinical Pharmacy Programs

UnitedHealthcare prior authorization and medical necessity policy for Zepatier (elbasvir/grazoprevir) governing approval criteria, treatment duration, and program rules for members starting 2026-01-01. Applies to chronic hepatitis C genotypes 1a, 1b, and 4 in eligible patients.

Policy Summary

PayerUnitedHealthcare

PolicyUnitedHealthcare Pharmacy Clinical Pharmacy Programs

Policy CodePolicy 2025 P 2078-13

Change TypeReorganized criteria; authorization duration updated

Effective DateJan 1, 2026

Next Review Date

Key ActionZepatier requires prior authorization and will be approved only if all listed clinical criteria are met; authorization is issued for 12 months.

POLICY UPDATE CHANGES

Program reorganized so chronic HCV infection for treatment-experienced patients and other specific populations are addressed in one section; authorization updated to 12 months.

Updated polymorphism criteria for treatment of chronic hepatitis C genotype 1a infection to include 'one or more' baseline NS5A polymorphisms (2/2025).

Annual reviews in 2/2024 and 2/2023 with updates to background/references and no change to clinical coverage criteria.

3Covered genotypes

12 moAuthorization duration

1Program number

Coverage Summary

UnitedHealthcare prior authorization and medical necessity policy for Zepatier (elbasvir/grazoprevir) governing approval criteria, treatment duration, and program rules for members starting 2026-01-01. Zepatier is covered_with_criteria when all listed criteria are met. The policy applies to chronic hepatitis C genotypes 1a, 1b, and 4 in eligible patients.

Eligible patient population per the policy and background: adults and pediatric patients 12 years of age and older or weighing at least 30 kg.

Key coverage facts

Covered genotypesGenotypes 1a, 1b, and 4

Number of covered genotypes (stats)3

Authorization duration12 months

Policy number2025 P 2078-13

Effective date2026-01-01

Last review2025-10-01

Initial Therapy Criteria

Initial Authorization - Zepatier

Zepatier will be approved based on all of the following criteria:

ALL of the following

Diagnosis of chronic hepatitis C genotype 1a, 1b, or 4 infection
Physician/provider asserts patient demonstrates treatment readiness, including the ability to adhere to the treatment regimen
Patient is not receiving Zepatier in combination with another HCV direct acting antiviral agent (e.g., Sovaldi [sofosbuvir])

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Zepatier requires prior authorization and will be approved only if all listed clinical criteria are met; authorization is issued for 12 months.

Documentation Required

Treatment readiness assertion

Provider must assert the patient demonstrates treatment readiness, including ability to adhere to the regimen.

Billing Rule

Concomitant therapy exclusion

Do not authorize Zepatier when the patient is receiving Zepatier in combination with another HCV direct-acting antiviral agent (e.g., sofosbuvir).

Denial Risk

Automated approval criteria may be used

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes and/or claim logic; automated processes and supply limits may apply.

Clinical Evidence & Background

Zepatier is a fixed-dose combination product containing elbasvir (an HCV NS5A inhibitor) and grazoprevir (an HCV NS3/4A protease inhibitor).

Indication: treatment of chronic hepatitis C virus infection due to genotypes 1 or 4 in adult and pediatric patients 12 years of age and older or weighing at least 30 kg.

Zepatier may be used with ribavirin in certain patient populations, per prescribing information and clinical guidance.

Revision History

2025-10-01revisedLatest

Program reorganized so chronic HCV infection for treatment-experienced patients and other specific populations are addressed in one section; authorization updated to 12 months.

2025-02-01revised

Updated polymorphism criteria for treatment of chronic hepatitis C genotype 1a infection to include 'one or more' baseline NS5A polymorphisms (2/2025).

2024-02-01revised

Annual review in 2/2024 with updates to background/references and no change to clinical coverage criteria.

2023-02-01revised

Annual review in 2/2023 with updates to background/references and no change to clinical coverage criteria.