CurrentUnitedHealthcarePolicy N/A

Zepatier (elbasvir/grazoprevir) prior authorization criteria and form

Form and clinical criteria governing prior authorization requests for Zepatier (elbasvir/grazoprevir) for treatment of chronic hepatitis C genotypes 1 and 4; intended for prescribers and pharmacy PA reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyZepatier (elbasvir/grazoprevir) prior authorization criteria and form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form with beneficiary and prescriber details, attach genotype/subtype and baseline quantitative HCV RNA (tested within past 6 months), select treatment duration, and include prescriber signature.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weeksduration option for treatment

16 weeksduration option for treatment

>=18minimum beneficiary age required

1,4eligible HCV genotypes referenced

within 6 moHCV RNA documentation timing

Coverage Criteria for Zepatier (elbasvir/grazoprevir)

Authorization criteria for Zepatier

Covered when ALL of the following are met

Age and Diagnosis: Beneficiary is 18 years of age or older with documented chronic hepatitis C (CHC) genotype 1 or 4.age >= 18

checkbox on form

Documentation of genotype/subtype: Medical records documenting chronic hepatitis C diagnosis with genotype and subtype are submitted with the request; lab test results must be attached to the prior authorization.genotype/subtype documented

explicitly required on form: 'Lab test results MUST be attached to the PA to be approved.'

Baseline viral load:

Policy Summary

PayerUnitedHealthcare

PolicyZepatier (elbasvir/grazoprevir) prior authorization criteria and form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Documented quantitative HCV RNA at baseline tested within the past 6 months is submitted.

HCV RNA within 6 months

form requests IU/ml or log10 value

Treatment regimen and duration selection: Prescriber selects appropriate treatment duration (12 or 16 weeks) consistent with genotype, prior treatment history, and NS5A polymorphism status; if indicated, Zepatier is prescribed with ribavirin per specified scenarios.duration selected

form lists genotype/prior treatment criteria linking to 12 vs 16 weeks and asks about coadministration with ribavirin

Contraindications and hepatic status: Prescriber certifies absence of FDA-labeled contraindications to Zepatier and documents whether beneficiary has moderate to severe hepatic impairment (Child-Pugh B or C) or prior hepatic decompensation.no contraindication or documented consideration

form queries FDA contraindications and asks about Child-Pugh B or C or prior decompensation

Prescriber attestation: Prescriber attests that treatment will improve the beneficiary's overall health status and provides a mandatory signature on the form.signed attestation

Prescriber signature mandatory

Beneficiaries with moderate to severe hepatic impairment—defined on the form as Child‑Pugh B or C—or any history of prior hepatic decompensation are specifically queried on the PA form and require special consideration. The form asks the prescriber to indicate presence or absence of these findings, which may contraindicate use or prompt additional review before approval.

Requests that do not include required documentation are effectively not approvable per the form. The form requires submission of medical records documenting chronic hepatitis C with genotype and subtype and states that lab test results MUST be attached to the PA to be approved. In addition, a documented baseline quantitative HCV RNA tested within the past 6 months must be provided. Missing prescriber signature or other prescriber information also compromises approval, since the prescriber’s signature is mandatory.

Testing and Laboratory Timing Requirements

HCV RNA timing — quantitative HCV RNA tested within the past 6 months

Required timingQuantitative HCV RNA at baseline tested within the past 6 months (documented on the PA; IU/ml or log10 value may be provided).

Documentation requirementMedical documentation of the quantitative result must be attached to the prior authorization request for approval.

Form fieldPA form explicitly asks: 'Does the beneficiary have a documented quantitative HCV RNA at baseline that was tested within the past 6 months?' with spaces to record IU/ml and/or log10 value.

Provider Submission and Authorization Actions

Prior Authorization

Prior Authorization Completion Requirements

Prior authorization requires completion of the entire form including beneficiary and prescriber details and selection of the requested treatment duration (12 or 16 weeks). The prescriber must sign and date the request.

Select treatment duration: 12 weeks or 16 weeks (as applicable)
Prescriber signature and date are mandatory

Denial Risk

Documentation-linked Denial Risk

Failure to attach required documentation — including laboratory test results confirming HCV genotype and subtype, and medical records documenting chronic hepatitis C and baseline quantitative HCV RNA (tested within the past 6 months) — may prevent approval and increases the risk of denial.

Lab test results confirming genotype and subtype must be attached
Medical records documenting chronic hepatitis C must be submitted
Baseline quantitative HCV RNA (IU/ml and/or log10) tested within 6 months must be included

Documentation Required

Required Submission Information

Provide complete prescriber and requester contact information and beneficiary identifiers; include the drug details and selected treatment duration on the PA form.

Prescribing Provider NPI # and Provider Fax #
Requester contact name, phone number, and extension
Beneficiary identifiers and date of birth (as applicable on the form)
Drug name, strength, and quantity per 30 days
Selected treatment duration (12 weeks or 16 weeks)

Background

This prior authorization form applies to Zepatier (elbasvir/grazoprevir) for adults aged 18 years or older with chronic hepatitis C virus (HCV) infection of genotype 1 or 4. Treatment duration options listed on the form are 12 weeks or 16 weeks, with selection dependent on genotype, prior treatment history, and presence of baseline NS5A polymorphisms. The form requires documentation of genotype/subtype and baseline quantitative HCV RNA (tested within the past 6 months) and includes a mandatory prescriber attestation and signature.

Definitions and Clinical Terms

NS5A polymorphisms — Baseline NS5A polymorphisms

DefinitionBaseline NS5A polymorphisms (as referenced on the PA form).

Clinical relevancePresence of baseline NS5A polymorphisms affects treatment duration decisions (e.g., genotype 1a with baseline NS5A polymorphisms may require 16 weeks).

Treatment promptForm asks whether Zepatier is being prescribed with ribavirin for beneficiaries with genotype 1a baseline NS5A polymorphisms or certain prior-treatment scenarios.

Moderate to severe hepatic impairment — Child‑Pugh B/C or prior hepatic decompensation

DefinitionModerate to severe hepatic impairment is defined as Child-Pugh class B or C.

History of decompensationAny history of prior hepatic decompensation is included in this definition and queried on the form.

Clinical considerationBeneficiaries with Child-Pugh B or C or prior hepatic decompensation are specifically queried and may be excluded or require special consideration for Zepatier therapy.