CurrentUnitedHealthcarePolicy N/A

Zepatier (elbasvir/grazoprevir) prior authorization

Prior authorization form and clinical criteria for prescribing Zepatier for adults with chronic hepatitis C genotype 1 or 4; governs documentation and therapy length determinations for UnitedHealthcare beneficiaries.

Policy Summary

PayerUnitedHealthcare

PolicyZepatier (elbasvir/grazoprevir) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionAttach medical records including HCV genotype/subtype and baseline quantitative HCV RNA tested within the past 6 months when submitting the prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+minimum beneficiary age

12 or 16 wksdocumented therapy durations

1, 4HCV genotypes addressed

PA call centerPA contact

Coverage Criteria for Zepatier (elbasvir/grazoprevir)

Initial therapy

Covered when ALL of the following are met

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

Documentation: Medical records documenting diagnosis with genotype and subtype are submitted and lab test results (including baseline quantitative HCV RNA) MUST be attached to the prior authorization request; baseline HCV RNA must have been tested within the past 6 months.HCV RNA within 6 months

Providers must attach lab results to PA

Treatment duration and prior experience: Therapy length is selected as 12 weeks or 16 weeks based on genotype, prior treatment history, and presence of baseline NS5A (NSSA) polymorphisms as specified: 12 weeks for genotype 1a (treatment-naive or PegIFN/RBV-experienced) without baseline NSSA polymorphisms; 12 weeks for genotype 1b (treatment-naive or PegIFN/RBV-experienced); 12 weeks for genotype 1a or 1b who are PegIFN/RBV/PI-experienced; 12 weeks for genotype 4 treatment-naive. 16 weeks for genotype 1a (treatment-naive or PegIFN/RBV-experienced) with baseline NSSA polymorphisms; 16 weeks for genotype 4 who are PegIFN/RBV-experienced.

Policy Summary

PayerUnitedHealthcare

PolicyZepatier (elbasvir/grazoprevir) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionAttach medical records including HCV genotype/subtype and baseline quantitative HCV RNA tested within the past 6 months when submitting the prior authorization.

SourceLink

On This Page

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Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization form and signature

Prior authorization form and prescriber signature are required. Complete all beneficiary, prescriber, drug, and clinical information fields on the PA form, including beneficiary name, ID, DOB, gender; prescribing provider NPI and contact/fax; requester contact name and phone. The prescriber signature and date are mandatory — unsigned requests will be returned. Pharmacy PA Call Center: 1-855-258-1593.

Beneficiary: last name, first name, Beneficiary ID #, DOB, gender
Prescriber: NPI #, provider fax #, requester contact name and phone/ext
Prescriber signature and date are required (Prescriber Signature Mandatory)

Denial Risk

Missing required labs

Baseline genotype/subtype and quantitative HCV RNA lab results must be attached to the PA. If genotype/subtype and a baseline quantitative HCV RNA (tested within the past 6 months) are not provided, the request may be denied or returned for incomplete information.

Lab test results (genotype/subtype) MUST be attached to the PA to be approved
Baseline quantitative HCV RNA with date (tested within past 6 months) required

Documentation Required

Required documentation

Submit medical records documenting: chronic hepatitis C diagnosis, HCV genotype and subtype, and baseline quantitative HCV RNA (IU/mL and/or log10) tested within the past 6 months. Indicate whether beneficiary is 18 years or older and complete clinical questionnaire items regarding prior treatments, presence of NS5A polymorphisms, contraindications, hepatic impairment (Child‑Pugh B/C), and coadministration with OATP1B1/3 inhibitors, strong CYP3A inducers, or efavirenz.

Medical records documenting chronic HCV diagnosis, genotype and subtype
Baseline quantitative HCV RNA (IU/mL and/or log10) with test date (within 6 months)
Documentation of prior HCV therapies and presence/absence of baseline NS5A polymorphisms
Assessment of contraindications and hepatic impairment (Child‑Pugh B or C)
Documentation of any concomitant interacting medications (OATP1B1/3 inhibitors, strong CYP3A inducers, efavirenz)

Definitions

Baseline NSSA polymorphisms — definition and clinical relevance for elbasvir-containing regimens

DefinitionBaseline NS5A resistance-associated substitutions (polymorphisms) that affect response to elbasvir-containing regimens and may necessitate extended therapy or addition of ribavirin.

Clinical impact on durationPresence of baseline NS5A (NSSA) polymorphisms for genotype 1a requires extending therapy to 16 weeks in some scenarios (see regimen-specific rules).

Coadministration requirementIf baseline NS5A polymorphisms are present for genotype 1a, Zepatier must be prescribed in conjunction with ribavirin as indicated on the PA form.

Relevant genotypesMost impactful for genotype 1a; influences treatment selection for genotype 1a and certain treatment-experienced patients (genotype 1a/1b).

Documentation requirementBaseline NS5A polymorphism status should be documented on the prior authorization; lab test results and genotype/subtype must be attached to the PA.

PegIFN/RBV-experienced — definition for patients with prior pegylated interferon and ribavirin exposure

DefinitionPatient with prior exposure to pegylated interferon alfa plus ribavirin (PegIFN/RBV) therapy.

Role in regimen selectionPrior PegIFN/RBV experience is used to determine treatment duration (12 vs 16 weeks) and need for adjunct ribavirin per genotype and baseline NSSA status.

Specific scenarios from the form12 weeks applies to PegIFN/RBV-experienced patients without baseline NSSA polymorphisms for genotype 1a and for genotype 1b; 16 weeks applies for PegIFN/RBV-experienced genotype 4 and genotype 1a with baseline NSSA polymorphisms.

DocumentationProviders must submit medical records documenting prior treatment history on the PA form along with genotype/subtype and baseline quantitative HCV RNA (labs MUST be attached).

OpenPayer

Zepatier (elbasvir/grazoprevir) prior authorization

Coverage Criteria for Zepatier (elbasvir/grazoprevir)

Prior Authorization and Provider Requirements

Definitions

Background