CurrentCignaPolicy IP0158

Hepatitis C - Zepatier Prior Authorization Policy

Defines Cigna's prior authorization requirements, prescribing provider qualifications, approved indications, dosing duration logic, and restrictions for Zepatier for treatment of chronic hepatitis C genotypes 1 and 4 for covered members.

Policy Summary

PayerCigna

PolicyHepatitis C - Zepatier Prior Authorization Policy

Policy CodePolicy IP0158

Change TypeAnnual revision with removals and an added preferred product note

Effective Date

Next Review Date

Key ActionObtain prior authorization and document FDA-approved indication, treatment history, NS5A test results when applicable, and that prescribing is by or in consultation with an appropriate specialist.

SourceLink

POLICY UPDATE CHANGES

Life Expectancy Less Than 12 Months Due To Non-Liver Related Comorbidities was removed from conditions not recommended for approval.

Medical Necessity Criterion excluding patients with decompensated cirrhosis (Child-Pugh B or C) was removed.

Note requiring use of preferred products and referral to the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM026).

Genotypes 1 & 4FDA genotypes covered

Age ≥12 or ≥30 kgMinimum age/weight

12 or 16 wksTreatment durations

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Coverage Criteria for Zepatier (grazoprevir/elbasvir)

Continuation Therapy

Covered when ALL of the following are met:

Currently Receiving Zepatier: Approve the duration necessary to complete an FDA-indicated course of therapy (for example, remaining weeks to complete a 12- or 16-week regimen).

Zepatier is contraindicated in patients with Child‑Pugh Class B or C (moderate or severe hepatic impairment). Requests for Zepatier for members with decompensated cirrhosis (Child‑Pugh B or C) will be denied as not medically necessary or contraindicated.

This contraindication is consistent with the product labeling and the policy's exclusions; note that the policy's Annual Revision removed a separate medical necessity criterion related to decompensated cirrhosis but the contraindication for Child‑Pugh B or C remains a coverage exclusion.

Combination use of Zepatier with any other direct‑acting antiviral (DAA) agent, excluding ribavirin, is not covered. Zepatier provides a complete antiviral regimen for the approved genotypes, and concomitant use with other DAAs is considered not medically necessary.

Providers should not request combination DAA regimens involving Zepatier (except when ribavirin is used as specified by regimen guidance); such requests will be denied.

Zepatier is approved only for patients who are ≥ 12 years of age or who weigh ≥ 30 kg. Pediatric patients younger than 12 years or weighing less than 30 kg are excluded from coverage because safety and efficacy have not been established in these populations.

For pediatric patients with genotypes 1 or 4, guidelines recommend alternative products (for example, ledipasvir/sofosbuvir) when appropriate; requests for Zepatier in patients <12 years or <30 kg will be denied.

Retreatment with Zepatier in patients who have previously received Zepatier is not recommended and is considered not medically necessary. This includes prior null responders, partial responders, relapsers, and patients who did not complete a prior course of Zepatier because of adverse reactions or other reasons.

Requests for retreatment with Zepatier after prior exposure to the same product will be denied unless an approved indication in the policy specifically supports the request.

Use of Zepatier for any indication not explicitly listed in the FDA‑approved criteria is considered not medically necessary. This includes unapproved DAA combinations (other than ribavirin), pediatric use below the specified age/weight, patients with Child‑Pugh B or C hepatic impairment, and retreatment after prior Zepatier exposure.

Providers should submit requests only for FDA‑approved indications and follow the policy's specified clinical criteria; requests outside those criteria will be denied as not medically necessary.

Coding and Product Information

Covered NDC / ProductNDCCovered

NDC	Zepatier (grazoprevir/elbasvir) product billing (use appropriate NDC)

Minimum age/weight

Minimum age or weightPatient is ≥ 12 years of age OR patient weighs ≥ 30 kg

ApplicabilityApplies to all FDA‑approved indications for Zepatier (genotypes 1 and 4) per policy criteria

Pediatric exclusionPatients under 12 years of age or weighing less than 30 kg are not covered

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required for Zepatier. All approvals are provided for the duration noted in the FDA‑Approved Indications and Other Uses with Supportive Evidence sections. Approval requires the medication to be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician. This product also requires use of preferred products per the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM026) prior to approval.

Prior authorization required
Approvals match treatment course duration (e.g., remaining weeks to complete therapy)
Prescriber specialty required: gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician

Step Therapy

Preferred Product Step

Use of preferred products is required before approval of Zepatier. Refer to PSM026 (Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Individual and Family Plans) for preferred product criteria and exceptions. For applicable lines of business, preferred product requirements may have been removed or relocated per payer guidance.

Definitions and Abbreviations

NS5A resistance-associated polymorphisms

DefinitionAmino acid substitutions at NS5A positions 28, 30, 31, or 93 that reduce response to NS5A inhibitors

Clinical impactPresence of these baseline NS5A resistance-associated polymorphisms in genotype 1a influences recommended treatment duration and the addition of ribavirin (may warrant 16 weeks with ribavirin)

Testing recommendationNS5A resistance-associated polymorphism testing is recommended prior to initiating Zepatier in genotype 1a to guide treatment duration

Abbreviations

TNTreatment‑naïve

PRPegylated interferon + ribavirin

Background

Zepatier is an oral fixed‑dose combination tablet containing grazoprevir (a second‑generation HCV protease inhibitor) and elbasvir (an NS5A inhibitor). It is indicated, with or without ribavirin, for treatment of chronic hepatitis C virus infection for patients with HCV genotype 1 or 4 who are ≥ 12 years of age or weigh ≥ 30 kg.

Per product labeling and this policy, Zepatier is contraindicated in patients with moderate or severe hepatic impairment (Child‑Pugh Class B or C). The policy requires prior authorization for Zepatier and specifies documentation and prescriber qualifications to support FDA‑approved use.

Revision History and Policy Changes

2025-07-01Annual revisionLatest

Preferred product related criteria were relocated to the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM026) for Individual and Family Plans; preferred product criteria requirements were removed for Employer Plans.

2024-06-01Annual revision

Removed 'Life Expectancy Less Than 12 Months Due to Non-Liver Related Comorbidities' from conditions not recommended for approval and removed the medical necessity exclusion for decompensated cirrhosis (Child-Pugh B or C).