CurrentBlue Cross Blue Shield - IowaPolicy 05.01.102

Zepatier (elbasvir/grazoprevir) — Coverage Criteria for Chronic Hepatitis C

Defines prior authorization, coverage criteria, and restrictions for use of Zepatier in treating chronic Hepatitis C virus (HCV) infection for Wellmark members; affects prescribers, pharmacists, and prior authorization reviewers.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyZepatier (elbasvir/grazoprevir) — Coverage Criteria for Chronic Hepatitis C

Policy CodePolicy 05.01.102

Change TypeNo material changes

Effective DateApr 21, 2023

Next Review DateAug 1, 2025

Key ActionObtain prior authorization and document baseline NS5A (NSSA) resistance testing for genotype 1a when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12-16 wksauthorization duration

>=12 yrs / >=30 kgminimum age/weight

1a, 1b, 4genotypes addressed

M28/Q30/L31/Y93baseline RASs

28 tabs/28 daysdispense limit

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Coverage Criteria for Zepatier (elbasvir/grazoprevir)

Initial Approval by genotype and clinical scenario

Covered when the specific regimen and all related conditions below are met for the given genotype/scenario:

General requirements: Use is consistent with plan's step therapy (preferred agents tried or clinically excluded); prescriber is specialist in infectious disease, gastroenterology, hepatology, or transplant; member is >=12 years or >=30 kg; required baseline testing performed when applicable.

See documentation and step therapy requirements; baseline NS5A (NSSA) RAS testing required for genotype 1a when applicable.

Genotype 1a — Zepatier + ribavirin: For genotype 1a infection treated in combination with ribavirin: treatment-naive members with baseline NS5A (NSSA) resistance-associated substitutions (RASs) may be authorized up to 16 weeks; members who failed prior PEG-IFN + RBV +/- an HCV protease inhibitor may be authorized up to 16 weeks if baseline NS5A (NSSA) RASs are present, or up to 12 weeks if RASs are absent.

Baseline NS5A (NSSA) RAS testing required for genotype 1a (see Appendix A).

Genotype 1b: Members with genotype 1b may be authorized up to 12 weeks: this applies to treatment-naive members and to members who failed prior PEG-IFN + RBV with or without an HCV protease inhibitor.

Genotype 4: Members with genotype 4 who failed prior PEG-IFN + RBV may be authorized up to 16 weeks; treatment-naive genotype 4 members may be authorized up to 12 weeks.

Kidney transplant recipients with HCV genotype 1 or 4 who are treatment-naive or have not failed prior direct-acting antiviral therapy and do not have baseline NS5A (NSSA) RASs may be authorized up to 12 weeks.

HIV coinfection: Members with HCV/HIV coinfection may be authorized when the criteria for the requested regimen in the relevant genotype sections above are met.

Continuation of Therapy

Continuation of therapy:

Continuation: All members (including new members) requesting continuation of therapy must meet ALL initial authorization criteria.

Continuation requests are reviewed against the initial approval criteria and prior authorization requirements.

Non-Formulary Exception and Dispensing Criteria

Coverage for non-formulary targeted hepatitis C agents is allowed when ALL of the following are met:

Non-Formulary Exception Core Requirements: Requested drug must be used for an FDA-approved indication, or an indication supported in accepted compendia (examples: AHFS, Micromedex, current accepted guidelines). Diagnostic testing/lab results required when applicable.

Meeting the criteria for approval may satisfy portions of the non-formulary exception; documentation required.

Dosing: Prescribed dose and quantity must fall within FDA-approved labeling or dosing guidelines found in accepted compendia.

Approvals may be subject to dosing limits in accordance with FDA labeling, compendia, or evidence-based guidelines.

Formulary Alternatives: All covered formulary alternative drugs on any tier must be ineffective, have been ineffective, would not be as effective, or would have adverse effects. Documentation is required and must include chart notes or other documentation indicating treatment failure, severity of adverse event(s), and dosage and duration of prior treatment; or documentation of contraindication to formulary alternatives.

Coverage will not be provided for members with decompensated cirrhosis/moderate or severe hepatic impairment (Child‑Turcotte‑Pugh Class B or C). When the requested drug is part of a combination antiviral regimen, the exclusion extends to the other antiviral agents used in that regimen.

Requests for drugs that are non‑formulary require meeting the plan’s Non‑Formulary Exception Criteria. The requested agent must be used for an FDA‑approved indication or an indication supported in accepted compendia, the prescribed dose/quantity must fall within FDA labeling or compendia dosing guidelines, and documentation must show that all covered formulary alternatives were ineffective, contraindicated, or would be less effective (including chart notes detailing prior treatment failure, adverse events, dosage, and duration). Diagnostic testing or laboratory results are required when applicable.

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for all hepatitis C antiviral requests. Continuation/renewal requests must meet all initial authorization criteria and documentation requirements used for the initial approval.

Authorization duration guidance: up to 12 weeks for most regimens; up to 16 weeks for genotype 1a with baseline NS5A resistance-associated substitutions (RASs) when indicated per criteria.
All continuation requests (including new members) must meet ALL initial authorization criteria.

Step Therapy

Preferred Agent Step Therapy

The plan requires that the health plan's preferred chronic HCV agents be tried and documented prior to approval of non-preferred agents unless a clinical exception is documented (see formulary alternative trial requirement). If the member has a paid claim for the requested non-preferred agent within the past 30 days, the agent may be paid at the standard specialty copay; otherwise step therapy / post-step criteria will be applied.

Preferred agents: Epclusa, Harvoni, Mavyret, Vosevi (use of these agents is required before non-preferred agents unless excluded clinically or patient is currently on non-preferred therapy).

Procedures and Billing Codes

Procedures and billing codesmixed

Code(s), if applicable

Placeholder indicating CPT/HCPCS/Revenue/ICD codes should be used as appropriate per service

Definitions and Resistance Markers

NSSA resistance-associated substitutions (RASs)

DefinitionNSSA resistance-associated substitutions (polymorphisms) present at amino acid positions M28, Q30, L31, or Y93.

RelevanceBaseline NSSA RAS testing is required for genotype 1a and influences authorized treatment duration (e.g., up to 16 weeks when present).

Location in policyListed in Appendix A as the NSSA resistance-associated substitutions to assess prior to treatment decisions.

NS5A resistance-associated substitutions (RAS)

DefinitionNS5A resistance-associated substitutions (polymorphisms) at amino acid positions M28, Q30, L31, or Y93.

Clinical actionPresence of NS5A RASs (M28, Q30, L31, Y93) requires consideration when selecting regimen and may extend therapy duration for genotype 1a.

Background

Zepatier (elbasvir/grazoprevir) is managed as a non‑preferred hepatitis C agent under the plan criteria. Use decisions and authorization durations depend on the member’s HCV genotype, prior treatment history, and presence of baseline NS5A resistance‑associated substitutions. The policy references product labeling and accepted clinical guidance (for example, AASLD/IDSA) as the basis for covered indications and dosing.

Revision History

2025-08-01reviewedLatest

Policy reviewed (next review date listed in brief).

2023-01-01revised

Policy revised (document lists 'Revised: January 2023').

2023-04-21effective_date