CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zepatier (elbasvir and grazoprevir) — Coverage Criteria for Chronic Hepatitis C (Genotypes 1 and 4)

Covers clinical authorization criteria for Zepatier (elbasvir and grazoprevir) for treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 in patients ≥12 years or ≥30 kg, including combination with ribavirin and special populations; applies to Neighborhood Health Plan of Rhode Island members governed by this policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZepatier (elbasvir and grazoprevir) — Coverage Criteria for Chronic Hepatitis C (Genotypes 1 and 4)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with documentation showing genotype, prior-treatment history, and baseline NS5A resistance status as required for approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 & 4Genotypes covered

Age ≥12 / ≥30 kgMinimum age/weight

Child‑Pugh B/CHepatic impairment excluded

12–16 wksTreatment duration

Specialist required

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Coverage Criteria for Zepatier (elbasvir and grazoprevir)

Covered indications and regimen-specific criteria

Covered when ALL of the following are met for the listed clinical scenarios:

FDA indication: Patient has chronic HCV genotype 1 or 4 infection and is an adult or pediatric patient ≥12 years of age or weighing ≥30 kg.age >=12 or weight >=30 kg

Includes FDA-approved uses and compendial uses when approval criteria met.

Prescriber: Medication is prescribed by or in consultation with a prescriber specializing in infectious disease, gastroenterology, hepatology, or transplant.

Genotype 1a with ribavirin: If genotype 1a and used in combination with ribavirin: authorization of up to 16 weeks may be granted for members with baseline NS5A resistance-associated substitutions (RASs)/polymorphisms who are either treatment-naïve or failed prior PEG-IFN + RBV (with or without an HCV protease inhibitor); authorization of up to 12 weeks may be granted for members without baseline NS5A RASs who failed prior PEG-IFN + RBV with an HCV protease inhibitor (boceprevir, simeprevir, or telaprevir).duration 12-16 weeks based on baseline NS5A RASs and prior therapy

See Appendix for RAS definitions.

Genotype 1b with ribavirin: If genotype 1b and used in combination with ribavirin: authorization of up to 12 weeks may be granted for members who failed prior PEG-IFN + RBV without an HCV protease inhibitor.12 weeks

Genotype 4 with ribavirin: If genotype 4 and used in combination with ribavirin: authorization of up to 16 weeks may be granted for members who failed prior PEG-IFN + RBV.16 weeks for prior PEG-IFN + RBV failures

Genotype 1a without ribavirin: If genotype 1a without ribavirin: authorization of up to 12 weeks may be granted for members without baseline NS5A RASs who are treatment-naïve or who failed prior PEG-IFN + RBV without an HCV protease inhibitor.12 weeks

Genotype 1b without ribavirin: If genotype 1b without ribavirin: authorization of up to 12 weeks may be granted for members who are treatment-naïve or who failed prior PEG-IFN + RBV without an HCV protease inhibitor.12 weeks

Genotype 4 without ribavirin: If genotype 4 without ribavirin: authorization of up to 12 weeks may be granted for members who are treatment-naïve.12 weeks

Kidney transplant recipients with HCV genotype 1 or 4 infection who are treatment-naïve or who have not failed prior direct-acting antiviral therapy and who lack baseline NS5A RASs may be authorized for up to 12 weeks.12 weeks; no baseline NS5A RASs

HCV/HIV coinfection: Members with HCV and HIV coinfection may be authorized when they meet the applicable regimen criteria in Sections A or B above.

Requests for Zepatier will be denied for members with decompensated cirrhosis or moderate to severe hepatic impairment (Child‑Turcotte‑Pugh Class B or C). Coverage is not provided for these clinical states and such requests should be expected to be rejected.

All indications other than the FDA‑approved indications and recognized compendial uses described in this policy are considered experimental/investigational and are not medically necessary; therefore coverage will not be provided for non‑FDA/non‑compendial uses.

Use of Zepatier for HCV infections outside of genotype 1 or genotype 4 (i.e., any genotype other than 1 or 4) is considered experimental/investigational and is not medically necessary, and therefore is not covered under this policy.

Provider Requirements and Authorization Process

Prior Authorization

Prior authorization required

Prior authorization is required. Authorization is contingent on meeting the genotype-, baseline resistance- and prior‑therapy–based clinical criteria listed in Sections A–C (e.g., genotype, prior treatment history, and presence or absence of baseline NS5A resistance‑associated substitutions [RASs]). When submitting a PA request, provide documentation that demonstrates the member meets the specific clinical criteria for the requested regimen.

Authorization contingent on listed clinical criteria (genotype, NS5A RAS status, prior therapy).
Provide treatment history and any genotype/ras testing used to determine baseline NS5A status.

Note

Authorization duration varies by resistance and prior therapy

Authorization durations vary based on prior therapy and baseline NS5A resistance-associated substitutions (RASs). For example: genotype 1a with RBV and baseline NS5A RASs may be authorized up to 16 weeks, whereas genotype 1a without baseline NS5A RASs may be authorized up to 12 weeks. ZEPATIER may be authorized up to 12 weeks for members who failed prior PEG‑IFN + RBV with an HCV protease inhibitor. Genotype 4 and other listed scenarios have differing maximum durations as specified in Sections A–C.

Background

Zepatier (elbasvir and grazoprevir) is an approved direct‑acting antiviral (DAA) regimen for the treatment of chronic hepatitis C virus infection of genotype 1 or 4 in adult and pediatric patients 12 years of age or older or weighing at least 30 kg. The product may be used with ribavirin in specified patient populations per the approved indications.

Definitions

NS5A resistance-associated substitutions (RASs)

Relevant NS5A amino acid positionsM28, Q30, L31, Y93

Example substitutions at M28M28A, M28T

Example substitutions at Q30Q30H, Q30R

Example substitutions at L31L31M, L31V

Example substitutions at Y93Y93C, Y93H, Y93N