CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Zepatier (elbasvir + grazoprevir) for chronic hepatitis C virus (HCV) genotypes 1 and 4

Defines coverage criteria, prescriber requirements, treatment durations, exclusions, and continuation criteria for Zepatier (elbasvir + grazoprevir) for treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 in patients aged ≥12 years or weighing ≥30 kg, including use with or without ribavirin and special populations (kidney transplant recipients, HCV/HIV coinfection).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZepatier (elbasvir + grazoprevir) for chronic hepatitis C virus (HCV) genotypes 1 and 4

Policy CodePolicy N/A

Change TypeClarified

Effective DateN/A

Next Review DateN/A

Key ActionProviders must request authorization specifying HCV genotype, baseline NS5A resistance-associated substitutions (RASs) status when applicable, prior treatment history, and indicate use with or without ribavirin to determine allowed duration.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made to the policy.

2Covered HCV genotypes

12-16 wksAuthorization durations

≥12 yrs / ≥30 kgMinimum age/weight

Coverage Summary

Zepatier (elbasvir + grazoprevir) is covered with criteria for the treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection in patients aged ≥12 years or weighing ≥30 kg. Coverage requires meeting the policy’s approval criteria and prescriber specialty requirements. Regimens may be used with or without ribavirin; authorization durations are typically 12 weeks for many scenarios but may be extended up to 16 weeks for specific genotypes, prior-treatment histories, or when baseline NS5A resistance-associated substitutions are present.

Quick facts and thresholds

Minimum age/weightAge ≥ 12 years OR weight ≥ 30 kg

Covered HCV genotypesGenotype 1 and 4

Typical authorization durations12–16 weeks (12 weeks when no baseline NS5A RASs in many scenarios; up to 16 weeks when baseline NS5A RASs present or for certain prior-treatment scenarios)

Initial Therapy Criteria

General Covered Indication

Covered when ALL of the following are met:

General Covered Indication - top level

Diagnosis of chronic hepatitis C virus (HCV) genotype 1 or 4 infection
Age/Weight: Patient is adult or pediatric aged 12 years or older OR weighs at least 30 kg
Prescriber specialty: Prescribed by or in consultation with a prescriber specializing in infectious disease, gastroenterology, hepatology, or transplant
No exclusions: Member has no exclusions to the prescribed therapy (see Exclusions)

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title_virtual":"General Covered Indication" } , { "ref": "b1_1", "citations": [ "4", "6", "7", "5", "15" ], "title": "A. HCV with ribavirin (RBV)", "intro": "Authorization durations when used with ribavirin for specific genotypes and resistance status:", "nodes": [ "{\"operator\":\"any\",\"n\":0,\"label\":\"Genotype-specific rules\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"Genotype 1a\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"any\",\"n\":0,\"label\":\"Patient status\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"Treatment-naive\",\"text\":\"Treatment-naive\",\"threshold\":\"\",\"note\":\"If baseline NS5A resistance-associated substitutions (RASs) present, authorization of up to 16 weeks total may be granted\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"Failed prior PEG-IFN + RBV with protease inhibitor\",\"text\":\"Failed prior treatment with peginterferon alfa (PEG-IFN) and RBV with an HCV protease inhibitor (boceprevir, simeprevir or telaprevir)\",\"threshold\":\"\",\"note\":\"If without baseline NS5A RASs, authorization of up to 12 weeks total may be granted; if baseline NS5A RASs present, authorization of up to 16 weeks may be granted\",\"children\":[]}]}]},{\"operator\":\"all\",\"n\":0,\"label\":\"Genotype 1b\",\"text\":\"Authorization of up to 12 weeks total may be granted for members who failed prior treatment with PEG-IFN and RBV with an HCV protease inhibitor (boceprevir, simeprevir or telaprevir)\",\"threshold\":\"\",\"note\":\"\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"Genotype 4\",\"text\":\"Authorization of up to 16 weeks total may be granted for members who failed prior treatment with PEG-IFN and RBV\",\"threshold\":\"\",\"note\":\"\",\"children\":[]}]}" ] }, { "ref": "b1_2", "citations": [ "8", "9", "10", "15" ], "title": "B. HCV without ribavirin (RBV)", "intro": "Authorization durations when used without ribavirin for specific genotypes and resistance status:", "nodes": [ "{\"operator\":\"any\",\"n\":0,\"label\":\"Genotype-specific rules\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"Genotype 1a\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"any\",\"n\":0,\"label\":\"Patient status\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"Treatment-naive\",\"text\":\"Treatment-naive\",\"threshold\":\"\",\"note\":\"Authorization of up to 12 weeks total may be granted for members without baseline NS5A RASs\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"Failed prior PEG-IFN + RBV without protease inhibitor\",\"text\":\"Failed prior treatment with PEG-IFN and RBV without an HCV protease inhibitor (boceprevir, simeprevir or telaprevir)\",\"threshold\":\"\",\"note\":\"Authorization of up to 12 weeks total may be granted for members without baseline NS5A RASs\",\"children\":[]}] }]},{\"operator\":\"all\",\"n\":0,\"label\":\"Genotype 1b\",\"text\":\"Treatment-naive: Authorization of up to 12 weeks total may be granted; Failed prior treatment with PEG-IFN and RBV without an HCV protease inhibitor: Authorization of up to 12 weeks total may be granted\",\"threshold\":\"\",\"note\":\"\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"Genotype 4\",\"text\":\"Treatment-naive: Authorization of up to 12 weeks total may be granted\",\"threshold\":\"\",\"note\":\"\",\"children\":[]}]" ] }, { "ref": "b1_3", "citations": [ "11", "12", "4", "8" ], "title": "Special Populations", "intro": "Coverage conditional on meeting genotype/resistance/treatment history criteria below:", "nodes": [ "{\"operator\":\"any\",\"n\":0,\"label\":\"Special populations top\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"Kidney transplant recipients\",\"text\":\"HCV genotype 4 infection and are treatment-naive OR have not failed prior treatment with a direct-acting antiviral\",\"threshold\":\"\",\"note\":\"Authorization of up to 12 weeks total may be granted for members without baseline NS5A RASs\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"HCV and HIV coinfection\",\"text\":\"Authorization may be granted when the criteria for approval of the requested regimen in Section A or B are met\",\"threshold\":\"\",\"note\":\"\",\"children\":[]}]}" ] }, { "ref": "b2_0", "citations": [ "2", "0", "14" ], "title": "Exclusions / Not Medically Necessary", "intro": "", "nodes": [ "{\"operator\":\"all\",\"n\":0,\"label\":\"Exclusions - all required\",\"text\":\"\",\"threshold\":\"\",\"note\":\"\",\"children\":[{\"operator\":\"all\",\"n\":0,\"label\":\"Decompensated cirrhosis / hepatic impairment\",\"text\":\"Members with decompensated cirrhosis / moderate or severe hepatic impairment (Child Turcotte Pugh Class B or C) are excluded from coverage\",\"threshold\":\"\",\"note\":\"\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"Non-FDA-approved uses\",\"text\":\"All other indications not listed (i.e., non-FDA-approved and non-compendial uses) are considered experimental/investigational and not medically necessary\",\"threshold\":\"\",\"note\":\"\",\"children\":[]},{\"operator\":\"all\",\"n\":0,\"label\":\"Combination therapy exclusions\",\"text\":\"When the requested drug is used in a combination therapy regimen, exclusions to the other antiviral drugs also apply\",\"threshold\":\"\",\"note\":\"\",\"children\":[]}]}" ] }, { "ref": "b3_0", "citations": [ "13" ], "title": "Continuation of Therapy", "intro": "", "nodes": [ "{\"operator\":\"all\",\"n\":0,\"label\":\"Continuation requirement\",\"text\":\"All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria\",\"threshold\":\"\",\"note\":\"\",\"children\":[]}" ] } ]}avenport_concatenation_fix_remove_extraneous_characters

Exclusions and Not Medically Necessary

Denial Risk

Excluded hepatic impairment — denial risk

Members with decompensated cirrhosis (moderate or severe hepatic impairment; Child Turcotte Pugh Class B or C) are excluded from coverage — claims for such members risk denial.

Continuation Therapy Criteria

Provider Actions / Prior Authorization

Prior Authorization

Authorization required with genotype/resistance and treatment history

Authorization required. Request must specify HCV genotype, baseline NS5A resistance-associated substitutions (RASs) status when applicable, prior treatment history (treatment-naive or prior PEG-IFN + RBV with/without an HCV protease inhibitor), and whether the regimen will include ribavirin to determine allowed duration (typically up to 12 or 16 weeks depending on genotype, RASs, and prior treatment).

Documentation Required

Prescriber specialty requirement

Medication must be prescribed by or in consultation with a prescriber specializing in infectious disease, gastroenterology, hepatology, or transplant.

Documentation Required

Supportive information that may be requested

The following supportive information may be requested to meet regulatory requirements: treatment status (treatment-naive or retreatment), reason for retreatment (e.g., prior treatment failure, reinfection), confirmation of member readiness and ability to adhere to the proposed treatment plan, Hepatitis B screening results, and Metavir/Fibrosis score. These items may support regulatory requirements but will not be used alone to decide individual requests.

Treatment status (treatment-naive or retreatment)
Reason for retreatment (e.g., prior treatment failure, reinfection)
Confirmation of member readiness and ability to adhere
Hepatitis B screening results
Metavir/Fibrosis score

To request prior authorization, providers must submit HCV genotype, baseline NS5A resistance-associated substitutions (RASs) status when applicable, prior treatment history (treatment-naive or details of prior PEG-IFN + RBV with or without an HCV protease inhibitor), and indicate whether the regimen includes ribavirin; these elements determine whether approval is for 12 weeks or up to 16 weeks depending on genotype, resistance, and prior therapy.

Applicable Codes

Reference numbers / internal IDsmixed

2145-A	CVS Caremark reference number
2684-A	CVS Caremark reference number

Clinical Evidence & References

Evidence and guidance sources include the product labeling: Zepatier [package insert], Merck & Co., Inc., 2022, and the guideline: AASLD/IDSA HCV Recommendations (last changes Oct 5, 2021). Baseline NS5A resistance-associated substitutions at amino acid positions M28, Q30, L31, or Y93 influence recommended treatment duration and may lead to authorization of up to 16 weeks in affected scenarios.

Definitions

NS5A resistance-associated substitutions (RASs)Polymorphisms at NS5A amino acid positions M28, Q30, L31, or Y93

Decompensated cirrhosisModerate or severe hepatic impairment (Child–Turcotte–Pugh Class B or C) — excluded from coverage

Background

Zepatier (elbasvir + grazoprevir) is FDA-approved for chronic HCV genotype 1 or 4 infection in adults and pediatric patients aged 12 years and older or weighing at least 30 kg; some regimens are indicated for use with ribavirin. Baseline NS5A resistance-associated substitutions (RASs) at positions M28, Q30, L31, or Y93 affect recommended duration and may lead to extending therapy authorization (for certain situations) from the typical 12 weeks up to 16 weeks.

Revision History

clarification

Policy clarifies authorization durations (up to 12 or up to 16 weeks) based on HCV genotype, prior treatment history, use with or without ribavirin, and presence of baseline NS5A resistance-associated substitutions (RASs) at positions M28, Q30, L31, or Y93.

clarification

With ribavirin: for genotype 1a (treatment-naive) and genotype 1a who failed prior PEG-IFN + RBV with an HCV protease inhibitor, members without baseline NS5A RASs may be authorized up to 12 weeks, while members with baseline NS5A RASs may be authorized up to 16 weeks; genotype 1b patients who failed prior PEG-IFN + RBV with a protease inhibitor may be authorized up to 12 weeks; genotype 4 patients who failed prior PEG-IFN + RBV may be authorized up to 16 weeks.

clarification

Without ribavirin: members without baseline NS5A RASs may be authorized up to 12 weeks for genotype 1a (treatment-naive or failed prior PEG-IFN + RBV without a protease inhibitor), genotype 1b (treatment-naive or failed prior PEG-IFN + RBV without a protease inhibitor), and genotype 4 (treatment-naive).

clarification

Defines NS5A RASs as polymorphisms at amino acid positions M28, Q30, L31, or Y93 which influence the allowed authorization duration (12 vs 16 weeks).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyZepatier (elbasvir + grazoprevir) for chronic hepatitis C virus (HCV) genotypes 1 and 4

Policy CodePolicy N/A

Change TypeClarified

Effective DateN/A

Next Review DateN/A

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