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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsPremera WA Hepatitis Antiviral Coverage | OpenPaye…
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    ModifiedPremera Blue Cross of WashingtonPolicy 5.01.636

    Chronic Hepatitis B and D Antiviral Therapy

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    This policy governs medical-necessity criteria, documentation, authorization duration, and benefit administration for Baraclude, Hepcludex, and Vemlidy used to treat chronic hepatitis B or D infection. It is intended for providers submitting requests for these pharmacy-benefit medications.

    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyChronic Hepatitis B and D Antiviral Therapy
    Policy CodePolicy 5.01.636
    Change TypeModified
    Effective DateNov 1, 2026
    Next Review DateNot scheduled
    Key ActionSubmit records documenting medical necessity, including diagnosis, history, examination, laboratory tests, and medication history.
    SourceLink
    POLICY UPDATE CHANGES

    Coverage criteria were added for Hepcludex (bulevirtide-gmod) for treatment of chronic hepatitis delta virus.

    The policy title was changed from Chronic Hepatitis B Antiviral Therapy to Chronic Hepatitis B and D Antiviral Therapy.

    Coverage criteria for Pegasys (peginterferon alfa-2a) were removed from this policy and moved to policy 5.01.664.

    Coverage criteria for Epivir-HBV (lamivudine) were removed because the product was discontinued.

    Coverage criteria for Viread (tenofovir disoproxil fumarate) were removed.

    Vemlidy age criteria were updated from 12 years and older to 6 years and older, and a generic tenofovir disoproxil fumarate trial-first requirement was added.

    Coverage criteria for Viread (tenofovir disoproxil fumarate) were previously added to the policy.

    Non-formulary exception review authorizations for drugs listed in the policy were clarified as eligible for approval for up to 12 months.

    3Antiviral drugs addressed

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    12 months
    Maximum initial authorization
    12 monthsMaximum reauthorization
    2 yearsBaraclude minimum age
    18 yearsHepcludex minimum age
    6 yearsVemlidy minimum age

    Coverage Criteria

    Initial therapy: Baraclude (entecavir)

    Baraclude may be considered medically necessary when all of the following are met.

    Baraclude criteria

    • Required criteria

      • The individual is aged 2 years or older.
      • The individual has a confirmed diagnosis of chronic hepatitis B virus (HBV) infection.

      • Liver disease

        • The individual is aged 18 years or older with compensated or decompensated liver disease.
        • The individual is aged 2 to 17 years with compensated liver disease.

      • HIV status or treatment

        • The individual does not have HIV coinfection.
        • The individual has HIV coinfection and is receiving highly active antiretroviral therapy.
      • The individual has tried generic entecavir and had an inadequate response or intolerance.

    Initial therapy: Hepcludex (bulevirtide-gmod)

    Hepcludex may be considered medically necessary when all of the following are met.

    Hepcludex criteria

    • The individual is aged 18 years or older.
    • The individual has a confirmed diagnosis of chronic hepatitis D virus (HDV) infection with a current positive HDV RNA test.

    • Cirrhosis status

      • The individual is without cirrhosis.
      • The individual has compensated cirrhosis classified as Child-Pugh A.

    Initial therapy: Vemlidy (tenofovir alafenamide)

    Vemlidy may be considered medically necessary when all of the following are met.

    Vemlidy criteria

    • The individual is aged 6 years or older.
    • The individual has a confirmed diagnosis of chronic hepatitis B virus (HBV) infection.
    • The individual has compensated liver disease.

    • HIV status or treatment

      • The individual does not have HIV coinfection.
      • The individual has HIV coinfection and is receiving highly active antiretroviral therapy (HAART).

    Continuation therapy

    Reauthorization may be approved when the applicable medical-necessity criteria continue to be met and continued positive clinical response is documented.

    • The individual continues to meet the applicable medical-necessity criteria.
    • The individual demonstrates a positive clinical response to therapy, such as a reduction in hepatitis B or D virus DNA levels.

    Coding and Clinical Thresholds

    HCPCSHCPCS
    S0145Injection, PEGylated interferon alfa-2A (Pegasys), 180 mcg per ml (code terminated 11/01/26)
    Baraclude minimum age
    Minimum ageAge 2 years or older
    Covered medicationBaraclude (entecavir)
    Eligibility contextThe individual must also have confirmed chronic hepatitis B virus infection and meet the applicable liver-disease, HIV-treatment, and generic-entecavir requirements.
    Hepcludex minimum age
    Minimum ageAge 18 years or older
    Covered medicationHepcludex (bulevirtide-gmod)
    Eligibility context

    Authorization and Documentation Requirements

    Prior Authorization

    Baraclude Prior Authorization

    Obtain prior authorization before coverage of Baraclude (entecavir). The individual must meet all applicable medical-necessity criteria for chronic HBV treatment.

    • Age 2 years or older.
    • Confirmed diagnosis of chronic hepatitis B virus (HBV) infection.
    • Adults (18 years or older) must have compensated or decompensated liver disease; individuals ages 2–17 must have compensated liver disease.
    • The individual either does not have HIV co-infection or has HIV co-infection and is receiving highly active antiretroviral therapy (HAART).
    Prior Authorization

    Hepcludex Prior Authorization

    Obtain prior authorization before coverage of Hepcludex (bulevirtide-gmod). The individual must meet all chronic HDV, virologic, and cirrhosis-status requirements.

    • Age 18 years or older.
    • Confirmed diagnosis of chronic hepatitis D virus (HDV) infection with a current positive HDV RNA test.

    Clinical Background

    Chronic hepatitis B (CHB) is a vaccine-preventable liver infection caused by HBV. Although most individuals recover, some develop chronic infection, which may progress to liver damage, cirrhosis, and hepatocellular carcinoma. Hepatitis D (HDV) requires HBV to reproduce and can accelerate liver damage and progression to cirrhosis, increasing the risk of liver cancer and death. This policy addresses antiviral treatment for chronic HBV and HDV, including selected individuals with compensated or decompensated liver disease.

    Clinical Definitions

    Hepatitis B surface antigen (HBsAg)
    LocationFound on the surface of the hepatitis B virus
    InfectiousnessAll persons with HBsAg are infectious.
    Clinical useHBsAg positivity for at least 6 months is a defining feature of chronic hepatitis B.
    Hepatitis B e-antigen (HBeAg)
    LocationFound in the inner core of the hepatitis B virus
    InfectiousnessPersons with positive HBeAg are described as most infectious.
    Clinical association

    Initial Therapy Criteria

    Baraclude: Detailed initial-therapy medical-necessity criteria

    Baraclude may be considered medically necessary when all of the following are met.

    Baraclude criteria

    • Required criteria

      • The individual is aged 2 years or older.
      • The individual has a confirmed diagnosis of chronic hepatitis B virus (HBV) infection.

      • Liver disease

        • The individual is aged 18 years or older with compensated or decompensated liver disease.

    Continuation and Reauthorization

    Reauthorization

    All reviews may be approved for up to 12 months when medical-necessity criteria are met and continued positive clinical response is documented.

    • The individual continues to meet the applicable medical-necessity criteria.
    • The individual demonstrates a positive clinical response to therapy, such as a reduction in hepatitis B or D virus DNA levels.

    Step-Therapy Requirements

    StepTry firstThen requestedCoverage requirement
    1Generic entecavirBaraclude (entecavir)The individual must have tried generic entecavir and had an inadequate response or intolerance.
    StepTry firstApplies toThen requestedCoverage requirement
    1Generic tenofovir disoproxil fumarateAdults and pediatric individuals weighing at least 35 kgVemlidy (tenofovir alafenamide)The individual must have tried generic tenofovir disoproxil fumarate and had an inadequate response or intolerance.
    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyChronic Hepatitis B and D Antiviral Therapy
    Policy CodePolicy 5.01.636
    Change TypeModified
    Effective DateNov 1, 2026
    Next Review DateNot scheduled
    Key ActionSubmit records documenting medical necessity, including diagnosis, history, examination, laboratory tests, and medication history.
    SourceLink
    On This Page
    Coverage CriteriaCoding and Clinical ThresholdsAuthorization and Documentation RequirementsClinical BackgroundClinical DefinitionsInitial Therapy CriteriaContinuation and ReauthorizationStep-Therapy Requirements
  1. For adults and pediatric individuals who weigh at least 35 kg, the individual has tried generic tenofovir disoproxil fumarate and had an inadequate response or intolerance.

    This prerequisite applies to adults and pediatric individuals weighing at least 35 kg.

    2. The individual must also have confirmed chronic hepatitis D virus infection with a current positive HDV RNA test and no cirrhosis or compensated Child-Pugh A cirrhosis.
    Vemlidy minimum age
    Minimum ageAge 6 years or older
    Covered medicationVemlidy (tenofovir alafenamide)
    Eligibility contextThe individual must also have confirmed chronic hepatitis B virus infection and compensated liver disease.
    Vemlidy weight-specific prerequisite
    Weight thresholdAt least 35 kg
    Applies toAdults and pediatric individuals who weigh at least 35 kg
    Related prerequisiteA prior trial of generic tenofovir disoproxil fumarate with inadequate response or intolerance is required for this group.
    Chronic hepatitis B duration
    Chronic infection durationHBsAg positive for at least 6 months
    Associated testHBV DNA may range from undetectable to several billion IU/mL
    Liver findingsALT and/or AST levels may be normal or elevated, with variable necroinflammation and/or fibrosis.
    Immune-active CHB HBV DNA threshold
    HBeAg-positive CHBHBV DNA greater than 20,000 IU/mL
    HBeAg-negative CHBHBV DNA greater than 2,000 IU/mL
    Additional featuresImmune-active CHB may include intermittently or persistently elevated ALT and/or AST and moderate or severe necroinflammation, with or without fibrosis.
    Inactive CHB HBV DNA threshold
    HBV DNA thresholdBelow 2,000 IU/mL
    Antigen statusHBeAg negative and anti-HBe positive
    Liver findingsPersistently normal ALT and/or AST levels and no significant necroinflammation.
  2. The individual must be without cirrhosis or have compensated cirrhosis (Child-Pugh A).
    3. Prior Authorization

    Vemlidy Prior Authorization

    Obtain prior authorization before coverage of Vemlidy (tenofovir alafenamide). The individual must meet all applicable HBV, liver-disease, HIV, weight, and treatment-history criteria.

    • Age 6 years or older.
    • Confirmed diagnosis of chronic HBV infection and compensated liver disease.
    • The individual either does not have HIV co-infection or has HIV co-infection and is receiving HAART.
    • For adults and pediatric individuals weighing at least 35 kg, the individual must have tried generic tenofovir disoproxil fumarate and had an inadequate response or intolerance.

    Unsupported block type: step_therapy [REJECTED] prior_auth

    Step Therapy

    Generic Tenofovir Disoproxil Fumarate Prerequisite

    Before Vemlidy coverage, qualifying adults and pediatric individuals who weigh at least 35 kg must have tried generic tenofovir disoproxil fumarate. Document the trial and its outcome in the authorization request.

    • Applies to adults and pediatric individuals weighing at least 35 kg.
    • Document a trial of generic tenofovir disoproxil fumarate before requesting Vemlidy.
    Documentation Required

    Required Clinical Documentation

    Submit medical records demonstrating that the applicable medical-necessity criteria are met. Records for all conditions should support the diagnosis, relevant clinical findings, laboratory evaluation, and treatment history.

    • Office visit notes containing the diagnosis, relevant history, physical evaluation, laboratory tests, and medication history.
    • Include treatment information and documentation supporting the requested drug and applicable prerequisite therapy.
    Documentation Required

    Drug-Specific Supporting Records

    Include drug-specific supporting records with the prior-authorization submission. Documentation should establish the individual’s age, diagnosis, liver-disease status, HIV status, and relevant antiretroviral or prior-treatment details.

    • Baraclude: age, chronic HBV diagnosis, liver-disease status, HIV status, HAART status if HIV co-infected, and generic entecavir trial outcome.
    • Hepcludex: age, chronic HDV diagnosis, current positive HDV RNA result, and absence of cirrhosis or compensated cirrhosis (Child-Pugh A).
    • Vemlidy: age, chronic HBV diagnosis, compensated liver disease, HIV/HAART status, weight when applicable, and generic tenofovir disoproxil fumarate trial history.
    Documentation Required

    Continuation-Response Documentation

    For reauthorization, provide evidence that the individual continues to meet medical-necessity criteria and is showing a positive clinical response to therapy. Drug reviews may be approved for up to 12 months when continued response is documented.

    • Document ongoing positive clinical response, such as a reduction in hepatitis B or D virus DNA levels.
    • Reauthorization may be approved for up to 12 months when criteria and continued response are demonstrated.
    Denial Risk

    Failure to Meet Medical-Necessity Criteria

    Coverage may be denied when drug-specific medical-necessity requirements are not met or are not documented. This includes failure to satisfy age, diagnosis, liver-disease, HIV/HAART, or required prerequisite-therapy criteria.

    • Baraclude: denial risk if the individual is under age 2, lacks chronic HBV, does not meet the applicable liver-disease requirement, does not meet the HIV/HAART requirement, or lacks an inadequate response or intolerance to generic entecavir.
    • Vemlidy: denial risk if the individual is under age 6, lacks chronic HBV or compensated liver disease, does not meet the HIV/HAART requirement, or—when applicable—has not tried generic tenofovir disoproxil fumarate.
    • Requests may also be denied when required clinical records are incomplete or do not support the criteria.
    Denial Risk

    Unsupported Chronic HDV or Cirrhosis Status

    Hepcludex may be denied when chronic HDV infection or the required virologic and cirrhosis-status documentation is not established.

    • No confirmed chronic HDV diagnosis or no current positive HDV RNA test.
    • Individual is under age 18.
    • Individual has cirrhosis other than compensated cirrhosis (Child-Pugh A), or the cirrhosis status is undocumented.
    Denial Risk

    Insufficient Response for Reauthorization

    Reauthorization may be denied when the individual no longer meets medical-necessity criteria or the submission does not demonstrate continued positive clinical response to therapy.

    • Insufficient evidence of ongoing response, such as no documented reduction in hepatitis B or D virus DNA levels when clinically applicable.
    • Missing or inadequate records supporting continued treatment, the diagnosis, or other applicable criteria.
    • Initial and reauthorization reviews may be approved for up to 12 months only when the relevant criteria are met.
    HBeAg-positive chronic hepatitis B is typically associated with higher HBV DNA levels.
    Anti-hepatitis B e-antigen (anti-HBe)
    DefinitionAntibodies to hepatitis B e-antigen (HBeAg)
    Clinical significanceAn indicator of resolution of acute infection
    Relationship to HBeAgAnti-HBe is detected when HBeAg is no longer present during seroconversion.
    HBV DNA
    StructureA partially double-stranded DNA molecule
    LocationFound in the inner core of the hepatitis B virus
    InfectiousnessElevated HBV DNA is associated with greater infectiousness.
    Chronic hepatitis B (CHB)
    Duration criterionHBsAg positive for at least 6 months
    Viral-load rangeHBV DNA varies from undetectable to several billion IU/mL
    Liver findingsALT and/or AST levels may be normal or elevated, with variable necroinflammation and/or fibrosis.
    Immune-tolerant chronic hepatitis B
    Antigen statusHBsAg present for at least 6 months and HBeAg positive
    Viral loadVery high HBV DNA, typically greater than 1 million IU/mL
    Liver findingsNormal or minimally elevated ALT and/or AST, with no fibrosis and minimal inflammation.
    Immune-active CHB
    Viral-load criteriaHBV DNA greater than 20,000 IU/mL in HBeAg-positive CHB and greater than 2,000 IU/mL in HBeAg-negative CHB
    Liver enzymesALT and/or AST levels are intermittently or persistently elevated.
    Liver pathologyModerate or severe necroinflammation, with or without fibrosis.
    Inactive CHB
    Antigen statusHBsAg present for at least 6 months; HBeAg negative and anti-HBe positive
    Viral loadHBV DNA below 2,000 IU/mL
    Liver findingsPersistently normal ALT and/or AST, no significant necroinflammation, and variable fibrosis.
    HBeAg seroconversion
    HBeAg changeLoss of HBeAg
    Anti-HBe changeDetection of anti-HBe
    Prior statusOccurs in a person previously HBeAg positive and anti-HBe negative.
    Combined response
    HDV RNA responseUndetectable HDV RNA or at least a 2 log10 IU/mL decline from baseline
    ALT responseALT normalization
    Combined endpointBoth the HDV RNA response and ALT normalization are required.
    Virologic response
    Undetectable resultHDV RNA is undetectable
    Decline alternativeAt least a 2 log10 IU/mL decline from baseline
    Response definitionEither the undetectable result or the specified decline meets the virologic-response definition.
    Undetectable HDV RNA
    Quantitative thresholdLess than the lower limit of quantification of 50 IU/mL
    Qualitative resultThe target is not detected
    Test measureThe definition applies to HDV RNA testing.
    Vemlidy
    Medication classHepatitis B virus nucleoside analog reverse transcriptase inhibitor
    Prodrug descriptionTenofovir alafenamide is a phosphonamidite prodrug of tenofovir.
    MechanismIts active metabolite incorporates into viral DNA reverse transcriptase and inhibits HBV replication.
    The individual is aged 2 to 17 years with compensated liver disease.

  3. HIV status or treatment

    • The individual does not have HIV coinfection.
    • The individual has HIV coinfection and is receiving highly active antiretroviral therapy.
  4. The individual has tried generic entecavir and had an inadequate response or intolerance.

    5. Hepcludex: Detailed initial-therapy medical-necessity criteria

    Hepcludex may be considered medically necessary when all of the following are met.

    Hepcludex criteria

    • The individual is aged 18 years or older.
    • The individual has a confirmed diagnosis of chronic hepatitis D virus (HDV) infection with a current positive HDV RNA test.

    • Cirrhosis status

      • The individual is without cirrhosis.
      • The individual has compensated cirrhosis classified as Child-Pugh A.

    Vemlidy: Detailed initial-therapy medical-necessity criteria

    Vemlidy may be considered medically necessary when all of the following are met.

    Vemlidy criteria

    • The individual is aged 6 years or older.
    • The individual has a confirmed diagnosis of chronic hepatitis B virus (HBV) infection.
    • The individual has compensated liver disease.

    • HIV status or treatment

      • The individual does not have HIV coinfection.
      • The individual has HIV coinfection and is receiving highly active antiretroviral therapy (HAART).
    • For adults and pediatric individuals who weigh at least 35 kg, the individual has tried generic tenofovir disoproxil fumarate and had an inadequate response or intolerance.

      This prerequisite applies to adults and pediatric individuals weighing at least 35 kg.