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    v1.0.30
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsPremera Pegasys Prior Auth Coverage | OpenPayer
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    CurrentPremera Blue Cross of WashingtonPolicy 5.01.664

    Pegasys (peginterferon alfa-2a) Coverage

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    Medical-necessity and prior-authorization coverage for Pegasys, including covered uses, documentation, authorization duration, and pharmacy-benefit administration.

    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyPegasys (peginterferon alfa-2a) Coverage
    Policy CodePolicy 5.01.664
    Change TypeNew policy consolidating existing criteria
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit medical records documenting that the applicable medical-necessity criteria are met, including diagnosis, relevant history, physical evaluation, laboratory tests, and medication history.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    12 monthsMaximum initial authorization
    12 monthsMaximum reauthorization
    3 yearsMinimum pediatric age
    48 weeksHepatitis D treatment duration
    Pharmacy

    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.

    Benefit

    Medical Necessity and Covered Uses

    Medically Necessary Indications

    Pegasys (peginterferon alfa-2a) may be considered medically necessary when the applicable disease-specific criteria below are met. The medication is subject to the product's U.S. Food and Drug Administration (FDA) dosage and administration prescribing information.

    ONE of the following indications and applicable criteria

    • Chronic hepatitis B virus (HBV) infection

      • ALL of the following

        • Individual is aged 18 years or older with HBeAg-positive or HBeAg-negative chronic HBV infection.
        • Individual has compensated liver disease.
        • There is evidence of viral replication and liver inflammation.

      • ALL of the following

        • Individual is a non-cirrhotic pediatric individual aged 3 years or older with HBeAg-positive chronic hepatitis B.
        • There is evidence of viral replication and elevations in serum alanine aminotransferase (ALT).
    • Treatment of chronic hepatitis C virus infection when used in accordance with current guidelines.

    • Chronic hepatitis D virus (HDV) infection

      • Individual has compensated liver disease.
      • Pegasys (peginterferon alfa-2a) is used as a single agent for 48 weeks.
    • First- or second-line treatment of essential thrombocytopenia.

    • Myelofibrosis

      • Individual is aged 18 years or older.
      • Individual has myelofibrosis with a JAK2 V617F mutation.

    Investigational or Unlisted Uses

    Uses of Pegasys (peginterferon alfa-2a) that are not outlined in this policy are not considered medically necessary and are considered investigational.

    All other uses of Pegasys (peginterferon alfa-2a) for conditions not outlined in this policy are considered investigational.

    Reauthorization

    Reauthorization may be approved when the medical necessity criteria continue to be met and the individual demonstrates a positive clinical response to therapy.

    ALL of the following

    • The medical necessity criteria for the applicable indication continue to be met.
    • There is evidence that the individual continues to show a positive clinical response to therapy.

    All other uses of Pegasys (peginterferon alfa-2a) for conditions not outlined in this policy are considered investigational.

    Authorization and Submission Requirements

    Prior Authorization

    Initial Authorization Period

    Authorization is required for all drugs listed in this policy. Initial authorization may be approved for up to 12 months.

    Documentation Required

    Required Clinical Documentation

    Submit medical records demonstrating that the applicable medical necessity criteria are met. Records should include office visit notes with the diagnosis, relevant history, physical evaluation, laboratory tests, and medication history.

    Denial Risk

    Unlisted Indications

    Drug Background

    Peginterferon alfa-2a is an alpha interferon that modulates immune responses and may inhibit viral replication and abnormal-cell growth. The policy addresses its use in chronic hepatitis B, chronic hepatitis C, chronic hepatitis D, essential thrombocytopenia, and myelofibrosis in adults with a JAK2 V617F mutation.

    Clinical Definitions

    Hepatitis B surface antigen (HBsAg)
    DefinitionA surface antigen found on the surface of hepatitis B virus.
    InfectiousnessAll persons with HBsAg are infectious.
    Clinical significanceHBsAg positivity is part of the definition of chronic hepatitis B when present for at least 6 months.
    Hepatitis B e-antigen (HBeAg)
    DefinitionAn antigen found in the inner core of hepatitis B virus.
    InfectiousnessAll persons with positive HBeAg are most infectious.
    Disease association

    Initial Therapy

    Initial Therapy Criteria

    Initial coverage may be considered when the individual meets an applicable covered indication.

    Covered initial indications: The individual has an applicable covered indication for Pegasys, including chronic hepatitis B, chronic hepatitis C, chronic hepatitis D, essential thrombocytopenia, or qualifying myelofibrosis.

    Disease-specific requirements apply; see the applicable covered-indication criteria.

    Reauthorization Criteria

    Reauthorization Criteria

    Reauthorization may be approved for up to 12 months when the criteria below are met.

    Continued therapy: The applicable medical-necessity criteria continue to be met and the individual continues to show a positive clinical response to Pegasys.Up to 12 months

    Treatment Duration

    Pegasys (peginterferon alfa-2a)
    MedicationPegasys (peginterferon alfa-2a).
    AdministrationUse as a single agent.
    Treatment duration48 weeks.
    Policy Summary
    PayerPremera Blue Cross of Washington
    PolicyPegasys (peginterferon alfa-2a) Coverage
    Policy CodePolicy 5.01.664
    Change TypeNew policy consolidating existing criteria
    Effective DateN/A
    Next Review DateN/A
    Key ActionSubmit medical records documenting that the applicable medical-necessity criteria are met, including diagnosis, relevant history, physical evaluation, laboratory tests, and medication history.
    SourceLink
    On This Page
    Medical Necessity and Covered UsesAuthorization and Submission RequirementsDrug BackgroundClinical DefinitionsInitial TherapyReauthorization CriteriaTreatment Duration

    All other uses of Pegasys (peginterferon alfa-2a) for conditions not outlined in this policy are considered investigational and may be denied. Use must also follow the product’s U.S. Food and Drug Administration dosage and administration prescribing information.

    Note

    Chronic Hepatitis D Criteria

    Pegasys may be considered medically necessary for chronic hepatitis D virus (HDV) infection when the individual has compensated liver disease and Pegasys (peginterferon alfa-2a) is used as a single agent for 48 weeks.

    Prior Authorization

    Reauthorization Requirements

    Reauthorization may be approved for up to 12 months when the applicable medical necessity criteria continue to be met and there is evidence that the individual continues to show a positive clinical response to therapy.

    HBeAg-positive chronic hepatitis B is typically associated with higher HBV DNA levels, greater than 20,000 IU/mL.
    Anti-hepatitis B e-antigen (anti-HBe)
    DefinitionAntibodies to hepatitis B e-antigen (HBeAg).
    Clinical significanceAnti-HBe is an indicator of resolution of acute infection.
    Serologic contextAnti-HBe detection is used in defining HBeAg seroconversion.
    HBV DNA
    DefinitionA partially double-stranded DNA molecule found in the inner core of hepatitis B virus.
    Infectivity relationshipElevated HBV DNA levels indicate greater infectiousness.
    MeasurementHBV DNA levels in chronic hepatitis B may range from undetectable to several billion IU/mL.
    Chronic hepatitis B (CHB)
    Duration criterionHBsAg positive for at least 6 months.
    Virologic and serologic characteristicsHBV DNA varies from undetectable to several billion IU/mL; individuals may be HBeAg positive or HBeAg negative.
    Laboratory and pathology characteristicsALT and/or AST levels may be normal or elevated; liver biopsy may show chronic hepatitis with variable necroinflammation and/or fibrosis.
    Immune-tolerant chronic hepatitis B
    HBsAg and HBeAgHBsAg is present for at least 6 months and HBeAg is positive.
    Viral and biochemical findingsHBV DNA levels are very high, typically greater than 1 million IU/mL, with normal or minimally elevated ALT and/or AST.
    Liver findingsBiopsy or noninvasive testing shows no fibrosis and minimal inflammation.
    Immune-active CHB
    Duration criterionHBsAg is present for at least 6 months.
    HBV DNA thresholdsHBV DNA is greater than 20,000 IU/mL in HBeAg-positive CHB and greater than 2,000 IU/mL in HBeAg-negative CHB.
    Biochemical and disease activity findingsALT and/or AST levels are intermittently or persistently elevated, and biopsy or noninvasive testing shows moderate or severe necroinflammation with or without fibrosis.
    Inactive CHB
    Serologic findingsHBsAg is present for at least 6 months; HBeAg is negative and anti-HBe is positive.
    Virologic and biochemical findingsHBV DNA is below 2,000 IU/mL and ALT and/or AST levels are persistently normal.
    Liver findingsLiver biopsy confirms absence of significant necroinflammation; biopsy or noninvasive testing may show variable fibrosis.
    HBeAg seroconversion
    DefinitionLoss of HBeAg and detection of anti-HBe.
    Prior serologic statusOccurs in a person previously positive for HBeAg and negative for anti-HBe.
    InterpretationRepresents a change from HBeAg-positive to anti-HBe-positive status.
    Sustained virologic response (SVR)
    DefinitionClearance of HCV RNA by qualitative analysis 24 weeks after therapy cessation.
    Assessment timingEvaluated 24 weeks after treatment ends.
    Clinical roleThe current gold-standard measure of response to chronic hepatitis C pharmacotherapy.
    Early virologic response (EVR)
    DefinitionClearance of HCV RNA during the first 12 weeks of therapy.
    Assessment timingEvaluated during the first 12 weeks of treatment.
    Related response measureA partial response is a minimum 2-log decrease in hepatitis C viral load after 12 weeks of therapy.
    Sustained virologic response (SVR)
    DefinitionClearance of HCV RNA by qualitative analysis 24 weeks after cessation of therapy.
    Assessment timingMeasured 24 weeks after treatment ends.
    Clinical roleThe current gold-standard measure of response to chronic HCV pharmacotherapy.
    Early virologic response (EVR)
    DefinitionClearance of HCV RNA during the first 12 weeks of therapy.
    Assessment timingMeasured during the first 12 weeks of treatment.
    Tested markerThe response is assessed by clearance of hepatitis C viral RNA.
    Partial response
    DefinitionA minimum 2-log decrease in hepatitis C viral load.
    Assessment timingMeasured after 12 weeks of therapy.
    Clinical contextA partial response is distinct from clearance of HCV RNA during the first 12 weeks of therapy.
    Relapse
    DefinitionInitial achievement of a sustained virologic response that is not sustained over time.
    Initial statusAn SVR is achieved initially.
    Subsequent statusThe response is subsequently lost over time.
    Nonresponse
    DefinitionNever achieving a sustained virologic response.
    Response statusThe individual does not initially achieve SVR during or after therapy.
    Distinction from relapseUnlike relapse, nonresponse does not involve an initial achievement of SVR.