CurrentPremera Blue Cross of WashingtonPolicy 5.01.664

Pegasys (peginterferon alfa-2a) Coverage Criteria

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This policy governs medical-necessity review and prior authorization for Pegasys under the pharmacy benefit for specified hepatitis B, hepatitis C, hepatitis D, essential thrombocytopenia, and myelofibrosis indications.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPegasys (peginterferon alfa-2a) Coverage Criteria

Policy CodePolicy 5.01.664

Change TypeNew policy consolidating coverage criteria

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests showing that the requested Pegasys indication meets the applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

A new policy was created to consolidate coverage criteria for Pegasys (peginterferon alfa-2a).

5Covered indications

Up to 12 monthsInitial authorization

Up to 12 monthsReauthorization

3 yearsYoungest covered age

Excluded

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CurrentPremera Blue Cross of WashingtonPolicy 5.01.664

Pegasys (peginterferon alfa-2a) Coverage Criteria

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyPegasys (peginterferon alfa-2a) Coverage Criteria

Policy CodePolicy 5.01.664

Change TypeNew policy consolidating coverage criteria

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests showing that the requested Pegasys indication meets the applicable medical-necessity criteria.

SourceLink

POLICY UPDATE CHANGES

A new policy was created to consolidate coverage criteria for Pegasys (peginterferon alfa-2a).

5Covered indications

Up to 12 monthsInitial authorization

Up to 12 monthsReauthorization

3 yearsYoungest covered age

Excluded

Covered Indications and Policy Scope

Chronic Hepatitis B

Covered when the applicable indication-specific criteria are met.

ONE of

Adults with chronic hepatitis B: Individual is aged 18 years or older; has HBeAg-positive or HBeAg-negative chronic HBV infection; has compensated liver disease; and has evidence of viral replication and liver inflammation.Age >=18 years
Pediatric chronic hepatitis B: Individual is aged 3 years or older, is non-cirrhotic, has HBeAg-positive chronic hepatitis B, and has evidence of viral replication and elevated serum ALT.Age >=3 years; non-cirrhotic

Chronic Hepatitis C

Covered when used in accordance with current guidelines.

Pegasys is used for treatment of chronic hepatitis C in accordance with current guidelines.

Coverage is subject to the applicable current guideline recommendations.

Chronic Hepatitis D

Covered when all requirements are met.

ALL of the following

Individual has compensated liver disease.
Pegasys is used as a single agent for 48 weeks.Single-agent treatment for 48 weeks

Essential Thrombocytopenia

Covered as first- or second-line treatment.

Pegasys is used as first-line or second-line treatment of essential thrombocytopenia.First- or second-line therapy

Myelofibrosis

Covered when all requirements are met.

ALL of the following

Individual is aged 18 years or older.Age >=18 years
Individual has myelofibrosis with a JAK2 V617F mutation.JAK2 V617F mutation

Reauthorization

Reauthorization requires continued medical necessity and positive clinical response.

ALL of the following

The applicable medical-necessity criteria continue to be met.
The individual continues to show a positive clinical response to therapy.

Uses not outlined in this policy are considered investigational and are not eligible for coverage under these criteria. The policy addresses specified uses of Pegasys (peginterferon alfa-2a) for chronic hepatitis B, chronic hepatitis C, chronic hepatitis D, essential thrombocytopenia, and myelofibrosis.

This medical policy does not apply to Medicare Advantage. Coverage determinations for Medicare Advantage members should follow the applicable Medicare Advantage benefit and policy requirements.

Authorization and Documentation Requirements

Prior Authorization

Medical-Necessity Prior Authorization

Prior authorization is required for Pegasys (peginterferon alfa-2a). The requested indication must meet the applicable medical-necessity criteria in this policy, and the medication must be used in accordance with FDA prescribing information.

Submit the request for the applicable covered indication.
Approval may be granted for up to 12 months when initial medical-necessity criteria are met.

Documentation Required

Required Clinical Records

Submit medical records demonstrating that the applicable medical-necessity criteria are met for the requested use of Pegasys.

Office visit notes documenting the diagnosis, relevant history, physical evaluation, laboratory tests, and medication history.

Clinical Background

Peginterferon alfa-2a is an alpha interferon that can regulate immune responses and help suppress viral replication or abnormal cell growth. In this policy, its clinical uses include chronic hepatitis B, chronic hepatitis C, chronic hepatitis D, essential thrombocytopenia, and myelofibrosis with a JAK2 V617F mutation. This background information is explanatory and does not independently establish coverage.

Clinical Definitions

Hepatitis B surface antigen (HBsAg)

DefinitionA hepatitis B surface antigen found on the virus surface.

InfectiousnessAll persons with HBsAg are infectious.

AbbreviationHBsAg.

Hepatitis B e-antigen (HBeAg)

DefinitionAn antigen found in the inner core of the hepatitis B virus.

InfectiousnessPersons with positive HBeAg are described as most infectious.

AbbreviationHBeAg.

Indication-Specific Initial Therapy

Initial therapy may be medically necessary for the following indications when the applicable criteria are met.

ONE of

Adult chronic hepatitis B: Individual is aged 18 years or older; has HBeAg-positive or HBeAg-negative chronic HBV infection; has compensated liver disease; and has evidence of viral replication and liver inflammation.Age >=18 years
Pediatric chronic hepatitis B: Individual is aged 3 years or older, is non-cirrhotic, has HBeAg-positive chronic hepatitis B, and has evidence of viral replication and elevated serum ALT.Age >=3 years; non-cirrhotic
Chronic hepatitis C:

Pegasys Reauthorization

Reauthorization is available when the medical-necessity criteria remain satisfied and clinical benefit continues.

ALL of the following

The applicable medical-necessity criteria are met.
The individual continues to show a positive clinical response to therapy.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyPegasys (peginterferon alfa-2a) Coverage Criteria

Policy CodePolicy 5.01.664

Change TypeNew policy consolidating coverage criteria

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests showing that the requested Pegasys indication meets the applicable medical-necessity criteria.

SourceLink

On This Page

Denial Risk

Unlisted or Investigational Use

Coverage may be denied for uses of Pegasys that are not outlined in this policy. Such uses are considered investigational.

Use the medication in accordance with current FDA dosage and administration prescribing information.

Denial Risk

Hepatitis D Criteria Must Be Met

For chronic hepatitis D virus (HDV), coverage requires compensated liver disease and use of Pegasys as a single agent for 48 weeks. If either criterion is not met, the request may be denied as not meeting medical-necessity requirements.

Compensated liver disease is required.
Pegasys must be used as a single agent for 48 weeks.

Denial Risk

Continuation Therapy Requires Positive Response

Reauthorization may be approved for up to 12 months only when the medical-necessity criteria continue to be met and there is evidence that the individual continues to show a positive clinical response to therapy. Without continued medical necessity or a positive clinical response, reauthorization may be denied.

Document ongoing response to therapy in the reauthorization request.

Anti-hepatitis B e-antigen (anti-HBe)

DefinitionAntibodies to hepatitis B e-antigen (HBeAg).

Clinical significanceAn indicator of resolution of acute infection.

AbbreviationAnti-HBe.

HBV DNA

DefinitionA partially double-stranded DNA molecule found in the inner core of the hepatitis B virus.

Clinical significanceElevated HBV DNA is associated with greater infectiousness.

MeasurementHBV DNA levels may range from undetectable to several billion IU/mL in chronic hepatitis B.

Chronic hepatitis B (CHB)

DefinitionChronic hepatitis B is HBsAg positivity for at least 6 months.

Viral loadHBV DNA may range from undetectable to several billion IU/mL; HBeAg-positive disease is typically associated with levels above 20,000 IU/mL.

Clinical findingsALT and/or AST levels may be normal or elevated, with variable necroinflammation and/or fibrosis on liver biopsy.

Immune-tolerant chronic hepatitis B

DefinitionHBsAg is present for at least 6 months and HBeAg is positive.

Viral and laboratory findingsHBV DNA levels are typically very high, above 1 million IU/mL, with normal or minimally elevated ALT and/or AST.

Liver findingsThere is no fibrosis and minimal inflammation on liver biopsy or noninvasive testing.

Immune-active CHB

DefinitionHBsAg is present for at least 6 months.

HBV DNA thresholdHBV DNA is above 20,000 IU/mL in HBeAg-positive CHB or above 2,000 IU/mL in HBeAg-negative CHB.

Clinical findingsALT and/or AST levels are intermittently or persistently elevated, with moderate or severe necroinflammation and with or without fibrosis.

Inactive CHB

Serologic findingsHBsAg is present for at least 6 months; HBeAg is negative and anti-HBe is positive.

HBV DNA thresholdHBV DNA is below 2,000 IU/mL.

Liver findingsALT and/or AST levels are persistently normal, with no significant necroinflammation and variable levels of fibrosis.

HBeAg seroconversion

DefinitionLoss of HBeAg and detection of anti-HBe.

Prior statusOccurs in a person who was previously HBeAg positive and anti-HBe negative.

Clinical contextThe change describes a serologic transition in chronic hepatitis B infection.

Sustained virologic response (SVR)

DefinitionClearance of HCV RNA by qualitative analysis 24 weeks after therapy cessation.

TimingThe response is assessed 24 weeks after treatment ends.

Clinical significanceSVR is the 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 periodEVR is evaluated during the first 12 weeks of treatment.

Partial-response thresholdA 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.

TimingSVR is measured 24 weeks after therapy ends.

Clinical significanceSVR is the 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 periodEVR is assessed during the first 12 weeks of treatment.

Clinical contextEVR is an early measure of response to chronic hepatitis C therapy.

Partial response

DefinitionA minimum 2-log decrease in hepatitis C viral load.

Assessment timeThe decrease is measured after 12 weeks of therapy.

Clinical contextA partial response is a form of early virologic response assessment.

Relapse

DefinitionInitial achievement of an SVR that is not sustained over time.

Initial responseThe individual first achieves a sustained virologic response.

Subsequent courseThe SVR is not maintained over time.

Nonresponse

DefinitionNever achieving an SVR.

Response statusThe individual does not achieve sustained virologic response at any point.

DistinctionNonresponse differs from relapse because there is no initial achievement of SVR.

Pegasys is used for treatment of chronic hepatitis C in accordance with current guidelines.

Chronic hepatitis D

Individual has compensated liver disease.
Pegasys is used as a single agent for 48 weeks.48 weeks

Essential thrombocytopenia: Pegasys is used as first-line or second-line treatment of essential thrombocytopenia.First- or second-line therapy

Myelofibrosis

Individual is aged 18 years or older.Age >=18 years
Individual has myelofibrosis with a JAK2 V617F mutation.JAK2 V617F mutation