CurrentNeighborhood Health Plan of Rhode IslandPolicy 4779-A

Entecavir (Baraclude) — Prior Authorization for Chronic Hepatitis B and HBV Prophylaxis

Defines coverage criteria and authorization requirements for entecavir (Baraclude) for treatment of chronic hepatitis B virus (HBV) infection, HBV/HIV coinfection, and HBV reactivation/reinfection prophylaxis for members of Neighborhood Health Plan of Rhode Island (as referenced by this document).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyEntecavir (Baraclude) — Prior Authorization for Chronic Hepatitis B and HBV Prophylaxis

Policy CodePolicy 4779-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization (approvals up to 12 months) when all listed clinical criteria and required documentation demonstrating active HBV replication are submitted.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

>=2 yrsminimum pediatric age

multiplecovered indications

experimentalother indications

Coverage Criteria for entecavir (Baraclude)

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Chronic Hepatitis B Virus Infection or HBV/HIV Coinfection - Initial Authorization

Authorization of 12 months may be granted when ALL of the following are met:

Initial authorization requirements: (1) Evidence of active viral replication (detectable serum HBV DNA by bDNA hybridization or PCR). (2) Evidence of persistent elevations in serum aminotransferases (ALT or AST). (3) Member meets ANY of: histologically active disease OR hepatic fibrosis detected by transient elastography or serum fibrosis markers (e.g., APRI, FIB-4, FibroSure). (4) Member meets either: HIV-1 negative OR coinfection with chronic HBV and HIV and currently receiving antiretroviral therapy.

Preserve logical grouping as in source.

Hepatitis B Virus Reactivation/Reinfection Prophylaxis

Authorization of 12 months may be granted for prophylaxis when ALL coverage requirements are met:

Prophylaxis authorization: Immunosuppressed members requiring prophylaxis for HBV reactivation/reinfection; all members requesting continuation must meet the coverage criteria.

Definition of immunosuppressed not specified in this document; continuation requests must meet all requirements in the coverage criteria.

Continuation / Reauthorization

Authorization of 12 months may be granted for continued treatment when ALL of the following are met:

Continuation therapy: Member demonstrates or maintains a positive clinical response (e.g., decreased HBV DNA level, histologic improvement, ALT normalization, or HBeAg seroconversion).

Continuation/reauthorization also requires meeting all applicable initial coverage requirements.

All indications for entecavir that are not listed as FDA‑approved or as compendial uses in this policy are considered experimental/investigational and not medically necessary. Requests for such indications may be denied.

Use of entecavir (Baraclude) for any indication beyond the FDA‑approved indications and the compendial uses listed in this policy (for example, indications not included under the compendia listing such as HBV reactivation prophylaxis or HBV/HIV coinfection) is considered not medically necessary.

Coding and Age Limits

Covered drugsNDC | mixedCovered

entecavir

Baraclude (entecavir) — brand and generic, all dosage forms and strengths

Minimum pediatric age — entecavir (Baraclude)

Minimum pediatric agePediatric patients 2 years of age and older (>= 2 years)

FDA indication contextApplies to treatment of chronic hepatitis B with evidence of active viral replication and either persistent ALT/AST elevations or histologically active disease

Applies to formulationsIncludes entecavir (Baraclude) for indicated doses and formulations for pediatric patients

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Approvals of up to 12 months may be granted when all listed clinical criteria are met.

Authorization may be granted for up to 12 months when criteria are met.

Note

Provider Action

Provider action required: submit supporting clinical documentation with initial request and for reauthorization.

Include evidence of active viral replication (e.g., detectable serum HBV DNA by PCR or bDNA).
Include evidence of persistent elevations in serum aminotransferases (ALT or AST).
For prophylaxis requests, document immunosuppressed status.
For coinfection with HIV, document current antiretroviral therapy when applicable.

Documentation Required

Required Clinical Documentation

Documentation must show evidence of active viral replication and persistent elevations in serum aminotransferases, and other supporting clinical findings as described in the coverage criteria.

Detectable serum HBV DNA measured by bDNA hybridization or PCR assay.
Persistent elevations in ALT or AST.
Histologic evidence of active disease or hepatic fibrosis (e.g., transient elastography, APRI, FIB-4, FibroSure) when applicable.
For HBV/HIV coinfection, documentation of HIV status and antiretroviral therapy as applicable.

Documentation Required

Reauthorization Documentation

For continuation/reauthorization, submit documentation demonstrating a positive clinical response to therapy.

Decreased HBV DNA level.
Histologic improvement.
ALT normalization.
HBeAg seroconversion when applicable.
For prophylaxis, documentation that member continues to meet criteria for immunosuppression or ongoing risk of reactivation.

Denial Risk

Non‑Covered Indications

Requests for indications other than FDA‑approved indications or listed compendial uses are considered experimental/investigational and are not covered.

Compendial uses that are covered include HBV reactivation/reinfection prophylaxis and coinfection with chronic HBV and HIV. All other indications are not medically necessary.

Definitions

Active viral replication — definition

DefinitionDetectable serum HBV DNA as measured by bDNA hybridization or polymerase chain reaction (PCR) assay

Role in authorizationRequired evidence for initial authorization of treatment for chronic HBV (one of the required criteria)

Documentation noteLaboratory report showing detectable HBV DNA by bDNA or PCR should be provided with the authorization request

Evidence of hepatic fibrosis

DefinitionHepatic fibrosis detected by transient elastography or serum markers of fibrosis (e.g., APRI, FIB-4, FibroSure)

Role in authorizationCounts as meeting the disease-severity criterion for initial authorization when histologic disease is not documented

Examples of serum markersAPRI (AST-to-platelet ratio index), FIB-4, FibroSure