CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Baraclude (entecavir) coverage

Defines coverage criteria for entecavir (Baraclude) for treatment of chronic hepatitis B (HBV) in adults and children >=2 years and for HBV reactivation/reinfection prophylaxis in immunosuppressed members, including initial and continuation authorization durations and required clinical response.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBaraclude (entecavir) coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionObtain prior authorization and document evidence of active HBV replication and required disease activity criteria (or ART for coinfected patients); initial authorizations: 6 months for chronic HBV, 12 months for HBV prophylaxis; continued therapy may be authorized for 12 months with documented positive clinical response.

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update.

2Covered Indications (FDA + compendia)

1Investigational / Not Medically Necessary categories

6m / 12mInitial authorization durations (treatment / prophylaxis)

Coverage Summary

Scope: Defines coverage criteria for entecavir (Baraclude) for treatment of chronic hepatitis B (HBV) in adults and children >= 2 years with evidence of active viral replication and liver injury, and for hepatitis B virus reactivation/reinfection prophylaxis in immunosuppressed members. Initial and continuation authorization durations are specified for the covered indications.

Coverage stance: Covered with criteria for the FDA-approved indication (treatment of chronic HBV in adults and children >= 2 years with evidence of active viral replication and either persistent ALT/AST elevations or histologically active disease) and for listed compendial uses (HBV/HIV coinfection and HBV reactivation/reinfection prophylaxis) when all approval criteria are met and there are no exclusions to therapy.

Initial Therapy Criteria

Covered Indications and Initial Authorization Criteria

Baraclude is covered for FDA-approved indications and listed compendial uses when ALL approval criteria are met and member has no exclusions to therapy.

Indication (choose one)

FDA-Approved indication: Treatment of chronic hepatitis B virus (HBV) infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
Compendial uses: Coinfection with chronic hepatitis B virus and human immunodeficiency virus (HIV); Hepatitis B virus reactivation/reinfection prophylaxis.

Chronic HBV infection and HBV/HIV coinfection initial authorization (6 months)

Evidence of active viral replication: There is evidence of active viral replication (e.g., detectable serum HBV DNA measured by bDNA hybridization or PCR assay).
Member must meet at least one of the following disease activity criteria
- Histologically active disease: Member has histologically active disease.
- Persistent aminotransferase elevations: Member has evidence of persistent elevations in serum aminotransferases (ALT or AST).
- Hepatic fibrosis: Member has hepatic fibrosis detected by transient elastography or serum markers of fibrosis (e.g., APRI score, FIB-4, FibroSure).
HIV/coinfection branches
- HIV-1 negative: Member is HIV-1 negative.
- HBV/HIV coinfection on ART: Member has coinfection with chronic hepatitis B virus and HIV and is currently receiving antiretroviral therapy.

HBV reactivation/reinfection prophylaxis initial authorization (12 months): Indication: Prophylaxis of hepatitis B virus reactivation/reinfection in immunosuppressed members.12 months

Continuation Therapy Criteria

Continuation of Therapy / Reauthorization Criteria

Criteria for continued treatment authorization (duration stated).

Chronic HBV infection and HBV/HIV coinfection continuation (12 months): Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for chronic HBV infection or coinfection with chronic HBV and HIV who achieve or maintain a positive clinical response (e.g., decreased HBV DNA level, histologic improvement; ALT normalization, HBeAg seroconversion).12 months

HBV reactivation/reinfection prophylaxis continuation: All members (including new members) requesting authorization for continuation of therapy must meet all initial authorization criteria.

Requirement to meet initial criteria: All members requesting continuation must meet the initial authorization criteria for the requested indication.

Not Medically Necessary / Experimental

All other indications not listed above are considered experimental/investigational and not medically necessary.

Not medically necessary / Experimental: Any indication for entecavir other than the FDA-approved indication for chronic HBV, coinfection with HIV (as defined above), or HBV reactivation/reinfection prophylaxis in immunosuppressed members.

Provider Actions

Prior Authorization

Authorization required

Prior authorization is required. Initial authorizations: 6 months for treatment of chronic HBV infection (including HBV/HIV coinfection when criteria met) and 12 months for HBV reactivation/reinfection prophylaxis in immunosuppressed members. Continued therapy authorizations may be granted for 12 months for members requesting reauthorization who achieve or maintain a positive clinical response.

Chronic HBV treatment initial authorization: 6 months
HBV reactivation/reinfection prophylaxis initial authorization: 12 months
Continued treatment authorization (when positive clinical response documented): 12 months

Documentation Required

Required clinical documentation

Providers must document evidence of active viral replication (detectable serum HBV DNA) and at least one disease activity criterion: histologically active disease OR persistent elevations in serum aminotransferases (ALT or AST) OR hepatic fibrosis detected by transient elastography or serum fibrosis markers (e.g., APRI, FIB-4, FibroSure). For HBV/HIV coinfected members, document current antiretroviral therapy. For continuation requests, document a positive clinical response (examples: decreased HBV DNA level, histologic improvement, ALT normalization, HBeAg seroconversion).

Clinical Evidence & References

Evidence and references: Package inserts (Aurobindo entecavir, April 2022; Baraclude/Bristol-Myers Squibb, November 2019), AASLD hepatitis B guidance (2018), U.S. Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents (2024), Micromedex, Clinical Pharmacology, and Lexicomp.

Background: Entecavir (Baraclude) is indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Compendial uses: Documented compendial uses include management of coinfection with chronic hepatitis B virus and human immunodeficiency virus (HIV) and prophylaxis against hepatitis B virus reactivation/reinfection in immunosuppressed patients; these uses are covered when the policy's approval criteria are met.