COVERED USES:

Treatment of chronic hepatitis B (HBV) in adults with evidence of active viral replication and either evidence of persistent elevation in serum aminotransferases (ALT or AST) or histologically active disease.

Requests for a non-FDA approved ("off-label") indication requires the proposed indication be listed in either the American Hospital Formulary System (AHFS), USP-DI, or Drugdex and is considered subject to evaluation of the prescriber's medical rationale, formulary alternatives, the available published evidence-based research and whether the proposed use is determined to be experimental/investigational.

AGE RESTRICTIONS:

NA

PRESCRIBER RESTRICTIONS:

NA

REQUIRED MEDICAL INFORMATION:

For initiation of treatment, a prior authorization form and relevant chart notes documenting medical rationale are required and for continuation of therapy, ongoing documentation of successful response to the medication may be necessary.

CRITERIA:

For Baraclude® and Tyzeka® must have:

• Documented diagnosis of Hepatitis B infection, and
• Meet at least one drug specific criteria below (for Baraclude® or Tyzeka®)

Baraclude®

1. Member has failed or is unable to tolerate Hepsera.

Tyzeka®

1. Members have failed or not tolerated, due to side effects, lamivudine, interferon, and Hepsera® treatment for chronic Hepatitis B, AND
2. Member does not have lamivudine-resistent strain (however, adofevir-resistant strains may still be susceptible to Tyzeka®), AND
3. Not to be used concomitantly with lamivudine

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Initial authorization and reauthorization will be approved for up to one year.