COVERED USES:

FDA Approved Indications:

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.

All FDA approved indications not otherwise excluded form Part D.

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. Member has 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.