COVERED USES:

Chronic hepatitis C and Chronic hepatitis B.

All FDA-approved indications not otherwise excluded from Part D.

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:

Initial therapy (previously untreated)

For all genotypes the following must be met:

1. Detectable serum HCV RNA
AND
2. If applicable, documentation of successful treatment and/or abstinence from alcohol or other illicit drugs for a minimum of six (6) months
AND
3. Peginterferon used in combination with ribavirin unless patient has contraindication to ribavirin
AND
4. In addition, for each genotype:
   Genotype 1:
   • Elevated ALT/AST within previous year
     • ALT: Adults greater than 56u/l
     • AST: Adults greater than 40u/l
   OR
   • Liver biopsy showing chronic hepatitis with more than portal fibrosis (must have greater than or equal to stage II or III - stage I or II with significant inflammation noted on biopsy)
   • Treatment duration will be authorized for 48 weeks
   
   Genotype 2 or 3:
   • Treatment duration will be authorized for 24 weeks except:
   • 48 weeks with HIV co-infection
   • 48 weeks with peginterferon monotherapy

For all genotypes the following must be met:

• Documentation that member meets # 1 and 2 above
AND
• Previous treatment with interferon with or without ribavirin
AND
• Retreatment should be with peginterferon plus ribavirin
• Treatment duration is 48 weeks regardless of genotype

Must have evidence of Hepatitis B requiring treatment and failure of oral agents used for the treatment of Hepatitis B

EXCLUSION CRITERIA:

NA

COVERAGE DURATION:

Genotype 1 or retreatment -48 weeks. Genotype 2 or 3 - 24-48 weeks.

For Hep B - up to 1 year.