Pegylated Interferon – Pegasys Prior Authorization Criteria - Medicare Part D

Prior Authorization Criteria for Approval

Pegasys will be approved when BOTH of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of chronic hepatitis B AND BOTH of the following:
      1. The chronic hepatitis B infection has been confirmed by serological markers
         AND
      2. The patient has NOT been administered the requested medication for more than 48 weeks for the treatment of chronic hepatitis B
         OR
   2. BOTH of the following:
      1. The patient has a diagnosis of chronic hepatitis C confirmed by serological markers
         AND
      2. The requested medication will be used in a treatment regimen and length of therapy that is supported in FDA approved labeling or AASLD/IDSA guidelines for the patient’s diagnosis and genotype
         OR
   3. The patient has an indication that is supported in CMS approved compendia for the requested medication
      AND
2. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of Approval:

Hepatitis B infection:

• No prior peginterferon alfa use, approve 48 weeks
• Prior peginterferon alfa use, approve remainder of 48 weeks of total therapy

Hepatitis C infection

• 12 - 48 weeks as determined in Table 1 or 2 (FDA labeling) OR supported in AASLD/IDSA guidelines: https://www.hcvguidelines.org/

All other diagnoses

• 12 months