peginterferon alfa- — Blue Cross Blue Shield of Montana

Initial criteria

• 1. ONE of the following: A. 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 peg-interferon for 48 weeks or longer for treatment of chronic hepatitis B OR B. The patient has a diagnosis of chronic hepatitis C genotype 1, 2, 3, or 4 AND the requested agent will be used in a treatment regimen and length of therapy recommended for the patient’s genotype per FDA labeling OR C. The patient has another FDA labeled indication for the requested agent and route of administration OR D. The patient has another non-oncology indication that is supported in compendia for the requested agent and route of administration OR E. The patient has an oncology indication supported in compendia for the requested agent and route of administration (meeting all specified requirements such as performance status, disease severity, previous failures, and combination use).
• 2. If the patient has an FDA labeled indication, ONE of the following: A. The patient’s age is within FDA labeling for the requested indication OR B. There is support for using the requested agent for the patient’s age for the requested indication.
• 3. The requested quantity (dose) is within FDA labeled dosing or supported in compendia for the indication.
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent.
• Compendia Allowed: NCCN 1, 2A, or 2B; AHFS; or DrugDex 1, 2A, or 2B.
• The requested agent will also be approved for: (1) certain BCBS NM Fully Insured or HIM members meeting contraindication, rare disease, and labeled or compendia-supported indication criteria; or (2) certain Ohio Fully Insured or HIM Shop members meeting contraindication and indication criteria or providing two supporting peer-reviewed journal articles.

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process.
• 2. ONE of the following: A. The patient has a diagnosis of chronic hepatitis B AND has NOT been administered peg-interferon for 48 weeks or longer for treatment of chronic hepatitis B OR B. The patient has a diagnosis of chronic hepatitis C genotype 1, 2, 3, or 4 AND did not complete the genotype-specific treatment duration per FDA labeling OR C. The patient has a diagnosis other than chronic hepatitis B or C AND has had clinical benefit with the requested agent.
• 3. The requested quantity (dose) is within FDA labeled dosing or supported in compendia for the requested indication.
• 4. The patient does NOT have any FDA labeled contraindications to the requested agent.
• Compendia Allowed: NCCN 1, 2A, or 2B; AHFS; or DrugDex 1, 2A, or 2B.

Approval duration

12 months (BCBSMT); Hepatitis B up to 48 weeks; Hepatitis C up to genotype-specific duration per labeling; other indications up to 12 months or shorter if limited by label or compendia