Tavneos — Blue Cross Blue Shield of Illinois

Initial criteria

• The patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) AND is at risk if therapy is changed OR BOTH of the following:
• The patient has a diagnosis of severe active ANCA-associated vasculitis (GPA and/or MPA) AND a positive ANCA test AND has been screened for prior or current hepatitis B infection AND if positive a prescriber specializing in hepatitis B treatment has been consulted OR the patient has another FDA labeled indication and route of administration AND has been screened for prior or current hepatitis B infection AND if positive a prescriber specializing in hepatitis B treatment has been consulted
• If the patient has an FDA labeled indication, then ONE of the following: the patient’s age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient’s age for the requested indication
• The patient does NOT have severe hepatic impairment (Child-Pugh C)
• If the patient has a diagnosis of ANCA-associated vasculitis, then BOTH of the following: The patient is currently treated with standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) AND will continue standard therapy in combination with the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had clinical benefit with the requested agent
• The patient does NOT have severe hepatic impairment (Child-Pugh C)
• If the patient has a diagnosis of ANCA-associated vasculitis, then BOTH of the following: The patient is currently treated with standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) AND will continue standard therapy in combination with the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months (BCBSIL, BCBSMT, BCBSTX); 36 months (BCBSOK); 6 months (all other plans)