avacopan — Blue Cross Blue Shield of Montana

Initial criteria

• 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 conditions are met:
• — Patient has a diagnosis of severe active ANCA-associated vasculitis (GPA and/or MPA) AND positive ANCA test AND screened for prior or current hepatitis B infection AND if positive prescriber specializing in hepatitis B treatment has been consulted OR
• — Patient has another FDA labeled indication and route of administration for the requested agent AND screened for prior or current hepatitis B infection AND if positive prescriber specializing in hepatitis B treatment has been consulted
• If the patient has an FDA labeled indication then ONE of the following: patient’s age is within FDA labeling for the requested indication OR there is support for use for the patient’s age for the requested indication
• Patient does NOT have severe hepatic impairment (Child-Pugh C)
• If the diagnosis is ANCA-associated vasculitis then BOTH of the following: currently treated with standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) AND will continue standard therapy in combination with Tavneos
• Prescriber is a specialist in rheumatology or has consulted such a specialist
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

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

Approval duration

12 months (BCBSMT); 36 months (BCBSOK); 6 months (others)