Tavneos — Blue Cross Blue Shield of New Mexico

Initial criteria

• ONE of the following: A. 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 B. BOTH of the following: 1. ONE of the following: A. ALL of the following: 1. The patient has a diagnosis of severe active ANCA-associated vasculitis (GPA and/or MPA) AND 2. The patient has a positive ANCA-test AND 3. The patient has been screened for prior or current hepatitis B infection AND if positive a prescriber specializing in hepatitis B treatment has been consulted OR B. BOTH of the following: 1. The patient has another FDA labeled indication and route of administration for the requested agent AND 2. The patient has been screened for prior or current hepatitis B infection AND if positive a prescriber specializing in hepatitis B treatment has been consulted AND 2. If the patient has an FDA labeled indication, then 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 AND 2. The patient does NOT have severe hepatic impairment (Child-Pugh C) AND 3. If the patient has a diagnosis of ANCA-associated vasculitis, then BOTH of the following: A. The patient is currently treated with standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) for the requested indication AND B. The patient will continue standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) in combination with the requested agent AND 4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or has consulted with a specialist AND 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND 2. The patient has had clinical benefit with the requested agent AND 3. The patient does NOT have severe hepatic impairment (Child-Pugh C) AND 4. If the patient has a diagnosis of ANCA-associated vasculitis, BOTH of the following: A. The patient is currently treated with standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) AND B. The patient will continue standard therapy (e.g., azathioprine, cyclophosphamide, methotrexate, rituximab, mycophenolate mofetil) in combination with the requested agent AND 5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., rheumatologist) or has consulted with a specialist AND 6. The patient does NOT have any FDA labeled contraindications

Approval duration

6–36 months (plan-specific: BCBSOK 36mo; BCBSIL/BCBSMT/BCBSTX 12mo; others 6mo initial, 12mo renewal)