tocilizumab-aazg — CareFirst (Caremark)

Initial criteria

• Member has had an intolerance or contraindication to both systemic corticosteroids and methotrexate (see Appendix A)
• For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) within 12 months of initiating therapy for persons naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB
• If the screening testing for TB is positive, there must be further testing to confirm no active disease (e.g., chest x-ray)
• Do not administer the requested medication to members with active TB infection
• If there is latent disease, TB treatment must be started before initiation of the requested medication
• For all indications: Member cannot use the requested medication concomitantly with any other biologic drug or targeted synthetic drug

Reauthorization criteria

• Rheumatoid arthritis: Member achieves or maintains a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability
• Articular juvenile idiopathic arthritis: Member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms with improvement from baseline in number of joints with active arthritis, number of joints with limitation of movement, or functional ability
• Systemic juvenile idiopathic arthritis: Member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms with improvement from baseline in number of joints with active arthritis, number of joints with limitation of movement, functional ability, or systemic features (fever, rash, lymphadenopathy, hepatomegaly, splenomegaly, serositis)
• Giant cell arteritis: Member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms with improvement from baseline in headaches, scalp tenderness, tenderness/thickening of temporal arteries, constitutional symptoms, jaw/tongue claudication, acute visual symptoms, symptoms of polymyalgia rheumatica, or limb claudication
• Systemic sclerosis-associated interstitial lung disease: Authorization may be granted when the member is currently receiving treatment with Actemra or Tyenne
• Immune checkpoint inhibitor-related inflammatory arthritis: Member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms
• Cytokine release syndrome, acute graft versus host disease, and immune checkpoint inhibitor-related toxicity: Member must meet all initial authorization criteria
• Unicentric Castleman disease and Multicentric Castleman disease: Continued treatment when there is no evidence of unacceptable toxicity or disease progression
• Polymyalgia rheumatica: Member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms with improvement from baseline in morning stiffness, hip or shoulder pain, hip or shoulder range of motion, or C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)

Approval duration

12 months