adalimumab-adbm — CareFirst (Caremark)

Initial criteria

• Rheumatoid arthritis (RA): age ≥ 18 years; biomarker testing positive for rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) or tested for RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR); AND one of the following: (1) failed to achieve low disease activity after 3-month trial of methotrexate (MTX) monotherapy ≥15 mg/week with inadequate response or intolerance to hydroxychloroquine and/or sulfasalazine or contraindications; (2) unable to tolerate MTX monotherapy with inadequate response or intolerance/contraindication to leflunomide, hydroxychloroquine, and/or sulfasalazine; (3) intolerable adverse event or contraindication to MTX plus inadequate response/intolerance/contraindication to leflunomide, hydroxychloroquine, and/or sulfasalazine; must have moderate to high disease activity.
• Articular juvenile idiopathic arthritis (JIA): age ≥ 2 years; inadequate response to methotrexate or other conventional synthetic drug (leflunomide, sulfasalazine, hydroxychloroquine) at adequate dose/duration, OR inadequate response to scheduled NSAIDs and/or intra-articular glucocorticoids with ≥1 poor-outcome risk factor (ankle, wrist, hip, sacroiliac, TMJ involvement; erosive disease; delayed diagnosis; elevated inflammatory markers; symmetric disease), OR risk factors indicating severe or refractory disease (high-risk joints, high disease activity, high risk for disabling disease).
• Psoriatic arthritis (PsA): age ≥ 18 years and diagnosis of active PsA; may be approved if previously received biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for PsA.
• Ankylosing spondylitis, non-radiographic axial spondyloarthritis, hidradenitis suppurativa, uveitis, immune checkpoint inhibitor-related toxicity: documentation of previous medications tried and clinical reason if therapy not advisable.
• Plaque psoriasis (PsO): documentation of affected area(s) and body surface area (BSA) affected; documentation of previous therapy trials including systemic and topical and their response; or medical reason to avoid standard systemic therapy.
• Crohn’s disease (CD) and ulcerative colitis (UC): chart notes or documentation of diagnosis and previous medication trials may be required per standard policy.
• Behcet’s disease: documentation of previous medications tried and clinical response (if applicable).
• Pyoderma gangrenosum: documentation of prior medications tried and response or reason therapy not advisable.

Reauthorization criteria

• Rheumatoid arthritis (RA), JIA, PsA, AS, nraxSpA, HS, uveitis, immune checkpoint inhibitor-related toxicity: positive clinical response to therapy documented in chart notes.
• Plaque psoriasis (PsO): documentation of decreased body surface area (BSA) affected and/or improvement in signs and symptoms.
• Crohn’s disease (CD) and ulcerative colitis (UC): documentation of positive clinical response or remission.

Approval duration

12 months