Simponi (golimumab) — CareFirst (Caremark)

Initial criteria

• Rheumatoid Arthritis (RA): Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active RA within the past 120 days. The requested medication must be prescribed in combination with methotrexate or leflunomide unless the member has a clinical reason not to use methotrexate or leflunomide.
• For adult members for treatment of moderately to severely active RA when all of the following are met: Member meets either of the following: (a) Tested for either rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) and the test was positive; OR (b) Tested for RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR). AND Member meets one of the following treatment history conditions: (1) Failed to achieve low disease activity after a 3-month trial of methotrexate monotherapy at ≥15 mg/week and had inadequate response to or intolerance/contraindication to hydroxychloroquine or sulfasalazine; OR (2) Unable to tolerate methotrexate monotherapy and had inadequate response to or intolerance/contraindication to other conventional synthetic DMARDs (leflunomide, hydroxychloroquine, and/or sulfasalazine); OR (3) Experienced documented intolerable adverse event or contraindication to methotrexate and had inadequate response to or intolerance/contraindication to other conventional synthetic DMARDs. The requested medication must be prescribed in combination with methotrexate or leflunomide or have a documented reason not to use them.
• Psoriatic Arthritis (PsA): Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Otezla) indicated for active PsA.
• For active PsA, authorization may be granted when: Member has mild to moderate disease and (a) inadequate response to methotrexate, leflunomide, or another conventional synthetic drug (e.g., sulfasalazine) administered at adequate dose and duration; OR (b) intolerance or contraindication to methotrexate, leflunomide, or another conventional synthetic drug. OR Member has enthesitis or predominantly axial disease. OR Member has severe disease.
• Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA): Authorization of 12 months may be granted for adult members who have previously received a biologic or targeted synthetic drug (e.g., Rinvoq, Xeljanz) indicated for active AS or active nr-axSpA. Authorization may also be granted when member had inadequate response to at least two NSAIDs or intolerance/contraindication to two or more NSAIDs.
• Ulcerative Colitis (UC): Authorization of 12 months may be granted for treatment of moderately to severely active UC.
• Immune Checkpoint Inhibitor-Related Toxicity: Authorization of 12 months may be granted for moderate or severe immunotherapy-related inflammatory arthritis when member had inadequate response to corticosteroids or a conventional synthetic drug (e.g., methotrexate, sulfasalazine, leflunomide, hydroxychloroquine), or has intolerance/contraindication to these agents.

Reauthorization criteria

• Rheumatoid Arthritis: Authorization of 12 months may be granted when member achieves or maintains a positive clinical response as evidenced by at least 20% improvement from baseline in tender joint count, swollen joint count, pain, or disability.
• Psoriatic Arthritis: Authorization of 12 months may be granted when member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement in any of the following: number of swollen joints, number of tender joints, dactylitis, enthesitis, axial disease, skin/nail involvement, functional status, or CRP.
• Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: Authorization of 12 months may be granted when member achieves or maintains a positive clinical response as evidenced by low disease activity or improvement from baseline in functional status, total spinal pain, inflammation (e.g., morning stiffness), swollen joints, tender joints, or CRP.
• Ulcerative Colitis: Authorization of 12 months may be granted when member achieves or maintains remission or low disease activity or improvement in stool frequency, rectal bleeding, or urgency of defecation.

Approval duration

12 months