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Simponi — Blue Cross Blue Shield of Kansas

moderately to severely active Crohn’s disease (CD)

Initial criteria

  • For rheumatoid arthritis (RA): 1. Has tried and had an inadequate response to ONE conventional agent (methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) used in RA for ≥3 months OR 2. Has intolerance or hypersensitivity to ONE conventional agent OR 3. Has FDA labeled contraindication to ALL conventional agents OR 4. Medication history indicates use of another biologic immunomodulator agent for RA. AND if the request is for Simponi, then ONE of the following: A. Will use methotrexate in combination OR B. Has intolerance, hypersensitivity, or FDA labeled contraindication to methotrexate.
  • For psoriatic arthritis (PsA): 1. Has tried and had an inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) used in PsA for ≥3 months OR 2. Has intolerance or hypersensitivity to ONE conventional agent OR 3. Has FDA labeled contraindication to ALL conventional agents OR 4. Has severe active PsA (e.g., erosive disease, elevated ESR/CRP, long-term damage, rapidly progressive) OR 5. Has concomitant severe psoriasis (e.g., >10% BSA, select locations, intractable pruritus, serious emotional consequences) OR 6. Medication history indicates use of another biologic immunomodulator agent or Otezla for PsA.
  • For plaque psoriasis (PS): 1. Has tried and had an inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) used in PS for ≥3 months OR 2. Has intolerance or hypersensitivity to ONE conventional agent OR 3. Has FDA labeled contraindication to ALL conventional agents OR 4. Has severe active PS OR 5. Has concomitant severe PsA OR 6. Medication history indicates use of another biologic immunomodulator agent or Otezla for PS.
  • For Crohn’s disease (CD): 1. Has tried and had an inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) used in CD for ≥3 months OR 2. Has intolerance or hypersensitivity to ONE conventional agent OR 3. Has FDA labeled contraindication to ALL conventional agents OR 4. Medication history indicates use of another biologic immunomodulator agent for CD.
  • For ulcerative colitis (UC): 1. Has tried and had an inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) used in UC for ≥3 months OR 2. Has intolerance or hypersensitivity to ONE conventional agent OR 3. Has FDA labeled contraindication to ALL conventional agents OR 4. Has severely active UC OR 5. Medication history indicates use of another biologic immunomodulator agent for UC.
  • For non-infectious intermediate uveitis, posterior uveitis, or panuveitis: 1. BOTH of the following: A. ONE of the following: • Tried and inadequate response to ONE oral corticosteroid for ≥2 weeks OR • Tried and inadequate response to ONE periocular or intravitreal corticosteroid injection OR • Has intolerance or hypersensitivity to ONE corticosteroid formulation OR • Has FDA labeled contraindication to ALL corticosteroid formulations. AND B. ONE of the following: • Tried and inadequate response to ONE conventional systemic agent (azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) for ≥3 months OR • Has intolerance or hypersensitivity to ONE conventional systemic agent OR • Has FDA labeled contraindication to ALL conventional systemic agents. OR 2. Medication history indicates use of another biologic immunomodulator agent for uveitis.
  • For giant cell arteritis (GCA): 1. Has tried and had an inadequate response to ONE systemic corticosteroid (prednisone, methylprednisolone) for ≥7 days OR 2. Has intolerance or hypersensitivity to ONE systemic corticosteroid OR 3. Has FDA labeled contraindication to ALL systemic corticosteroids OR 4. Medication history indicates use of another biologic immunomodulator agent for GCA.
  • For ankylosing spondylitis (AS): 1. Has tried and had an inadequate response to TWO different NSAIDs for ≥4 weeks total OR 2. Has tried and had an inadequate response to ONE NSAID ≥4 weeks and intolerance or hypersensitivity to ONE additional NSAID OR 3. Has intolerance or hypersensitivity to TWO different NSAIDs OR 4. Has FDA labeled contraindication to ALL NSAIDs OR 5. Medication history indicates use of another biologic immunomodulator agent for AS.
  • For non-radiographic axial spondyloarthritis (nr-axSpA): 1. Has tried and inadequate response to TWO different NSAIDs for ≥4 weeks total OR 2. Has inadequate response to ONE NSAID ≥4 weeks and intolerance or hypersensitivity to ONE additional NSAID OR 3. Has intolerance or hypersensitivity to TWO different NSAIDs OR 4. Has FDA labeled contraindication to ALL NSAIDs OR 5. Medication history indicates use of another biologic immunomodulator agent for nr-axSpA.
  • For polyarticular juvenile idiopathic arthritis (PJIA): 1. Has tried and had an inadequate response to ONE conventional agent (methotrexate, leflunomide) for ≥3 months OR 2. Has intolerance or hypersensitivity to ONE conventional agent OR 3. Has FDA labeled contraindication to ALL conventional agents OR 4. Medication history indicates use of another biologic immunomodulator agent for PJIA.