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Simponi — Blue Cross Blue Shield of Alabama

Rheumatoid arthritis (RA)

Initial criteria

  • For RA: Has an intolerance or hypersensitivity to ONE conventional agent (methotrexate, hydroxychloroquine, leflunomide, sulfasalazine) OR has an FDA labeled contraindication to ALL conventional agents OR medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for RA AND if request is for Simponi, will use with methotrexate OR has intolerance, hypersensitivity, or contraindication to methotrexate.
  • For PsA: Has tried and had an inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL conventional agents OR severe active PsA OR concomitant severe psoriasis OR medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported in compendia for PsA.
  • For PS: Has tried and had an inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL conventional agents OR severe active PS OR concomitant severe PsA OR medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported in compendia for PS.
  • For CD: Has tried and had an inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL conventional agents OR medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for CD.
  • For UC: Has tried and had an inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL conventional agents OR severely active UC OR medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for UC.
  • For non-infectious uveitis forms: Has tried and had an inadequate response to ONE oral OR periocular/intravitreal corticosteroid for ≥2 weeks OR intolerance/hypersensitivity OR contraindication to ALL corticosteroids AND has tried and had an inadequate response to ONE conventional systemic agent (azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL systemic agents OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for uveitis.
  • For GCA: Has tried and had an inadequate response to ONE systemic corticosteroid (e.g., prednisone, methylprednisolone) for ≥7 days OR intolerance/hypersensitivity OR contraindication to ALL systemic corticosteroids OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for GCA.
  • For AS: Has tried and had an inadequate response to TWO different NSAIDs for ≥4 weeks total OR inadequate response to ONE NSAID for ≥4 weeks AND intolerance/hypersensitivity to one additional NSAID OR intolerance/hypersensitivity to TWO different NSAIDs OR contraindication to ALL NSAIDs OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for AS.
  • For nr-axSpA: Has tried and had an inadequate response to TWO different NSAIDs for ≥4 weeks total OR inadequate response to ONE NSAID for ≥4 weeks AND intolerance/hypersensitivity to one additional NSAID OR intolerance/hypersensitivity to TWO different NSAIDs OR contraindication to ALL NSAIDs OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for nr-axSpA.
  • For PJIA: Has tried and had an inadequate response to ONE conventional agent (methotrexate, leflunomide) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL conventional agents OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for PJIA.
  • For HS: Has tried and had an inadequate response to ONE conventional agent (oral tetracyclines, oral contraceptives, metformin, finasteride, spironolactone, intralesional corticosteroids, clindamycin+rifampin, rifampin+moxifloxacin+metronidazole, cyclosporine, oral retinoids) for ≥3 months OR intolerance/hypersensitivity OR contraindication to ALL conventional agents OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for HS.
  • For SSc-ILD: Has diagnosis of systemic sclerosis associated interstitial lung disease confirmed by high-resolution computed tomography or chest radiography scans.
  • For ERA: Has tried and had an inadequate response to TWO different NSAIDs for ≥4 weeks total OR inadequate response to ONE NSAID for ≥4 weeks AND intolerance/hypersensitivity to one additional NSAID OR intolerance/hypersensitivity to TWO different NSAIDs OR contraindication to ALL NSAIDs OR medication history indicates use of another biologic immunomodulator agent labeled or supported in compendia for ERA.
  • For AD: Has diagnosis of moderate-to-severe atopic dermatitis AND (≥10% body surface area OR difficult-to-treat sites OR EASI ≥16 OR IGA ≥3) AND has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid for ≥4 weeks OR intolerance/hypersensitivity/contraindication to ALL medium-, high-, or super-potency corticosteroids AND has tried and had an inadequate response to ONE topical calcineurin inhibitor (pimecrolimus, tacrolimus) for ≥6 weeks OR intolerance/hypersensitivity/contraindication to ALL topical calcineurin inhibitors.