Simponi — Blue Cross Blue Shield of Texas

Initial criteria

• For RA: The patient has tried and had an inadequate response to ONE conventional DMARD (e.g., hydroxychloroquine, leflunomide, sulfasalazine) OR the patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of RA; AND for Simponi, the patient will be taking the requested agent in combination with methotrexate OR has intolerance, FDA labeled contraindication, or hypersensitivity to methotrexate.
• For PsA: The patient has tried and had an inadequate response to ONE conventional agent (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) after at least 3 months OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL such agents OR severe active PsA OR concomitant severe psoriasis OR use of another biologic immunomodulator or Otezla for PsA.
• For PS: The patient has tried and had an inadequate response to ONE conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after at least 3 months OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL such agents OR severe active PS OR concomitant severe PsA OR use of another biologic immunomodulator or Otezla for PS.
• For CD: The patient is stable on the requested agent OR has tried and had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, corticosteroids, methotrexate) after at least 3 months OR discontinued due to lack of efficacy or adverse event OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL such agents OR conventional therapy expected to be ineffective or not in best interest OR use of another biologic immunomodulator for CD.
• For UC: The patient is stable on the requested agent OR has tried and had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after at least 3 months OR discontinued due to lack of efficacy or adverse event OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL such agents OR conventional therapy expected to be ineffective or not in best interest OR has severely active UC OR use of another biologic immunomodulator for UC.
• For non-infectious intermediate/posterior/panuveitis: The patient has tried and had an inadequate response to ONE oral or periocular/intravitreal corticosteroid OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL corticosteroids AND has tried and had an inadequate response to ONE conventional systemic agent (e.g., azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) after at least 3 months OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL systemic agents OR severe active sight-threatening disease OR use of another biologic immunomodulator for this indication.
• For GCA: The patient has tried and had an inadequate response to ONE systemic corticosteroid (e.g., prednisone, methylprednisolone) after at least 7 days OR intolerance/hypersensitivity OR FDA labeled contraindication to ALL systemic corticosteroids OR use of another biologic immunomodulator for GCA.
• For AS: The patient has tried and had an inadequate response to TWO different NSAIDs after at least 4-week total therapy OR one NSAID and intolerance/hypersensitivity to another OR intolerance/hypersensitivity to TWO NSAIDs OR FDA labeled contraindication to ALL NSAIDs OR use of another biologic immunomodulator for AS.