Simponi — Blue Cross Blue Shield of Montana

Initial criteria

• For rheumatoid arthritis (RA):
• 1. Patient medication history indicates use of hydroxychloroquine, leflunomide, or sulfasalazine used in treatment of RA OR another biologic immunomodulator agent that is FDA-labeled or supported in compendia for RA; AND
• 2. If request is for Simponi, ONE of the following: (A) patient will take requested agent with methotrexate OR (B) patient has intolerance, FDA-labeled contraindication, or hypersensitivity to methotrexate.
• For active psoriatic arthritis (PsA):
• 1. ONE of the following:
• A. Tried and had inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) used in PsA after ≥3 months OR
• B. Intolerance or hypersensitivity to ONE conventional agent used in PsA OR
• 2. FDA-labeled contraindication to ALL conventional agents used in PsA OR
• 3. Severe active PsA (e.g., erosive disease, elevated inflammatory markers, long-term damage, rapidly progressive) OR
• 4. Concomitant severe psoriasis (≥10% body surface area, involvement of hands/feet/scalp/face/genitals, intractable pruritus, serious emotional consequences) OR
• 5. Medication history indicates use of another biologic immunomodulator agent or Otezla for PsA.
• For moderate to severe plaque psoriasis (PS):
• 1. ONE of the following:
• A. Tried and had inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) for ≥3 months OR
• B. Intolerance or hypersensitivity to ONE conventional agent OR
• 2. FDA-labeled contraindication to ALL conventional agents used in PS OR
• 3. Severe active PS (≥10% BSA, select site involvement, pruritus, serious emotional consequences) OR
• 4. Concomitant severe PsA OR
• 5. Medication history indicates use of another biologic immunomodulator agent or Otezla for PS.
• For moderately to severely active Crohn’s disease (CD):
• 1. Currently stable on requested agent OR
• 2. Tried and inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) after ≥3 months OR
• 3. Discontinued a conventional agent due to lack of efficacy/effectiveness, diminished effect, or adverse event OR
• 4. Intolerance or hypersensitivity to ONE conventional agent OR
• 5. FDA-labeled contraindication to ALL conventional agents OR
• 6-8. Use not appropriate due to expected inefficacy, adherence barrier, worsening comorbid condition, safety risks, or medical necessity considerations OR
• 9. Medication history indicates use of another biologic immunomodulator agent for CD.
• For moderately to severely active ulcerative colitis (UC):
• 1. Currently stable on requested agent OR
• 2. Tried and inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months OR
• 3. Discontinued conventional agent due to lack of efficacy/effectiveness, diminished effect, or adverse event OR
• 4. Intolerance or hypersensitivity to ONE conventional agent OR
• 5. FDA-labeled contraindication to ALL conventional agents OR
• 6-7. Use of conventional agent expected to be ineffective, inappropriate, or not in patient’s best interest OR
• 8. Tried another drug in same class with similar failure/adverse event OR
• 9. Severely active UC OR
• 10. 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: inadequate response or intolerance to oral or periocular/intravitreal corticosteroids (after ≥2 weeks) OR FDA-labeled contraindication to all such corticosteroids; AND
• B. ONE of the following: inadequate response, intolerance, or contraindication to ONE conventional systemic agent (azathioprine, mycophenolate, methotrexate, cyclosporine, tacrolimus) after ≥3 months OR severe, active, sight-threatening disease; OR
• 2. Medication history indicates use of another biologic immunomodulator agent for this indication.
• For giant cell arteritis (GCA):
• 1. ONE of the following: inadequate response to ONE systemic corticosteroid (prednisone, methylprednisolone) after ≥7 days OR intolerance or hypersensitivity to ONE systemic corticosteroid; OR
• 2. FDA-labeled contraindication to ALL systemic corticosteroids; OR
• 3. Medication history indicates use of another biologic immunomodulator agent for GCA.
• For active ankylosing spondylitis (AS):
• 1. ONE of the following: inadequate response to TWO different NSAIDs after ≥4 weeks total OR inadequate response to ONE NSAID after ≥4 weeks + intolerance/hypersensitivity to an additional NSAID OR intolerance/hypersensitivity to TWO different NSAIDs; OR
• 2. FDA-labeled contraindication to ALL NSAIDs; OR
• 3. Medication history indicates use of another biologic immunomodulator agent for AS.
• For active non-radiographic axial spondyloarthritis (nr-axSpA):
• criteria continue (not shown).