ustekinumab 90 mg product — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has an FDA labeled indication or an indication supported in compendia for the requested agent and route of administration
• Psoriatic arthritis (PsA): The patient has active PsA AND ONE of the following: has tried and had inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR FDA labeled contraindication to ALL conventional agents OR severe active PsA (erosive disease, elevated markers, joint damage, rapidly progressive) OR concomitant severe psoriasis (≥10% BSA or critical areas, pruritus, emotional impact) OR patient’s medication history indicates use of another biologic immunomodulator or Otezla for PsA
• Plaque psoriasis (PS): The patient has moderate to severe PS AND ONE of the following: has tried and had inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR FDA labeled contraindication to ALL conventional agents OR severe active PS (≥10% BSA, critical areas, pruritus, emotional impact) OR concomitant severe PsA OR prior use of another biologic immunomodulator or Otezla
• Crohn’s disease (CD): The patient has moderately to severely active CD AND ONE of the following: currently stable on the requested agent OR inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) after ≥3 months OR discontinued due to lack of efficacy/adverse event OR intolerance/hypersensitivity to ONE agent OR FDA labeled contraindication to ALL conventional agents OR conventional agent expected ineffective or unsafe OR not in patient’s best interest OR failed another drug in same pharmacologic class OR prior use of another biologic immunomodulator for CD
• Ulcerative colitis (UC): The patient has moderately to severely active UC AND ONE of the following: currently stable on the requested agent OR inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months OR discontinued due to lack of efficacy/adverse event OR intolerance/hypersensitivity to ONE agent OR FDA labeled contraindication to ALL conventional agents OR expected inefficacy or harm OR not in best interest OR failed another drug in same class OR severely active UC OR prior use of another biologic immunomodulator for UC
• Other conditions: The requested agent is preferred OR (if non-preferred) the patient meets one of the following: has stage IV metastatic cancer and agent is used for the cancer or an associated condition and consistent with best practices OR is currently stable on requested agent OR tried and failed THREE preferred agents (≥6-month trial each) OR three preferred agents discontinued due to inefficacy/adverse event OR intolerance/hypersensitivity to THREE preferred agents OR FDA labeled contraindication to ALL preferred agents OR THREE preferred agents expected ineffective or unsafe OR THREE preferred agents not in best interest OR failed another drug in same pharmacologic class as THREE preferred agents
• If ustekinumab requested for CD or UC: The patient received OR will receive ustekinumab IV product for induction therapy
• If ustekinumab 90 mg product requested: the patient has psoriasis and weight >100 kg OR has dual diagnosis Psoriasis + PsA and weight >100 kg OR has diagnosis of CD or UC
• The patient’s age is within FDA labeling for the indication or supported by evidence
• The prescriber is a specialist (rheumatologist, gastroenterologist, dermatologist) or has consulted with one
• The patient will NOT use requested agent concomitantly with another immunomodulator OR if combination is planned, labeling does not limit use and literature supports combination
• The patient has no FDA labeled contraindications to the requested agent
• The patient has been tested for latent TB and if positive is receiving therapy

Approval duration

12 months