ustekinumab IV product — Blue Cross Blue Shield of Oklahoma

Initial criteria

• Patient has an FDA labeled indication or an indication supported in compendia for the requested agent and route of administration
• AND ONE of the following diagnosis conditions:
• - Psoriatic arthritis (PsA): Patient has tried and had inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) for ≥3 months OR has intolerance/hypersensitivity to one conventional agent OR has contraindication to all conventional agents OR has severe active PsA (e.g., erosive disease, elevated ESR/CRP, long-term functional damage, or rapidly progressive disease) OR has concomitant severe psoriasis OR prior use of another biologic immunomodulator agent or Otezla labeled or supported in compendia for PsA
• - Plaque psoriasis (PS): Patient has tried and had 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 to one conventional agent OR contraindication to all conventional agents OR severe active PS OR concomitant severe PsA OR prior biologic immunomodulator or Otezla labeled or supported in compendia for PS
• - Crohn’s disease (CD): Patient currently stable on requested agent OR inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) for ≥3 months OR discontinued due to lack of efficacy/adverse event OR intolerance/hypersensitivity OR contraindication to all conventional agents OR conventional agent expected ineffective/not in best interest per medical necessity OR previous biologic immunomodulator use labeled for CD
• - Ulcerative colitis (UC): Patient currently stable on requested agent OR inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) for ≥3 months OR discontinued due to lack of efficacy/adverse event OR intolerance/hypersensitivity OR contraindication to all conventional agents OR conventional agent expected ineffective or not in patient’s best interest OR severely active disease OR prior biologic immunomodulator use supported for UC
• - Other diagnoses: ONE of the following applies: requested agent is preferred OR stage IV advanced/metastatic cancer and use consistent with evidence-based practice OR patient stable on therapy OR inadequate response/intolerance/contraindication to THREE preferred agents each ≥6 months OR preferred agents expected ineffective or not in best interest OR previous failure of same class agent
• If ustekinumab requested for CD or UC: patient received IV product for induction or will receive IV induction if new to therapy
• If ustekinumab 90 mg requested: patient has psoriasis and weight >100 kg OR dual psoriasis and PsA and weight >100 kg OR Crohn’s disease or UC
• Prescriber is or consulted with appropriate specialist (rheumatologist, gastroenterologist, dermatologist)
• Requested agent not used concurrently with another immunomodulatory agent unless labeling and literature support combination
• No FDA labeled contraindications to requested agent
• Patient tested for latent TB and treated if positive

Approval duration

12 months