Stelara (ustekinumab) — Blue Cross Blue Shield of Alabama

Preferred products

• Selarsdi (ustekinumab-aekn)
• Steqeyma (ustekinumab-stba)
• Yesintek (ustekinumab-kfce)

Initial criteria

• Diagnosis of non-radiographic axial spondyloarthritis (nr-axSpA) AND ONE of the following: • Tried and had inadequate response to TWO different NSAIDs for ≥4 weeks total OR • Tried one NSAID ≥4 weeks and intolerance or hypersensitivity to one additional NSAID OR • Intolerance or hypersensitivity to TWO different NSAIDs OR • FDA labeled contraindication to ALL NSAIDs OR • Medication history indicates use of another biologic immunomodulator for nr-axSpA
• Diagnosis of moderately to severely active polyarticular juvenile idiopathic arthritis (PJIA) AND ONE of the following: • Tried and had inadequate response to ONE conventional agent (methotrexate, leflunomide) ≥3 months OR • Intolerance or hypersensitivity to ONE conventional agent OR • FDA labeled contraindication to ALL conventional agents OR • Medication history indicates use of another biologic immunomodulator for PJIA
• Diagnosis of moderate to severe hidradenitis suppurativa (HS) AND ONE of the following: • Tried and had inadequate response to ONE conventional agent (oral tetracyclines, oral contraceptives [females], metformin [females], finasteride [females], spironolactone [females], intralesional corticosteroids, clindamycin+rifampin, rifampin+moxifloxacin+metronidazole, cyclosporine, oral retinoids) ≥3 months OR • Intolerance or hypersensitivity to ONE conventional agent OR • FDA labeled contraindication to ALL conventional agents OR • Medication history indicates use of another biologic immunomodulator for HS
• If client has preferred agents, then ONE of the following: • Requested agent is a preferred agent OR • Tried and inadequate response to THREE preferred agents ≥3 months per agent OR • Tried and inadequate response to TWO preferred agents ≥3 months and intolerance/hypersensitivity to ONE additional preferred agent not expected with requested agent OR • Tried and inadequate response to ONE preferred agent ≥3 months and intolerance/hypersensitivity to TWO preferred agents not expected with requested agent OR • Intolerance or hypersensitivity to THREE preferred agents not expected with requested agent OR • FDA labeled contraindication to ALL preferred agents that is not expected with requested agent OR • ALL preferred agents not clinically appropriate AND prescriber provided list of previously tried agents
• FDA labeled indication or compendia-supported indication for requested agent AND ONE of the following: • Diagnosis of active psoriatic arthritis (PsA) AND ONE of: – Tried and inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) ≥3 months – Intolerance/hypersensitivity to ONE conventional agent – FDA labeled contraindication to ALL conventional agents – Severe active PsA (erosive disease, elevated ESR/CRP, long-term damage interfering with function, rapidly progressive) – Concomitant severe psoriasis – Medication history indicates use of another biologic immunomodulator or Otezla for PsA OR • Diagnosis of moderate to severe plaque psoriasis (PS) AND ONE of: – Tried and inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) ≥3 months – Intolerance/hypersensitivity to ONE conventional agent – FDA labeled contraindication to ALL conventional agents – Severe active PS (≥10% BSA or special locations, intractable pruritus, serious emotional consequences) – Concomitant severe PsA – Medication history indicates use of another biologic immunomodulator or Otezla for PS OR • Diagnosis of moderately to severely active Crohn’s disease (CD) AND ONE of: – Tried and inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) ≥3 months – Intolerance/hypersensitivity to ONE conventional agent – FDA labeled contraindication to ALL conventional agents – Medication history indicates use of another biologic immunomodulator for CD OR • Diagnosis of moderately to severely active ulcerative colitis (UC) AND ONE of: – Tried and inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) ≥3 months – Intolerance/hypersensitivity to ONE conventional agent – FDA labeled contraindication to ALL conventional agents – Severely active UC – Medication history indicates use of another biologic immunomodulator for UC
• Patient age within or supported for FDA labeling for requested indication
• Prescriber is or has consulted with a relevant specialist
• Not used in combination with another immunomodulator unless prescribing information allows and there is supportive evidence
• No FDA labeled contraindications to the requested agent
• Patient tested for latent TB and, if positive, has begun therapy for latent TB

Reauthorization criteria

• Previously approved through plan’s prior authorization process
• Has had clinical benefit with requested agent
• If client has preferred agents then ONE of the following: • Requested agent is a preferred agent OR • Tried and inadequate response to THREE preferred agents ≥3 months each OR • Tried and inadequate response to TWO preferred agents and intolerance/hypersensitivity to ONE additional OR • Tried and inadequate response to ONE preferred agent and intolerance/hypersensitivity to TWO additional OR • Intolerance/hypersensitivity to THREE preferred agents OR • FDA labeled contraindication to ALL preferred agents OR • ALL preferred agents not clinically appropriate AND prescriber provides list of previously tried agents
• Prescriber is/has consulted with specialist in patient’s diagnosis field
• Not used in combination with another immunomodulator unless prescribing information allows and supportive evidence is provided
• No FDA labeled contraindications to requested agent

Approval duration

12 months (UC: 12 weeks)