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Ustekinumab-aekn — Blue Cross Blue Shield of Alabama

Ankylosing spondylitis (AS)

Preferred products

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

Initial criteria

  • Patient has an FDA labeled indication or one supported in compendia (AHFS, DrugDex 1/2a, NCCN 1/2a).
  • For psoriatic arthritis (PsA): has tried and had an inadequate response to ONE conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months OR has intolerance/hypersensitivity to ONE conventional agent OR has contraindication to ALL conventional agents OR has severe active PsA OR has concomitant severe psoriasis OR has medication history indicating use of another biologic immunomodulator agent or Otezla labeled/supported for PsA.
  • For plaque psoriasis (PS): has tried and had inadequate response to ONE conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months OR has intolerance/hypersensitivity to ONE conventional agent OR contraindication to ALL conventional agents.
  • For ankylosing spondylitis (AS): has tried and had inadequate response to ONE NSAID for ≥4 weeks AND intolerance/hypersensitivity to ONE additional NSAID OR intolerance/hypersensitivity to TWO NSAIDs OR contraindication to ALL NSAIDs OR prior biologic immunomodulator use labeled/supported for AS.
  • For non-radiographic axial spondyloarthritis (nr-axSpA): has inadequate response to TWO NSAIDs totaling ≥4 weeks OR inadequate response to ONE NSAID for ≥4 weeks AND intolerance/hypersensitivity to ONE additional OR intolerance/hypersensitivity to TWO NSAIDs OR contraindication to ALL NSAIDs OR prior biologic immunomodulator use labeled/supported for nr-axSpA.
  • For polyarticular juvenile idiopathic arthritis (PJIA): has inadequate response to ONE conventional agent (methotrexate, leflunomide) after ≥3 months OR intolerance/hypersensitivity to ONE OR contraindication to ALL OR prior biologic immunomodulator use labeled/supported for PJIA.
  • For hidradenitis suppurativa (HS): has inadequate response to ONE conventional agent (oral tetracyclines, oral contraceptives, metformin, finasteride, spironolactone, intralesional corticosteroids [triamcinolone], clindamycin+rifampin, rifampin+moxifloxacin+metronidazole, cyclosporine, oral retinoids) after ≥3 months OR intolerance/hypersensitivity to ONE OR contraindication to ALL OR prior biologic immunomodulator use labeled/supported for HS.
  • For other indications: if client has preferred agents, requested agent must meet preferred biosimilar/brand/non-preferred step-therapy rules depending on plan chart. If patient has FDA-labeled indication, age must be within labeling or supported for age; prescriber must be a specialist or consult one.
  • Agents not to be used concomitantly per policy; patient must not use combination immunomodulatory therapy unless supported. Patient must have been tested for latent TB and treated if positive.
  • Requested agent not contraindicated per FDA labeling.

Reauthorization criteria

  • Patient previously approved for requested agent through plan PA process.
  • Patient has had clinical benefit from therapy.
  • If preferred agents apply: must meet same preferred biosimilar/brand/non-preferred agent step-therapy criteria as described in initial evaluation.
  • Prescriber must be a specialist or have consulted with one.
  • Patient will not use agent in combination with other immunomodulators unless supported.
  • Patient has no FDA labeled contraindications.

Approval duration

12 months (UC: 12 weeks initial)