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The Policy VaultThe Policy Vault

Otulfi (ustekinumab-aauz) — Blue Cross Blue Shield of Illinois

moderate to severe plaque psoriasis (PS)

Preferred products

  • Ustekinumab
  • Ustekinumab-aekn
  • Ustekinumab-ttwe
  • Wezlana (ustekinumab-auub)
  • Stelara (ustekinumab)

Initial criteria

  • ONE of the following: A. The requested agent is eligible for continuation of therapy AND the prescriber states patient has been treated with the requested agent within the past 90 days (not samples) and is at risk if therapy changed OR B. ALL of the following criteria below apply:
  • 1. The patient has an FDA labeled indication or compendia supported indication for the requested agent and route of administration.
  • 2. Diagnosis of active psoriatic arthritis (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 such agent OR contraindication to ALL such agents OR severe active PsA OR concomitant severe psoriasis OR medication history indicates use of another biologic immunomodulator or Otezla.
  • 3. OR diagnosis of moderate to severe plaque psoriasis (PS) AND ONE of the following: has tried and had inadequate response to ONE conventional therapy (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR contraindication to ALL conventional agents OR severe active PS OR concomitant severe PsA OR medication history indicating biologic or Otezla use.
  • 4. OR diagnosis of moderately to severely active Crohn’s disease (CD) AND ONE of the following: inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) after ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR contraindication to ALL OR prior biologic use.
  • 5. OR diagnosis of moderately to severely active ulcerative colitis (UC) AND ONE of the following: inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months OR intolerance to ONE OR contraindication to ALL OR severely active UC OR prior biologic use.
  • 6. AND ONE of the following (reference preferred agents table): A. The requested agent is a preferred agent OR B. The patient has tried and had inadequate response to 3 preferred agents after at least 6 months/agent OR has specific combinations of inadequate response plus intolerance/hypersensitivity to preferred agents as listed OR C. Contraindication to ALL preferred agents not expected to occur with requested agent.
  • 7. If an ustekinumab product is requested for CD or UC, additional specific indication requirements apply.
  • The prescriber must be a specialist in the area of patient’s diagnosis or has consulted with one.
  • The patient will NOT use requested agent in combination with another immunomodulatory agent unless allowed per prescribing information and clinical support for combination provided.
  • The patient does NOT have any FDA labeled contraindications to requested agent.
  • Patient has been tested for latent tuberculosis and initiated therapy if positive.

Reauthorization criteria

  • 1. Patient previously approved for requested agent through plan’s prior authorization process.
  • 2. Patient has had clinical benefit with requested agent.
  • 3. ONE of the following: A. Requested agent is a preferred agent OR B. Patient has tried and had inadequate response to three preferred agents after ≥3 months per agent OR combinations of inadequate response/intolerance per policy OR C. Patient has contraindication to all preferred agents OR D. All preferred agents are not clinically appropriate and prescriber has provided complete medication history.
  • 4. Prescriber is specialist in area of diagnosis or has consulted one.
  • 5. ONE of the following: patient will NOT be using requested agent in combination with another immunomodulatory agent OR if in combination, (a) prescribing information does not limit such use AND (b) evidence supports combination therapy.
  • 6. Patient does NOT have FDA labeled contraindications to requested agent.

Approval duration

12 months (UC: 12 weeks)