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Imuldosa (ustekinumab-srlf) — Blue Cross Blue Shield of Texas

moderately to severely active Crohn’s disease (CD)

Preferred products

  • Selarsdi (ustekinumab-aekn)
  • Steqeyma (ustekinumab-stba)
  • Yesintek (ustekinumab-kfce)
  • Wezlana (ustekinumab-auub)
  • Stelara (ustekinumab)

Initial criteria

  • ONE of the following: A. The requested agent is eligible for continuation of therapy AND one of the following; if NOT preferred then prescriber states patient has been treated with requested agent within past 90 days and is at risk if therapy changed OR if preferred similarly has been treated within past 90 days AND is at risk if therapy changed; OR B. ALL of the following:
  • The 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 disease-specific criteria apply:
  • For active psoriatic arthritis (PsA): ONE of the following is met: 1. 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 contraindication to ALL conventional agents OR severe active PsA OR concomitant severe psoriasis OR medication history indicates use of another biologic immunomodulator or Otezla labeled or supported for PsA.
  • For moderate to severe plaque psoriasis (PS): ONE of the following is met: 1. 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 intolerance/hypersensitivity to ONE conventional agent OR contraindication to ALL conventional agents OR severe active PS OR concomitant severe PsA OR medication history indicates another biologic immunomodulator or Otezla labeled or supported for PS.
  • For moderately to severely active Crohn’s disease (CD): ONE of the following is met: Has tried and had 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 conventional agents OR medication history indicates use of another biologic immunomodulator labeled or supported for CD.
  • For moderately to severely active ulcerative colitis (UC): ONE of the following is met: Has tried and had inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR contraindication to ALL conventional agents OR severely active UC OR medication history indicates use of another biologic immunomodulator labeled or supported for UC.
  • E. The patient has a diagnosis not mentioned previously AND ONE of the following (reference preferred agents table): 1. The requested agent is a preferred agent OR 2. The patient has tried and had inadequate response to THREE preferred agents after ≥6 months per agent OR similar combinations of inadequate response and intolerance/hypersensitivity as outlined OR has FDA labeled contraindication to ALL preferred agents.

Reauthorization criteria

  • Patient previously approved for requested agent via prior authorization AND has had clinical benefit with requested agent AND one of the following applies: requested agent is a preferred agent OR patient has tried and had inadequate response to multiple preferred agents (3 for 3 months each, 2 with 1 intolerance, etc.) OR contraindication to ALL preferred agents OR all preferred agents not clinically appropriate per medical documentation.
  • Prescriber is a specialist or has consulted with a specialist in the area of diagnosis.
  • If used in combination with another immunomodulatory agent then prescribing information does not limit such use AND there is supporting evidence for the combination (e.g. clinical trials).
  • Patient does not have any FDA labeled contraindications to the requested agent.

Approval duration

12 months (12 weeks for ulcerative colitis initial approval)