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Ustekinumab-aekn — Blue Cross Blue Shield of Illinois

moderately to severely active Crohn’s disease (CD)

Initial criteria

  • - Continuation: requested agent eligible except listed excluded agents AND (if non-preferred: prescriber states patient treated with requested agent within past 90 days and is at risk if therapy changed; OR if preferred agent: same requirements).
  • - Active PsA: FDA labeled indication AND one of the following: (1) inadequate response to ≥1 conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months; OR (2) intolerance/hypersensitivity to ≥1 conventional agent; OR (3) contraindication to all conventional agents; OR (4) severe active PsA; OR (5) concomitant severe psoriasis; OR (6) medication history indicates use of another biologic immunomodulator or Otezla.
  • - Moderate-severe PS: FDA labeled indication AND one of the following: (1) inadequate response to ≥1 conventional topical/systemic or phototherapy agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months; OR (2) intolerance/hypersensitivity to ≥1 conventional agent; OR (3) contraindication to all conventional agents; OR (4) severe active PS; OR (5) concomitant severe PsA; OR (6) medication history indicates use of another biologic immunomodulator or Otezla.
  • - Moderate-severe CD: one of the following: (1) currently stable on requested agent; OR (2) inadequate response to ≥1 conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) after ≥3 months; OR (3) discontinued due to lack of efficacy/adverse event; OR (4) intolerance/hypersensitivity; OR (5) contraindication to all conventional agents; OR (6) expected ineffectiveness, adherence barrier, comorbidity, or risk of harm; OR (7) not in best interest medical necessity; OR (8) prior drug in same class failed; OR (9) prior biologic immunomodulator use allowed.
  • - Moderate-severe UC: one of the following: (1) stable on requested agent; OR (2) inadequate response to ≥1 conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months; OR (3) discontinued due to lack of efficacy/adverse event; OR (4) intolerance/hypersensitivity; OR (5) contraindication to all conventional agents; OR (6) expected ineffectiveness, adherence barrier, comorbidity, risk of harm; OR (7) not in best interest medical necessity; OR (8) failure of same class drug; OR (9) severely active UC; OR (10) prior biologic immunomodulator use allowed.
  • - For any other indication: patient must have FDA labeled or compendia supported use AND preferred agent considerations: requested agent is preferred OR meets high-level exceptions (e.g., stage IV metastatic cancer treatment/associated condition, currently stable, OR after failure/intolerance/contraindication/expected ineffectiveness/medical necessity issues to ≥3 preferred agents).
  • - Ustekinumab induction: for CD or UC, patient must have received IV ustekinumab for induction or will receive it for induction (new therapy).
  • - Age: patient age within FDA labeling or supported for indication.
  • - Ustekinumab 90 mg: requires psoriasis AND weight >100kg, or dual diagnosis psoriasis + PsA with weight >100kg, or CD/UC diagnosis.
  • - Prescriber: must be or have consulted appropriate specialist (rheumatologist for PsA; gastroenterologist for CD/UC; dermatologist for PS).
  • - Concomitant therapy: not to be used with another immunomodulatory agent, unless labeling allows combination and there is supporting evidence.

Reauthorization criteria

  • - Continuation permitted if patient eligible for continuation of therapy per above and has documented benefit or stability on current therapy (chart notes required).