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Ustekinumab-ttwe — Blue Cross Blue Shield of Oklahoma

Other diagnosis as specified

Initial criteria

  • A. The requested agent is eligible for continuation of therapy AND ONE of the following: 1) If the requested agent is NOT a preferred agent, then prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days [chart notes required] AND is at risk if therapy is changed; OR 2) If the requested agent is a preferred agent, then prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed.
  • 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 indication-specific criteria listed below:
  • — Psoriatic arthritis (PsA): ONE of the following: (1) Tried and had inadequate response to ONE conventional agent (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months OR (2) Intolerance or hypersensitivity to ONE conventional agent OR (3) FDA labeled 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 for PsA.
  • — Plaque psoriasis (PS): ONE of the following: (1) Tried and had inadequate response to ONE conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months OR (2) Intolerance or hypersensitivity to ONE conventional agent OR (3) FDA labeled 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 for PS.
  • — Crohn’s disease (CD): ONE of the following: (1) Currently being treated with and stable on requested agent OR (2) Tried and inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, corticosteroids, methotrexate) after ≥3 months OR (3) Conventional agent discontinued due to lack of efficacy or adverse event OR (4) Intolerance or hypersensitivity to ONE conventional agent OR (5) FDA labeled contraindication to ALL conventional agents OR (6) Conventional agent expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease function, or cause harm OR (7) Conventional agent not in best interest of patient OR (8) Tried another drug in same class/ mechanism that was discontinued due to lack of effect or adverse event OR (9) Medication history shows use of another biologic immunomodulator for CD.
  • — Ulcerative colitis (UC): ONE of the following: (1) Currently being treated with and stable on requested agent OR (2) Tried and inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months OR (3) Conventional agent discontinued due to lack of efficacy or adverse event OR (4) Intolerance or hypersensitivity to ONE conventional agent OR (5) FDA labeled contraindication to ALL conventional agents OR (6) Conventional agent expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease function, or cause harm OR (7) Conventional agent not in best interest of patient OR (8) Tried another drug in same class/ mechanism discontinued due to lack of efficacy or adverse event OR (9) Severely active UC OR (10) Medication history shows use of another biologic immunomodulator for UC.
  • — Other diagnosis: ONE of the following (reference preferred agents table): (A) Requested agent is a preferred agent OR (B) BOTH of the following: (1) Patient has stage 4 advanced, metastatic cancer and requested agent used to treat the cancer or associated condition [chart notes required]; AND (2) Use is consistent with best practices, peer-reviewed literature, and FDA approved; OR (C) Patient currently being treated and stable [chart notes required]; OR (D) Has tried and inadequate response to THREE preferred agents after ≥6-month trial per agent [medical records required]; OR (E) THREE preferred agents discontinued due to lack of efficacy or adverse events [chart notes required]; OR (F) Intolerance or hypersensitivity to THREE preferred agents not expected with requested agent [medical records required]; OR (G) FDA labeled contraindication to ALL preferred agents not expected with requested agent [medical records required]; OR (H) THREE preferred agents expected to be ineffective, cause barrier, worsen comorbidity, decrease function, or cause harm [chart notes required]; OR (I) THREE preferred agents not in patient’s best interest based on medical necessity [chart notes required]; OR (J) Tried another drug in same class/mechanism as THREE preferred agents discontinued due to lack of efficacy or adverse event [chart notes required].
  • If ustekinumab product requested for CD or UC: ONE of the following: (A) Patient received ustekinumab IV product for induction therapy OR (B) Patient is new and will receive ustekinumab IV product for induction therapy.
  • If FDA labeled indication: ONE of the following: (A) Patient age within labeled indication OR (B) Support exists for agent use in that age.
  • If ustekinumab 90 mg product requested: ONE of the following: (A) Diagnosis of psoriasis AND weight >100 kg OR (B) Dual diagnosis of psoriasis and psoriatic arthritis AND weight >100 kg OR (C) Diagnosis of Crohn’s disease or ulcerative colitis.
  • Prescriber is specialist in area of patient diagnosis (rheumatologist for PsA, gastroenterologist for CD/UC, dermatologist for PS) or has consulted with such specialist.
  • Combination therapy: ONE of the following: (A) Will NOT use in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) Will use in combination AND BOTH: (1) Prescribing info does NOT limit combination; AND (2) Support for combination therapy exists (submission of clinical evidence required).