ustekinumab products — Blue Cross Blue Shield of Texas

Initial criteria

• Patient has an FDA labeled indication or compendia-supported indication for the requested agent and route of administration
• AND for PsA: diagnosis of active PsA AND ONE of the following: inadequate response to ≥1 conventional agent (cyclosporine, leflunomide, methotrexate, sulfasalazine) after ≥3 months; intolerance or hypersensitivity to ≥1 conventional agent; contraindication to ALL conventional agents; severe active PsA (e.g., erosive disease, elevated ESR/CRP, long-term damage interfering with function, rapidly progressive); concomitant severe psoriasis; medication history indicates use of another biologic immunomodulator or Otezla for PsA
• OR for PS: diagnosis of moderate to severe plaque psoriasis AND ONE of the following: inadequate response to ≥1 conventional agent (acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA, tacrolimus, tazarotene, topical corticosteroids) after ≥3 months; intolerance or hypersensitivity to ≥1 conventional agent; contraindication to ALL conventional agents; severe active PS; concomitant severe PsA; medication history indicates biologic immunomodulator or Otezla use for PS
• OR for CD: diagnosis of moderately to severely active Crohn’s disease AND ONE of the following: currently stable on requested agent; inadequate response to ≥1 conventional agent (6‑mercaptopurine, azathioprine, corticosteroids, methotrexate) after ≥3 months; discontinuation due to lack of efficacy or adverse event; intolerance or hypersensitivity; contraindication to ALL conventional agents; expected ineffectiveness or poor adherence risk or comorbid worsening; not in patient’s best interest; prior trial of drug in same class discontinued; or history of biologic immunomodulator for CD
• OR for UC: diagnosis of moderately to severely active ulcerative colitis AND ONE of the following: currently stable on requested agent; inadequate response to ≥1 conventional agent (6‑mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) after ≥3 months; discontinuation due to lack of efficacy/adverse event; intolerance or hypersensitivity; contraindication to ALL conventional agents; expected ineffectiveness or poor adherence risk or comorbid worsening; not in patient’s best interest; prior class agent discontinued; severely active UC; or history of biologic immunomodulator for UC
• OR for other diagnoses: requested agent is preferred OR (if nonpreferred) all of the following apply: patient has stage IV metastatic cancer or related condition and use consistent with best practices; OR currently stable on requested agent; OR inadequate response/intolerance/contraindication to THREE preferred agents after ≥6‑month trials; OR preferred agents expected ineffective, unsafe, or not medically appropriate; OR prior trial of drug in same class discontinued
• If ustekinumab is requested for CD or UC: patient received or will receive ustekinumab IV induction
• Age within FDA labeling or supported by evidence for pediatric/adult use as applicable
• If ustekinumab 90 mg requested: PS diagnosis and weight > 100 kg OR dual PS+PsA and weight > 100 kg OR diagnosis of CD/UC
• Prescriber is a specialist (rheumatologist, gastroenterologist, dermatologist) or has consulted with one
• Requested agent not used concomitantly with another immunomodulator OR combination therapy is supported and labeling does not prohibit it
• No FDA labeled contraindications to requested agent
• Patient tested for latent tuberculosis and if positive, begun therapy
• Compendia sources allowed: AHFS, DrugDex (1, 2a, 2b), NCCN (1, 2a, 2b)
• Members residing in Ohio, Fully Insured or HIM Shop, also approved if no contraindications and have another FDA labeled indication

Approval duration

12 months