Stelara — Blue Cross Blue Shield of Alabama

Preferred products

• Selarsdi (ustekinumab-aekn)
• Steqeyma (ustekinumab-stba)
• Yesintek (ustekinumab-kfce)
• Imuldosa (ustekinumab-srlf)
• Otulfi (ustekinumab-aauz)
• Pyzchiva (ustekinumab-ttwe)
• Wezlana (ustekinumab-auub)

Initial criteria

• Requested agent is eligible for continuation of therapy OR patient has an FDA labeled indication or compendia-supported indication for the requested agent and route of administration
• For PsA: has tried and had inadequate response to ≥1 conventional agent (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) for ≥3 months OR intolerance/hypersensitivity to one conventional agent OR contraindication to all conventional agents OR severe active PsA (e.g., erosive disease, elevated ESR/CRP, long-term damage) OR concomitant severe psoriasis OR prior biologic/Otezla use for PsA
• For PS: has tried and had inadequate response to ≥1 conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA phototherapy, tacrolimus, tazarotene, topical corticosteroids) for ≥3 months OR intolerance/hypersensitivity to one conventional agent OR contraindication to all conventional agents OR severe active PS (≥10% BSA involvement or select locations, intractable pruritus, serious emotional consequences) OR concomitant severe psoriatic arthritis OR prior biologic/Otezla use for PS
• For CD: has tried and had inadequate response to ≥1 conventional agent (e.g., 6-mercaptopurine, azathioprine, corticosteroids such as prednisone or budesonide EC capsule, methotrexate) for ≥3 months OR intolerance/hypersensitivity to one conventional agent OR contraindication to all conventional agents OR prior biologic use for CD
• For UC: has tried and had inadequate response to ≥1 conventional agent (e.g., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) for ≥3 months OR intolerance/hypersensitivity to one conventional agent OR contraindication to all conventional agents OR severely active UC OR prior biologic use for UC
• Specialist requirement: prescriber is a relevant specialist (e.g., rheumatologist, gastroenterologist, dermatologist) or has consulted one
• If preferred agents exist: must meet step therapy criteria (preferred biosimilar or brand per policy)
• No FDA labeled contraindications to the requested agent
• Latent TB testing has been done and therapy initiated if positive
• Combination use allowed only if label does not prohibit and evidence supports use

Reauthorization criteria

• Previously approved for the requested agent through PA process
• Demonstrated clinical benefit with the requested agent
• If client has preferred agents: must meet same step therapy requirements as initial evaluation (preferred biosimilar, preferred brand, or non-preferred with required trials or intolerance)
• Prescriber is relevant specialist or has consulted one
• No FDA labeled contraindications to the requested agent
• Combination with other immunomodulators follows the same restrictions as initial approval

Approval duration

12 months (except UC: 12 weeks initial; 12 months renewal)