Ustekinumab (Stelara®) is a human monoclonal antibody. It is directed against interleukin 12 and interleukin-23, naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab (Stelara) may be self-administered by subcutaneous injection and is also available as an infusion that may be administered intravenously by a health care professional.

Ustekinumab (Stelara) Intravenous (IV)

Ustekinumab (Stelara) as a single IV infusion dose may be considered medically necessary when an individual meets ANY ONE of the following indications:  

• Crohn’s Disease (CD)
  • The individual is 18 years of age or older with moderate to severe CD;  and
  • Authorization is for 90 days.
• Ulcerative Colitis (UC)
  • The individual is 18 years of age or older with moderate to severe UC; and
  • Authorization is for 90 days.

The use of ustekinumab (Stelara) for any other indication or in combination with any other biologic disease-modifying antirheumatic drug (DMARD) (e.g. etanercept, infliximab, certolizumab) is considered not medically necessary.

Ustekinumab (Stelara) Subcutaneous (SC)

Ustekinumab (Stelara) SC may be considered medically necessary when an individual meets the criteria for ANY ONE of the following indications:

• Crohn’s Disease (CD)
• The individual is 18 years of age or older with moderate to severe CD; and
• The individual received a single induction dose of ustekinumab (Stelara) IV within two (2) months of initiating therapy with ustekinumab (Stelara) SC and achieved clinical response or remission; or
• Initial authorization will be for 12 months; or

• Immune-Checkpoint Inhibitor-Related Toxicities
  • The individual has mild (grade 1) diarrhea or colitis; and
    • Has persistent or progressive symptoms after standard therapy; and
    • Has positive lactoferrin/calprotectin; or
  • The individual has infliximab- and/or vedolizumab-refractory moderate (grade 2) or severe (grade 3-4) diarrhea or colitis; or

• Plaque Psoriasis (PsO)
  • The individual is six (6) years of age or older with moderate to severe PsO; and
  • The individual meets one (1) of the following criteria;
    • Treatment with phototherapy (e.g., psoralen plus ultraviolet A [PUVA], ultraviolet B [UVB]) was ineffective or not tolerated. If an individual is not a candidate for phototherapy treatment (e.g. phototherapy is contraindicated due to history of lupus erythematosus, porphyria, or xeroderma pigmentosum), treatment with systemic therapy (e.g. methotrexate, cyclosporine) must have been ineffective or not tolerated, or all systemic therapies are contraindicated; or
    • Treatment with systemic therapy (e.g., methotrexate, cyclosporine) was ineffective or not tolerated, or 
    • The individual has a contradication to all systemic therapies; or
  • Initial authorization will be for 12 months; or

• Psoriatic Arthritis (PsA)
  • Spinal or Axial Psoriatic Arthritis (PsA)
    • The individual is six (6) years of age or older with spinal or axial PsA; and
    • Treatment with at least one (1) non-steroidal anti-inflammatory drug (NSAID) was ineffective or not tolerated or all NSAIDs are contraindicated; or
  • Psoriatic Arthristis (PsA) without Spinal or Axial Disease
    • The individual is six (6) years of age or older with PsA; and
    • Treatment with one (1) or more non-biologic DMARD (e.g. methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, cyclosporine) was ineffective or not tolerated, or all non-biologic DMARDs are contraindicated; or
    • Initial authorization will be for 12 months; or
  • Enthesitis and/or Dactylitis Associated Psoriatic Arthritis (PsA)
    • The individual is six (6) years of age or older with enthesitis and/or dactylitis associated with PsA; and
    • Treatment with at least one (1) NSAID or a local glucocorticoid injection was ineffective or not tolerated; or
    • All NSAIDs and all local glucocorticoid injections are contraindicated; and
    • Initial authorization will be for 12 months; or
• Ulcerative Colitis (UC)
  • The individual is 18 years of age or older with moderate to severe UC; and
  • The individual received a single induction dose of ustekinumab (Stelara) IV within two (2) months of initiating therapy with ustekinumab (Stelara) SC and achieved clinical response or remission; and
  • Initial authorization will be for 12 months.

Reauthorization Criteria for Ustekinumab (Stelara) Subcutaneous (SC)

• Continuation of therapy with ustekinumab (Stelara) SC may be considered medically necessary when the following criteria is met:
  • The individual has one of the above diagnoses; and
  • Provider attestation that individual has demonstrated a disease stability or beneficial response to therapy; and
  • Reauthorization valid for 12 months. 

The use of ustekinumab (Stelara) for the treatment of immune checkpoint inhibitor-related toxicities exceeding four (4) treatment courses per six (6) month period may be considered experimental/investigational, and therefore, non-covered.

The use of ustekinumab (Stelara) for any other indication or in combination with any other biologic disease-modifying antirheumatic drug (DMARD) (e.g. etanercept, infliximab, certolizumab, etc.) is considered not medically necessary.

NOTE: If an individual has already had a trial of at least one (1) biologic agent, they are not requried to "step back" and try a non-biologic agent.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.