Ustekinumab (Stelara®)

OFFICE ADMINISTRATION - SELF-INJECTION

Indications for Prior Authorization:

  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis
  • Crohn's Disease

Stelara is a preferred biologic agent for treatment of the following indications when all criteria below are met for specific indications:

  • Psoriatic Arthritis
  • Plaque Psoriasis

Patients must meet the following criteria for the indications above:

Moderate to Severe Plaque Psoriasis

  • > 18 years of age, AND
  • Diagnosed and prescribed by a Dermatologist or Rheumatologist, AND
  • Baseline PASI score of 10 or more, psoriasis affecting 10% BSA or more, or psoriasis affecting palms, soles of feet, head/neck, or genitalia, AND
  • One of the following:
    • Inadequate response, intolerance or contraindication to PUVA or UVB treatment, OR,
    • UVB treatment, OR,
    • Has difficulty accessing PUVA or UVB. OR
  • One of the following:
    • Experienced inadequate response/intolerance to at least one of the following treatments: methotrexate, cyclosporine (Neoral®), acitretin (Soriatane®), OR
    • Contraindication to all of the treatments listed. (A trial of these agents is not applicable for females actively attempting to conceive). AND
  • Inadequate response, intolerance, or contraindication to Enbrel or Humira

Psoriatic Arthritis

  • Psoriatic arthritis diagnosed by a rheumatologist AND
  • Age > 18 years AND
  • Inadequate response, intolerance, or contraindication to one or more Disease Modifying anti-Rheumatic Drugs [(DMARDs) Auranofin (Ridaura®), Azathioprine (Imuran®), Cyclosporine (Neoral®), Methotrexate (Rheumatrex®), sulfasalazine (Azulfidine®), Leflunomide (Arava®)] OR has a medical reason why methotrexate, sulfasalazine, and leflunomide cannot be used AND
  • Inadequate response, intolerance, or contraindication to Enbrel or Humira

Crohn’s disease

  • Failed or have a documented intolerance or contraindication to one agent from either of the following classes: oral corticosteroids or immunosuppressants (azathioprine, mercaptopurine, methotrexate, or cyclosporine), AND
  • Tried and failed Humira, AND
  • Is not used in conjunction with another anti-TNF drug or interleukin-1 receptor antagonist

The drug is not covered for the following conditions:

  • Multiple Sclerosis
  • Any condition not listed in the indication section above

Dosing:

Moderate to Severe Plaque Psoriasis

  • ≤100 kg (220 pounds up to 45 mg initially and then four weeks later, followed by every 12 weeks
  • > 100 kg, up to 90 mg initially and then four weeks later, followed by every 12 weeks

Psoriatic Arthritis

  • Up to 45mg SC initially and 4 weeks later, followed by 45mg every 12 weeks
  • For co-existent moderate-to-severe plaque psoriasis in patients weighing >100kg (220lbs): up to 90mg SC initially and 4 weeks later, followed by 90mg every 12 weeks

Crohn's Disease

  • Induction: IV
    • 55 kg or less: 260 mg as single dose
    • More than 55 kg to 85 kg: 390 mg as single dose
    • Greater than 85 kg: 520 as single dose
  • Maintenance: SubQ: 90 mg every 8 weeks; begin maintenance dosing 8 weeks after the IV induction dose.

Approval:

  • Initial approval six months to assess patient’s response
  • Renew for one year if patient has clinical response

Warnings:

  • Risk of Tuberculosis and Serious Infection
  • Patients should be evaluated for latent tuberculosis infection with a TB skin test
  • Treatment of latent tuberculosis infection should be initiated prior to therapy with golimumab
  • Do not administer live vaccines or attenuated vaccines concurrently with ustekinumab

 

Last review date: July 6, 2015

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