Ustekinumab (Stelara®)

OFFICE ADMINISTRATION - SELF-INJECTION

Indications for Prior Authorization:

  • Moderate to severe plaque psoriasis
  • Psoriatic arthritis

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, 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, AND
    • Inadequate response, intolerance, or contraindication to Enbrel or Humira. AND
  • 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)

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

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

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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