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

Ustekinumab is self-administered.

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 Period

Initial approval six months to assess patient’s response.

Renew for one year if patient has clinical response.

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.


Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: July 2015                                       Reviewed: