Brodalumab (Siliq™)

SELF ADMINISTRATION

FDA approved Indication:

Treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy and have failed to respond or have lost response to other systemic therapies.

Risk of Tuberculosis:

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 Siliq™.

Patients must meet the following criteria for Plaque Psoriasis:
  • Diagnosis of chronic moderate to severe plaque psoriasis in adults (psoriasis affects 10% or more of the body, or psoriasis involves hands, feet, head/neck or genitalia) confirmed by specialist chart note documentation, AND
  • Prescribed by or in collaboration with a dermatologist, AND
  • Patient has tried and failed topical therapy (e.g., Calcipotriene, Tazarotene, topical steroids), AND
  • Documented failure or clinically significant adverse effects to one of the following therapies alone or in combination, unless contraindicated:
    • Methotrexate (doses up to 15-20 mg per week), OR 
    • If Methotrexate is contraindicated: Cyclosporine, Acitretin, or a trial with PUVA or UVB for at least 3 months unless intolerant, AND
  • Patient has tried and failed:
    • Three of the following, Cimzia®, Humira®, Stelara®, Tremfya®, or Skyrizi®, AND
    • Taltz®, AND
  • Siliq will not be used concomitantly with other biologic DMARDs, AND
  • Patient does not have Crohn's disease, AND
  • Patient meets one of the following:
    • Initiation of biologic therapy: patient has a negative tuberculosis test result (e.g. TB skin test, Quantiferon TB Gold test, or chest x-ray) prior to therapy initiation as evidenced by a recent TB test result OR
    • Continuation of therapy or switching biologic therapies: patient had a negative TB test result within the past year (as evidenced by a current TB test result)
Dosing:
  • 210 mg administered by subcutaneous injection at weeks 0, 1, and 2 followed by 210 mg every 2 weeks
Approval Period:
  • Initial approval 3 months to assess patient's response
  • Continuation: 1 year with specialist chart notes documenting a clinical response to therapy and current TB (tuberculosis) test results
 

Last review date: July 1, 2020

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