Ixekizumab (Taltz®)

OFFICE / HOME HEALTH/ SELF ADMINISTRATION

Indications for Prior Authorization:
  • Plaque psoriasis
  • Psoriatic Arthritis
  • Ankylosing Spondylitis
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 Taltz®.

Patients must meet the following criteria for the indications above:

Plaque Psoriasis:

  • Diagnosis of chronic moderate to severe plaque psoriasis in patients 6 years of age and older (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 or rheumatologist, 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 at least one of the following preferred: Humira®, Cimzia®, Stelara®, Tremfya®,  or Skyrizi™, 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)

Psoriatic Arthritis:

  • Diagnosis of active psoriatic arthritis confirmed by specialist chart note documentation, AND
  • Prescribed by or in collaboration with a rheumatologist or dermatologist, AND
  • Inadequate response, intolerance, or contraindication to one or more oral DMARDs [e.g., Methotrexate, Leflunomide, Sulfasalazine, Azathioprine, Cyclosporine], OR has a medical reason why Methotrexate, Leflunomide, and Sulfasalazine, cannot be used, AND
  • Patient has tried and failed at least one of the following preferred: Humira®, Cimzia®, Simponi®, or Stelara®, 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)

Ankylosing Spondylitis:

  • Diagnosis of active ankylosing spondylitis confirmed by specialist chart note documentation, AND
  • Prescribed by or in collaboration with a rheumatologist, AND
  • Patient meets one of the following:
    • Inadequate response to two NSAIDs (non-steroidal anti-inflammatory drugs), OR
    • Intolerable GI adverse effects after a trial of an NSAID in combination with a PPI, OR
    • Unable to take NSAIDs due to history of GI bleed, AND
  • Patient meets one of the following:
    • In patients without axial disease:
      • Inadequate response or intolerable side effect to one disease modifying anti-rheumatic drug (DMARD) or medical rationale why Sulfasalazine and Methotrexate cannot be used, OR
    • In patients with axial disease:
      • Inadequate response or intolerable side effect to NSAIDs as stated above.  Methotrexate or other DMARDs are not required prior to Taltz® consideration, AND
  • Patient has tried and failed at least one of the following preferred: Humira®, Cimzia®, or Simponi®, 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:
  • Plaque Psoriasis: 160 mg (two 80 mg injections) at week 0, followed by 80 mg at weeks 2, 4, 6, 8, 10 and 12, then 80 mg every 4 weeks
  • Psoriatic Arthritis: 160 mg (two 80 mg injections) at week 0, followed by 80 mg every 4 weeks
  • Ankylosing Spondylitis: 160 mg (two 80 mg injections) at week 0, followed by 80 mg every 4 weeks
  • Non-radiographic Axial Spondyloarthritis: 80 mg every 4 weeks
Approval:
  • One year 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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