Golimumab (Simponi®)

SELF / OFFICE ADMINISTRATION

Indications for Prior Authorization:

  • Moderate to severe rheumatoid arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Ulcerative colitis

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

  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Ulcerative colitis
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 golimumab

Patients must meet the following criteria for the indications above:

Rheumatoid Arthritis

  • Diagnosis of moderate to severe rheumatoid arthritis confirmed by chart note documentation, AND
  • Diagnosis confirmed by a Rheumatologist (the prescribing MD does not have to be a rheumatologist), AND
  • Inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Auranofin, Azathioprine, Gold sodium thiomalate, Hydroxychloroquine, Methotrexate, D-penicillamine, Sulfasalazine or has a medical reason why Methotrexate, Hydroxychloroquine, and Sulfasalazine cannot be used, AND
  • Not used in conjunction with another anti-TNF drug or interleukin-1 receptor antagonist, 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 effects to NSAIDs as stated above.  Methotrexate or other DMARDs are not required prior to Simponi® consideration, 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 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)

Ulcerative Colitis

  • Diagnosis is Moderate to Severe Ulcerative Colitis AND
  • Diagnosis confirmed by a gastroenterologist AND
  • One of the following conditions is met:
    • Patient is steroid-refractory or steroid-dependent OR
    • Patient has experienced an inadequate response or intolerance to an immunomodulatory agent (i.e., azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, etc.), 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:

Rheumatoid Arthritis

  • Golimumab is patient-administered by subcutaneous injection (SubQ) 50 mg, once monthly

Ankylosing Spondylitis

  • Up to 50mg SubQ once a month

Psoriatic Arthritis

  • Up to 50mg SubQ once a month

Ulcerative Colitis

  • Self-inject 200 mg SubQ initially, then 100 mg SubQ at week two. Inject 100 mg once a month for maintenance therapy
Approval:
  • 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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