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Drug - Cimzia® (certolizumab pegol) [Biovitrum AB]

September 2019

Therapeutic area - Auto-inflammatory diseases

Approval criteria

  • Patient is ≥ 18 years old AND
  • Negative tuberculin test or, if positive, therapy with isoniazid was initiated at least 1 month prior to request AND
  • Patient is not using biological DMARDs or other tumor necrosis factor (TNF) blocker in combination AND
  • Patient does not have an active infection or a history of recurring infections AND
  • Patient has the diagnosis of Non-radiographic Axial Spondyloarthritis AND
  • Patient has objective signs of inflammation as documented in chart notes AND
  • Cimzia is prescribed by a rheumatologist AND
  • Patient has tried and failed at least two NSAIDs for two months (i.e., one month trial for each NSAID) AND
  • Patient has tried and failed at least one tier 1 immunomodulator product (e.g., Enbrel or Humira)


  • Refer to the PA criteria sheet, “Immunomodulators,” if patient has one of the following diagnosis:
    • Rheumatoid Arthritis (RA) OR
    • Psoriatic Arthritis OR
    • Ankylosing Spondylitis OR
    • Plaque Psoriasis OR
    • Crohn’s Disease

Quantity limit

Quantity limits depend on patient’s diagnosis. Non-radiographic Axial Spondyloarthritis:

  • 400 mg every 2 weeks through week 4
  • 400 mg every 4 weeks thereafter


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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