Cimzia

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)

OR

• 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

Questions?

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