Description

Certolizumab (Cimzia®) is a recombinant humanized antibody with specificity for human tumor necrosis factor (TNF) alpha. Certolizumab (Cimzia) may be self-administered by subcutaneous injection and is also available in a lyophilized powder that may be administered subcutaneously by a health care professional.

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Certolizumab (Cimzia) administration by a healthcare provider may be considered medically necessary when ALL the following:

• There is a medical contraindication to the self-administration of certolizumab (Cimzia) or documentation as to why the individual is unable to self-inject; and
• One of the following:
  • The individual is not currently being treated with another biologic immunomodulator or Otezla; or
  • The individual is currently being treated with another biologic immunomodulator or Otezla and will discontinue prior to starting Cimzia; and
• The individual has been tested for latent tuberculosis (TB); if positive, treatment for TB should be started prior to starting Cimzia. In addition, individuals should be monitored for active TB during treatment, even if initial latent TB test is negative; and
• The prescriber is a specialist in the area of the individual’s diagnosis or has consulted with a specialist in the area of the individual’s diagnosis [e.g., rheumatologist for Psoriatic Arthritis (PsA), Rheumatoid Arthritis (RA); gastroenterologist for Crohn’s Disease (CD); dermatologist for Plague Psoriasis (PsO)]; and
• The individual does NOT have any FDA labeled contraindications to Cimzia; and
• The individual meets ANY ONE of the following:
  • Ankylosing Spondylitis (AS)
    • The individual is 18 years of age or older with active AS; and
    • ONE of the following:
      • The individual has tried and had an inadequate response to two different NSAIDs used in the treatment of AS for at least a 4-week total trial; or
      • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of AS; or
      • The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of AS; and
    • Previous medication history indicates separate trials and failure of two preferred agents, Cosentyx (secukinumab), Humira (adalimumab), or Enbrel (etanercept); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents; or
  • Crohn’s disease (CD)
    • The individual is 18 years of age or older with moderately to severely active CD; and
    • ONE of the following:
      • The individual has tried and had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, corticosteroids [e.g., prednisone, budesonide EC capsule], methotrexate, sulfasalazine) used in the treatment of CD for at least 3-months; or
      • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of CD; or
      • The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of CD; or
      • The individual is currently pregnant; and
    • Previous medication history indicates separate trials and failure of the two preferred agents, Humira (adalimumab), and Stelara (ustekinumab); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents; or
  • Psoriatic Arthritis (PsA)
    • The individual is 18 years of age or older with predominant spinal or axial PsA; and
    • ONE of the following:
      • The individual has tried and had an inadequate response to ONE conventional agent (e.g., cyclosporine, leflunomide, methotrexate, sulfasalazine) used in the treatment of PsA for at least 3-months; or
      • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of PsA; or
      • The individual has severe active PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
      • The individual has concomitant severe PsO (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
      • The individual’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of PsA; and
    • Previous medication history indicates separate trials and failure of two preferred agents, Cosentyx (secukinumab), Humira (adalimumab), Enbrel (etanercept), or Stelara (ustekinumab); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents. or
  • Non-radiographic Axial Spondyloarthritis (nr-axSpA)
    • The individual is 18 years of age or older with active nr-axSpA; and
    • ONE of the following:
      • The individual has tried and had an inadequate response to two different NSAIDs used in the treatment of nr-axSpA for at least a 4-week total trial; or
      • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL NSAIDs used in the treatment of nr-axSpA; or
      • The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of nr-axSpA; or
  • Plaque Psoriasis (PsO)
    • The individual is 18 years of age or older with moderate to severe PsO; and
    • ONE of the following:
      • The individual has tried and had an inadequate response to ONE conventional agent (e.g., acitretin, anthralin, calcipotriene, calcitriol, coal tar products, cyclosporine, methotrexate, pimecrolimus, PUVA [phototherapy], tacrolimus, tazarotene, topical corticosteroids) used in the treatment of PsO for at least 3-months; or
      • The individual has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents used in the treatment of PsO; or
      • The individual has severe active PsO (e.g., greater than 10% body surface area involvement, occurring on select locations [i.e., hands, feet, scalp, face, or genitals], intractable pruritus, serious emotional consequences); or
      • The individual has concomitant severe PsA (e.g., erosive disease, elevated markers of inflammation [e.g., ESR, CRP] attributable to PsA, long-term damage that interferes with function [i.e., joint deformities], rapidly progressive); or
      • The individual’s medication history indicates use of another biologic immunomodulator agent OR Otezla that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of PsO; and
    • Previous medication history indicates separate trials and failure of three preferred agents, Cosentyx (secukinumab), Humira (adalimumab), Enbrel (etanercept), Skyrizi (risankizumab-rzaa), Tremfya (guselkumab), or Stelara (ustekinumab); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents; or
  • Rheumatoid Arthritis (RA)
    • The individual is 18 years of age or older with moderately to severely active rheumatoid arthritis; and
    • ONE of the following:
      • The individual has tried and had an inadequate response to maximally tolerated methotrexate (e.g., titrated to 25 mg weekly) for at least 3-months; or
      • The individual has tried and had an inadequate response to another conventional agent (e.g., hydroxychloroquine, leflunomide, or sulfasalazine) used in the treatment of RA for at least 3-months; or
      • The individual has a documented intolerance, FDA labeled contraindication or hypersensitivity to ALL conventional agents (i.e., methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine) used in the treatment of RA; or
      • The individual’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in DrugDex with 1 or 2a level of evidence or AHFS for the treatment of RA; and
    • Previous medication history indicates separate trials and failure of two preferred agents, Humira (adalimumab), Enbrel (etanercept), or Rinvoq (upadacitinib); or there is a documented intolerance, FDA labeled contraindication, or hypersensitivity to all the preferred agents. or
  • Information has been provided that indicated the individual is currently being treated with Cimzia (starting on samples is not approvable); or
  • The prescriber states the individual is currently being treated with Cimzia (starting on samples is not approvable) and is at risk if therapy is changed.

The use of Certolizumab (Cimzia) for any other indications than those listed in this policy is considered experimental/investigational, and therefore, non-covered. Scientific evidence does not support the use of certolizumab (Cimzia) for other indications.

Procedure Codes

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

NA