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Certolizumab (Cimzia)

Section: Injections
Effective Date: February 01, 2020
Revised Date: January 27, 2020
Last Reviewed: January 22, 2020

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

J0717

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

K50.00 K50.10 K50.80 K50.90 K50.011 K50.012 K50.013
K50.014 K50.018 K50.019 K50.111 K50.112 K50.113 K50.114
K50.118 K50.119 K50.811 K50.812 K50.813 K50.814 K50.818
K50.819 K50.911 K50.912 K50.913 K50.914 K50.918 K50.919
L40.0 L40.50 L40.51 L40.52 L40.53 L40.59 M05.9
M05.00 M05.09 M05.20 M05.29 M05.30 M05.39 M05.40
M05.49 M05.50 M05.59 M05.60 M05.69 M05.70 M05.79
M05.80 M05.89 M05.011 M05.012 M05.019 M05.021 M05.022
M05.029 M05.031 M05.032 M05.039 M05.041 M05.042 M05.049
M05.051 M05.052 M05.059 M05.061 M05.062 M05.069 M05.071
M05.072 M05.079 M05.211 M05.212 M05.219 M05.221 M05.222
M05.229 M05.231 M05.232 M05.239 M05.241 M05.242 M05.249
M05.251 M05.252 M05.259 M05.261 M05.262 M05.269 M05.271
M05.272 M05.279 M05.311 M05.312 M05.319 M05.321 M05.322
M05.329 M05.331 M05.332 M05.339 M05.341 M05.342 M05.349
M05.351 M05.352 M05.359 M05.361 M05.362 M05.369 M05.371
M05.372 M05.379 M05.411 M05.412 M05.419 M05.421 M05.422
M05.429 M05.431 M05.432 M05.439 M05.441 M05.442 M05.449
M05.451 M05.452 M05.459 M05.461 M05.462 M05.469 M05.471
M05.472 M05.479 M05.511 M05.512 M05.519 M05.521 M05.522
M05.529 M05.531 M05.532 M05.539 M05.541 M05.542 M05.549
M05.551 M05.552 M05.559 M05.561 M05.562 M05.569 M05.571
M05.572 M05.579 M05.611 M05.612 M05.619 M05.621 M05.622
M05.629 M05.631 M05.632 M05.639 M05.641 M05.642 M05.649
M05.651 M05.652 M05.659 M05.661 M05.662 M05.669 M05.671
M05.672 M05.679 M05.711 M05.712 M05.719 M05.721 M05.722
M05.729 M05.731 M05.732 M05.739 M05.741 M05.742 M05.749
M05.751 M05.752 M05.759 M05.761 M05.762 M05.769 M05.771
M05.772 M05.779 M05.811 M05.812 M05.819 M05.821 M05.822
M05.829 M05.831 M05.832 M05.839 M05.841 M05.842 M05.849
M05.851 M05.852 M05.859 M05.861 M05.862 M05.869 M05.871
M05.872 M05.879 M06.1 M06.4 M06.9 M06.00 M06.08
M06.09 M06.20 M06.28 M06.29 M06.30 M06.38 M06.39
M06.80 M06.88 M06.89 M06.011 M06.012 M06.019 M06.021
M06.022 M06.029 M06.031 M06.032 M06.039 M06.041 M06.042
M06.049 M06.051 M06.052 M06.059 M06.061 M06.062 M06.069
M06.071 M06.072 M06.079 M06.211 M06.212 M06.219 M06.221
M06.222 M06.229 M06.231 M06.232 M06.239 M06.241 M06.242
M06.249 M06.251 M06.252 M06.259 M06.261 M06.262 M06.269
M06.271 M06.272 M06.279 M06.311 M06.312 M06.319 M06.321
M06.322 M06.329 M06.331 M06.332 M06.339 M06.341 M06.342
M06.349 M06.351 M06.352 M06.359 M06.361 M06.362 M06.369
M06.371 M06.372 M06.379 M06.811 M06.812 M06.819 M06.821
M06.822 M06.829 M06.831 M06.832 M06.839 M06.841 M06.842
M06.849 M06.851 M06.852 M06.859 M06.861 M06.862 M06.869
M06.871 M06.872 M06.879 M45.0 M45.1 M45.2 M45.3
M45.4 M45.5 M45.6 M45.7 M45.8 M45.9

Professional Statements and Societal Positions Guidelines

NA

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