Cimzia (Certolizumab Pegol) Notification

Tumor necrosis factor (TNF) is a cytokine produced by macrophages and T cells. Its name is based on the original observations 25 years ago that TNF killed tumor cells in vitro. Further research has revealed that TNF has a broad spectrum of biologic activities; in particular, it is a key mediator of inflammation and is produced in response to infection and immunologic injury.

Cimzia is a tumor necrosis factor (TNF) blocker indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patient with moderately to severely active disease who have had an inadequate response to conventional therapy and for treatment of adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

BCBSNC will provide coverage for Cimzia when it is determined to be medically necessary because the medical criteria and guidelines shown below are met.

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy.  

Cimzia (certolizumab pegol) for subcutaneous injection may be considered medically necessary when the following criteria are met:

1. The patient is 18 years of age or older; AND
   
2. The patient is not using Cimzia in combination with another biologic agent: AND
   1. The patient is diagnosed with moderately to severely active rheumatoid arthritis; AND
      1. The patient has tried and failed or has a clinical contraindication/intolerance to methotrexate therapy; OR
   2. The patient is diagnosed with active psoriatic arthritis; AND
      1. The patient has tried and failed or has a clinical contraindication/intolerance to conventional therapy (e.g. MTX, leflunomide, sulfasalazine); OR
   3. The patient is diagnosed with moderately to severely active Crohn’s disease; AND
      1. The patient has tried and failed or has a clinical contraindication/intolerance to conventional therapy (e.g., corticosteroids, 5-aminosalicylate, azathioprine, 6- mercaptopurine, metronidazole, methotrexate);OR
   4. The patient is diagnosed with active ankylosing spondylitis

When the criteria listed above are not met.

The prescribing information for Cimzia does not list any contraindications, however there are several warnings and precautions. 

• Serious infections – do not start Cimzia during an active infection. If an infection develops, monitor carefully, and stop Cimzia if infection becomes serious 
• Invasive fungal infections – for patients who develop a systemic illness on Cimzia, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic 
• Cases of lymphoma and other malignancies have been observed among patients receiving TNF blockers 
• Heart failure, worsening or new onset may occur 
• Anaphylaxis or serious allergic reactions may occur 
• Hepatitis B virus reactivation – test for HBV infection before starting Cimzia. Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop Cimzia and begin anti-viral therapy 
• Demyelinating disease, exacerbation or new onset, may occur 
• Cytopenias, pancytopenia – advise patients to seek immediate medical attention if symptoms develop, and consider stopping Cimzia 
• Lupus-like syndrome – stop Cimzia if syndrome develops

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

Applicable service codes: J0717

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

U.S. Food and Drug Administration. Cimzia (certolizumab pegol) injection, for subcutaneous use, prescribing information. Available at: https://www.cimzia.com/sites/default/files/docs/Prescribing_Information.pdf

Cimzia Official Site: http://www.cimziahcp.com/