Coverage for certolizumab (Cimzia®) (J0718) is determined according to individual or group customer benefits.  Certolizumab is eligible for patients who are not currently using another biological DMARD [e.g. etanercept (Enbrel®), anikinra (Kineret®), etc.] and meet the following criteria:

• Crohn's disease - for the reduction in signs and symptoms and maintaining clinical response in adult patients with moderate to severe active Crohn's disease who have failed two alternative therapies or monotherapy with infliximab (Remicade®).
  
  The recommended initial adult dose of certolizumab is 400 mg (given as two subcutaneous injections of 200 mg) initially, and at weeks 2 and 4.  In patients who obtain a clinical response, the recommended maintenance regimen is 400 mg every four weeks.
  
  
• Rheumatoid arthritis - to be used alone or in combination with methotrexate for the treatment of adults with moderate to severe active rheumatoid arthritis.
  
  The recommended dose of certolizumab for adult patients with rheumatoid arthritis is 400 mg (given as two subcutaneous injections of 200 mg) initially and at weeks 2 and 4, followed by 200 mg every other week.  For maintenance dosing, certolizumab 400 mg every 4 weeks can be considered.

The use of certolizumab for any diagnosis not listed on this policy is considered experimental/investigational, and therefore, not covered.  A participating, preferred, or network provider can bill the member for the non-covered service.

Description

Certolizumab pegol is a recombinant humanized antibody with specificity for human tumor necrosis factor alpha and is self administered by subcutaneous injection.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient's condition.

Sandborn W, Feagan B, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med. 2007;357:228-38.

Schreiber S, Kareemi M, Lawrence I, et al. Maintenance therapy with Certolizumab pegol for Crohn’s disease. N Engl J Med. 2007;357:239-50.

Lewis JD. Anti-TNF antibodies for Crohn’s disease-In pursuit of the perfect clinical trial. N Engl J Med. 2007;357(3):296-98.

Camilleri M. Anti-TNF antibodies for Crohn’s disease. N Engl J Med. 2007;357(16):1662.

Kuehn BM. Severe fungal infections linked to drugs. JAMA. 2008;300(14):1639.

Feagan BG, Sandborn WJ, Mittmann U, et al. Omega-3 free fatty acids for the maintenance of remission in Crohn disease. JAMA. 2008;299(14):1690-1697.

Kuehn BM. TNF blocker risks. JAMA. 2009;302(11):1162.

Cimzia® (certolizumab pegol) [package insert]. Smyrna. GA: UCB, Inc.; 07/2010