Highmark Commercial Medical Policy in West Virginia
Section: Injections
Number: I-27
Topic: Certolizumab (Cimzia®)
Effective Date: February 21, 2011
Issued Date: May 2, 2011
Date Last Reviewed: 09/2010

General Policy Guidelines

Indications and Limitations of Coverage

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.

Procedure Codes

J0718     

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

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.

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

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

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Table Attachment

Text Attachment

Procedure Code Attachments

Diagnosis Codes

ICD-9 Diagnosis Codes

555.0555.1555.2555.9
714.0714.1714.2714.89

ICD-10 Diagnosis Codes

Glossary

TermDescription

Disease-modifying antirheumatic drug (DMARD)

Medicines classified as disease-modifying antirheumatic drugs (DMARDs) have the potential to reduce or prevent joint damage and preserve joint integrity and function.

Commonly used traditional DMARDs include but are not limited to leflunomide, sulfasalazine, hydroxychloroquine, azathioprine, and methotrexate.




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.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Highmark West Virginia plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Highmark West Virginia retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark West Virginia. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.