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Medical Policy: 05.01.26
Original Effective Date: July 2009
Reviewed: October 2011
Revised:
Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
Description:
Certolizumab pegol, marketed under the trade name Cimzia®, is the first pegylated anti-tumor necrosis factor (TNF)-alpha monoclonal antibody that has a high affinity for human TNF-alpha and selectively targets TNF-alpha in inflamed tissue. TNF is a naturally-occurring cytokine involved in normal inflammatory and immune responses. Excess TNF-alpha production has been associated with a number of disease processes including rheumatoid arthritis, Crohn’s disease, and other autoimmune diseases. Certolizumab pegol is administered by subcutaneous injection.
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Prior Approval:
Prior approval is recommended. Submit a prior approva/treatment request now
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Policy:
Certolizumab pegol may be considered medically necessary in patients 18 years of age or older for the following indications:
Rheumatoid arthritis:
- To reduce signs and symptoms in patients with moderately to severely active disease who have had an inadequate response to traditional systemic therapies.
Crohn’s disease:
- To reduce signs and symptoms and maintain clinical response in patients with moderately to severely active disease who have had an inadequate response to one or more of the following:
- glucocorticoids
- methotrexate
- sulfasalazine
Any patient being considered for certolizumab pegol to treat either of the above indications must have been evaluated for active and latent tuberculosis prior to the initiation of certolizumab pegol therapy. Due to the potential for new tuberculosis infections while receiving certolizumab pegol, patients should continue to be monitored for tuberculosis risk factors and tested periodically during therapy.
Due to the potential for serious infection, concurrent use of certolizumab pegol with interleukin-1 antagonists and other anti-TNF agents is not recommended, according to the manufacturer and the Food and Drug Administration (FDA).
The use of certolizumab pegol for indications other than those described above is considered investigational.
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Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or ICD-9-CM diagnostic codes.
- J0718 Injection, certolizumab pegol, 1 mg
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Selected References:
- Sandborn WJ, Feagan BG, Stoinov S et al. PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med. 2007; 357(3):228-238.
- Schreiber S, Khaliq-Kareemi M, Lawrance IC et al; PRECISE 2 Study Investigators. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med. 2007; 357(3): 239-50
- Keystone E, Heijde D, Mason D Jr. et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Arthritis Rheum. 2008 Nov; 58(11):3319-29.
- Smolen J, Landewe RB, Mease P et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomized controlled trial. Ann Rheum Dis. 2009 Jun; 68(6):797-804. Epub 2008 Nov 17.
- Fleischmann R, Vencovsky J, van Vollenhoven RF et al. Efficacy and safety of certolizumab monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009 Jun; 68(6):767-9.
- Vavricka SR, Bentele N, Scharl M et al. Systematic assessment of factors influencing preferences of Crohn’s disease patients in selecting an anti-tumor necrosis factor agent (CHOOSE TNF TRIAL). Inflamm Bowel Dis. 2011 Oct 10. doi: 10.1002/ibd.21888. [Epub ahead of print].
- Ananthakrishnan AN, Hur C, Korzenik JR. Certolizumab pegol compared to natalizumab in patients with moderate to severe Crihn’s disease: results of a decision analysis. Dig Dis Sci. 2011 Sep 11. [Epub ahead of print].
- Sandborn WJ, Schreiber S, Feagan BG et al. Certolizumab pegol for active Crohn’s disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug;9(8):670-78. E3. Epub 2011 May 13.
- Tak PP, Kalden JR. Advances in Rheumatology: new targeted therapeutics. Arthritis Res Ther. 2011 May 25; 13 Suppl 1:S5.
- Strand V, Smolen JS, van Vollenhoven RF et al. Certolizumab pegol plus methotrexate provides broad relief from the burden of rheumatoid arthritis: analysis of patient-reported outcomes from the RAPID 2 trial. Ann Rheum Dis. 2011 Jun; 70(6):996-1002. Epub 2011 Mar 17.
- Feagan BG, Sandborn WJ, Wolf DC et al. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn’s disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar; 33(5): 541-50. doi: 10.1111/j/1365-2036.2010.04568.x. Epub 2011 Jan 12.
- Launois R, Avouac B, Berenbaum F et al. Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis. J Rheumatol. 2011 May;38(5):835-45. Epub 2011 Jan 15.
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Policy History:
Date Reason Action
September 2010 Annual review Policy renewed
October 2011 Annual review Policy renewed
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Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2010 American Medical Association. All Rights Reserved.
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