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Medical Policy: 05.01.31
Original Effective Date: July 2010
Reviewed: April 2011
Revised: April 2011
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:
Tocilizumab, marketed as Actemra®, is an interleukin-6 (IL-6) receptor inhibitor indicated for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Tocilizumab binds specifically to both the soluble and membrane-bound IL-6 receptors. IL-6 is involved in processes such as T-cell activation, induction of immunoglobulin secretion, initiation of hepatic acute phase protein synthesis, and stimulation of hematopoietic precursor cell proliferation and differentiation. IL-6 is produced by a variety of cell types including T- and B-cells, lymphocytes, monocytes, and fibroblasts as well as by synovial and endothelial cells leading to local production of IL-6 in joints affected by inflammatory processes such as rheumatoid arthritis.
When used with methotrexate, tocilizumab can inhibit and slow structural joint damage, increase physical function, and achieve a better clinical response.
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Prior Approval:
Prior approval is recommended. Submit a prior approval/treatment plan now.
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Policy:
Tocilizumab may be considered medically necessary for treatment of moderately to severely active rheumatoid arthritis in patients who are 18 years of age or older when the following criteria have been met:
- Patient has had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDS)
AND
- Patient has had an inadequate response to one or more TNF antagonist therapies
Tocilizumab may be considered medically necessary for treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older.
All other uses of tocilizumab are considered investigational.
All patients being considered for treatment with tocilizumab should be tested for latent tuberculosis (TB). If positive, treatment for TB should be initiated prior to starting tocilizumab.
All patients receiving treatment with tocilizumab should be monitored for active TB during treatment, even if initial latent TB testing is negative.
Tocilizumab has not been studied and its use should be avoided in combination with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators because of the possibility of increased immunosuppression and increased risk of infection.
It is recommended that tocilizumab not be initiated in patients with an absolute neutrophil count (ANC) below 2000/mm3, platelet count below 100,000/mm3, or who have ALT or AST above 1.5 times the upper limit of normal (ULN).
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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.
- J3262 Injection, tocilizumab, 1 mg
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Selected References:
- Maini RN, Taylor PC, Szechinski J et al. Double-blind randomized controlled clinical trial of interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate. Arthritis Rheum. 2006 Sep; 54(9): 2817-29.
- Nishimoto N, Miyasaka N, Yamamoto K et al. Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy. Mod Rheumatol. 2009; 19(1):12-19. Epub 2008 Nov 1.
- Jones G, Sebba A, Gu J et al. Comparison of tocilizumab monotherapy versus methotrexate monotherapyin patients with moderate to severe rheumatoid arthritis: the AMBITION study. Ann Rheum Dis. 2010 Jan; 69(1): 88-96.
- Emery P, Keystone E, Tony HP et al. IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomized placebo-controlled trial. Ann Rheum Dis 2008 Nov; 67(11):1516-23. Epub 2008 Jul 14.
- Dayer JM, Choy E. Therapeutic targets in rheumatoid arthritis: the interleukin-6 receptor. Rheumatology (Oxford). 2010 Jan; 49(1):15-24.
- Mihara M, Kasutani K, Okazaki M et al. Tocilizumab inhibits signal transduction mediated by both mIL-6R and sIL-6R, but not by the receptors of other members of IL-6 cytokine family. Int Immunopharmacol. 2005 Nov;5(12):1731-40.
- Kremer JL, Blanco R, Brzosko M et al. Tocilizumab inhibits structural joint damage in rheumatoid arthritis patients with inadequate responses to methotrexate at 1 year: the LITHE study. Arthritis Rheum. 2010 Nov. 19 [Epub ahead of print].
- Yokota S, Kishimoto T, Tocilizumab: molecular intervention therapy in children with systemic juvenile idiopathic arthritis. Expert Rev Clin Immunol. 2010 Sep;6(5): 735-43.
- Inaba Y, Ozawa R, Imaqawa T et al. Radiographic improvement of damaged large joints in children with systemic juvenile idiopathic arthritis following tocilizumab treatment. Ann Rheum Dis. 2011 Mar 14 [Epub ahead of print].
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Policy History:
Date Reason Action
April 2011 Annual review Policy revised
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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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